SS-31 (Elamipretide)
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Complete Research Guide
Open each section for the available evidence. Gaps are stated rather than inferred.
Overview
SS-31 (Elamipretide) is listed as mitochondrial / cardiolipin-targeted peptide.
- •Mitochondrial dysfunction
- •Primary mitochondrial myopathy (orphan)
- •Heart failure
- •Dry AMD
Regulatory status: Investigational (Stealth BioTherapeutics) — orphan & fast-track designations.
Structure & Properties
Compound: SS-31 (Elamipretide); also known as Bendavia, MTP-131.
Pharmacologic class: Mitochondrial / Cardiolipin-Targeted Peptide.
Known delivery routes: Subcutaneous.
Sequence, molecular weight, salt form, and excipient details are formulation-specific and are not listed unless verified by a manufacturer or laboratory COA.
How It Works
Aromatic-cationic tetrapeptide that selectively binds cardiolipin on the inner mitochondrial membrane — restores cristae structure, ATP synthesis, and reduces ROS.
- •Improved mitochondrial bioenergetics
- •Restored cristae morphology
- •Improved 6-min walk in some trials
Human Research
Evidence grade: Clinical RCT (Limited)
Clinical RCT (Limited). Phase 3 trials in Barth syndrome and primary mitochondrial myopathy.
Laboratory Research
Phase 3 trials in Barth syndrome and primary mitochondrial myopathy
Preclinical findings describe biological plausibility, not proven benefit in people. Animal and laboratory doses do not translate directly to human use.
Processing & Interactions
Timing and exposure
Once daily SubQ, consistent time of day.
Potential interactions and combinations to avoid
- •No known peptide contraindications; check with cardiologist if on QT-prolonging drugs
Absorption, half-life, metabolism, and clearance can vary by formulation and route. Use prescribing information when an approved product exists.
Safety & Precautions
Known or reported risks
- •Injection-site reactions
- •Mixed late-stage trial results
- •Unknown chronic safety
Contraindications
- •Pregnancy
- •Known hypersensitivity
- •Primary mitochondrial disease under specialist management (treatment interference)
- •Severe hepatic or renal impairment
- •Concurrent high-dose antioxidant or metformin therapy without metabolic monitoring
- •Bleeding disorders or anticoagulant therapy without physician guidance (injection-site haematoma)
- •Active skin infection, cellulitis, or lipohypertrophy at intended injection sites
- •Inability to maintain sterile technique or safe sharps disposal
- •Not FDA-approved for human therapeutic use — no verified purity, sterility, or potency standards
- •Immunocompromised or transplant patients (unverified sterility and immunogenicity risk)
- •Concurrent participation in drug-tested sport (WADA prohibited or non-cleared substance)
- •Known hypersensitivity or prior reaction to this compound or any excipient/diluent
- •Pregnancy, attempting conception, or breastfeeding unless prescribed and monitored by a physician
- •Children and adolescents with open growth plates (unless under specialist endocrine care)
- •Active or recently treated malignancy without oncology clearance
- •Use without a confirmed diagnosis, baseline labs, and licensed clinical supervision
Unknown long-term toxicity should be assumed where controlled human data are limited. Seek urgent care for a severe or unexpected reaction.
Administration & Studied Formulations
Reference range: 40 mg/day (SQ, trials)
Frequency: Daily
Cycling: Continuous daily dosing in trials.
Subcutaneous (SubQ)
Default route for most research and therapeutic peptides — best absorption for reconstituted powder.
31G × 5/16" insulin syringe (U-100). 100 units = 1 mL. Pinch skin at abdomen (2" from navel), outer thigh, or love handle. Insert at 45–90°. Rotate sites daily to prevent lipohypertrophy. Alcohol-swab site, air-dry, inject slow, hold 5 sec.
Dosing information is educational context, not a personal recommendation. Approved products must follow their label and prescriber instructions.
Applications & Related Therapies
Potentially complementary measures
- •MOTS-c, Humanin for broader mitochondrial support
Clinical use should account for diagnosis, approved alternatives, nutrition, activity, sleep, rehabilitation, current medicines, and appropriate monitoring.
Cases, Considerations & Ethics
Decision framework: establish the clinical goal, confirm evidence quality and legal status, screen contraindications and interactions, compare approved alternatives, define monitoring and stopping criteria, and use shared decision-making with a licensed clinician.
Case evidence: individual reports cannot establish safety or effectiveness and should not outweigh controlled trials.
Ethics: informed consent should distinguish established care from experimental use, disclose uncertainty and cost, avoid overstated claims, and never substitute research products for medically necessary care.
What is SS-31 (Elamipretide)?
In plain words
SS-31 is a short chain of four amino acids studied for problems with mitochondria, the parts of cells that make energy, including a muscle disease called primary mitochondrial myopathy. It attaches to a fat called cardiolipin inside mitochondria, helping restore their inner folds and energy production while reducing harmful oxygen-based molecules. Trial results are mixed, injection-site reactions can occur, and long-term safety is unknown. It is investigational and not FDA-approved.
Technical definition
SS-31 (elamipretide), also called Bendavia or MTP-131, is an aromatic-cationic tetrapeptide that selectively binds cardiolipin in the inner mitochondrial membrane, restoring cristae structure and ATP synthesis while reducing reactive oxygen species (ROS). It is investigational at Stealth BioTherapeutics, with orphan and fast-track designations but no FDA approval, and is studied for mitochondrial dysfunction and primary mitochondrial myopathy. Randomized controlled clinical evidence is limited, with mixed late-stage trial results, injection-site reactions, and unknown chronic safety.
Function
Dosing
Recommended Time of Day
Morning, fasted.
See “Timing & Interactions” below for full fasted/fed circumstances, what to avoid combining, and what pairs well.
Administration & Technique
Injection & Application Sites
- Abdomen — 2 in (5 cm) away from the navel, either side. Fastest, most consistent SubQ absorption.
- Flank / love handle — Lateral fat pad above the hip. Good rotation site when the abdomen is tender.
- Outer thigh — Upper outer quadrant, a hand-width below the hip. SubQ pinch at 45°.
Diagram is a general illustration, not a medical instruction. Rotate sites every injection, keep 1 in (2.5 cm) between recent sites, and avoid scars, moles, bruises and the navel area.
Cycling
Continuous daily dosing in trials.
Timing & Interactions
- ·No known peptide contraindications; check with cardiologist if on QT-prolonging drugs
- ·MOTS-c, Humanin for broader mitochondrial support
Storage & Reconstitution
Reconstitution Calculator
1 mL = 100 units on a standard U-100 insulin syringe. Draw to the nearest 0.5 unit and confirm dosing with a clinician before injection.
Your Notes
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Benefits
- ·Improved mitochondrial bioenergetics
- ·Restored cristae morphology
- ·Improved 6-min walk in some trials
Risks
- ·Injection-site reactions
- ·Mixed late-stage trial results
- ·Unknown chronic safety
Contraindications
- ·Pregnancy
- ·Known hypersensitivity
- ·Primary mitochondrial disease under specialist management (treatment interference)
- ·Severe hepatic or renal impairment
- ·Concurrent high-dose antioxidant or metformin therapy without metabolic monitoring
- ·Bleeding disorders or anticoagulant therapy without physician guidance (injection-site haematoma)
- ·Active skin infection, cellulitis, or lipohypertrophy at intended injection sites
- ·Inability to maintain sterile technique or safe sharps disposal
- ·Not FDA-approved for human therapeutic use — no verified purity, sterility, or potency standards
- ·Immunocompromised or transplant patients (unverified sterility and immunogenicity risk)
- ·Concurrent participation in drug-tested sport (WADA prohibited or non-cleared substance)
- ·Known hypersensitivity or prior reaction to this compound or any excipient/diluent
- ·Pregnancy, attempting conception, or breastfeeding unless prescribed and monitored by a physician
- ·Children and adolescents with open growth plates (unless under specialist endocrine care)
- ·Active or recently treated malignancy without oncology clearance
- ·Use without a confirmed diagnosis, baseline labs, and licensed clinical supervision
Regulatory
Investigational (Stealth BioTherapeutics) — orphan & fast-track designations
Veterinary Use (Pets)
Research use in mitochondrial and cardiac disease models in dogs; not commercially available for vet use.
Functional Groups
Cited Works
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