Vamorolone (VBP15)

Vamorolone (VBP15)

Status

Phase |||

Therapeutic Approach

Reducing Inflammation

Vamorolone is a first-in-class drug that borrows some activities of corticosteroids (anti-inflammatory activity via NFkB repression), while adding new activities not seen with corticosteroids (eplerenone-like activity; membrane stabilization activity). Vamorolone hopes to retain the beneficial anti-inflammatory and muscle strengthening aspects of corticosteroids, while decreasing some of the undesirable side effects (bone fragility, stunted growth, insulin resistance, mood changes, delay of puberty and others). Vamorolone is given as an oral liquid flavored formulation at home daily.

Status

Santhera currently has a New Drug Application (NDA) under review with the FDA with a target date of October 26th, 2023. Learn more here.

Sponsor

This program is sponsored by Santhera Pharmaceuticals and has been partially funded by Parent Project Muscular Dystrophy.

Related Studies

ONGOING
A Study to Assess the Efficacy and Safety of Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)
ACTIVELY RECRUITING
A Study to Assess Vamorolone in Becker Muscular Dystrophy (BMD)
ACTIVELY RECRUITING
A Study to Assess Vamorolone in Boys Ages 2 to <4 Years and 7 to <18 Years With Duchenne Muscular Dystrophy (DMD)
OPEN LABEL EXTENSION
Long-term Extension Study to Assess Vamorolone

Media Library

JUNE 2021

Santhera Pharmaceuticals Presents at the PPMD 2021 Virtual Annual Conference


Pre-recorded content for PPMD's 2021 Virtual Annual Conference On-Demand Library
MAR 2021

Santhera Pharmaceuticals Duchenne Drug Development Update


Santhera Pharmaceuticals joined Parent Project Muscular Dystrophy (PPMD) for a webinar on March 24, 2021 to provide an update to the community about the investigational therapy vamorolone, the use of steroids to treat Duchenne muscular dystrophy, clinical trials for vamorolone, and development timelines.
JULY 2020

ReveraGen Presents at the PPMD 2020 Virtual Annual Conference

Pre-recorded content for PPMD's 2020 Virtual Annual Conference On-Demand Library
JUNE 2019

Paula Clemmons, MD Presents at the PPMD 2019 Annual Conference

JAN 2019

Webinar: Vamorolone Clinical Trials in Duchenne

On January 30, 2019, ReveraGen joined Parent Project Muscular Dystrophy for a webinar to provide the community with an overview of the vamorolone drug development program for Duchenne, including results showing improved muscle function in completed clinical trials in 48 Duchenne boys, and a description of an ongoing clinical trial of 120 Duchenne boys that is accepting new patients at 30 sites internationally.
JUNE 2018

ReveraGen Presents at the PPMD 2018 Annual Conference

JAN 2017

Webinar: Vamorolone (VBP15) Clinical Trials in Duchenne

On January 18, 2017, PPMD was joined by ReveraGen BioPharma for a webinar discussion on vamorolone (VBP15) clinical trials in Duchenne.

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