Drugs / Enobosarm
Trials 15
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03264651 | Feb 2017 → Mar 2018 | breast disorder | Havah Therapeutics Pty Ltd | Completed | No outcome recorded |
| Phase 210 trials · 1 met primary | ||||||
| Phase 2 | NCT07446998 | Mar 2026 → Oct 2027 expected | obesity disorder | Veru Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06282458 | Apr 2024 → Apr 2025 | muscular atrophy, obesity disorder | Veru Inc. | Completed | Met primary |
| Phase 2 | NCT03566290 | Jun → Sep 2018 | female stress incontinence | GTx | Withdrawn | No outcome recorded |
| Phase 2 | NCT02971761 | Jun 2017 → Oct 2020 | hormone receptor-positive breast cancer, triple-negative breast carcinoma | City of Hope Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT02746328 | Apr 2016 → Feb 2018 | estrogen-receptor positive breast cancer | GTx | Withdrawn | No outcome recorded |
| Phase 2 | NCT02658448 | Jan 2016 → Jun 2018 | female stress incontinence | GTx | Completed | No outcome recorded |
| Phase 2 | NCT02463032 | Aug 2015 → Mar 2019 | estrogen-receptor positive breast cancer | GTx | Completed | No outcome recorded |
| Phase 2 | NCT02368691 | Jun 2015 → Sep 2017 | triple-negative breast carcinoma | GTx | Terminated | No outcome recorded |
| Phase 2 | NCT01616758 | Apr 2013 → Jun 2014 | breast cancer | GTx | Terminated | No outcome recorded |
| Phase 2 | NCT00467844 | May 2007 → Sep 2008 | hypoproteinemia, hypercatabolic | GTx | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT05065411 | Apr 2022 → Oct 2023 | breast cancer | Veru Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT04869943 | Oct 2021 → Jan 2024 | breast cancer | Veru Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT01355497 | Jul 2011 → May 2013 | muscular atrophy, non-small cell lung carcinoma | GTx | Completed | No outcome recorded |
| Phase 3 | NCT01355484 | Jul 2011 → May 2013 | muscular atrophy, non-small cell lung carcinoma | GTx | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT03508648 Comparator | May → Sep 2018 | female stress incontinence | GTx | Withdrawn | No outcome recorded |
| Phase 2 | NCT03241342 Comparator | Aug 2017 → Sep 2018 | female stress incontinence | GTx | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 19
| Date | Issuer | Release |
|---|---|---|
| 2025-09-23 | Veru Inc. | Regulatory 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 verupharma.com ↗
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. |
| 2025-08-11 | Veru Inc. | Results Veru Announces Selection of Novel Modified Release Oral Enobosarm Formulation for Chronic Weight Loss Management Following Pharmacokinetic Clinical Study verupharma.com ↗
The new formulation demonstrated the intended distinct target product release profile, which includes 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. |
| 2025-06-24 | Veru Inc. | Results Veru Reports Positive Results from Phase 2b QUALITY and Maintenance Extension Study Showing Enobosarm Significantly Reduced Body Weight Regain, Prevented Fat Regain, and Preserved Lean Mass After Semaglutide Discontinuation verupharma.com ↗ |
| 2025-05-28 | Veru Inc. | Results Veru Reports Positive Safety Results from Phase 2b QUALITY Study: Enobosarm Added to Semaglutide Led to Greater Fat Loss, Preservation of Muscle, and Fewer Gastrointestinal Side Effects Compared to Semaglutide Alone verupharma.com ↗
Enobosarm 3mg + semaglutide combination had the added benefit of fewer gastrointestinal side effects (Diarrhea, Nausea, and GERD) compared to semaglutide alone |
| 2025-01-27 | Veru Inc. | Results Veru Announces Positive Topline Data from Phase 2b QUALITY Clinical Study: Enobosarm Preserved Lean Mass in Patients Receiving WEGOVY® (Semaglutide) for Weight Reduction verupharma.com ↗
Enobosarm treatment resulted in statistically significant reduction in the loss of lean mass in subjects receiving WEGOVY (p=0.002) |
| 2024-11-05 | Veru Inc. | Results Veru Announces Meta-analysis of Body Composition Data from Older Patients with Obesity which Supports Potential for Enobosarm to Optimize Weight Loss at ObesityWeek verupharma.com ↗
At Day 147, enobosarm 3mg treated subjects compared to placebo had greater total weight loss by DEXA scan (-2.93 kg for enobosarm and -2.11 kg for placebo). |
| 2024-06-24 | Veru Inc. | Results Veru Announces Safety and Body Composition Data from Two Late-Breaker Presentations at the American Diabetes Association's 84th Scientific Sessions verupharma.com ↗
In a pooled analysis of 1,027 older men, postmenopausal women, and older patients with advanced cancer, enobosarm was well tolerated with an adverse event profile comparable to the control patients. |
| 2024-02-08 | Veru Inc. | Regulatory Veru Reports Fiscal 2024 First Quarter Financial Highlights verupharma.com ↗ |
| 2024-02-06 | Veru Inc. | Regulatory Veru Announces FDA Clearance of IND Application to Initiate Phase 2b Clinical Trial with Enobosarm to Treat Muscle Loss Associated with Weight Loss Drugs verupharma.com ↗ |
| 2024-01-08 | Veru Inc. | Regulatory Veru Submits IND Application to FDA for the Development of Enobosarm to Prevent Muscle Loss While Augmenting Fat Loss in Combination with GLP-1 Drugs for Weight Loss verupharma.com ↗
Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of obesity, oncology, and viral induced acute respiratory distress syndrome, today announced submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration for the development of enobosarm for obesity. |
| 2023-10-04 | Veru Inc. | Results Veru Reports Muscle Data from 5 Clinical Studies of Enobosarm that Support the Advancement of Enobosarm in Combination with Weight-Loss GLP-1 Drugs, Ozempic®, Wegovy®, or Mounjaro®, to Optimize Weight Loss by Preventing Muscle Wasting and Further Increasing Fat Loss in a Phase 2b Obesity Clinical Study verupharma.com ↗
In 5 clinical studies involving 968 older men and postmenopausal women with and without muscle wasting, enobosarm has demonstrated the ability to decrease fat mass, increase muscle mass, and improve muscle strength and physical function |
| 2023-09-11 | Veru Inc. | Results Veru Reports Clinical Data from the Discontinued ARTEST Study of Enobosarm, Novel Selective Androgen Receptor Targeting Agonist, in AR+ ER+ HER2- Metastatic Breast Cancer verupharma.com ↗
Overall response rates of 12.5% are observed in the enobosarm group in a heavily pretreated population versus no responses in the standard of care active control arm. |
| 2022-01-10 | Veru Inc. | Regulatory Veru Announces FDA Grant of Fast Track Designation for Enobosarm for the Treatment of AR+ ER+ HER2- Metastatic Breast Cancer verupharma.com ↗ |
| 2021-12-08 | Veru Inc. | Results Veru Announces Presentation of Preclinical Evidence Supporting the Therapeutic Benefit of Enobosarm Alone or in Synergistic Combination with a CDK4/6 Inhibitor Against Palbociclib Resistant Metastatic Breast Cancer at the 2021 San Antonio Breast Cancer Symposium verupharma.com ↗
The combination of palbociclib and enobosarm treatment was synergistic and resulted in the almost complete inhibition of the growth of the tumors in the human PDX AR+ER+ breast cancer model (CTPx4353). |
| 2021-06-07 | Veru Inc. | Results Veru Announces Positive Phase 2 Clinical Data: Efficacy of Enobosarm Therapy Correlates with Androgen Receptor Levels in AR+ER+HER2- Metastatic Breast Cancer Presented at the 2021 ASCO Annual Meeting verupharma.com ↗
In Phase 2 study, enobosarm, an oral selective androgen receptor (AR) agonist, had the most significant antitumor effects in heavily pretreated AR+ER+ metastatic breast cancer subjects with ≥ 40% AR expression in cancer tissue |
| 2021-05-24 | Veru Inc. | Results Veru Announces Acceptance of Two Abstracts for Presentation at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting verupharma.com ↗
Efficacy of enobosarm, a selective androgen receptor (AR) targeting agent, correlates with degree of AR positivity in advanced AR+/estrogen receptor (ER)+ breast cancer in an international Phase 2 clinical study |
| 2021-05-05 | Veru Inc. | Results Veru Announces the Presentation of Positive Phase 2 Clinical Data of Enobosarm in AR+ER+HER2- Metastatic Breast Cancer Patients that Have Progressed on Estrogen Blocking Agents and CDK 4/6 Inhibitor at the ESMO Breast Cancer Congress 2021 verupharma.com ↗
The overall mean radiographic progression free survival for the 9mg dose was 10 months. |
| 2021-01-19 | Veru Inc. | Results Veru Announces Nature Medicine Publication Demonstrating that Enobosarm, an Androgen Receptor Targeted Agent, Inhibits Hormone Receptor Positive Metastatic Breast Cancer that has Become Resistant to Estrogen Receptor Targeted Endocrine and CDK4/6 Inhibitor Therapies verupharma.com ↗
In the Nature Medicine publication, Dr. Hickey and colleagues provide scientific evidence supporting a new discovery in breast cancer demonstrating that the androgen receptor acts like a tumor suppressor. |
| 2020-12-14 | Veru Inc. | Results Veru Reports Positive Phase 2 Clinical Trial Results for Enobosarm, Selective Androgen Receptor Targeting Agent, for Endocrine Resistant Metastatic Breast Cancer verupharma.com ↗
Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate and breast cancer, announces positive Phase 2 clinical trial results for enobosarm, an oral, novel selective androgen receptor (AR) targeting agent, for the treatment of endocrine and chemotherapy resistant ER+/HER2- metastatic breast cancer, which was selected as a Spotlight Presentation at the 2020 San Antonio Breast Cancer Symposium. |
All press releases naming this drug 33 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | enobosarm | “This randomised, double-blind, placebo-controlled phase 2 trial assessed the efficacy and safety of enobosarm, a selective androgen receptor modulator, in patients with cancer.” PMID 23499390 ↗ Mar 20137“Enobosarm, a nonsteroidal SARM, is an agent in clinical development for prevention and treatment of muscle wasting in patients with cancer” PMID 27138015 ↗ Jun 2016 |
| Known as | GTx-024 | “Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.” NCT03241342 ↗ |
| Known as | MK-2866 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1738889 ↗ |
| Known as | Ostarine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1738889 ↗ |
| Action | Inhibit | “Hormone therapy using enobosarm may fight breast cancer by blocking the use of androgen by the tumor cells.” NCT02971761 ↗ |
| Modality | Small molecule | “Enobosarm, a nonsteroidal SARM” PMID 27138015 ↗ Jun 2016 |
| Route | Oral | “receive once-daily oral enobosarm 1 mg, 3 mg, or placebo” PMID 23499390 ↗ Mar 2013 |
| Target | AR | “enobosarm, a selective androgen receptor modulator” PMID 23499390 ↗ Mar 2013 |