Veru Inc. announced the selection of a novel modified-release oral formulation for enobosarm, a selective androgen receptor modulator (SARM), following confirmation of pharmacokinetic endpoints in a clinical study. The late-stage biopharmaceutical company is developing enobosarm as a next-generation drug to enhance weight reduction by GLP-1 receptor agonist drugs through more tissue-selective fat loss and lean mass preservation.
Advanced Drug Delivery Technology Achieves Target Profile
The single-dose, open-label pilot study evaluated the plasma concentration versus time profile of a proprietary, patentable modified-release formulation of enobosarm 3mg. The new formulation demonstrated the intended distinct target product release profile, including a reduction in maximum plasma concentration (Cmax), a delayed time to maximum plasma concentration (Tmax), a distinct secondary peak plasma concentration, and similar extent of absorption (AUC) compared to historical values for enobosarm immediate-release capsules.
The novel modified-release oral formulation was developed in collaboration with Laxxon Medical using smart delivery systems, including the company's proprietary patented SPID®-Technology to create advanced, unique oral delivery release profiles, as well as an innovative additive manufacturing process.
"This milestone underscores the strength of our SPID®-Technology in enhancing bioavailability and optimizing drug release profiles," said Helmut Kerschbaumer, Chief Executive Officer of Laxxon Medical. "The collaboration with Veru reflects our commitment to advancing next-generation drug formulations, and we are excited to support them on their product development pathway."
Robust Patent Protection and Commercial Strategy
The novel enobosarm oral formulation's unique manufacturing process is protected by a robust patent estate of already issued global patents with protection through 2037 and beyond. Patent applications on enobosarm's new oral formulation have been filed and if issued, expiry is expected to be 2046.
"The novel enobosarm oral formulation's unique manufacturing process is protected by a robust patent estate of already issued global patents with protection through 2037 and beyond," said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. "This novel modified-release oral enobosarm formulation is planned to be available for the Phase 3 clinical studies and for commercialization."
Clinical Development Program and Previous Results
Veru has previously announced positive topline and safety results from the Phase 2b QUALITY clinical study, a 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 prevent muscle loss in 168 older patients (≥60 years of age) receiving semaglutide (Wegovy®) for chronic weight management.
After completing the efficacy dose-finding portion of the Phase 2b QUALITY clinical trial, 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. On June 24, 2025, the company announced positive results from the Phase 2b QUALITY and Maintenance Extension clinical study showing enobosarm significantly reduced body weight regain, prevented fat regain, and preserved lean mass after semaglutide discontinuation.
The Phase 2b QUALITY and Maintenance Extension clinical trial confirmed that preserving lean mass with enobosarm plus semaglutide led to greater fat loss during the active weight loss period, and after semaglutide was discontinued, enobosarm monotherapy significantly prevented the regain of both weight and fat mass during the maintenance period such that by end of study there was greater loss of fat mass while preserving lean mass for a higher quality weight reduction compared to the placebo group.
Advanced Manufacturing Technology Platform
SPID®-Technology enables sequential release of active pharmaceutical ingredients, processing of molecules like peptides in combination with permeation enhancers, processing of nanoparticles, and multi-compartment tablets starting at a micro-tablet dimension as small as less than 750 microns. Multiple functionalities can be combined in one tablet with the potential for upscaling from laboratory to mass production.
Laxxon can fully utilize the FDA's 505b(2) regulatory pathway in the US and Hybrid applications under article 10(3) of Directive 2001/83/EC in the EU, which fast tracks product routes to market. The company has been granted an FDA meeting to discuss its Phase 3 program for enobosarm.
