5 completed, 1 active not recruiting, 1 available, 1 recruiting. 3 Phase 2, 2 Phase 1, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 3 | Completed 3 |
| Phase 1 | 2 | Completed 2 |
| Phase 4 | 1 | Active not recruiting 1 |
Follow Vamorolone: new trials by email Literature Review of Vamorolone trials Research Report on Vamorolone
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study on Safety and Effectiveness of Long-term Treatment With Vamorolone in Boys With Duchenne Muscular Dystrophy vamorolone 40 mg/mL oral suspension - Duchenne Muscular Dystrophy | Phase 4 | Active not recruiting | Santhera Pharmaceuticals | 80 | 2024-11-10 | 2026-04-23 |
| Registry Study to Observe Long-term Safety of Vamorolone (AGAMREE®) in Patients With Duchenne Muscular Dystrophy-SUMMIT Vamorolone - Duchenne Muscular Dystrophy | Recruiting | Catalyst Pharmaceuticals, Inc. | 250 | 2024-09-25 | 2026-09-24 | |
| Evaluation of Vamorolone CYP3A4 Induction on Midazolam (a Sensitive CYP 3A4 Substrate) Pharmacokinetics Vamorolone, Midazolam - Drug Interaction | Phase 1 | Completed | Santhera Pharmaceuticals | 18 | 2024-08-13 | 2025-12-15 |
| Evaluation of Vamorolone Mineralocorticoid Receptor Antagonism in Healthy Subjects Vamorolone, Eplerenone, Fludrocortisone - Pharmacodynamic | Phase 1 | Completed | Santhera Pharmaceuticals | 30 | 2024-06-05 | 2025-09-11 |
| A Study to Assess Vamorolone in Becker Muscular Dystrophy (BMD) Vamorolone, Placebo - Becker Muscular Dystrophy | Phase 2 | Completed | ReveraGen BioPharma, Inc. | 46 | 2022-07-07 | 2026-09-15 |
| A Study to Assess Vamorolone in Boys Ages 2 to <4 Years and 7 to <18 Years With Duchenne Muscular Dystrophy (DMD) Vamorolone - Duchenne Muscular Dystrophy | Phase 2 | Completed | Santhera Pharmaceuticals | 54 | 2022-03-21 | 2025-10-24 |
| A Study to Assess the Efficacy and Safety of Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD) Vamorolone, Prednisone, Placebo - Duchenne Muscular Dystrophy | Phase 2 | Completed | ReveraGen BioPharma, Inc. | 121 | 2018-06-29 | 2023-03-09 |
| Expanded Access Protocol for Boys With Duchenne Muscular Dystrophy Vamorolone - Duchenne Muscular Dystrophy | Available | Santhera Pharmaceuticals | 2026-01-20 |
Muscular Dystrophy, Duchenne (6) · Muscular Dystrophies (3)
Santhera Pharmaceuticals (5) · ReveraGen BioPharma, Inc. (2) · Catalyst Pharmaceuticals, Inc. (1)
United States (4) · Canada (3) · Israel (3) · Belgium (2) · Czechia (2) · Germany (2) · Greece (2) · Netherlands (2) · Spain (2) · United Kingdom (2) · Australia (1) · Ireland (1) · Italy (1) · New Zealand (1) · Puerto Rico (1)
Paula Clemens, M.D. (2) · Aravindham Veerapandiyan, MD (1) · Jean K Mah, M.D. (1) · Michael Lissy, MD (1) · Michela Guglieri, M.D. (1) · Steffen Haffner, MD (1) · William Andrews, MD (1)
PMID 40957504, PMID 41774261, PMID 42139656, PMID 36036925, PMID 38335499, PMID 42202243, PMID 42547787, PMID 42613652