Trial Profile
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Crossover Trial to Evaluate the Safety, Tolerability, and Efficacy of Subcutaneous Injections of Elamipretide (MTP-131) in Subjects With Genetically Confirmed Barth Syndrome Followed by an Open-Label Treatment Extension
Status:
Completed
Phase of Trial:
Phase II/III
Latest Information Update: 14 Mar 2023
Price :
$35
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At a glance
- Drugs Elamipretide (Primary)
- Indications Barth syndrome
- Focus Registrational; Therapeutic Use
- Acronyms TAZPOWER
- Sponsors Stealth BioTherapeutics
- 09 Mar 2023 Results presented in a Stealth BioTherapeutics media release.
- 09 Mar 2023 According to a Stealth BioTherapeutics media release, company will present data from week 168 at the 2023 American College of Medical Genetics Meeting, to be held March 14-18, 2023 in Salt Lake City, Utah.
- 15 Sep 2022 According to a Stealth BioTherapeutics media release, the company met with the Division of Cardiology and Nephrology at the FDA to discuss data from Week 168 Part 2 open-label extension. The company has requested an additional meeting with the FDA to gain further clarity on a regulatory path forward.