Ozmosi | Vamorolone Drug Profile
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Vamorolone

Pronounced as: vuh-MOR-uh-lone

Alternative Names: vamorolone, vbp15
Clinical Status: Active
Latest Update: 2026-02-27
Latest Update Note: Clinical Trial Update

Product Description

Vamorolone is a first-in-class drug candidate that binds to the same receptors as corticosteroids but modifies the downstream activity of the receptors1,2. This has the potential to 'dissociate' efficacy from typical steroid safety concerns and therefore could emerge as a valuable alternative to corticosteroids, the current standard of care in children and adolescent patients with DMD. There is a clear unmet medical need in this patient group as high dose corticosteroids have significant systemic side effects that detract from patient quality of life. On September 2, 2020, Santhera exercised its option and obtained worldwide rights to vamorolone in Duchenne muscular dystrophy and all other indications. (Sourced from: https://www.santhera.com/health-care-professionals/vamorolone)

Mechanisms of Action: Steroid receptor Agonist

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: Priority Review - Muscular Dystrophies|Muscular Dystrophy, Duchenne *

Approval Status: Approved

Approved Countries: Czech

Approved Indications: None

Known Adverse Events: None

Company: Santhera
Company Location:
Company Founding Year: None
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Vamorolone

Countries in Clinic: Canada, China, Germany, Italy, United States

Active Clinical Trial Count: 7

Recent & Upcoming Milestones

  • Clinical Outcomes Reported - Catalyst Biosciences presented P2 Muscular Dystrophy, Duchenne results on 2024-03-03 for Vamorolone
  • Clinical Outcomes Reported - Catalyst Biosciences presented P2 Muscular Dystrophy, Duchenne results on 2024-02-21 for Vamorolone
  • Catalyst Pharmaceuticals announced a PDUFA action date of October 26, 2023, for vamorolone, a promising treatment for Duchenne muscular dystrophy.

Highest Development Phases

Phase 2: Muscular Dystrophy, Becker|Muscular Dystrophy, Duchenne

Phase 1: Healthy Volunteers

Trial ID

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated

NCT05166109

VBP15-BMD-001

P2

Completed

Muscular Dystrophy, Duchenne|Muscular Dystrophy, Becker

2025-08-18

50%

2025-09-19

NCT06649409

SNT-I-VAM-026

P1

Completed

Healthy Volunteers

2024-06-29

2024-10-19

Primary Endpoints|Treatments

CTR20232865

CTR20232865

P1

Completed

Muscular Dystrophy, Duchenne

2024-01-08

2025-04-29

NCT06689527

SNT-I-VAM-025

P1

Completed

Healthy Volunteers

2024-09-24

2025-12-16

Primary Endpoints|Treatments

2022-000844-31

Trial of Vamorolone vs. Placebo for the Treatment of Becker Muscular Dystrophy

P2

Completed

Muscular Dystrophy, Becker

2025-05-18

2025-05-06

NCT05185622

VBP15-006

P2

Completed

Muscular Dystrophy, Duchenne

2024-07-16

50%

2025-10-28

2025-000201-16

006

P2

Completed

Muscular Dystrophy, Duchenne

2024-05-07

2025-07-09

Primary Completion Date|Start Date|Study Completion Date|Treatments