Health
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
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
About this update from Veru Inc.
[{"type":"image","alt":"Veru Inc.","displaySize":"","headline":null,"caption":"Veru Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":214,"url":"https://media.zenfs.com/en/globenewswire.com/0a5f4ba487ea74752851101a11482743"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/mewu0yec4GXSU1yHV5yukA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTMwMDtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/0a5f4ba487ea74752851101a11482743","width":300,"height":214}},"lazy":false},{"type":"text","content":"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.","length":488,"tagName":"p"},{"type":"text","content":"Highlights from FDA meeting","length":27,"tagName":"p"},{"type":"text","content":"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.","length":659,"tagName":"p"},{"type":"text","content":"“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 w...