Elamipretide
Also known as: Bendavia, D-Arg-2',6'-Dmt-Lys-Phe-NH2, Elamipretide, MTP-131, SS-31, SS‑31
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Summary
Elamipretide (SS‑31, Bendavia) is a synthetic tetrapeptide that targets mitochondria to restore bioenergetic function and limit oxidative damage. It is being evaluated for mitochondrial diseases, heart failure, and ischemia‑reperfusion injury.
Mechanism of Action
Binds cardiolipin in the inner mitochondrial membrane, stabilizing the electron transport chain, reducing reactive oxygen species and improving ATP production.
Routes of Administration
Goals & Uses
- Heart failureCardiovascularModerate
- Age‑related macular degenerationOphthalmologyLow
- Ischemia‑reperfusion injuryTissue ProtectionModerate
- Reduction of oxidative stressAntioxidant / CytoprotectionModerate
- mitochondrial diseaseGeneticModerate
- Mitochondrial dysfunction improvementBioenergeticsModerate
- Barth syndrome treatmentRare Genetic DiseaseModerate
- Heart failure with preserved ejection fraction (HFpEF)CardiovascularModerate
- Renal ischemia-reperfusion protectionNephroprotectionModerate
- Primary mitochondrial myopathyNeuromuscular DiseaseModerate
Contraindications
- Severe hepatic impairmentOrganLowLiver function concerns
- PregnancyPopulationModeratePotential fetal risk or insufficient safety data
- Known hypersensitivity to elamipretide or excipientsAllergyHigh
Adverse Effects
- Injection site reactionsLocalCommon
- Injection site painLocalCommonPain at the injection site
- HeadacheNeurologicUncommonPain in the head or upper neck
- Hypersensitivity reactionImmunologicRare
- NauseaGastrointestinalUncommonFeeling of sickness or urge to vomit
- FatigueGeneralUncommonLow energy or tiredness
Drug Interactions
- CyclosporineModerate
- ImmunosuppressantsLowPotential interaction with immune pathways or infection risk
- Anticoagulants (e.g., warfarin, heparin)Low
Population Constraints
- Severe renal impairmentOrgan ImpairmentRelative
- Pediatric patientsAgeRelative
- Pediatric (<12 y)AgeRelative
- Pregnant or breastfeeding womenReproductiveRelative
Regulatory Status
- European UnionInvestigationalUnder clinical evaluation; not yet authorized.
- United StatesInvestigationalPhase II/III trials ongoing for mitochondrial disease and heart failure.
- United KingdomInvestigationalNo approval; investigational status following EMA framework pre-Brexit alignment.
Not approved in any major jurisdiction; currently in Phase II/III clinical trials for several indications.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Elamipretide?
Elamipretide (SS‑31, Bendavia) is a synthetic tetrapeptide that targets mitochondria to restore bioenergetic function and limit oxidative damage. It is being evaluated for mitochondrial diseases, heart failure, and ischemia‑reperfusion injury.
What is Elamipretide used for?
Elamipretide is educationally associated with: Heart failure, Age‑related macular degeneration, Ischemia‑reperfusion injury, Reduction of oxidative stress, mitochondrial disease, Mitochondrial dysfunction improvement, Barth syndrome treatment, Heart failure with preserved ejection fraction (HFpEF), Renal ischemia-reperfusion protection, Primary mitochondrial myopathy. Educational only — not medical advice.
How is Elamipretide administered?
Recorded routes of administration: Intravenous, Subcutaneous.
What are the potential side effects of Elamipretide?
Reported adverse effects include: Injection site reactions, Injection site pain, Headache, Hypersensitivity reaction, Nausea, Fatigue. This list is not exhaustive — consult a qualified clinician.
Who should avoid Elamipretide?
Recorded contraindications: Severe hepatic impairment, Pregnancy, Known hypersensitivity to elamipretide or excipients. Consult a qualified clinician before use.