Puldysa (Idebenone)

Puldysa (Idebenone)

Status

Phase |||

Therapeutic Approach

Restoring the Cells Energy

Puldysa is thought to have a dual effect in Duchenne – mitochondrial activation and protection. Puldysa is thought to increase the energy output of the cells’ mitochondria – the parts (“factories”) of the cell that generate all of a cells’ energy. Mitochondria produce the energy necessary for the cell functioning through a process called “cellular respiration” which requires oxygen and produces energy. During cellular respiration, some toxic forms of oxygen (called oxygen free radicals) can be produced. These free radicals must be neutralized by other substances to avoid cellular damage. Puldysa is expected to act as a neutralizer of these toxic forms of oxygen. Thus, Puldysa is expected to have an antioxidant effect, and consequently prevent cellular damage.

Status

A Phase 3 study is currently actively recruiting.

On April 1, 2020, Santhera Pharmaceuticals shared an update with the community regarding the SIDEROS clinical trial and their activities during the COVID-19 epidemic.

Sponsor

This program is sponsored by Santhera Pharmaceuticals.

Related Studies

ONGOING
A Phase III Double-blind Study With Idebenone in Patients With Duchenne Muscular Dystrophy (DMD) Taking Glucocorticoid Steroids
OPEN LABEL EXTENSION
Phase III Study With Idebenone in Patients With Duchenne Muscular Dystrophy (SIDEROS-E)

Media Library

JUNE 2019

Santhera Presents at the PPMD 2019 Annual Conference

MAY 2019

Webinar: Santhera Update to the Duchenne Community

Parent Project Muscular Dystrophy and Santhera Pharmaceuticals hosted a webinar May 8, 2019 to provide the community with an update about respiratory health in Duchenne muscular dystrophy and the ongoing SIDEROS clinical trial.
JUNE 2018

Santhera Presents at the PPMD 2018 Annual Conference

MARCH 2017

Webinar: Idebenone Clinical Trials in Duchenne

Parent Project Muscular Dystrophy and Santhera Pharmaceuticals hosted a webinar on March 9, 2017 to discuss idebenone clinical trials in Duchenne.

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