§ 01 Overview
Overview
Tetrapeptide that targets the inner mitochondrial membrane, stabilizes cardiolipin, and improves ATP production in dysfunctional mitochondria.
Multiple Phase II/III trials (MMPOWER, ReCLAIM). Mixed results; Barth syndrome trial showed functional improvements.
§ 02 Mechanism
Mechanism of action
SS-31 selectively binds cardiolipin on the inner mitochondrial membrane, preserving cristae structure, reducing ROS leakage from the electron transport chain, and restoring ATP synthesis in stressed mitochondria.
- 01Improved mitochondrial efficiency
- 02Reduced oxidative stress
- 03Investigated for heart failure, Barth syndrome, and primary mitochondrial myopathy
§ 03 Dosing
Dosing protocol
Standard Protocol
- Vial
- 50 mg
- BAC Water
- 2 ml BAC water
- Dose Range
- 20 – 40 mg daily (trial protocol)
- Starting Dose
- 20 mg
- Route
- SubQ
- Timing
- AM
- Frequency
- Daily
- Cycle
- 8–12 weeks
§ 04 Evidence
Evidence & research
Multiple Phase II/III trials (MMPOWER, ReCLAIM). Mixed results; Barth syndrome trial showed functional improvements.
FDA Status
Under FDA review for Barth syndrome; denied approval in 2020 for primary mitochondrial myopathy; resubmitted in 2024.
§ 05 Stacks
Common stacks
§ 06 News
In the news
8 articles from the last 12 months · updates hourly
The ‘rising tide’ of mitochondrial therapies in longevity - Longevity.Technology
The ‘rising tide’ of mitochondrial therapies in longevity Longevity.Technology
The Winding Road from Bench to FDA Approval for First Mitochondria-Targeting Drug - WCM Newsroom
The Winding Road from Bench to FDA Approval for First Mitochondria-Targeting Drug WCM Newsroom
Some reviewers opposed FDA's approval of new drug for life-threatening disease - Cardiovascular Business
Some reviewers opposed FDA's approval of new drug for life-threatening disease Cardiovascular Business
Exclusive: US FDA cleared pricey rare disease drug over reviewer objections - Reuters
Exclusive: US FDA cleared pricey rare disease drug over reviewer objections Reuters
Former US FDA CDER Director Says He Played Key Role In Stealth’s Elamipretide Approval - Citeline News & Insights
Former US FDA CDER Director Says He Played Key Role In Stealth’s Elamipretide Approval Citeline News & Insights
Stealth BioTherapeutics Announces Mito Assist™ Patient Support Program and Specialty Pharmacy Partnership with AnovoRx to Distribute FORZINITY™(elamipretide) injection - PR Newswire
Stealth BioTherapeutics Announces Mito Assist™ Patient Support Program and Specialty Pharmacy Partnership with AnovoRx to Distribute FORZINITY™(elamipretide) injection PR Newswire
Colorado family's fight for livesaving medication for infant with Barth syndrome leads to FDA approval - CBS News
Colorado family's fight for livesaving medication for infant with Barth syndrome leads to FDA approval CBS News
First-ever approval for Barth Syndrome treatment: what does this mean for ultra-rare disease therapeutics? - labiotech.eu
First-ever approval for Barth Syndrome treatment: what does this mean for ultra-rare disease therapeutics? labiotech.eu
§ 07 Sourcing
Sourcing & supply
Regulatory status
FDA-approved
This compound has an FDA approval for at least one indication. Brand pharmacy channels exist. Compounding may or may not be available depending on shortage status.
No suppliers in our directory currently stock this compound. For investigational or research-only compounds, legitimate channels may not exist outside clinical trials.
Browse full supplier directory§ 09 Safety
Safety & side effects
Side effects
- 01Injection site reactions
- 02Mild headache
Contraindications
None specified.