Metastatic Colorectal Cancer Market Poised for Expansion Across the 7MM During the Forecast Period (2025-2034) as Breakthrough Therapies Gain Traction
The metastatic colorectal cancer (mCRC) market is experiencing significant growth, driven by advancements in targeted therapies, immunotherapies, and personalized medicine. The increasing prevalence of colorectal cancer, along with growing awareness of early diagnosis and treatment options, is fueling demand for innovative treatments.
LAS VEGAS, April 23, 2025 /PRNewswire/ — Colorectal cancer (CRC) ranks as the third most prevalent cancer, with metastasis being the leading cause of mortality among affected patients. The liver and peritoneum are the most frequent sites of distant spread. For most individuals, metastatic CRC (mCRC) remains largely incurable, with common metastatic locations including the liver, lungs, lymph nodes, and peritoneum.
Seen in approximately 45% CRC patients, KRAS mutations significantly influence the prognosis and treatment outcomes. These mutations are associated with a more aggressive disease course, resistance to chemotherapy and targeted therapies, and overall poorer survival rates.
In 2024, the incidence of metastatic colorectal cancer was around 294K cases across the seven major markets, with the United States reporting the highest incidence. This number is expected to rise by 2034. Surgical intervention is the mainstay for resectable CRC, while unresectable cases are typically managed with chemotherapy, radiotherapy, and immunotherapy. These conventional therapies, however, often lack specificity and can harm healthy cells, leading to additional health complications.
The treatment paradigm for mCRC involves multiple lines of therapy. First-line (1L) metastatic colorectal cancer treatments include combination chemotherapy regimens such as FOLFOX, FOLFIRI, and CAPEOX, alongside anti-angiogenic agents and targeted therapies like VECTIBIX and ERBITUX, with or without chemotherapy. KEYTRUDA and BRAFTOVI (in combination with ERBITUX and mFOLFOX6) are also approved for use in the first line. In the second-line (2L) setting, treatment options expand to include OPDIVO (± YERVOY), JEMPERLI, TUKYSA (± Trastuzumab), LONSURF (± Bevacizumab), and KRAZATI plus ERBITUX. For third-line (3L) therapy, specific agents such as STIVARGA and FRUZAQLA are utilized.
Learn more about the metastatic colorectal cancer treatment landscape @ Metastatic Colorectal Cancer Drugs Market
FRUZAQLA (fruquintinib) is a once-daily oral capsule developed by Takeda Pharmaceuticals. It is a kinase inhibitor approved for adult patients with metastatic colorectal cancer who have previously been treated with chemotherapy regimens including fluoropyrimidine, oxaliplatin, and irinotecan, as well as anti-VEGF therapy and, for RAS wild-type patients, anti-EGFR therapy. FRUZAQLA works by selectively targeting and inhibiting VEGFR-1, -2, and -3, thereby disrupting VEGF-driven blood vessel formation and tumor growth.
The FDA approved FRUZAQLA for previously treated mCRC in November 2023, followed by the European Commission in June 2024, and Japan in September 2024—marking it as the first new targeted therapy for mCRC in more than ten years in the Japanese market.
OPDIVO QVANTIG (nivolumab and hyaluronidase-nvhy) is indicated for adult patients with MSI-H or dMMR mCRC that has progressed after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan. It can be used as a standalone treatment or following prior combination therapy with intravenous nivolumab and ipilimumab. This drug works by blocking the PD-1 receptor, preventing its interaction with PD-L1 and PD-L2 to boost immune system activity against cancer cells.
In December 2024, the FDA approved OPDIVO QVANTIG as a subcutaneous injection for mCRC, making it the first PD-1 inhibitor available in this form. This new route of administration offers quicker treatment delivery—just 3 to 5 minutes—compared to the traditional 30-minute intravenous infusion of OPDIVO.
To know more about metastatic colorectal cancer treatments, visit @ Metastatic Colorectal Cancer Aggressive Treatment
Despite several advancements, the metastatic colorectal cancer drug market remains highly competitive, with significant unmet needs for durable and long-term treatment responses. Ongoing research into investigational agents like amivantamab, zanzalintinib, and vactosertib highlights the push for more effective, resistance-targeting, and tumor microenvironment-modifying therapies, signaling a dynamic and evolving future for mCRC treatment.
Key companies such as Johnson & Johnson Innovative Medicine, Shanghai Henlius Biotech, Inspirna, Treos Bio, Cardiff Oncology, Agenus, Leap Therapeutics, Arcus Biosciences, Enterome, Tizona Therapeutics, Innovative Cellular Therapeutics, and others are currently active in the metastatic colorectal cancer drug market.
Discover which therapies are expected to grab major metastatic colorectal cancer drug market share @ Metastatic Colorectal Cancer Market Report
Amivantamab is a bispecific antibody designed to target specific genetic alterations, especially EGFR exon 20 insertion mutations. Its dual mechanism focuses on inhibiting both the Epidermal Growth Factor Receptor (EGFR) and the MET receptor—two key players in cancer cell growth and survival. By binding to these receptors, amivantamab interferes with their signaling pathways, helping to overcome resistance that tumors often develop to other treatments.
This dual targeting not only suppresses tumor cell growth but also enhances the body's immune response, leading to greater cancer cell destruction. The drug is currently in Phase III clinical trials for treating metastatic colorectal cancer (mCRC).
Zanzalintinib (XL-092) is a third-generation oral tyrosine kinase inhibitor that blocks several cancer-related receptor tyrosine kinases, including VEGF receptors, MET, AXL, and MER. These kinases play a role in normal cell function as well as pathological processes like cancer development, metastasis, angiogenesis, and resistance to therapies such as immune checkpoint inhibitors. Developed by Exelixis, Zanzalintinib builds on the company's experience with cabozantinib, aiming to improve attributes like pharmacokinetic half-life. It is also in Phase III clinical trials for mCRC.
DKN-01 is a humanized monoclonal antibody that targets the DKK1 protein and is being developed for treating esophagogastric, gynecologic, and colorectal cancers. Initial findings from Part A of the DeFianCe trial were shared at the 2024 ASCO Gastrointestinal Cancers Symposium. Enrollment for Part B of the DeFianCe trial (NCT05480306) concluded in September 2024. This Phase II, randomized, open-label, controlled study is assessing DKN-01 in combination with bevacizumab and chemotherapy as a second-line treatment for advanced colorectal cancer in patients previously treated with one systemic therapy. The study enrolled 188 patients, with early results anticipated by mid-2025.
Discover more about drugs for metastatic colorectal cancer in development @ Metastatic Colorectal Cancer Clinical Trials
The anticipated launch of these emerging metastatic colorectal cancer treatments are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the metastatic colorectal cancer market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
DelveInsight estimates that the market size for metastatic colorectal cancer in the 7MM is expected to grow from USD 13 billion in 2024 with a significant CAGR by 2034. This growth is fueled by advancements in precision medicine, including targeted therapies and immunotherapies, which have shown promise in improving patient outcomes.
DelveInsight's latest published market report titled as Metastatic Colorectal Cancer Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the metastatic colorectal cancer country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The metastatic colorectal cancer market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into:
Total Incident Cases of CRC
Gender-specific Cases of CRC
Age-specific Cases of CRC
Tumor Location-specific Cases of CRC
Stage-specific Cases of CRC
Total Incident Cases of mCRC
Mutation Type-specific Cases of mCRC
Total Treated Cases of mCRC by Line of Therapy
The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM metastatic colorectal cancer market. Highlights include:
10-year Forecast
7MM Analysis
Epidemiology-based Market Forecasting
Historical and Forecasted Market Analysis upto 2034
Emerging Drug Market Uptake
Peak Sales Analysis
Key Cross Competition Analysis
Industry Expert's Opinion
Access and Reimbursement
Download this metastatic colorectal cancer market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the metastatic colorectal cancer market. Also, stay abreast of the mitigating factors to improve your market position in the metastatic colorectal cancer therapeutic space.
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Metastatic Colorectal Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key metastatic colorectal cancer companies, including Shanghai Henlius Biotech, Eisai Inc., Treos Bio, AUM Biosciences, Leap Therapeutics, Inc., Hoffmann-La Roche, Replimune, Qilu Pharmaceutical, Lutris Pharma, Ipsen, Bold Therapeutics, Pacylex Pharmaceuticals, FivepHusion, SystImmune, Inspirna, Inc., Sapience Therapeutics, Exelixis, Daiichi Sankyo, Hutchmed, Merus N.V., REVOLUTION Medicines, Pure Tech Health, Medicenna Therapeutics, Inc., Verastem Inc., Next Cure Inc., Isofol Medical, Zentalis Pharmaceuticals, Oncoinvent, KaryoPharm Therapeutics, Aadi Biosciences, among others.
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Metastatic Colorectal Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key metastatic colorectal cancer companies, including Johnson & Johnson Innovative Medicine, Shanghai Henlius Biotech, Inspirna, Treos Bio, Cardiff Oncology, Agenus, Leap Therapeutics, Arcus Biosciences, Enterome, Tizona Therapeutics, Innovative Cellular Therapeutics, among others.
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Lilly's once-weekly insulin efsitora alfa demonstrated A1C reduction and a safety profile consistent with daily insulin in multiple Phase 3 trials
Results from the fixed-dose QWINT-1 study, along with the QWINT-3 and QWINT-4 studies, reinforce efsitora's potential to simplify insulin management with weekly dosing Lilly plans to submit efsitora for the treatment of adults with type 2 diabetes to global regulatory agencies by the end of this year INDIANAPOLIS, June 22, 2025 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced detailed results from QWINT-1, QWINT-3, and QWINT-4 Phase 3 clinical trials evaluating the safety and efficacy of investigational once-weekly insulin efsitora alfa (efsitora) in adults with type 2 diabetes who used insulin for the first time, previously used daily basal insulin, and previously used daily basal insulin and mealtime insulin, respectively. In each trial, once-weekly efsitora met the primary endpoint of non-inferior A1C reduction compared to daily basal insulin. The complete results from these studies were presented at the American Diabetes Association (ADA) 85th Scientific Sessions 2025. Simultaneously, results from QWINT-1, a first-of-its-kind fixed-dose study, were published in The New England Journal of Medicine, while results from QWINT-3 and QWINT-4 were published in The Lancet. In QWINT-1, efsitora reduced A1C by 1.31% compared to 1.27% for insulin glargine at week 52 for the efficacy estimand.1,2 In the trial, efsitora was titrated to four fixed doses at four-week intervals, as needed for blood glucose control.3 In QWINT-3, efsitora reduced A1C by 0.86% compared to 0.75% for insulin degludec at week 26 for the efficacy estimand.4 In QWINT-4, efsitora reduced A1C by 1.07% compared to 1.07% for insulin glargine at week 26 for the efficacy estimand.5 In these two trials, efsitora was administered using traditional insulin dosing with adjustments based on each patient's glucose level. 'The novel fixed-dose regimen used in QWINT-1 for once-weekly efsitora, which consisted of only four single-dose titration options, has the potential to facilitate and simplify insulin therapy, reducing the hesitation often associated with starting insulin to treat type 2 diabetes,' said Dr. Julio Rosenstock, senior scientific advisor for Velocity Clinical Research at Medical City Dallas, clinical professor of medicine, University of Texas Southwestern Medical Center, and lead trial investigator for QWINT-1. 'A simpler, once-weekly regimen with efsitora may help people with type 2 diabetes initiate and manage insulin therapy with the goal of improving blood sugar levels. Across all QWINT trials, the results showed that once-weekly efsitora controlled glucose as effectively as the most popular once-daily basal insulins.' QWINT-1 Primary Endpoint Efficacy Estimand Treatment-RegimenEstimand6 Primary Endpoint – A1C Reduction (Resulting A1C) at Week 52 Efsitora -1.31 % (6.92 %) -1.19 % (7.05 %) Glargine -1.27 % (6.96 %) -1.16 % (7.08 %) QWINT-3 Primary and Key Secondary Endpoints Efficacy Estimand Treatment-RegimenEstimand Primary Endpoint – A1C Reduction (Resulting A1C) at Week 26 Efsitora -0.86 % (6.93 %) -0.81 % (6.99 %) Degludec -0.75 % (7.03 %) -0.72 % (7.08 %) Key Secondary Endpoint – Rates of Clinically Significant or Severe Nocturnal Hypoglycemic Events Per Patient-Year of Exposure up to Week 787,8 Efsitora 0.11 Degludec 0.10 Key Secondary Endpoint – Percent Time in Range (70-180 mg/dL) During the FourWeeks Prior to Week 26 Efsitora 62.8 % 61.4 % Degludec 61.3 % 61.0 % QWINT-4 Primary and Key Secondary Endpoints Efficacy Estimand Treatment-Regimen Estimand Primary Endpoint – A1C Reduction (Resulting A1C) at Week 26 Efsitora -1.07 % (7.12 %) -1.01 % (7.17 %) Glargine -1.07 % (7.11 %) -1.00 % (7.18 %) Key Secondary Endpoint – Participants Achieving A1C <7% at Week 26 Without Nocturnal Hypoglycemia Efsitora 39.5 % 38.6 % Glargine 36.6 % 35.9 % Key Secondary Endpoint – Rates of Clinically Significant or Severe NocturnalHypoglycemic Events Per Patient-Year of Exposure up to Week 26 Efsitora 0.67 Glargine 1.00 'Building on Lilly's legacy of innovation in insulin therapy, once-weekly efsitora may offer a significant advancement for people with type 2 diabetes who need insulin by eliminating over 300 injections per year,' said Jeff Emmick, M.D., Ph.D., senior vice president of product development at Lilly. 'These results reinforce the potential for once-weekly efsitora to help reduce the overall burden of insulin therapy through a simplified treatment approach. We look forward to working with regulatory agencies to bring this innovation to patients around the world.' Across the three trials, efsitora demonstrated an overall safety profile similar to two of the most commonly used daily basal insulin therapies for the treatment of type 2 diabetes. In QWINT-1, efsitora resulted in approximately 40% fewer hypoglycemic events compared to insulin glargine, with estimated combined rates of severe or clinically significant hypoglycemic events per patient-year of exposure of 0.50 with efsitora vs. 0.88 with insulin glargine at 52 weeks. In QWINT-3, these rates were 0.84 with efsitora vs. 0.74 with insulin degludec at 78 weeks. In QWINT-4, estimated combined rates of severe or clinically significant hypoglycemic events per patient-year of exposure were 6.6 with efsitora vs. 5.9 with insulin glargine at 26 weeks. Lilly plans to submit efsitora for the treatment of adults with type 2 diabetes to global regulatory agencies by the end of this year. About the QWINT clinical trial programThe QWINT Phase 3 global clinical development program for insulin efsitora alfa (efsitora) in diabetes began in 2022 and has enrolled more than 3,000 people living with type 2 diabetes across four global registration studies. QWINT-1 (NCT05662332) was a parallel-design, open-label, treat-to-target, randomized controlled clinical trial comparing the efficacy and safety of efsitora as a once-weekly basal insulin using a fixed dose escalation to daily insulin glargine for 52 weeks in insulin-naïve adults with type 2 diabetes. The trial randomized 795 participants across the U.S., Argentina and Mexico to receive efsitora once weekly or insulin glargine once daily, administered subcutaneously. Participants treated with efsitora received a starting dose of 100 units of insulin, followed by escalation to fixed dosages of 150 units, 250 units and 400 units every four weeks, as needed, until achieving a target fasting blood glucose of 80-130 mg/dL. Participants with fasting blood glucose greater than 130 mg/dL on or after 16 weeks were transferred to flexible dosing. The primary objective of the trial was to demonstrate non-inferiority in reducing A1C at week 52 with efsitora compared to daily use of insulin glargine. QWINT-3 (NCT05275400) was a multicenter, randomized, parallel-design, open-label trial comparing the efficacy and safety of efsitora as a once-weekly basal insulin to insulin degludec for 78 weeks after a three-week lead-in followed by a five-week safety follow up period, in adults with type 2 diabetes who are currently treated with basal insulin. The trial randomized 986 participants across the U.S., Argentina, Hungary, Japan, Korea, Poland, Puerto Rico, Slovakia, Spain and Taiwan to receive efsitora once weekly or insulin degludec once daily, administered subcutaneously. The primary objective of the study was to demonstrate non-inferiority in reducing A1C at week 26 with efsitora compared to insulin degludec. QWINT-4 (NCT05462756) was a parallel-design, open-label, treat-to-target, randomized controlled clinical trial comparing the efficacy and safety of efsitora as a weekly basal insulin to insulin glargine for 26 weeks in adults with type 2 diabetes who have previously been treated with basal insulin and at least two injections per day of mealtime insulin. The trial randomized 730 participants across the U.S., Argentina, Germany, India, Italy, Mexico, Puerto Rico and Spain to receive efsitora once weekly or insulin glargine once daily, both of which were administered subcutaneously along with insulin lispro. The primary objective of the trial was to demonstrate non-inferiority in reducing A1C at week 26 with efsitora compared to insulin glargine. About insulin efsitora alfaInsulin efsitora alfa (efsitora) is a once-weekly basal insulin, a fusion protein that combines a novel single-chain variant of insulin with a human IgG2 Fc domain. It is specifically designed for once-weekly subcutaneous administration, and with its low peak-to-trough ratio, it has the potential to provide more stable glucose levels (less glucose variability) throughout the week. About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit and or follow us on Facebook, Instagram, and LinkedIn. P-LLY The efficacy estimand represents the treatment effect on all participants who adhered to the study drug without initiating rescue therapy for persistent severe hyperglycemia. From a baseline of 8.20% for efsitora and 8.28% for insulin glargine. Participants treated with efsitora received a starting dose of 100 units of insulin, followed by escalation to fixed dosages of 150 units, 250 units and 400 units every four weeks, as needed, until achieving a target fasting blood glucose of 80-130 mg/dL. Participants with fasting blood glucose greater than 130 mg/dL on or after 16 weeks were transferred to flexible dosing. From a baseline of 7.80% for both efsitora and insulin degludec. From a baseline of 8.18% for both efsitora and insulin glargine. The treatment-regimen estimand represents the estimated average treatment effect regardless of treatment discontinuation or introduction of rescue therapy for persistent severe hyperglycemia. Blood glucose <54 mg/dL. Nocturnal hypoglycemia was defined as any event that occurred at night between midnight and 6 a.m. Cautionary Statement Regarding Forward-Looking StatementsThis press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about insulin efsitora alfa as a potential treatment for people with type 2 diabetes and the timeline for future readouts, presentations, and other milestones relating to insulin efsitora alfa and its clinical trials and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that future study results will be consistent with study results to date, that insulin efsitora alfa will prove to be a safe and effective treatment for type 2 diabetes, that insulin efsitora alfa will receive regulatory approval, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. Trademarks and Trade NamesAll trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. Refer to: Niki Biro; niki_biro@ 317-358-9074 (Media) Michael Czapar; czapar_michael_c@ 317-617-0983 (Investors)
Malaysian Reserve
a day ago
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Lilly's oral GLP-1, orforglipron, showed compelling efficacy and a safety profile consistent with injectable GLP-1 medicines, in complete Phase 3 results published in The New England Journal of Medici
The investigational once-daily pill lowered A1C by an average of 1.3% to 1.6% across doses, with improvements seen as early as four weeks, in adults with type 2 diabetes In ACHIEVE-1, orforglipron also led to an average weight loss of 16.0 lbs (7.9%) at the highest dose by week 40 in a key secondary endpoint The safety profile of orforglipron was consistent with the established GLP-1 class INDIANAPOLIS, June 21, 2025 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced detailed results from ACHIEVE-1, a Phase 3 trial evaluating the safety and efficacy of orforglipron compared to placebo in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone. Orforglipron is the first oral small molecule (non-peptide) glucagon-like peptide-1 (GLP-1) receptor agonist, taken without food and water restrictions, to successfully complete a Phase 3 trial. At 40 weeks, all three doses (3 mg, 12 mg, 36 mg) of orforglipron achieved the primary endpoint of superior A1C reduction. In addition, the 12 mg and 36 mg doses showed clinically meaningful and statistically significant reductions in body weight vs. placebo. In the study, orforglipron had a safety profile similar to the established GLP-1 class, and the most frequently reported adverse events were gastrointestinal-related. The results were presented at the American Diabetes Association (ADA) 85th Scientific Sessions 2025 and simultaneously published in The New England Journal of Medicine. In the study, orforglipron met the primary endpoint of superior A1C reduction compared to placebo at 40 weeks, lowering A1C by 1.3% to 1.6% from a baseline of 8.0%, for the efficacy estimand.1 In key secondary endpoints, up to 76.2% of participants taking orforglipron achieved the ADA treatment target A1C of <7%, 66.0% achieved an A1C of ≤6.5%, and 25.8% achieved <5.7%, defined as a normal A1C value.2,3 Improvements in A1C were observed as early as four weeks and were accompanied by similar reductions in fasting serum glucose. In another key secondary endpoint, participants taking the highest dose of orforglipron lost an average of 16.0 lbs (7.9%). While participants in ACHIEVE-1 did not appear to reach a weight plateau, longer-duration trials, such as the ATTAIN trials, will provide a comprehensive evaluation of the safety and efficacy of orforglipron for the treatment of obesity. 'The ACHIEVE-1 trial demonstrated that orforglipron, a novel oral small-molecule GLP-1, achieved clinically meaningful reductions in A1C and body weight over 40 weeks in adults with type 2 diabetes,' said Dr. Julio Rosenstock, senior scientific advisor for Velocity Clinical Research at Medical City Dallas, clinical professor of medicine, University of Texas Southwestern Medical Center, and lead trial investigator. 'The early onset of glycemic improvement, observed as soon as four weeks, reinforces the therapeutic potential of orforglipron as an effective, oral GLP-1 therapy for early type 2 diabetes treatment. These findings support further investigation in broader populations and longer-duration studies.' Full Results Orforglipron 3 mg Orforglipron 12 mg Orforglipron 36 mg Placebo Primary Endpoint A1C reduction from baseline of 8.0 %i Efficacy estimand 1.3 % 1.6 % 1.5 % 0.1 % Treatment-regimen estimand4 1.2 % 1.5 % 1.5 % 0.4 % Key Secondary Endpointsii Percent weight reduction from baseline of 90.2 kg (198.9 lbs)i,iii Efficacy estimand 4.7 % 6.1 % 7.9 % 1.6 % Treatment-regimen estimand 4.5 % 5.8 % 7.6 % 1.7 % Weight reduction from baseline of 90.2 kg (198.9 lbs)i,iii Efficacy estimand 4.4 kg (9.7 lbs) 5.5 kg (12.2 lbs) 7.3 kg (16.0 lbs) 1.3 kg (2.9 lbs) Treatment-regimen estimand 4.2 kg (9.3 lbs) 5.2 kg (11.5 lbs) 7.2 kg (15.8 lbs) 1.5 kg (3.4 lbs) Percent of participants achieving A1C <7 %i Efficacy estimand 72.9 % 76.2 % 74.9 % 28.0 % Treatment-regimen estimand 68.1 % 72.9 % 72.7 % 33.0 % Percent of participants achieving A1C ≤6.5 %i,ii Efficacy estimand 61.5 % 62.3 % 66.0 % 13.5 % Treatment-regimen estimand 56.9 % 58.1 % 61.9 % 14.9 % Percent of participants achieving A1C <5.7 %iii Efficacy estimand 17.7 % 25.8 % 23.9 % 3.8 % Treatment-regimen estimand 16.8 % 23.9 % 21.5 % 3.8 % Fasting serum glucose reduction from baseline of 147.5 mg/dLi Efficacy estimand 30.6 mg/dL 37.4 mg/dL 37.8 mg/dL 1.1 mg/dL Treatment-regimen estimand 30.7 mg/dL 36.5 mg/dL 34.7 mg/dL 10.8 mg/dL iSuperiority test was adjusted for from the full list of key secondary endpoints are available in the of participants achieving A1C <5.7% across all orforglipron doses and body weight for orforglipron 3 mg were not controlled for Type 1 error. 'This convenient once-daily pill with no restrictions on food and water intake could be an option for millions of people with type 2 diabetes who prefer oral medications over injectables,' said Jeff Emmick, M.D., Ph.D., senior vice president of product development at Lilly. 'The positive ACHIEVE-1 results position orforglipron as a potential treatment option with meaningful A1C and weight reduction, and a safety profile similar to injectable GLP-1 therapies. We look forward to the four remaining global readouts from the ACHIEVE program, as well as results of the ATTAIN program in obesity, and working with regulators to bring this once-daily oral GLP-1 to people around the world.' The overall safety profile of orforglipron in ACHIEVE-1 was consistent with the established GLP-1 class. The most common adverse events for participants treated with orforglipron (3 mg, 12 mg and 36 mg, respectively) were diarrhea (19%, 21% and 26%) vs. 9% with placebo, nausea (13%, 18% and 16%) vs. 2% with placebo, dyspepsia (11%, 20% and 15%) vs. 7% with placebo, constipation (8%, 17% and 14%) vs. 4% with placebo, and vomiting (5%, 7% and 14%) vs. 1% with placebo. These gastrointestinal-related adverse events were generally mild-to-moderate in severity and occurred primarily during dose escalation. Overall treatment discontinuation rates due to adverse events were 6% (3 mg), 4% (12 mg) and 8% (36 mg) for orforglipron vs. 1% with placebo. No hepatic safety signal was observed. Later this year, Lilly expects to share topline results from ACHIEVE-2, evaluating orforglipron compared with dapagliflozin, and ACHIEVE-3, evaluating orforglipron compared to oral semaglutide, both in adults with type 2 diabetes inadequately controlled with metformin. ATTAIN-1 and ATTAIN-2, evaluating orforglipron for weight management, will also be shared in the third quarter of this year. Lilly remains on track to submit orforglipron for weight management to global regulatory agencies by the end of this year and for the treatment of type 2 diabetes in 2026. About orforglipron Orforglipron (or-for-GLIP-ron) is an investigational, once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist that can be taken any time of the day without restrictions on food and water intake.5 Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. Chugai and Lilly published the preclinical pharmacology data of this molecule together.6 Lilly is running Phase 3 studies on orforglipron for the treatment of type 2 diabetes and for weight management in adults with obesity or overweight with at least one weight-related medical problem. It is also being studied as a potential treatment for obstructive sleep apnea and hypertension in adults with obesity. About ACHIEVE-1 and the ACHIEVE clinical trial program ACHIEVE-1 (NCT05971940) is a Phase 3, 40-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of orforglipron 3 mg, 12 mg and 36 mg as monotherapy to placebo in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone. The trial randomized 559 participants across the U.S., China, India, Japan and Mexico in 1:1:1:1 ratio to receive either 3 mg, 12 mg or 36 mg orforglipron or placebo. The primary objective of the study was to demonstrate that orforglipron (3 mg, 12 mg, 36 mg) is superior in A1C reduction from baseline after 40 weeks, compared to placebo, in people with type 2 diabetes who have not taken any anti-diabetic medications for at least 90 days prior to visit 1, and are naïve to insulin therapy. Study participants had a HbA1c between ≥7.0% and ≤9.5% and a BMI of ≥23 kg/m2. All participants in the orforglipron treatment arms started the study at a dose of orforglipron 1 mg once-daily and then increased the dose in a step-wise approach at four-week intervals to their final randomized maintenance dose of 3 mg (via a 1 mg step), 12 mg (via steps at 1 mg, 3 mg and 6 mg) or 36 mg (via steps at 1 mg, 3 mg, 6 mg, 12 mg and 24 mg). Flexible dosing was not permitted. The ACHIEVE Phase 3 global clinical development program for orforglipron has enrolled more than 6,000 people with type 2 diabetes across five global registration trials. The program began in 2023 with results anticipated later this year and into 2026. About LillyLilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit and or follow us on Facebook, Instagram and LinkedIn. P-LLY The efficacy estimand represents the treatment effect had on all participants who adhered to the study drug (with possible dose interruptions) for 40 weeks without initiating additional antihyperglycemic medications (>14 days of use). American Diabetes Association. Standards of Care in Diabetes—2020 Abridged for Primary Care Providers. Clinical Diabetes 2020; 38(1):10–38. Percent of participants achieving A1C <5.7% across all doses was not controlled for Type 1 error. The treatment-regimen estimand represents the estimated average treatment effect regardless of treatment discontinuation or initiation of additional antihyperglycemic medications. Ma X, Liu R, Pratt EJ, Benson CT, Bhattachar SN, Sloop KW. Effect of Food Consumption on the Pharmacokinetics, Safety, and Tolerability of Once-Daily Orally Administered Orforglipron (LY3502970), a Non-peptide GLP-1 Receptor Agonist. Diabetes Ther. 2024 Apr;15(4):819-832. Epub 2024 Feb 24. PMID: 38402332; PMCID: PMC10951152. T. Kawai, B. Sun, H. Yoshino, D. Feng, Y. Suzuki, M. Fukazawa, S. Nagao, D.B. Wainscott, A.D. Showalter, B.A. Droz, T.S. Kobilka, M.P. Coghlan, F.S. Willard, Y. Kawabe, B.K. Kobilka, & K.W. Sloop, Structural basis for GLP-1 receptor activation by LY3502970, an orally active nonpeptide agonist, Proc. Natl. Acad. Sci. U.S.A. 117 (47) 29959-29967, (2020). Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about orforglipron as a potential treatment for adults with type 2 diabetes, and the timeline for future readouts, presentations, and other milestones relating to orforglipron and its clinical trials and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that orforglipron will prove to be a safe and effective treatment for type 2 diabetes, that orforglipron will receive regulatory approval, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. Trademarks and Trade Names All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. Refer to: Brooke Frost; 317-432-9145 (Media) Michael Czapar; czapar_michael_c@ 317-617-0983 (Investors)
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Novo Nordisk advances early-stage obesity medication, amycretin, to phase 3 clinical development based on early-phase clinical trial results in people with obesity or excess weight, published in The L
Both subcutaneous and oral formulations will advance straight to phase 3 development based on completed clinical studies and feedback received from regulatory authorities1,2 PLAINSBORO, N.J., June 20, 2025 /PRNewswire/ — Today, results from two early-phase clinical trials evaluating Novo Nordisk's amycretin, an innovative investigational obesity treatment designed to target appetite regulation, were published in The Lancet.1 In a phase 1b/2a clinical trial of 125 adults with overweight or obesity, once-weekly subcutaneous amycretin appeared to be safe and tolerable in trial participants, who also achieved significantly greater weight loss across the full range of doses investigated versus placebo.1 A related phase 1 trial of once-daily oral amycretin in adults with obesity or overweight also showed that treatment was safe and tolerable with an observed reduction in body weight compared to placebo.2 No weight loss plateau was observed in either trial at the end of the respective treatment durations.1,2 Data on subcutaneous amycretin is scheduled to be presented on Sunday, June 22nd, during a late-breaking poster session at the American Diabetes Association's® (ADA) 85th Scientific Sessions.1 'We are pleased with the promising results of amycretin and the feedback from regulatory authorities and are excited to advance both subcutaneous and oral versions of this molecule into phase 3 development for weight management. At Novo Nordisk, we understand that addressing obesity is a complex challenge that many patients face. These results reflect our robust pipeline in obesity, our focus on progressing scientific innovation and expanding the range of options available to patients and healthcare professionals,' said Martin Holst Lange, executive vice president for Development at Novo Nordisk. 'We remain steadfast in our mission to discover and develop therapies that can have a meaningful impact in the lives of those affected by obesity.' Results from the phase 1b/2a trial of subcutaneous amycretin showed treatment-emergent adverse events (TEAEs) were mild or moderate in severity and increased in frequency in a dose-dependent manner. The most frequent reported TEAEs were gastrointestinal in nature. Compared to placebo, participants receiving amycretin observed greater weight loss across the full range of doses investigated.1 Subcutaneous amycretin at multiple doses demonstrated greater weight reduction than placebo at the end of the trial. Participants who received the highest doses (up to 60 mg) reported body weight reductions of up to 24.3% versus 1.1% with placebo after 36 weeks of treatment. Results from this first-in-human phase 1b/2a study support further investigation of potential weight-loss efficacy of amycretin. Results from the published phase 1 trial of oral amycretin showed that the most common TEAEs were related to gastrointestinal symptoms (mainly nausea and vomiting) and decreased appetite; these were most frequent for the higher doses. Trial participants receiving the study treatment demonstrated significantly greater weight loss across the full range of doses investigated versus the placebo group.2 Exploratory results showed participants taking 100 mg per day of oral amycretin achieved a mean weight loss of 13.1% versus 1.2% with placebo after 12 weeks.2 Based on these phase 1 results, longer evaluation with more participants is warranted to substantiate the full efficacy findings of oral amycretin on body weight reductions and changes in metabolic parameters. Novo Nordisk will advance both subcutaneous and oral amycretin formulations straight to phase 3 development for weight management based on these and other completed clinical studies, as well as feedback received from regulatory authorities. About amycretinAmycretin is a unimolecular long-acting GLP-1 and amylin receptor agonist under development by Novo Nordisk, to provide a treatment for adults with overweight or obesity and as a treatment for adults with type 2 diabetes. Amycretin is under investigation for oral and subcutaneous administration, and is not approved in the US for weight loss. About the phase 1b/2a subcutaneous amycretin trialThe phase 1b/2a trial was a randomized, placebo-controlled, single-center, double-blinded study of 125 participants assessing the safety, tolerability, pharmacokinetics, and effects on body weight after subcutaneous administration of amycretin in people with overweight or obesity.1 Adults with a body mass index of 27-39.9kg/m2 and glycated hemoglobin (HbA1c) <6.5% were eligible for the trial.1 The trial was conducted in 5 parts: a single ascending dose (Part A) for determination of pharmacokinetics and starting dose for the first multiple dose cohort in which the safety and tolerability were explored using dose escalation until 36 weeks of total treatment duration (Part B).1 Lastly, in the multiple ascending dose – dose response parts, body weight loss was explored for up to 36 weeks of dosing by escalating to dose levels of 1.25 mg, 5 mg, and 20 mg, respectively, dosed for 12 weeks (Part E, D and C).1 About the phase 1 oral amycretin trial The phase 1 single-center, randomized, placebo-controlled study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses (Part A) and multiple ascending doses (Part B, 10 days of treatment; Part C/D, 12 weeks of treatment) of 144 adult participants with overweight or obesity.2 The primary endpoint was the number of treatment-emergent adverse events (TEAEs) observed in the trial. The trial evaluated the single-ascending dose and multiple ascending doses for oral amycretin, up to 2 times 50 mg, in people with overweight or obesity, with a total treatment duration of up to 12 weeks.2 About obesityObesity is a serious chronic, progressive, and complex disease that requires long-term management.3-5 One key misunderstanding is that this is a disease of just lack of willpower, when in fact there is underlying biology that may impede people with obesity from losing weight and keeping it off.3,5 Obesity is influenced by a variety of factors, including genetics, social determinants of health, and the environment.6,7 The prevalence of overweight and obesity is a public health issue that has severe cost implications to healthcare systems.8,9 In the US, about 40% of adults live with obesity.10 About Novo NordiskNovo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. With a US presence spanning 40 years, Novo Nordisk US is headquartered in New Jersey and employs over 10,000 people throughout the country across 12 manufacturing, R&D and corporate locations in eight states plus Washington DC. For more information, visit Facebook, Instagram, and X. Novo Nordisk is committed to the responsible use of our semaglutide-containing medicines which represent distinct products with different indications, dosages, prescribing information, titration schedules, and delivery forms. These products are not interchangeable and should not be used outside of their approved indications. Learn more at Contacts for further information Media: Liz Skrbkova (US)+1 609 917 0632USMediaRelations@ Ambre James-Brown (Global)+45 3079 9289Globalmedia@ Investors: Frederik Taylor Pitter (US)+1 609 613 0568fptr@ Jacob Martin Wiborg Rode (Global)+45 3075 5956jrde@ Sina Meyer (Global)+45 3079 6656 azey@ Ida Schaap Melvold (Global)+45 3077 5649 idmg@ Max Ung (Global)+45 3077 6414mxun@ References Dahl K, Toubro S, Dey S, et al. Amycretin, a novel, unimolecular GLP-1 and amylin receptor agonist administered subcutaneously: Results of a randomised, controlled, phase 1b/2a study. The Lancet. Published online: June 20, 2025. Gasiorek A, Heydorn A, Gabery S, et al. Safety, tolerability, pharmacokinetics, and pharmacodynamics of the first-in-class GLP-1 and amylin receptor agonist, amycretin: a first-in-human, phase 1, randomised, placebo-controlled study. The Lancet. Published online: June 20, 2025. Kaplan LM, Golden A, Jinnett K, et al. Perceptions of barriers to effective obesity care: results from the national action study. Obesity. 2018;26(1):61-69. Bray GA, Kim KK, Wilding JPH; World Obesity Federation. Obesity: a chronic relapsing progressive disease process. A position statement of the World Obesity Federation. Rev. 2017;18(7):715-723. Garvey WT, Mechanick JI, Brett EM, et al. American association of clinical endocrinologists and American College of Endocrinology comprehensive clinical practice guidelines for medical care of patients with obesity. Endocr Pract. 2016;22 (Suppl 3):1-203. Centers for Disease Control and Prevention. Adult obesity facts. Last accessed: June 2025. Available at: World Obesity Federation. World Obesity Atlas 2023. Last accessed: June 2025. Available at: Centers for Disease Control and Prevention. Risk Factors for Obesity. Last accessed: June 2025. Available at: Centers for Disease Control and Prevention. Why it matters. Last accessed: June 2025. Available at: Centers for Disease Control and Prevention. Obesity and Severe Obesity Prevalence in Adults: United States, August 2021–August 2023. Last accessed June 2025. Available at: © 2025 Novo Nordisk All rights reserved. US25SEMO01477 June 2025
