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AMIRAVOResearch Library
Cycle-length evidence

SS-31 (Elamipretide) cycle length: what human studies ran

FDA-approvedAHuman trial evidence
Short answer: SS-31 (Elamipretide) has no "cycle". As an approved drug it is used as its label and a prescriber direct.

Treatment and follow-up in human studies

  1. The label describes a 12-week randomized crossover treatment period and a 192-week open-label extension; ten of the twelve subjects entered the extension and eight participated through week 168, with knee extensor muscle strength measured by handheld dynamometry as a secondary endpoint that increased during the extension but not during the randomized trial 3.
  2. MMPOWER-3 administered study drug for 24 weeks 6; the MMPOWER phase 1/2 trial administered 2-hour infusions over 5 days 7.

What has not been tested

  • On-and-off schedules or breaks between courses.
  • Repeated courses and long-term exposure beyond the periods listed.
  • SS-31 (Elamipretide) combined with other compounds, unless a study above says so.

Frequently asked questions

Is there an established SS-31 (Elamipretide) cycle length?
No cycle is defined. SS-31 (Elamipretide) is an approved drug whose label describes treatment under a prescriber's care; the label, not a cycle, governs duration.
What is the longest human study of SS-31 (Elamipretide)?
The durations are listed on this page with their sources; compare them directly rather than relying on a summary.
Do study durations tell me how long to use something?
No. A study duration is how long investigators administered a compound to selected participants under monitoring. It is not a recommended course, and a break between courses has not been tested for any compound on this site that is not approved.
SS-31 (Elamipretide) dosing reference Full research page

References

  1. Elamipretide: A Review of Its Structure, Mechanism of Action, and Therapeutic Potential Int J Mol Sci. 2025
  2. The mitochondria-targeted peptide SS-31 binds lipid bilayers and modulates surface electrostatics as a key component of its mechanism of action J Biol Chem. 2020
  3. FORZINITY (elamipretide) injection, prescribing information FDA label (DailyMed). 2025
  4. FDA grants accelerated approval to first treatment for Barth syndrome FDA press announcement. 2025
  5. A Phase 2 Randomized, Double-Blind, Placebo-Controlled Crossover Trial to Evaluate the Safety and Efficacy of Subcutaneous Injections of Elamipretide in Subjects With Genetically Confirmed Barth Syndrome (NCT03098797) ClinicalTrials.gov. 2017
  6. Efficacy and Safety of Elamipretide in Individuals With Primary Mitochondrial Myopathy: The MMPOWER-3 Randomized Clinical Trial Neurology. 2023
  7. Randomized dose-escalation trial of elamipretide in adults with primary mitochondrial myopathy Neurology. 2018
  8. Clinical Trial in Patients With Barth Syndrome- 4TAZPower (NCT07531251) ClinicalTrials.gov. 2026
  9. WADA 2026 Prohibited List World Anti-Doping Agency. 2026