A mitochondria-targeted peptide that improves cellular energy production. FDA approved for Barth syndrome (September 2025) as FORZINITY, the first approved mitochondria-targeted therapeutic.

Is SS-31 FDA approved?

Yes, SS-31 is FDA approved. FDA Approved - Barth syndrome (FORZINITY); Phase 3 for other indications

What are the side effects of SS-31?

Reported side effects of SS-31 include: Injection site reactions (very common - 80%), Headache, Dizziness, Nausea, May trigger histamine release - use caution with MCAS or histamine sensitivity, No serious adverse events in trials, FDA approved September 2025.

What is the typical dosing for SS-31?

Doses from clinical trials. Common doses observed in research: 40 mg IV or subcutaneous, Clinical trial doses vary by indication. Duration: Variable by condition. Administration: Subcutaneous injection or IV infusion.

Anti-Aging

SS-31

Also known as: Elamipretide, Bendavia, MTP-131, FORZINITY

FDA Approved

Popular For

Mitochondrial function, energy, heart health, aging

Key Facts: SS-31

Category: Anti-Aging
FDA Status: FDA Approved
Clinical Status: FDA Approved - Barth syndrome (FORZINITY); Phase 3 for other indications
Administration: Subcutaneous injection or IV infusion
Typical Dose: 40 mg subcutaneous daily
Frequency: Once daily
Evidence Level: FDA Approved
Duration: Variable by condition

Also Known As

Elamipretide, Bendavia, MTP-131, FORZINITY

Mechanism of Action

SS-31 concentrates 1000-fold in mitochondria, binding to cardiolipin on the inner membrane. It optimizes electron transport chain function, reduces reactive oxygen species, and prevents cardiolipin peroxidation during cellular stress.

Research Summary

FDA approved for Barth syndrome in September 2025 under accelerated approval. Ongoing trials for dry age-related macular degeneration and primary mitochondrial myopathy. Studies show improved cardiac function, exercise capacity, and mitochondrial efficiency.

Clinical Status:FDA Approved - Barth syndrome (FORZINITY); Phase 3 for other indications

Trial Progress:FDA Approved

Pre

III

FDA

Dosing Information

FDA Approved·FDA approved for Barth syndrome (September 2025)

Typical DosingⓘDoses commonly used by people in practice, based on community reports and anecdotal experience.

Community experience

Common Dose

40 mg subcutaneous daily

Range

40 mg daily

Frequency

Once daily

FDA approved as FORZINITY for Barth syndrome. Subcutaneous injection for patients weighing at least 30 kg.

Research DosingⓘDoses from published scientific studies and clinical trials. May include human or animal research.

Scientific studies

Doses from clinical trials

Doses from Studies

40 mg IV or subcutaneous

Clinical Trial Data - Phase 3 Clinical Trials ↗

Clinical trial doses vary by indication

Clinical Trial Data - Phase 3 Clinical Trials ↗

Duration

Variable by condition

Administration

Subcutaneous injection or IV infusion

Timing & Administration

Best Time to Take

Morning

Once daily

Food Recommendation

With or without food

Why This Timing?

SS-31 (Elamipretide) targets mitochondria. Morning use supports daytime energy production.

Possible Side Effects

Not everyone experiences these effects. Individual responses vary based on dosage, duration, and personal factors.

●Injection site reactions (very common - 80%)
●Headache
●Dizziness
●Nausea
●May trigger histamine release - use caution with MCAS or histamine sensitivity
●No serious adverse events in trials
●FDA approved September 2025

References

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