SS-31 (Elamipretide)

Forzinity

SS-31 is the first FDA-approved drug that directly targets your mitochondria. It binds to cardiolipin on the inner mitochondrial membrane and improves the electron transport chain — basically makes your cells' power plants run like they did ten years ago. The Barth syndrome approval is narrow, but the mechanism is relevant to anyone whose energy isn't what it used to be. The off-label longevity community has been running this for years. The clinical dose (40mg) is expensive; community protocols use 5-20mg.

Protocol

Dose: 40mg SubQ daily (FDA-approved dose for Barth). Research community uses 5-20mg for longevity protocols. | Frequency: Once daily | Cycle: Continuous in clinical setting. Community protocols often run 4-8 week cycles. | Route: SubQ

Reconstitution: 1mL bacteriostatic water per 10mg vial (10mg/mL). For 50mg vials, 2.5mL gives 20mg/mL.. Use our free reconstitution calculator for exact syringe units.

Effects

• Mitochondrial function (80%) — Improves ADP sensitivity and electron transport chain efficiency in aged mitochondria. This is the core mechanism.
• Muscle strength (65%) — The FDA approval endpoint — measurable improvement in skeletal muscle strength via better cellular energy production
• Exercise capacity (55%) — Better mitochondrial output translates to improved exercise tolerance and reduced fatigue
• Cellular energy (50%) — General improvement in ATP production. People describe feeling less systemically tired.

Side Effects

• Injection-site reactions (25%) — Red, swollen, or sore where you pinned. Most common side effect in trials. Rotate your sites.
• Nausea (10%) — Mild nausea for some people. Comes and goes. Not a pattern, just your body adjusting.
• Headache (8%) — Occasional headache. Doesn't seem related to dose — just happens sometimes early on.

Evidence

Strong evidence — FDA accelerated approval September 19, 2025 for Barth syndrome under the brand name Forzinity — making it the first approved mitochondria-targeted therapeutic in history. The TAZPOWER trial used 40mg SubQ daily. Approval was based on improved knee extensor muscle strength. Continued approval contingent on a confirmatory trial, but the regulatory bar has been cleared.

Approval status: FDA accelerated approval (Sept 2025) for Barth syndrome

References

1. Reid Thompson W et al. A phase 2/3 randomized clinical trial followed by an open-label extension to evaluate the effectiveness of elamipretide in Barth syndrome, a genetic disorder of mitochondrial cardiolipin metabolism Genet Med, 2021. PMID: 33077895
2. Roshanravan B et al. In vivo mitochondrial ATP production is improved in older adult skeletal muscle after a single dose of elamipretide in a randomized trial PLoS One, 2021. PMID: 34264994
3. Karaa A et al. Efficacy and Safety of Elamipretide in Individuals With Primary Mitochondrial Myopathy: The MMPOWER-3 Randomized Clinical Trial Neurology, 2023. PMID: 37268435
4. Karaa A et al. A randomized crossover trial of elamipretide in adults with primary mitochondrial myopathy J Cachexia Sarcopenia Muscle, 2020. PMID: 32096613
5. Sabbah HN et al. Chronic Therapy With Elamipretide (MTP-131), a Novel Mitochondria-Targeting Peptide, Improves Left Ventricular and Mitochondrial Function in Dogs With Advanced Heart Failure Circ Heart Fail, 2016. PMID: 26839394
6. Karaa A et al. Randomized dose-escalation trial of elamipretide in adults with primary mitochondrial myopathy Neurology, 2018. PMID: 29500292

Storage

• Lyophilized: Freeze at -20C for long-term storage. Stable for 2+ years. Refrigerate for short-term.
• Reconstituted: Refrigerate at 2-8C. Use within 4 weeks. Do not freeze.
• Water: Bacteriostatic water. 1mL per 10mg vial is standard.
• Needle: 29-30 gauge, 0.5 inch for SubQ injection

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These statements have not been evaluated by the FDA. This content is for educational purposes only and is not intended to diagnose, treat, cure, or prevent any disease. Consult a healthcare professional before starting any protocol.

vialprep research · Sources: PubMed, FDA, peer-reviewed trials · How we verify