PeptideOS
← Library

SS-31 (Elamipretide)

Mitochondrial (cardiolipin-binding tetrapeptide)

Also known as: Elamipretide, Forzinity, MTP-131, Bendavia, SS-31

Tier 1, Approved, characterised

Approved by at least one major regulator for a defined indication, with published human pharmacokinetics and a prescribing label. Well-characterised does not mean risk-free, read the label warnings.

Half-life
Not established · human data · subcutaneous

FDA Forzinity label reports maximum concentrations reached 0.5-1 h after SC administration (Tmax), but does NOT state an elimination half-life; reported null rather than repeat the widely-cited ~3.5-4 h human half-life, which I could not trace to an allowed primary source.

Dosing
40000 mcg

Approved Forzinity dose: 40 mg (40,000 mcg) subcutaneously once daily in patients weighing ≥30 kg. Fixed dose, no titration. Indication is Barth syndrome muscle strength, NOT a weight-loss/metabolic indication.

Titration
None, fixed 40 mg once daily (no dose titration in label).
Frequency
Once daily
Regulatory status
FDA-approved (accelerated approval, Sept 2025) as FORZINITY for improving muscle strength in adult and pediatric Barth syndrome patients ≥30 kg. First approved mitochondria-targeted therapeutic. (Approval is for Barth syndrome, not obesity/metabolic disease.)
Evidence base
human clinical · confidence: high

FDA label (DailyMed) based on the TAZPOWER crossover trial (n=12); accelerated approval, confirmatory trial ongoing. High-quality label data for the approved indication; metabolic/obesity use is not an approved or well-evidenced indication.

Storage

Lyophilised: Not applicable, supplied as a solution for injection (not lyophilized).

Reconstituted: Store refrigerated 2-8°C; do not freeze. After first opening, store refrigerated 2-8°C or at room temperature 20-25°C; discard vial 8 days after first opening.

Safety

No boxed warning. Label WARNINGS: benzyl alcohol toxicity (excipient), risk in neonates/low-birth-weight infants; hypersensitivity/injection-site reactions. Approved only for Barth syndrome; efficacy/safety for metabolic or weight-management use is not established.

Sources