Vamorolone

Generic Name
Vamorolone
Brand Names
Agamree
Drug Type
Small Molecule
Chemical Formula
C22H28O4
CAS Number
13209-41-1
Unique Ingredient Identifier
8XP29XMB43
Background

Vamorolone is under investigation in clinical trial NCT03439670 (A Study to Assess the Efficacy and Safety of Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)).

Indication

Vamorolone is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients ≥2 years of age.

Associated Conditions
Duchenne Muscular Dystrophy (DMD)
Associated Therapies
-

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

First Posted Date
2024-11-14
Last Posted Date
2024-11-14
Lead Sponsor
Santhera Pharmaceuticals
Target Recruit Count
18
Registration Number
NCT06689527
Locations
🇩🇪

Nuvisan GmbH, Neu-Ulm, Germany

Evaluation of Vamorolone Mineralocorticoid Receptor Antagonism in Healthy Subjects

First Posted Date
2024-10-18
Last Posted Date
2024-10-18
Lead Sponsor
Santhera Pharmaceuticals
Target Recruit Count
30
Registration Number
NCT06649409
Locations
🇩🇪

Nuvisan GmbH, Neu-Ulm, Germany

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

Recruiting
Conditions
First Posted Date
2024-08-21
Last Posted Date
2024-12-13
Lead Sponsor
Catalyst Pharmaceuticals, Inc.
Target Recruit Count
250
Registration Number
NCT06564974
Locations
🇺🇸

Arkansas Childrens Hospital, Little Rock, Arkansas, United States

🇺🇸

University of Massachusetts Memorial Medical Center, North Worcester, Massachusetts, United States

🇺🇸

Duke University Medical Center and Childrens Health Center, Durham, North Carolina, United States

and more 3 locations

A Study to Assess Vamorolone in Boys Ages 2 to <4 Years and 7 to <18 Years With Duchenne Muscular Dystrophy (DMD)

Phase 2
Completed
Conditions
Interventions
First Posted Date
2022-01-11
Last Posted Date
2024-10-16
Lead Sponsor
Santhera Pharmaceuticals
Target Recruit Count
54
Registration Number
NCT05185622
Locations
🇨🇦

Alberta's Children Hospital, Calgary, Alberta, Canada

🇨🇦

Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada

🇨🇦

The Hospital for Sick Children, Toronto, Ontario, Canada

and more 2 locations

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

Phase 2
Recruiting
Conditions
Interventions
First Posted Date
2021-12-21
Last Posted Date
2024-08-19
Lead Sponsor
ReveraGen BioPharma, Inc.
Target Recruit Count
39
Registration Number
NCT05166109
Locations
🇺🇸

University of Pittsburgh, Pittsburgh, Pennsylvania, United States

🇮🇹

Azienda Ospedale Universita Padova, Padova, Italy

Expanded Access Protocol for Boys With Duchenne Muscular Dystrophy

First Posted Date
2019-03-05
Last Posted Date
2023-11-09
Lead Sponsor
Santhera Pharmaceuticals
Registration Number
NCT03863119
Locations
🇺🇸

Duke University, Durham, North Carolina, United States

🇺🇸

University of California Davis, Davis, California, United States

🇺🇸

Nemours Children's Hospital, Orlando, Florida, United States

and more 9 locations

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

First Posted Date
2018-02-20
Last Posted Date
2023-03-09
Lead Sponsor
ReveraGen BioPharma, Inc.
Target Recruit Count
121
Registration Number
NCT03439670
Locations
🇨🇦

Montreal Children's Hospital, Montréal, Quebec, Canada

🇧🇪

Ghent University Hospital, Ghent, Belgium

🇺🇸

University of Texas Southwestern Medical Center, Dallas, Texas, United States

and more 30 locations
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