Migraine Market Enters New Era Following Satsuma Pharmaceuticals' ATZUMI and Amneal Pharmaceuticals' BREKIYA Regulatory Approval
The approval of ATZUMI and BREKIYA is expected to significantly reshape the migraine market by introducing new, innovative treatment options. These therapies promise improved efficacy and convenience, potentially capturing a substantial share from existing CGRP inhibitors. Their entry may intensify competition, drive pricing adjustments, and stimulate further innovation.
LAS VEGAS, May 21, 2025 /PRNewswire/ — Migraine is recognized globally as the seventh most disabling condition across all diseases, accounting for approximately 2.9% of all years lived with disability (YLDs). It is also the top cause of disability among neurological disorders. Despite its prevalence, migraine is often underdiagnosed and undertreated. Around 50% of sufferers go undiagnosed, and fewer than half seek medical consultation. In 2024, the estimated number of individuals living with migraine in the 7MM reached roughly 119 million.
Current migraine management involves a dual approach—acute treatment to relieve symptoms during an attack, and preventive strategies to reduce the frequency and intensity of future episodes. Acute therapies generally include triptans, nonsteroidal anti-inflammatory drugs (NSAIDs), and anti-nausea medications, which target symptoms like pain and nausea. Recently, more focus has been placed on preventive care for patients with frequent or debilitating migraines. This includes the use of medications such as beta-blockers, antiepileptic drugs, and CGRP (calcitonin gene-related peptide) inhibitors, along with lifestyle changes to identify and avoid migraine triggers.
Preventive or prophylactic treatments aim to decrease the frequency, severity, and duration of migraine attacks, as previously discussed. FDA-approved preventive agents include propranolol, timolol, divalproex sodium, OnabotulinumtoxinA (Botox), and topiramate. While other migraine medications have demonstrated efficacy, they lack formal FDA approval for migraine prevention. For forecasting purposes, these therapies are grouped into classes such as antiepileptics, antihypertensives, and neurotoxins. Notably, Botox stands out as the only FDA-approved non-daily injectable option for chronic migraine, offering fewer side effects compared to daily oral medications.
Learn more about the migraine therapeutic market @ Migraine Treatment Market
Eptinezumab (ALD-403), marketed as VYEPTI, is approved for the preventive treatment of migraines in adults. Aimovig, developed by Amgen and Novartis, was the first FDA-approved migraine prevention therapy from a new drug class that blocks CGRP, a key molecule involved in migraine episodes.
FDA approved EMGALITY in September 2019 for preventing migraine in adults, but it's contraindicated for those hypersensitive to galcanezumab-gnlm or its components. In November 2019, the EU approved galcanezumab for adults with ≥4 migraine days/month.
In September 2019, the FDA sanctioned AJOVY for adult migraine prevention. By January 2020, an autoinjector for Fremanezumab received FDA approval. In March 2019, AJOVY earned European Commission approval for adult migraine prophylaxis. Teva's AJOVY gained approval in Japan in June 2021.
In September 2021, Impel Pharmaceuticals gained FDA approval for TRUDHESA, a nasal spray formulation of dihydroergotamine mesylate (0.725 mg per spray), intended for the acute treatment of migraines with or without aura in adults.
In March 2023, Pfizer's ZAVZPRET (zavegepant) received FDA approval. It is the first CGRP receptor antagonist nasal spray approved for acute migraine treatment in adults, with or without aura, and uniquely utilizes Precision Olfactory Delivery (POD) technology, targeting the upper nasal cavity for drug delivery.
The FDA also approved QULIPTA (atogepant) in April 2023 for chronic migraine prevention in adults. It stands out as the first oral CGRP receptor antagonist approved for both episodic and chronic migraine prevention. In the same month, IntelGenx Corp announced FDA approval of RIZAFILM, designed for the acute treatment of migraines.
Additionally, in January 2025, the FDA approved AXS-07, an oral multi-mechanistic treatment for acute migraine attacks, developed by Axsome Therapeutics. Branded as SYMBRAVO, it is expected to launch in the U.S. approximately four months after FDA acceptance of the company's NDA resubmission in September 2024.
Dive deep into the United States migraine drugs market @ Migraine Headache Drugs Market
On April 30, 2025, the FDA approved ATZUMI, a nasal powder formulation of dihydroergotamine (DHE), developed by Satsuma Pharmaceuticals, for the acute treatment of migraines in adults. Satsuma is a subsidiary of Shin Nippon Biomedical Laboratories.
ATZUMI is a drug-device combination that uses Satsuma's proprietary Simple MucoAdhesive Release Technology (SMART) platform. The medication is administered through a squeezable device inserted into the nostril, delivering DHE in powder form.
The FDA had previously rejected ATZUMI's marketing application last year, citing concerns related to chemistry, manufacturing, and controls. However, no issues were raised about the clinical data, nor were additional trials requested.
The recent approval was supported by results from a Phase I pharmacokinetics study and the Phase III ASCEND trial. These trials showed that ATZUMI is rapidly absorbed, maintains high and sustained DHE plasma levels, and is safe for individuals with migraines. Over one-third of patients experienced pain relief within two hours of use.
Recently, in May 2025, Amneal Pharmaceuticals, Inc. announced that the FDA had approved BREKIYA (dihydroergotamine mesylate) injection, the first and only autoinjector form of dihydroergotamine (DHE) for the acute treatment of migraine with or without aura, as well as cluster headaches in adults. The product is expected to become available to eligible patients in the second half of 2025.
The BREKIYA autoinjector offers the possibility of sustained pain relief† in a convenient, self-administered format. It delivers the same DHE medication traditionally used in hospital settings but in a prefilled, ready-to-use device. The autoinjector does not require refrigeration, assembly, or priming, and is designed for subcutaneous injection into the middle of the thigh. This delivery method may be especially useful for patients who have a poor response to oral medications, experience nausea or vomiting during migraine attacks, have delayed gastric emptying, or tend to postpone treatment until symptoms have worsened.
To know more about the migraine treatment devices, visit @ Migraine Treatment Devices Market
Although standardized treatment guidelines are widely available and a range of mostly affordable options for both acute and preventive migraine therapies exist, there remains a significant unmet need, contrary to common belief. Many of the currently used treatments are not universally effective, may pose cardiovascular risks for some patients, and are either too general or poorly tolerated. Response rates remain suboptimal, breakthrough migraines are frequent, and patients often rely on multiple medications to manage symptoms. Additionally, side effects contribute to poor compliance and adherence. Studies indicate that about half of patients are dissatisfied with the ability of their current therapy to prevent recurring pain, and nearly 80% are open to trying new acute or preventive options.
Looking ahead, the migraine treatment landscape is poised for major transformation, driven by shifts in market dynamics that began around 2020. Advances in novel drug development and biomarker-based targeting are expected to significantly enhance revenue potential across the 7MM during the forecast period of 2025 to 2034. Some of the migraine drugs in the pipeline include ABP-450 (Axsome Therapeutics), Aimovig (AEON Biopharma, Inc.), Lu AG09222 (Lundbeck), and others.
Discover which therapies are expected to grab major migraine therapeutics market share @ Migraine Drugs Market
ABP-450, developed by AEON Biopharma, Inc., is an injectable formulation containing a 900 kDa botulinum toxin type-A complex derived from Clostridium botulinum. At therapeutic doses, it induces chemical denervation of muscles, leading to a localized decrease in muscle activity. The drug is currently undergoing Phase II clinical trials for the treatment of episodic and chronic migraine.
Aimovig, produced by Amgen, is a monoclonal antibody that targets and blocks the calcitonin gene-related peptide receptor (CGRP-R). Already approved for preventive migraine treatment, it is now being evaluated for migraine prevention in pediatric patients, covering both episodic and chronic forms.
Lu AG09222, an investigational monoclonal antibody from Lundbeck, is designed to bind to and inhibit pituitary adenylate cyclase-activating polypeptide (PACAP). PACAP is a neuropeptide involved in migraine pathophysiology, making it a promising novel target. Lu AG09222 is being explored as a preventive therapy for individuals suffering from migraine.
Discover more about migraine drugs in development @ Migraine Clinical Trials
The anticipated launch of these emerging migraine 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 migraine market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
DelveInsight estimates that the migraine market size in the 7MM is expected to grow from USD 10.8 billion in 2023 at a significant CAGR by 2034. This expansion across the 7MM will be due to the rising awareness of the disease and incremental healthcare spending across the world, which would expand the migraine market size to enable the drug manufacturers to penetrate more into the migraine market.
DelveInsight's latest published market report titled Migraine 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 migraine country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The migraine market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into:
Total Prevalent Cases of Migraine
Gender-specific Prevalent Cases of Migraine
Severity-specific Prevalent Cases of Migraine
Diagnosed Cases of Episodic and Chronic Migraine
The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM migraine 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 migraine 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 migraine market. Also, stay abreast of the mitigating factors to improve your market position in the migraine therapeutic space.
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Migraine Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted migraine epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
Migraine Pipeline
Migraine Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key migraine companies, including Satsuma Pharmaceuticals, Biohaven Pharmaceuticals, Allodynic Therapeutics, Vaxxinity, AbbVie, Pulmatrix, AEON Biopharma, Eli Lilly and Company, Trevena, Xoc Pharmaceuticals, Pharmaleads, Pear Therapeutics, among others.
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Malaysian Reserve
18 hours ago
- Malaysian Reserve
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)
Malaysian Reserve
2 days ago
- Malaysian Reserve
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
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Johnson Pope Expands Legal Talent with the Addition of Jessica Warwick and Samuel C. Craig to Its St. Petersburg Office
ST. PETERSBURG, Fla., June 20, 2025 /PRNewswire/ — Johnson, Pope, Bokor, Ruppel & Burns, LLP is proud to announce the addition of two new associate attorneys, Jessica Warwick and Samuel C. Craig, to its St. Petersburg office. These strategic hires reflect the firm's continued growth and commitment to serving clients with deep, specialized knowledge across key practice areas. Jessica Warwick Joins Healthcare Practice GroupJessica Warwick has joined Johnson Pope's Healthcare Practice Group, where she advises hospitals, health systems, and medical providers on a wide range of regulatory and compliance matters. Her areas of focus include telemedicine, the corporate practice of medicine, and Medicare/Medicaid compliance. Jessica holds both a Juris Doctor and a Master of Health Administration from Penn State. Her experience includes drafting and negotiating management and professional services agreements, conducting regulatory compliance reviews for digital health platforms, and supporting healthcare M&A transactions. Jessica is admitted to the Florida Bar and currently serves as the Health and Wellness Chair for the Pinellas County chapter of the Florida Association for Women Lawyers. Samuel C. Craig Joins Tax, Trusts & Estates Practice GroupsSamuel C. Craig has joined Johnson Pope as an associate in the Tax, Trusts & Estates and Business Transactions Practice Groups. Sam focuses his practice on estate planning, tax law, and business matters, providing practical, strategic counsel to individuals, families, and business owners. Sam earned his J.D. from Stetson University College of Law, where he was a research assistant, president of the Business Law Society, and a member of both the Dispute Resolution Board and Trial Team. He received multiple awards for oral advocacy, including a national mock trial championship and induction into the National Order of the Barristers. He later earned his LL.M. in Taxation from the University of Florida on a merit scholarship where he earned multiple CALI book awards, further honing his knowledge of federal and state tax law. Sam is dedicated to helping clients protect their legacies, minimize tax burdens, and navigate complex legal issues with clarity and care. About Johnson PopeJohnson, Pope, Bokor, Ruppel & Burns, LLP is a full-service Florida-based law firm with offices in Tampa, Clearwater, and St. Petersburg. The firm is known for its commitment to excellence, innovative legal solutions, and deep roots in the communities it serves. To learn more, visit
