§ 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
Accelerated FDA Approval of Elamipretide (Forzinity) for Barth Syndrome: First Disease-Specific Therapy in Patients ≥30 kg - Vera Health
Accelerated FDA Approval of Elamipretide (Forzinity) for Barth Syndrome: First Disease-Specific Therapy in Patients ≥30 kg Vera Health
Mighty Therapeutics Announces First Patient Dosed in Phase 4 Confirmatory Study of Elamipretide in Barth Syndrome - Yahoo Finance
Mighty Therapeutics Announces First Patient Dosed in Phase 4 Confirmatory Study of Elamipretide in Barth Syndrome Yahoo Finance
Stealth BioTherapeutics removes cloak to become Mighty - Fierce Pharma
Stealth BioTherapeutics removes cloak to become Mighty Fierce Pharma
Stealth BioTherapeutics to Present Updates on Elamipretide in Barth Syndrome and POLG Disease at Euromit 2026 - AOL.com
Stealth BioTherapeutics to Present Updates on Elamipretide in Barth Syndrome and POLG Disease at Euromit 2026 AOL.com
Cardiolipin remodelling in mitochondrial therapeutics: translational evidence chains from elamipretide to emerging strategies - Frontiers
Cardiolipin remodelling in mitochondrial therapeutics: translational evidence chains from elamipretide to emerging strategies Frontiers
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
FORZINITY (elamipretide) for Muscle Strength in Barth syndrome, USA - Clinical Trials Arena
FORZINITY (elamipretide) for Muscle Strength in Barth syndrome, USA Clinical Trials Arena
§ 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.
§ 10 Questions
SS-31 (Elamipretide) FAQ
- What is SS-31 (Elamipretide)?
- Tetrapeptide that targets the inner mitochondrial membrane, stabilizes cardiolipin, and improves ATP production in dysfunctional mitochondria. 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.
- What is SS-31 (Elamipretide) used for?
- Reported uses include improved mitochondrial efficiency, reduced oxidative stress, and investigated for heart failure, barth syndrome, and primary mitochondrial myopathy. Evidence strength is rated Clinical — see the evidence section for detail.
- How is SS-31 (Elamipretide) dosed?
- Commonly referenced dosing is 20 – 40 mg daily (trial protocol), administered SubQ. This is educational reference only; consult a licensed clinician before use.
- How do you reconstitute SS-31 (Elamipretide)?
- For SS-31 (Elamipretide), vials commonly come in 50 mg and a common reconstitution is 2 ml BAC water. Use the reconstitution calculator to convert any vial size and water volume into exact insulin-syringe units.
- What are the side effects of SS-31 (Elamipretide)?
- Commonly reported side effects include injection site reactions and mild headache. This list is not exhaustive.
- Is SS-31 (Elamipretide) legal?
- 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. FDA status: Under FDA review for Barth syndrome; denied approval in 2020 for primary mitochondrial myopathy; resubmitted in 2024..