Veru Announces Successful FDA Meeting Providing Regulatory Clarity for Enobosarm for Muscle Preservation in Combination with GLP-1 RA for Greater Weight Loss in the Treatment of Obesity
Veru (NASDAQ: VERU) announced a successful FDA meeting regarding enobosarm, their muscle preservation drug candidate for obesity treatment. The FDA provided key regulatory clarity, accepting incremental weight loss as a primary endpoint when enobosarm is combined with GLP-1 RA treatments. The agency confirmed 3mg as an acceptable dosage and encouraged expanding the program to younger obesity patients.
Based on their positive Phase 2 QUALITY study results, Veru plans to initiate a Phase 2b PLATEAU clinical study in Q1 2026. The study will evaluate enobosarm 3mg in approximately 180 patients, both older (≥65) and younger (<65), who are starting tirzepatide treatment. The trial aims to demonstrate enobosarm's ability to preserve muscle mass while promoting additional fat loss, particularly in patients reaching the GLP-1 RA weight loss plateau.
Veru (NASDAQ: VERU) ha annunciato un incontro riuscito con la FDA riguardo enobosarm, il loro candidato farmaco per la conservazione della massa muscolare nel trattamento dell'obesità. La FDA ha fornito una chiara orientazione regolatoria, accettando la perdita di peso incrementale come endpoint primario quando enobosarm è combinato con trattamenti GLP-1 RA. L'agenzia ha confermato 3 mg come dosaggio accettabile e ha incoraggiato l'espansione del programma anche a pazienti obese più giovani.
Sulla base dei positivi risultati dello studio di Phase 2 QUALITY, Veru intende avviare uno studio clinico Phase 2b PLATEAU nel Q1 2026. Lo studio valuterà enobosarm 3 mg in circa 180 pazienti, sia anziani (≥65) sia più giovani (<65), che iniziano il trattamento con tirzepatide. Il trial mira a dimostrare la capacità dell'enobosarm di preservare la massa muscolare promuovendo al contempo una ulteriore perdita di grasso, in particolare nei pazienti che hanno raggiunto il plateau di perdita di peso con GLP-1 RA.
Veru (NASDAQ: VERU) anunció una reunión exitosa con la FDA respecto a enobosarm, su candidato a fármaco para la preservación muscular en el tratamiento de la obesidad. La FDA proporcionó clara claridad regulatoria, aceptando la pérdida de peso incremental como endpoint primario cuando enobosarm se combina con tratamientos GLP-1 RA. La agencia confirmó 3 mg como dosis aceptable y alentó a ampliar el programa a pacientes obesos más jóvenes.
Con base en los resultados positivos del estudio Phase 2 QUALITY, Veru planea iniciar un estudio clínico Phase 2b PLATEAU en el Q1 de 2026. El estudio evaluará enobosarm 3 mg en aproximadamente 180 pacientes, tanto mayores (≥65) como más jóvenes (<65), que comienzan tratamiento con tirzepatida. El ensayo busca demostrar la capacidad de enobosarm para conservar la masa muscular mientras promueve una pérdida adicional de grasa, especialmente en pacientes que alcanzan la meseta de pérdida de peso con GLP-1 RA.
Veru (NASDAQ: VERU)는 비만 치료를 위한 근육 보존 후보인 엔오보스암(enobosarm)에 대해 FDA 미팅이 성공적이었다고 발표했습니다. FDA는 규제 명확성을 제공했다, 엔오보스암과 GLP-1 RA 치료를 결합했을 때 점진적 체중 감소를 1차 평가 변수로 수용했습니다. 기관은 3mg를 허용 가능한 용량으로 확인했고 프로그램을 더 젊은 비만 환자들로 확장하는 것을 권장했습니다.
Positive Phase 2 QUALITY 연구 결과를 바탕으로 Veru는 Q1 2026에 Phase 2b PLATEAU 임상 연구를 시작할 계획입니다. 이 연구는 대략 180명의 환자, 연령대가 높은(≥65) 및 어린(<65)인 특히 티르제파티드 치료를 시작하는 환자를 대상으로 엔오보스암 3mg를 평가합니다. 이 시험의 목표는 GLP-1 RA 체중 감소 정체기에 도달한 환자들에서 추가 체지방 감소와 함께 근육 질량을 보존하는 엔오보스암의 능력을 입증하는 것입니다.
Veru (NASDAQ: VERU) a annoncé une réunion réussie avec la FDA concernant l'enobosarm, leur candidat médicament visant à la préservation de la masse musculaire dans le traitement de l'obésité. La FDA a fourni une clarté réglementaire clé, acceptant la perte de poids incrémentielle comme critère principal lorsque l'enobosarm est associé à des traitements GLP-1 RA. L'agence a confirmé 3 mg comme dosage acceptable et a encouragé l'expansion du programme à des patients obèses plus jeunes.
Sur la base des résultats positifs de l'étude Phase 2 QUALITY, Veru prévoit d'initier une étude clinique Phase 2b PLATEAU au T1 2026. L'étude évaluera l'enobosarm à 3 mg chez environ 180 patients, à la fois âgés (≥65) et plus jeunes (<65), qui débutent un traitement par tirzepatide. L'essai vise à démontrer la capacité de l'enobosarm à préserver la masse musculaire tout en favorisant une perte de graisse supplémentaire, en particulier chez les patients atteignant le plateau de perte de poids avec GLP-1 RA.
Veru (NASDAQ: VERU) gab bekannt, dass ein erfolgreicher FDA-Termin bezüglich Enobosarm, ihrem Kandidaten für den Muskelerhalt bei Fettleibigkeit, stattgefunden hat. Die FDA hatte eine klare regulatorische Orientierung geliefert und akzeptierte eine inkrementelle Gewichtsabnahme als primären Endpunkt, wenn Enobosarm mit GLP-1 RA-Behandlungen kombiniert wird. Die Behörde bestätigte 3 mg als akzeptable Dosierung und ermutigte, das Programm auf jüngere Fettleibigkeitspatienten auszuweiten.
Auf der Grundlage der positiven Phase-2-QUALITY-Studienergebnisse plant Veru, eine Phase-2b PLATEAU-Studie im Q1 2026 zu starten. Die Studie wird Enobosarm 3 mg in ca. 180 Patienten evaluieren, sowohl ältere (≥65) als auch jüngere (<65), die eine Tirzepatid-Behandlung beginnen. Ziel der Studie ist es, die Fähigkeit von Enobosarm zu zeigen, Muskelmasse zu erhalten, während zusätzlich Fett verloren wird, insbesondere bei Patienten, die das GLP-1-RA-Gewichtsabnahme-Plateau erreichen.
فيرو (ناسداك: VERU) أعلنت عن اجتماع ناجح مع FDA بخصوص إنوبوسفارم(enobosarm)، مرشح دواء للحفاظ على كتلة العضلات في علاج السمنة. قدمت FDA وضوحاً تنظيمياً رئيسياً، حيث قبلت فقدان الوزن التدريجي كمحصلة رئيسية عند دمج إنوبوسفارم مع علاجات GLP-1 RA. أكدت الوكالة جرعة 3mg كجرعة مقبولة وشجعت على توسيع البرنامج ليشمل مرضى السمنة الأصغر سناً.
استناداً إلى نتائج دراسة المرحلة 2 QUALITY الإيجابية، تخطط فيرو لبدء دراسة سريرية من المرحلة 2b PLATEAU في الربع الأول من 2026. ستقيّم الدراسة إنوبوسفارم 3mg في نحو 180 مريضاً، من كبار السن (≥65) وأصغر سناً (<65)، الذين يبدأون علاج تيرزيبيتيد. تهدف التجربة إلى إظهار قدرة إنوبوسفارم على الحفاظ على كتلة العضلات مع تعزيز فقدان الدهون الإضافي، خاصةً لدى المرضى الذين يحققون بلوغ plateau لانخفاض الوزن مع GLP-1 RA.
Veru (NASDAQ: VERU) 宣布在FDA关于他们的肌肉保留药物候选物enobosarm的会议取得圆满成功，用于肥胖治疗。FDA提供了关键的监管清晰度，在enobosarm与GLP-1 RA治疗联合使用时，接受以体重逐步下降作为主要终点。机构确认3mg为可接受剂量，并鼓励将项目扩展到更年轻的肥胖患者。
基于Phase 2 QUALITY研究的积极结果，Veru计划在2026年第一季度启动一个Phase 2b PLATEAU临床研究。该研究将评估大约180名患者，包括年龄较大的（≥65）和较年轻的（<65），这些患者将开始tirzepatide治疗。试验旨在证明enobosarm在促进额外脂肪减少的同时，能够保存肌肉质量，尤其是在达到GLP-1 RA减重平台期的患者中。
- FDA acceptance of incremental weight loss as primary endpoint provides clearer regulatory pathway
- Phase 2 QUALITY study showed enobosarm prevented weight regain by 46% after semaglutide discontinuation
- FDA approved expansion to younger population, broadening potential market
- Enobosarm demonstrated 100% fat loss with 0% lean mass loss in Phase 2 study
- Phase 2b PLATEAU study initiation dependent on sufficient capital availability
- Previous weight loss results showed similar outcomes across treatment groups at 16 weeks
Insights
FDA's pivotal regulatory shift allows Veru to pursue incremental weight loss as a primary endpoint for enobosarm, significantly advancing its obesity treatment program.
The FDA meeting represents a critical regulatory milestone for Veru's enobosarm development program. The agency has provided clarity on a key issue: incremental weight loss with enobosarm added to GLP-1 receptor agonist (GLP-1 RA) treatment versus GLP-1 RA alone can serve as an acceptable primary endpoint for approval. This shift dramatically simplifies Veru's regulatory pathway.
Enobosarm at 3mg has been confirmed as an acceptable dosage for future clinical trials, eliminating potential dose-finding delays. The FDA's encouragement to include younger obesity patients expands the potential market significantly beyond the initial older patient focus.
The company's previous Phase 2 QUALITY study demonstrated enobosarm's ability to preserve lean mass while increasing fat loss in patients taking semaglutide (a GLP-1 RA). Particularly noteworthy was enobosarm's ability to prevent weight regain by 46% after GLP-1 RA discontinuation, suggesting unique metabolic benefits beyond the initial treatment period.
Veru is leveraging this regulatory clarity to design a Phase 2b PLATEAU trial with approximately 180 patients that addresses a significant clinical challenge: the weight loss plateau experienced by most GLP-1 RA patients. According to data cited from Lilly's SURMOUNT-1 study, about 88% of tirzepatide patients plateau by 72 weeks, with 62.6% remaining clinically overweight.
The company plans to initiate this trial in Q1 2026, pending sufficient capital. This timeline suggests commercialization remains years away, but the clearer regulatory path significantly de-risks the development program and enhances partnership opportunities, which the company explicitly mentions pursuing.
MIAMI, FL, Sept. 23, 2025 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced a successful meeting with FDA providing regulatory clarity for enobosarm, a selective androgen receptor modulator, as a muscle preservation drug product candidate in combination with GLP-1 RA for greater weight loss for the treatment of obesity.
Highlights from FDA meeting
The regulatory landscape continues to evolve for muscle preservation drugs in the treatment of obesity. Based on FDA feedback on Veru’s clinical development program for enobosarm, FDA now guides that incremental weight loss with enobosarm added to GLP-1 RA treatment over the GLP-1 RA treatment alone is an acceptable primary endpoint to support approval. FDA confirmed that enobosarm 3mg is an acceptable dosage for future Veru clinical development. Further, FDA has encouraged Veru to expand the enobosarm development program to include a younger population with obesity as younger patients could also benefit from a muscle preservation drug like enobosarm.
“Although FDA’s position has evolved based on previous communications with Veru, this change is a big step forward as FDA’s current regulatory position that incremental weight loss is an acceptable approvable primary endpoint provides what we believe is a more certain regulatory pathway for the development of enobosarm for the treatment of obesity,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. “Our positive Phase 2 QUALITY clinical study provided proof of concept that 16 weeks of enobosarm treatment was able to preserve lean mass, burn additional fat mass, and improve physical function in older patients who have obesity and were receiving semaglutide for weight reduction. Although weight loss was similar across treatment groups at the end of this short active weight loss period of 16 weeks, it is expected that incremental weight loss will be observed in a longer clinical study in patients with obesity as preservation of lean mass and physical function will continue to increase energy expenditure coupled with enobosarm’s ability to directly cause greater fat loss. In fact, 12 weeks after discontinuation of semaglutide in the maintenance period of the Phase 2 QUALITY study, enobosarm monotherapy continued to burn fat and was able to prevent weight regain by
Advancing enobosarm clinical development program to benefit from recent FDA regulatory input: Preserve muscle and physical function and burn additional fat to reset the GLP-1 RA weight loss plateau resulting in clinically meaningful incremental weight reduction
The weight loss plateau occurs when the patient with obesity stops losing weight while on a GLP-1 RA. In the SURMOUNT-1 clinical study conducted by Eli Lilly and Company, about
The evolving FDA thinking for the development of muscle preservation drugs for obesity and the critical changes in the current FDA guidance related to the acceptable primary endpoint of incremental weight loss, have necessitated the change in Veru’s clinical development plan. The clinical development program of enobosarm will take advantage of both the FDA regulatory clarity on the acceptable primary endpoint and of enobosarm’s key attributes, preservation of muscle and physical function, and greater selective fat loss (
Planned Phase 2b PLATEAU clinical study
Veru’s planned Phase 2b PLATEAU clinical study will evaluate the effect of enobosarm 3mg on total body weight, physical function, and safety in approximately 180 older (≥65 yo) and younger (<65 yo) patients who have obesity and are initiating tirzepatide treatment for weight reduction. The primary efficacy endpoint of the study is the percent change from baseline in total body weight at 72 weeks. The key secondary endpoints are total fat mass, total lean mass, physical function (stair climb test), bone mineral density, and patient reported outcome questionnaires for physical function (SF-36 PF-10, and IWQOL-lite CT physical function).
The Phase 2b PLATEAU clinical study is designed to assess the ability of enobosarm treatment to break through the weight loss plateau observed in patients with obesity receiving tirzepatide treatment to achieve clinically meaningful incremental weight reduction and preserve muscle mass and physical function by 72 weeks. Subject to sufficient capital, the clinical study is expected to begin in calendar Q1 2026.
About Veru Inc.
Veru is a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases. The Company’s drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin. Enobosarm, a selective androgen receptor modulator (SARM), is being developed as a next generation drug that makes weight reduction by GLP-1 RA drugs more tissue selective for loss of fat and preservation of lean mass thereby improving body composition and physical function with expected clinically meaningful incremental weight reduction versus GLP-1 RA monotherapy. Sabizabulin, a microtubule disruptor, is being developed for the treatment of inflammation in atherosclerotic cardiovascular disease.
Enobosarm Obesity Program - Enobosarm is a next generation drug that makes weight reduction by GLP-1 RA more tissue selective for fat loss – Phase 2b QUALITY clinical study
The Phase 2b QUALITY clinical study was a positive multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial designed to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to augment fat loss and to prevent muscle loss in 168 older patients (≥60 years of age) receiving semaglutide (Wegovy®) for weight reduction. After completing the efficacy dose-finding portion of the Phase 2b QUALITY clinical trial ended at 16 weeks, participants continued into a Phase 2b maintenance extension study where all patients discontinued semaglutide treatment, but continued receiving placebo, enobosarm 3mg, or enobosarm 6mg as monotherapy in a double-blind fashion for 12 weeks. The Phase 2b QUALITY and Maintenance Extension clinical trial was a positive study that demonstrated that preserving lean mass and physical function with enobosarm plus semaglutide led to greater fat loss during the 16 week active weight loss period. While weight loss was similar across treatment groups in this short 16 week study, it is expected that preservation of lean mass and function will increase energy expenditure coupled with the direct effects of enobosarm on the additional selective reduction in fat mass will result in incremental weight reduction in a longer clinical study in patients who have obesity.
Forward-Looking Statements
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, express or implied statements related to the planned design, enrollment, timing, commencement, interim and full data readout timing, scope and regulatory pathways for the continued development of enobosarm in patients with obesity, including the planned PLATEAU Phase 2b study; whether clinically meaningful incremental weight loss in the PLATEAU Phase 2b study will continue to be seen as an acceptable primary endpoint by the FDA to support potential approval; whether the FDA will continue to accept 3mg as an acceptable dosage for enobosarm in the planned PLATEAU Phase 2b study or in any other studies; whether the FDA will further evolve its position on the acceptable patient population for the PLATEAU Phase 2b study or any other future studies; whether the Company will be able to partner with any other company in the development of enobosarm; whether the results of the Phase 2b QUALITY study and the extension maintenance study of enobosarm will be replicated to the same or any degree in the planned PLATEAU Phase 2b study or in any future Phase 3 studies; the expected costs, timing, patient population, design, endpoints and results of the planned PLATEAU Phase 2b study or any future Phase 3 studies of enobosarm in patients with obesity; whether the Company will be able to raise sufficient capital, dilutive or otherwise, to fund the PLATEAU Phase 2b study of enobosarm in patients with obesity or any other studies; whether the Company will be able to recruit a sufficient number of patients in a timely manner for the PLATEAU Phase 2b study; whether the modified-released formulation of enobosarm will be developed successfully and whether such formulation will have the same effectiveness or bioequivalence as the current formulation, and whether and when such modified-release formulation will be available for any planned or future clinical studies; whether and when any patents will actually issue regarding such modified-release formulation and what any expiration dates of any such patents might be; whether the Company will be able to obtain sufficient tirzepatide or any other GLP-1 RA drugs in a timely or cost-effective manner in the planned PLATEAU Phase 2b study or any future Phase 3 studies; whether the Company will be able to engage clinical research organizations and recruit patients for the PLATEAU Phase 2b program and in a timely or cost-effective manner; whether enobosarm will cause weight loss or preserve muscle in, or meet any unmet need for, obesity patients and whether it will cause weight loss in the planned PLATEAU Phase 2b study or any future Phase 3 studies or, if approved and commercialized, in clinical practice; whether patients treated with enobosarm for a longer period of time than in the Phase 2b QUALITY study will experience weight loss or have a greater loss of adiposity or greater weight loss than with tirzepatide, semaglutide or other GLP-1 drug alone; whether and when enobosarm will be approved by the FDA as a weight loss drug or a body composition drug or any other type of drug; and whether and when the Company will be able to further advance the development of sabizabulin in atherosclerotic disease. The words "anticipate," "believe," "could," "expect," "intend," "may," "opportunity," "plan," "predict," "potential," "estimate," "should," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based upon current plans and strategies of the Company and reflect the Company's current assessment of the risks and uncertainties related to its business and are made as of the date of this press release. The Company assumes no obligation to update any forward-looking statements contained in this press release because of new information or future events, developments, or circumstances. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions, and if any such risks or uncertainties materialize or if any of the assumptions prove incorrect, our actual results could differ materially from those expressed or implied by such statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to: the development of the Company’s product portfolio and the results of clinical studies possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the Company’s ability to reach agreement with FDA on study design requirements for the Company’s planned clinical studies, including for the Phase 2b program for enobosarm as a weight loss or body composition drug and the number of future Phase 3 studies to be required and the cost thereof; potential delays in the timing of and results from clinical trials and studies, including as a result of an inability to enroll sufficient numbers of subjects in clinical studies or an inability to enroll subjects in accordance with planned schedules; the ability to fund planned clinical development as well as other operations of the Company; the timing of any submission to the FDA or any other regulatory authority and any determinations made by the FDA or any other regulatory authority; the potential for disruptions at the FDA or other government agencies to negatively affect our business; any products of the Company, if approved, possibly not being commercially successful; the ability of the Company to obtain sufficient financing, including any partnership or collaboration agreements, on acceptable terms when needed to fund development and operations; demand for, market acceptance of, and competition against any of the Company’s products or product candidates; new or existing competitors with greater resources and capabilities and new competitive product approvals and/or introductions; changes in regulatory practices or policies or government-driven healthcare reform efforts, including pricing pressures and insurance coverage and reimbursement changes; the Company’s ability to protect and enforce its intellectual property; costs and other effects of litigation, including regulatory challenges, product liability claims, intellectual property and securities litigation; the Company’s ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company’s ability to successfully integrate acquired businesses, technologies or products; and other risks detailed from time to time in the Company’s press releases, shareholder communications and Securities and Exchange Commission filings, including the Company's Form 10-K for the year ended September 30, 2024, and subsequent quarterly reports on Form 10-Q. These documents are available on the “SEC Filings” section of our website at www.verupharma.com/investors.
Wegovy® is a registered trademark of Novo Nordisk A/S.
Investor and Media Contact:
Samuel Fisch
Executive Director, Investor Relations and Corporate Communications
Email: veruinvestor@verupharma.com
FAQ
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