Veru, Inc. is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of metabolic diseases, oncology, and ARDS. 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 for two indications: (i) Phase 2b clinical study of enobosarm as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness and (ii) subject to the availability of sufficient funding, Phase 3 clinical trial of enobosarm for the treatment of androgen receptor positive (AR+), estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer in the 2nd line setting. Sabizabulin, a microtubule disruptor, is being developed as a Phase 3 clinical trial for the treatment of hospitalized patients with viral-induced ARDS. The company was founded by William R. Gargiulo, Jr., O. B. Parrish, and Harry Fisch in 1971 and is headquartered in Miami, FL.
Clinical Trials
14
3 active
Approvals
2
Total approvals
Agencies
1
Regulatory bodies
Founded
N/A
Active, not recruiting
3
21.4%
Completed
4
28.6%
Terminated
5
35.7%
Withdrawn
2
14.3%
- Veru announced preclinical data showing sabizabulin overcomes daraxonrasib resistance with an IC50 of 18.2 nM in a resistant human pancreatic cancer cell line, a concentration achievable with current human dosing. - The company will advance oral sabizabulin into a planned Phase 2b trial for metastatic KRAS-driven pancreatic cancer that has progressed on the recently FDA-approved daraxonrasib. - Sabizabulin demonstrated collateral sensitivity (resistance index of 0.25) in daraxonrasib-resistant pancreatic cancer cells, with prior Phase 1b/2 data showing a favorable safety profile in 80 prostate cancer patients. - Veru plans a preIND meeting with the FDA in Q4 2026 and holds global rights to sabizabulin with patent protection until 2043.
- Serena Williams returned to professional tennis at Queen's Club, winning her doubles match while openly using GLP-1 drug Zepbound for weight management. - WADA has been monitoring semaglutide and tirzepatide since 2024 to detect potential patterns of misuse in sport, though they remain unprohibited. - Experts note GLP-1s' muscle-wasting effects may complicate classification as performance-enhancing, while new formulations with fewer side effects could shift the debate. - Williams stated the medication helped her lose 34 pounds post-pregnancy and improved joint mobility, saying she wished she had used it during her playing career.
- Veru Inc. reported positive Phase 2b QUALITY study results showing enobosarm combined with semaglutide achieved 100% preservation of lean mass and 12% greater fat loss compared to semaglutide alone in older patients with obesity. - The FDA confirmed incremental weight loss as an acceptable primary endpoint for approval, with enobosarm 3 mg dose approved for future development in combination with GLP-1 receptor agonists. - The company plans to initiate the Phase 2b PLATEAU clinical study in Q1 2026, targeting patients aged 65 or older with BMI ≥35, with interim analysis results expected in Q1 2027. - Veru completed a public offering raising approximately $23.4 million in net proceeds to fund the upcoming PLATEAU study and advance its obesity treatment program.
- DelveInsight's 2025 pipeline report identifies over 15 companies developing innovative therapies for hot flashes, including first-in-class neurokinin receptor antagonists and novel estrogen receptor modulators. - Bayer's elinzanetant and Astellas Pharma's fezolinetant represent promising dual and selective neurokinin receptor antagonists targeting vasomotor symptoms through hypothalamic KNDy neuron modulation. - Veru Inc's zuclomiphene citrate demonstrated statistically significant reduction in moderate to severe hot flashes in men with advanced prostate cancer receiving androgen deprivation therapy. - The pipeline encompasses diverse therapeutic approaches including oral small molecules, recombinant proteins, and combination therapies across all development stages from discovery to Phase III trials.
- Veru Inc. has selected a novel modified-release oral formulation of enobosarm, a selective androgen receptor modulator, for chronic weight loss management following successful pharmacokinetic clinical study results. - The new formulation, developed using Laxxon Medical's proprietary SPID®-Technology, demonstrated improved drug release profile with reduced maximum plasma concentration and delayed time to peak levels compared to immediate release capsules. - The formulation is protected by robust patent estate through 2037 and beyond, with new patent applications filed for the modified-release version potentially extending protection to 2046. - This advanced formulation will be available for Phase 3 clinical studies and commercialization of enobosarm as a next-generation drug to enhance GLP-1 receptor agonist therapy for obesity treatment.
- Veru's enobosarm combined with Wegovy demonstrated reduced gastrointestinal side effects compared to Wegovy alone in a 168-person Phase 2 trial. - The combination therapy preserved lean muscle mass significantly better than Wegovy alone, with only 1.2% lean body mass loss versus 4.1% with Wegovy plus placebo. - Veru plans to advance the 3 milligram daily dose of enobosarm into Phase 3 trials based on safety and efficacy data from the study. - The company is developing a novel modified-release oral formulation that could extend market exclusivity to 2045.
- Phase IIb QUALITY trial demonstrates significant improvements in lean mass retention and fat loss when combining enobosarm with semaglutide, compared to placebo. - The study reports 80.6% of treated patients maintained stair climb power near baseline, indicating enhanced functional benefits particularly relevant for older populations. - Higher 6mg dose of enobosarm showed superior improvements in fat loss metrics, prompting plans for Phase III program development.
- Veru's enobosarm significantly reduced lean mass loss in older, overweight or obese patients taking Wegovy, a GLP-1 receptor agonist, in a Phase 2b trial. - Patients on enobosarm plus Wegovy lost 1.2% of lean mass compared to 4.1% in the Wegovy-only group, demonstrating a statistically significant benefit in lean mass preservation. - Enobosarm treatment also resulted in greater fat mass reduction and improved physical function, as measured by a stair climb test, compared to placebo plus Wegovy. - Veru plans to meet with the FDA to discuss advancing enobosarm to Phase 3 trials, focusing on a 52-week study with stair-climb power as the primary endpoint.
- Veru Inc. announced positive topline results from its Phase 2b QUALITY study, where enobosarm significantly reduced lean mass loss in patients on WEGOVY. - Patients on enobosarm lost 71% less lean mass and 27% more fat mass compared to those receiving WEGOVY alone, indicating improved body composition. - The study met its primary endpoint, showing a statistically significant benefit in preserving total lean body mass with enobosarm plus semaglutide versus placebo plus semaglutide. - Veru plans to meet with the FDA to discuss the design of a Phase 3 clinical program based on these promising results.
- Veru Inc. has commenced its Phase 2b QUALITY trial, evaluating enobosarm combined with semaglutide for sarcopenic obesity, with 168 patients enrolled. - The QUALITY trial is a multicenter, double-blind, placebo-controlled study assessing enobosarm's safety and efficacy in preserving muscle and augmenting fat loss in elderly patients. - Veru Inc. sold its FC2 Female Condom business for US$18 million to Riva Ridge Capital Management, aiming to focus on biopharmaceutical development. - The sale is projected to provide approximately US$12.5 million in proceeds, strengthening Veru's financial position for clinical trials of enobosarm.
