SS-31 (Elamipretide)
Binds to the inner membrane of mitochondria. Received FDA accelerated approval in 2025 for Barth syndrome, a rare genetic disease.
Quick chart
Change these and every table below updates.
Dosing schedules (as studied)
From the FDA label for Forzinity® (elamipretide), approved for Barth syndrome in patients weighing 30 kg or more. Supplies are shown for 4 weeks. At 40 mg a day, most vial sizes cover only one or two doses.
Label dose
FDA approved40 mg injected under the skin once a day, at the same time each day.
| Phase | Weeks | Daily dose | Syringe units | Volume | Doses per vial* |
|---|---|---|---|---|---|
| Daily | 1–4 | 40 mg | 80 | 0.8 mL | 1 |
* Limited by the vial's contents or the 28-day use limit after mixing, whichever comes first.
A missed dose is skipped, not doubled.
- 28 × 50 mg vials (each vial is used for at most 28 days after mixing)
- 28 mL bacteriostatic water (1 mL per vial)
- 28 × 1 mL (100-unit) U-100 insulin syringes
- 84 alcohol prep pads, plus a sharps container
Severe kidney impairment
Label adjustmentFor adults with severe kidney impairment who are not on dialysis, the label halves the dose.
| Phase | Weeks | Daily dose | Syringe units | Volume | Doses per vial* |
|---|---|---|---|---|---|
| Daily | 1–4 | 20 mg | 40 | 0.4 mL | 2 |
* Limited by the vial's contents or the 28-day use limit after mixing, whichever comes first.
- 14 × 50 mg vials (each vial is used for at most 28 days after mixing)
- 14 mL bacteriostatic water (1 mL per vial)
- 28 × 0.5 mL (50-unit) U-100 insulin syringes
- 70 alcohol prep pads, plus a sharps container
Reconstitution for this setup
- Let the 50 mg vial reach room temperature and wipe both stoppers with alcohol.
- Slowly add 1 mL of bacteriostatic water, aiming down the inside wall of the vial.
- Swirl gently until clear. Never shake.
- Label the vial: 50 mg/mL, with today's date. Refrigerate and use within 28 days.
Label details
| Use | Dose | Schedule |
|---|---|---|
| Barth syndrome, patients 30 kg or more | 40 mg | Once daily, injected under the skin |
| Severe kidney impairment, not on dialysis | 20 mg (half dose) | Once daily |
- A missed dose is skipped, not doubled.
- Opened vials are discarded after 8 days.
Research summary
Elamipretide binds to cardiolipin, a fat found in the inner membrane of mitochondria, and is designed to stabilize energy production.
What the research shows
- The FDA granted accelerated approval in 2025 for Barth syndrome, a rare inherited mitochondrial disease.
- Trials in primary mitochondrial myopathy and age-related eye disease have had mixed results.
- There is no clinical evidence for "energy" or anti-aging use in healthy adults.
References
- FDA prescribing information, Forzinity® (elamipretide), via DailyMed. View source
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Last reviewed: November 2026