8 completed, 1 active not recruiting, 1 available, 1 recruiting. 7 Phase 2, 3 Phase 1, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 7 | Completed 6, Withdrawn 1 |
| Phase 1 | 3 | Completed 2, Withdrawn 1 |
| Phase 4 | 1 | Active not recruiting 1 |
Follow VBP15 compound: new trials by email Literature Review of VBP15 compound trials Research Report on VBP15 compound
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 |
| Proof of Concept Trial of Vamorolone in Pediatric Ulcerative Colitis Vamorolone 4% suspension for oral dosing - Pediatric Ulcerative Colitis | Phase 1 / Phase 2 | Withdrawn | ReveraGen BioPharma, Inc. | 2020-09-01 | 2020-09-29 | |
| 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 |
| Long-term Extension Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD) Vamorolone 0.25 mg/day/day, Vamorolone 0.75 mg/day/day, Vamorolone 2.0 mg/day/day - Duchenne Muscular Dystrophy | Phase 2 | Completed | ReveraGen BioPharma, Inc. | 46 | 2017-02-02 | 2021-05-20 |
| An Extension Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD) Vamorolone 0.25 mg/day/day, Vamorolone 0.75 mg/day/day, Vamorolone 2.0 mg/day/day - Duchenne Muscular Dystrophy | Phase 2 | Completed | ReveraGen BioPharma, Inc. | 48 | 2016-07-28 | 2019-07-23 |
| A Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD) Vamorolone 0.25 mg/kg/day, Vamorolone 0.75 mg/kg/day, Vamorolone 2.0 mg/kg/day - Duchenne Muscular Dystrophy | Phase 2 | Completed | ReveraGen BioPharma, Inc. | 48 | 2016-06-01 | 2019-01-02 |
| Expanded Access Protocol for Boys With Duchenne Muscular Dystrophy Vamorolone - Duchenne Muscular Dystrophy | Available | Santhera Pharmaceuticals | 2026-01-20 |
Muscular Dystrophy, Duchenne (9) · Muscular Dystrophies (3) · Pediatric ulcerative colitis (1)
ReveraGen BioPharma, Inc. (6) · Santhera Pharmaceuticals (5) · Catalyst Pharmaceuticals, Inc. (1)
United States (7) · Canada (6) · Israel (6) · United Kingdom (5) · Australia (4) · Sweden (4) · Belgium (2) · Czechia (2) · Germany (2) · Greece (2) · Netherlands (2) · Spain (2) · Ireland (1) · Italy (1) · New Zealand (1)
Paula R Clemens, MD (3) · Paula Clemens, M.D. (2) · Aravindham Veerapandiyan, MD (1) · Jean K Mah, M.D. (1) · Laurie Conklin, MD (1) · Michael Lissy, MD (1) · Michela Guglieri, M.D. (1) · Steffen Haffner, MD (1) · William Andrews, MD (1)
PMID 32956407, PMID 42613652, PMID 32434278, PMID 38521535, PMID 40957504, PMID 41774261, PMID 42139656, PMID 35076703, PMID 36036925, PMID 38335499, PMID 42202243, PMID 42547787
R44NS095423 (2), U34AR068616 (2)