MIAMI, FL — August 4, 2026 — Leads & Copy — Veru Inc. (NASDAQ: VERU) announced today that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a patent application titled “Compositions Comprising Selective Androgen Receptor Modulator Compounds in Combination with Weight Loss Drugs and Uses Thereof for Quality Weight Loss.” This allowance signifies that the USPTO has determined the application meets patentability requirements and is expected to be issued as a U.S. patent, providing protection until at least October 2044.
The patent covers treatment regimens where enobosarm is administered concurrently with semaglutide, added to initial semaglutide monotherapy, or continued or initiated as monotherapy after semaglutide treatment is discontinued. The allowed claims are directed to preserving or gaining lean body mass and muscle mass, enhancing fat mass loss, improving body composition, and reducing body fat content. They also include claims for preserving, restoring, or improving physical function and preventing or treating related conditions such as muscle weakness, poor balance, decreased gait speed, mobility disability, loss of independence, increased risk of falls, loss of physical function, physical disability, poor quality of life, high hospitalization rates, and increased mortality.
Further claims address the preservation, restoration, or gaining of bone and the prevention or treatment of bone fractures, as well as overcoming or improving insulin resistance, improving HbA1c, and reducing or preventing total body weight and fat mass rebound after discontinuing semaglutide. The patent also covers preventing or restoring lean mass loss during rebound after discontinuing semaglutide.
“We are delighted to hear this positive decision and action from the USPTO,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru Inc. “These allowed claims add to our growing intellectual property portfolio for enobosarm for quality weight loss, including already issued enobosarm specific polymorph composition of matter patents, as well as a number of other pending uses of selective androgen receptor modulator compounds alone or in combination with weight loss drugs for quality weight loss and chronic weight management patent applications.”
Steiner added, “In addition, the patent portfolio of Veru includes patent applications directed to a novel, oral, modified-release enobosarm formulation, which if such patent were to issue, would provide patent protection until at least May 2046.”
Veru Inc. holds a worldwide portfolio of patent applications for the use of enobosarm in combination with weight loss drugs for higher quality and incremental weight loss, including incretin-containing drugs such as GLP-1 RA drugs. The company is continuing to pursue patent applications for combinations with other weight loss drugs beyond semaglutide.
The company’s Veru Obesity Program is evaluating enobosarm in combination with GLP-1 RA for higher quality weight reduction in older patients with obesity. The fully enrolled Phase 2b PLATEAU clinical study is a double-blind, placebo-controlled trial investigating the effect of enobosarm 3mg on total body weight, fat mass, lean mass, physical function, bone mineral density, and safety in approximately 200 older patients (age 65 and older) with obesity (BMI 35 or greater) who are initiating semaglutide treatment. This study is designed to assess enobosarm’s ability to overcome the weight loss plateau seen in patients on GLP-1 RA treatment by preserving muscle mass and physical function for clinically meaningful incremental weight reduction by 68 weeks.
The primary efficacy endpoint for the PLATEAU study is the percent change from baseline in total body weight at 68 weeks. Key secondary endpoints include total fat mass, total lean mass, physical function (stair climb test), mobility disability assessment, bone mineral density, and patient-reported outcomes for physical function, HbA1c, and insulin resistance. An interim analysis of lean body mass and fat mass measured by DXA after 32 weeks is anticipated in the first quarter of 2027, with final topline clinical data expected in the fourth quarter of 2027.
In June 2026, Veru announced a clinical supply agreement with Novo Nordisk for its Phase 2b PLATEAU clinical study. Novo Nordisk’s participation does not constitute endorsement of enobosarm or the combination approach, and their supply of Wegovy® does not represent a representation regarding Wegovy’s requirement for adjunctive therapy.
Previously, Veru completed the Phase 2b QUALITY clinical study, a positive multicenter, double-blind, placebo-controlled trial that evaluated the safety and efficacy of enobosarm (3 mg or 6 mg) or placebo as a treatment to augment fat loss and prevent muscle loss in 168 older patients (age 60 and older) receiving semaglutide (Wegovy®) for weight reduction. Following the efficacy dose-finding portion at 16 weeks, participants entered a maintenance extension study where semaglutide was discontinued, and patients continued receiving placebo, enobosarm 3 mg, or enobosarm 6 mg as monotherapy for 12 weeks. This study demonstrated that enobosarm plus semaglutide preserved lean mass and physical function and led to greater fat loss during the active weight loss period. Furthermore, enobosarm monotherapy prevented the regain of fat mass and total body weight after GLP-1 RA discontinuation.
Veru Inc. is a late-stage clinical biopharmaceutical company developing innovative medicines for cardiometabolic and inflammatory diseases. Its drug development program includes enobosarm, an oral selective androgen receptor modulator, being developed to make weight reduction from GLP-1 RA drugs more tissue selective for fat loss and lean mass preservation, improving body composition and physical function. Sabizabulin, a microtubule disruptor, is being developed for chronic inflammation related to atherosclerotic cardiovascular disease.
Source: Veru Inc.
