Vamorolone

DRUG7 trials

Sponsors

ReveraGen BioPharma, Inc., Santhera Pharmaceuticals, Catalyst Pharmaceuticals, Inc.

Conditions

Becker Muscular DystrophyDrug InteractionDuchenne Muscular DystrophyPharmacodynamic

Phase 1

Evaluation of Vamorolone Mineralocorticoid Receptor Antagonism in Healthy Subjects

CompletedNCT06649409

Santhera PharmaceuticalsPharmacodynamic

Start: 2024-06-05End: 2024-07-06Updated: 2025-09-11

Evaluation of Vamorolone CYP3A4 Induction on Midazolam (a Sensitive CYP 3A4 Substrate) Pharmacokinetics

CompletedNCT06689527

Santhera PharmaceuticalsDrug Interaction

Start: 2024-08-13End: 2024-10-16Updated: 2025-12-15

Phase 2

A Study to Assess the Efficacy and Safety of Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)

CompletedNCT03439670

ReveraGen BioPharma, Inc.Duchenne Muscular Dystrophy

Start: 2018-06-29End: 2021-08-19Updated: 2023-03-09

A Study to Assess Vamorolone in Becker Muscular Dystrophy (BMD)

CompletedNCT05166109

ReveraGen BioPharma, Inc.Becker Muscular Dystrophy

Start: 2022-07-07End: 2025-08-18Updated: 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)

CompletedNCT05185622

Santhera PharmaceuticalsDuchenne Muscular Dystrophy

Start: 2022-03-21End: 2024-07-16Updated: 2025-10-24

Unknown Phase

Expanded Access Protocol for Boys With Duchenne Muscular Dystrophy

Santhera PharmaceuticalsDuchenne Muscular Dystrophy

Updated: 2026-01-20

Registry Study to Observe Long-term Safety of Vamorolone (AGAMREE®) in Patients With Duchenne Muscular Dystrophy-SUMMIT

RecruitingNCT06564974

Catalyst Pharmaceuticals, Inc.Duchenne Muscular Dystrophy

Start: 2024-09-25End: 2032-02-01Target: 250Updated: 2026-07-20

Related Papers

Prednisone, not vamorolone, suppresses novel serum bone and cartilage biomarkers associated with growth failure in children with Duchenne muscular dystrophy

Scientific Reports2026-08-03

Vamorolone for Duchenne Muscular Dystrophy: A Cross-Trial Efficacy Comparison With Classic Corticosteroids From the FOR-DMD Trial.

2026-05-27

Vamorolone Safety, Pharmacokinetics, and Exploratory Efficacy in Duchenne Muscular Dystrophy: A Phase II, Nonrandomized, Multiple-Dose Study in 2-<4-Year-Old Boys.

2026-05-15

Results of a phase II open-label, multiple-dose study of vamorolone (VBP15-006) in 7- to < 18-year-old boys with duchenne muscular dystrophy.

2026-03-03

Mineralocorticoid receptor antagonism of vamorolone: Evidence from LIONHEART and VISION-DMD clinical trials

Steroids2025-09-153 citations

Efficacy and Safety of Vamorolone Over 48 Weeks in Boys With Duchenne Muscular Dystrophy: A Randomized Controlled Trial.

2024-02-0947 citations

Efficacy and Safety of Vamorolone vs Placebo and Prednisone Among Boys With Duchenne Muscular Dystrophy

JAMA Neurology2022-08-29106 citations

Efficacy and Safety of Vamorolone in Duchenne Muscular Dystrophy

JAMA Network Open2022-01-2578 citations

Efficacy and safety of vamorolone in Duchenne muscular dystrophy: An 18-month interim analysis of a non-randomized open-label extension study

PLoS Medicine2020-09-2177 citations