Dose range
40 mg/day SC
Route
Subcutaneous injection, daily
Indication(s)
Mitochondrial; cardiolipin-targeting (Phase 3 BARTH/PMD)

Titration schedule

StepDoseDurationNotes
-40 mg/daySC dailyElamipretide; mitochondrial; investigational

Important notes

  • This research compound dosing chart is intended as a reference for clinicians and patients reviewing protocols, not a substitute for individualized prescriber guidance.
  • Research compound; not FDA-approved for any indication. Off-label or experimental use only.
  • Compounded versions, where applicable, must be prepared by a licensed 503A or 503B compounding pharmacy. The April 14, 2026 FDA action restricted salt-form active ingredients.

References

  1. SS-31 (elamipretide) prescribing information / clinical literature.
  2. FDA Section 503A Interim Bulk Drug Substances List, updated April 14, 2026.
  3. USP <797>: Pharmaceutical Compounding — Sterile Preparations.