Product Description
Enobosarm (aka ostarine, MK-2866, GTx-024, and VERU-024), a novel oral daily selective androgen receptor modulator (SARM), has been previously studied in 5 clinical studies involving 968 older normal men and postmenopausal women as well as older patients who have muscle wasting because of advanced cancer. Advanced cancer causes the loss of appetite where there is significant unintentional loss or wasting of both muscle and fat mass which is similar to what is observed with in patients taking GLP-1 RA drugs. We believe the totality of the clinical data from these previous five clinical trials demonstrates that enobosarm treatment leads to dose-dependent increases in muscle mass with improvements in physical function as well as significant dose-dependent reductions in fat mass. The patient data generated from these five enobosarm clinical trials in both elderly patients and in patients with a cancer induced appetite suppression provide strong clinical rationale for enobosarm. The expectation is that enobosarm in combination with a GLP-1 RA would potentially augment the fat reduction and total weight loss while preserving muscle mass. (Sourced from: https://ir.verupharma.com/news-events/press-releases/detail/225/veru-announces-positive-topline-data-from-phase-2b-quality)
Mechanisms of Action: SARM Modulator
Novel Mechanism: Yes
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Fast Track - Breast Cancer|Oncology Solid Tumor Unspecified *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Company: Oncternal Therapeutics
Company Location:
Company Founding Year: 2013
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: United States
Active Clinical Trial Count: 3
Recent & Upcoming Milestones
- Clinical Outcomes Expected - Veru announced they will present P2 Obesity results in 4Q27 for Enobosarm
- Clinical Outcomes Expected - Veru announced they will present P2 Obesity results in 1Q27 for Enobosarm
- Clinical Outcomes Reported - Veru presented Unknown Obesity results on 2025-11-07 for Enobosarm
Highest Development Phases
Phase 3: Breast Cancer
Phase 2: Muscular Atrophy|Obesity|Overweight
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT07446998 |
PLATEAU | P2 |
Recruiting |
Obesity|Overweight |
2027-10-01 |
50% |
2026-03-27 |
Primary Endpoints|Treatments|Trial Status |
NCT06282458 |
QUALITY | P2 |
Completed |
Obesity|Muscular Atrophy |
2025-04-11 |
37% |
2025-09-18 |
Primary Endpoints |
2021-002176-39 |
2021-002176-39 | P3 |
Active, not recruiting |
Breast Cancer |
2024-12-22 |
2022-03-13 |
Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
03/09/2026 |
News Article |
Veru Enrolls First Patient in Phase 2b PLATEAU Clinical Trial of Enobosarm and Semaglutide Combination for High Quality Weight Loss |
|
02/04/2026 |
News Article |
Veru to Report Fiscal 2026 First Quarter Financial Results on February 11th |
|
12/10/2025 |
News Article |
Veru to Report Fiscal Year 2025 Financial Results on December 17th |
|
12/04/2025 |
News Article |
Veru to Present at The Society on Sarcopenia, Cachexia, and Wasting Disorders 18th International Conference and Regulatory and Clinical Trials Update Regulatory Workshop |
