Anti-AgingFDA ApprovedFDA Approved

SS-31

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

A mitochondria-targeted peptide that improves cellular energy production. FDA approved for Barth syndrome in September 2025.

FDA Approved - Barth syndrome (FORZINITY, September 2025); Phase 3 for other indications

Regulatory Pathway

Preclinical
Phase I
Phase II
Phase III
Phase IV
Approved

Dosing Protocol

Typical Dose

40 mg subcutaneous daily

Frequency

Once daily

Duration

Variable by condition

Community-reported dosing. Individual results vary. Not a medical recommendation.
Typical community protocol: 40 mg subcutaneous daily via Subcutaneous injection or IV infusion, Once daily. Dose range: 40 mg daily. Duration: Variable by condition.

Timing & Administration

Administer via Subcutaneous injection or IV infusion. Frequency: Once daily.

Mechanism of Action

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

Research Summary

Evidence level: fda approved. Clinical status: FDA Approved - Barth syndrome (FORZINITY, September 2025); Phase 3 for other indications.

Side Effects & Safety

Important Warnings

  • May trigger histamine release - use caution with MCAS or histamine sensitivity
Injection site reactions (80%)
headache
dizziness
nausea
potential histamine release

References

No references available.