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
Known Adverse Events: None
Company: Oncternal Therapeutics
Company Location:
Company CEO: James B. Breitmeyer
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: United States
Active Clinical Trial Count: 2
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Veru presented Unknown Obesity results on 2025-11-07 for Enobosarm
- Clinical Outcomes Reported - Veru presented P2 Weight Loss results on 2025-06-24 for Enobosarm
- Clinical Outcomes Reported - Veru presented P2 Weight Loss results on 2025-05-28 for Enobosarm
Highest Development Phases
Phase 3: Breast Cancer
Phase 2: Muscular Atrophy|Obesity
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
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 |
