This section highlights FDA-related milestones and regulatory updates for drugs developed by Veru (VERU).
Over the past two years, Veru has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Enobosarm, Sabizabulin, and Wegovy. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Enobosarm - FDA Regulatory Timeline and Events
Enobosarm is a drug developed by Veru for the following indication: ER+/HER2- breast cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Enobosarm
- Announced Date:
- June 24, 2025
- Indication:
- ER+/HER2- breast cancer
Announcement
Veru Inc. announced positive topline efficacy and safety results from the maintenance extension portion of the Phase 2b QUALITY clinical study.
AI Summary
Veru Inc. announced positive topline efficacy and safety results from the maintenance extension part of its Phase 2b QUALITY clinical study. In this trial, after discontinuing semaglutide, patients on placebo regained 43% of their lost weight, while those treated with enobosarm 3mg reduced weight regain by 46% and completely prevented the return of fat mass. The study also showed that enobosarm led to up to 93% greater fat loss and preserved nearly all lean muscle mass compared to placebo.
These results were achieved with an excellent safety profile, as enobosarm had essentially no gastrointestinal side effects during the 12-week maintenance period. Based on these encouraging findings, the company plans to move forward with enobosarm 3mg as the proposed oral dose for its upcoming Phase 3 clinical program, offering a promising option for maintaining weight loss after discontinuing semaglutide.
Read Announcement- Drug:
- Enobosarm
- Announced Date:
- August 8, 2024
- Indication:
- ER+/HER2- breast cancer
Announcement
Veru Inc. provided a business update including progress on its Phase 2b QUALITY clinical trial
AI Summary
Veru Inc. recently shared a business update focused on its Phase 2b QUALITY clinical trial for enobosarm in combination with semaglutide, a GLP-1 receptor agonist for weight management. The trial is designed to determine if enobosarm can preserve muscle mass while enhancing fat loss among sarcopenic obese or overweight elderly patients. The study, which has now surpassed its targeted enrollment of over 150 patients, will measure total lean body mass as its primary endpoint, with additional assessments on body fat and physical function. Topline results for the primary endpoint are expected in January 2025. Veru’s leadership highlighted the significant unmet need for treatments that address muscle loss in patients receiving GLP-1 therapy and expressed optimism about how enobosarm could fill this gap, potentially improving both muscle preservation and physical function during high quality weight loss.
Read Announcement- Drug:
- Enobosarm
- Announced Date:
- June 10, 2024
- Indication:
- ER+/HER2- breast cancer
Announcement
Veru Inc announced that the Company will present two presentations at the American Diabetes Association's 84th Scientific Sessions, taking place June 21-24, 2024, in Orlando, Florida.
AI Summary
Veru Inc., a late-stage biopharmaceutical company, announced that it will present two sessions at the American Diabetes Association’s 84th Scientific Sessions. The meeting will take place from June 21‑24, 2024, in Orlando, Florida. Both presentations are scheduled for Saturday, June 22, 2024, from 12:30 PM to 1:30 PM Eastern Daylight Time at West Concourse A4-B2.
The first presentation will provide a pooled safety analysis of Enobosarm, drawing data from phase 2 and phase 3 placebo-controlled trials. The second session will focus on a meta-analysis of body composition data from three randomized clinical trials, demonstrating Enobosarm’s potential to preserve muscle and reduce fat. These sessions aim to share new insights on supporting weight management and muscle preservation, important topics for patients with sarcopenic obesity in the context of diabetes care.
Read Announcement- Drug:
- Enobosarm
- Announced Date:
- May 2, 2024
- Indication:
- ER+/HER2- breast cancer
Announcement
Veru Inc announced that the Company has been invited to give a presentation at the GLP-1 Based Therapeutics Summit, taking place May 15-16, 2024, in Philadelphia, PA.
AI Summary
Veru Inc. announced that it has been invited to present at the GLP-1 Based Therapeutics Summit in Philadelphia, PA, set for May 15-16, 2024. The presentation is scheduled for Thursday, May 16, 2024, from 9:00 AM to 9:30 AM Eastern Daylight Time. During the session, Veru will discuss its strategy to combine enobosarm—an oral selective androgen receptor modulator (SARM)—with GLP-1 receptor agonist drugs. This approach aims to preserve muscle mass while promoting high-quality fat loss, potentially overcoming common issues such as weight loss plateaus and weight rebound associated with GLP-1 therapies. The presentation will highlight clinical insights on preventing muscle loss, a significant concern for older, at-risk patients who may already suffer from frailty. The summit provides an excellent platform for sharing these innovative ideas and advancing safer and more effective weight loss solutions.
Read Announcement- Drug:
- Enobosarm
- Announced Date:
- April 30, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- 2024-LATE
- Indication:
- ER+/HER2- breast cancer
Announcement
Veru Inc announced that Topline clinical data expected in the fourth quarter calendar year 2024 --
AI Summary
Veru Inc has started its Phase 2b clinical trial across 15 United States clinical sites to test enobosarm, an oral selective androgen receptor modulator (SARM), in combination with semaglutide (Wegovy®). The trial aims to determine if enobosarm can effectively preserve muscle while enhancing fat loss in patients, especially older individuals at risk of muscle weakness during weight loss. Veru expects to provide topline clinical data from this study in the fourth quarter of 2024. The trial is a carefully designed, double-blind, placebo-controlled study involving approximately 90 patients with sarcopenic obesity or overweight elderly individuals. The goal is to offer insights into improving the quality of weight loss by potentially minimizing muscle loss often seen with GLP-1 drug therapy.
Read Announcement- Drug:
- Enobosarm
- Announced Date:
- April 30, 2024
- Indication:
- ER+/HER2- breast cancer
Announcement
Veru Inc announced that it has enrolled the first patients in its Phase 2b clinical trial of enobosarm, an oral selective androgen receptor modulator (SARM), to avoid muscle loss and to augment fat loss when combined with semaglutide (Wegovy®), a Glucagon-like peptide-1 receptor agonist (GLP-1 RA) drug, for potentially higher quality weight loss.
AI Summary
Veru Inc. has reached an important milestone by enrolling the first patients in its Phase 2b clinical trial studying enobosarm, an oral selective androgen receptor modulator (SARM), to prevent muscle loss and boost fat loss. This study will combine enobosarm with semaglutide (Wegovy®), a GLP-1 receptor agonist, with the goal of achieving higher quality weight loss in patients who are overweight, especially older adults who are prone to sarcopenic obesity. The trial will be conducted at 15 clinical sites across the United States and is designed to measure changes in lean body mass and fat mass, as well as improvements in physical function. Topline clinical data is expected by the fourth quarter of 2024, and it may offer new insights into how to reduce muscle loss during weight loss treatments while enhancing the overall benefits of semaglutide.
Read Announcement
Sabizabulin (VERACITY) - FDA Regulatory Timeline and Events
Sabizabulin (VERACITY) is a drug developed by Veru for the following indication: Metastatic Castration and AR Targeting Agent Resistant Prostate Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Sabizabulin (VERACITY)
- Announced Date:
- February 13, 2025
- Indication:
- Metastatic Castration and AR Targeting Agent Resistant Prostate Cancer
Announcement
Veru Inc provided an update on progress of its clinical development programs.
AI Summary
Veru Inc. provided an update on its clinical development programs. The company shared positive topline results from its Phase 2b QUALITY study, which evaluated enobosarm in combination with semaglutide versus semaglutide alone. The trial achieved its primary endpoint by preserving lean mass and delivering greater fat loss, with the enobosarm 3mg dose showing the best improvement in muscle preservation. In addition, an Independent Data Monitoring Committee reviewed unblinded safety data and recommended that the study continue as planned. Participants are now enrolled in a Phase 2b extension study where they will stop semaglutide while continuing on either placebo or enobosarm. This extension aims to determine if enobosarm can prevent the fat regain typically seen after discontinuing a GLP-1 receptor agonist. Topline results from the extension study are anticipated in the second quarter of 2025.
Read Announcement
Wegovy - FDA Regulatory Timeline and Events
Wegovy is a drug developed by Veru for the following indication: For cardiovascular risk reduction in adults with known heart disease and overweight or obesity.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Wegovy
- Announced Date:
- June 26, 2025
- Estimated Event Date Range:
- July 1, 2025 - July 1, 2025
- Target Action Date:
- July 1, 2025
- Indication:
- For cardiovascular risk reduction in adults with known heart disease and overweight or obesity
Announcement
Novo Nordisk continues expansion of patient access to Wegovy® (semaglutide) injection 2.4 mg through a new collaboration with WeightWatchers, a global leader in science-backed weight management, beginning July 1, 2025.
AI Summary
Starting July 1, 2025, Novo Nordisk is expanding patient access to its FDA-approved Wegovy® (semaglutide) injection 2.4 mg in a new collaboration with WeightWatchers, a leader in science-based weight management. Through this partnership, WeightWatchers will work with CenterWell Pharmacy to manage prescription fulfillment and home delivery for patients using NovoCare® Pharmacy. The initiative is designed to provide an integrated support system that combines convenient access to effective medication with lifestyle guidance, aiming to improve long-term health outcomes for those living with chronic obesity. This new approach reinforces Novo Nordisk’s commitment to making safe and effective treatments more accessible through partnerships with companies that share its patient-focused values. Additionally, a special introductory offer of $299 for self-paying patients will be available from July 1 to July 31, 2025, enhancing the affordability of Wegovy® for new patients.
Read Announcement- Drug:
- Wegovy
- Announced Date:
- May 2, 2025
- Indication:
- For cardiovascular risk reduction in adults with known heart disease and overweight or obesity
Announcement
Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) submission for an investigational once-daily, 25 mg oral formulation of Wegovy® (semaglutide) for chronic weight management in adults living with obesity or overweight with one or more comorbid conditions and to reduce the risk of major adverse cardiovascular events (MACE) in adults with overweight or obesity and established cardiovascular disease.
Read Announcement- Drug:
- Wegovy
- Announced Date:
- April 29, 2025
- Indication:
- For cardiovascular risk reduction in adults with known heart disease and overweight or obesity
Announcement
LifeMD, Inc announced plans to offer broad, affordable, and streamlined access to Wegovy® (semaglutide) through NovoCare® Pharmacy.
AI Summary
LifeMD, Inc. announced plans to offer broad, affordable, and streamlined access to Wegovy® (semaglutide) through its partnership with NovoCare® Pharmacy. This new integration will allow cash-pay patients to access all FDA-approved dose strengths of Wegovy® directly within LifeMD’s virtual care platform. The service is part of LifeMD’s fast-growing weight management program and is designed to simplify the patient journey by offering a convenient, end-to-end digital care experience.
The program not only includes virtual consultations, lab testing, and personalized diet and lifestyle support but also offers a recently reduced self-pay cost of $499 per month for Wegovy®. With direct access to the medication and home delivery through NovoCare® Pharmacy, LifeMD aims to expand access to this critical treatment and improve the overall patient experience in managing obesity.
Read Announcement- Drug:
- Wegovy
- Announced Date:
- January 27, 2025
- Indication:
- For cardiovascular risk reduction in adults with known heart disease and overweight or obesity
Announcement
Veru Inc. announced positive topline results from the Phase 2b QUALITY clinical study.
AI Summary
Veru Inc. announced positive topline results from its Phase 2b QUALITY clinical study. The study tested the use of enobosarm with WEGOVY (semaglutide) in older adults who are overweight or have obesity. Results showed that patients receiving enobosarm experienced 71% less loss of lean muscle compared to those taking WEGOVY alone. Although the overall weight loss was similar between the groups, enobosarm treatment led to a greater reduction in fat mass. The study also reported that fewer patients on enobosarm suffered a significant decline in physical function, as measured by a stair climb test.
These findings suggest that enobosarm may help preserve muscle while enhancing fat loss during weight reduction therapies. The promising results have encouraged Veru Inc. to plan further discussions with the FDA and additional studies to advance this treatment approach.
Read Announcement
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