Evidence strength for the context described on this page.
PEPTIDE ATLAS / ENERGY & LONGEVITY / ELAMIPRETIDE
FDA-approvedHigh for approved indication
Elamipretide
ALSO KNOWN ASForzinity · SS-31
The first FDA-approved Barth syndrome therapy; approval does not establish general mitochondrial enhancement.
01CATEGORYEnergy & longevity
02REGULATORY STATUSFDA-approved
03COMMON ROUTESubcutaneous injection
04DOSE BASISFDA-approved label
HOW TO USE THIS PAGE
Read the profile in the order that protects the decision.
- 01Verify what it is
Confirm the exact molecule, route, regulatory lane and actual human evidence.
- 02Read limits before dose
Unsupported claims, contraindications and uncertainty come before any protocol.
- 03Build the monitoring plan
Define the target, baseline checks, reassessment point and stop rules with a qualified clinician.
RESEARCH PASSPORT
The five facts to know first.
REVIEWED
JULY 2026
Status is product-, formulation- and indication-specific.
Trial, label or reported-practice basis is always named.
Official labels, regulators, trials and indexed literature where available.
Peptide hormones, growth factors and related substances may be prohibited.
Check Global DRO ↗OVERVIEW
What Elamipretide is.
A mitochondria-targeting tetrapeptide that binds cardiolipin. In 2025 the FDA granted accelerated approval for a narrow rare-disease indication based on an intermediate muscle-strength endpoint.
HOW IT IS THOUGHT TO WORK
Targets the inner mitochondrial membrane and cardiolipin with the goal of stabilizing membrane function in Barth syndrome.
EFFECTS & EVIDENCE
What the evidence supports—and what it does not.
- Improved knee-extensor muscle strength in the labeled Barth syndrome population weighing at least 30 kg
- Continued approval depends on confirmatory evidence
- General energy enhancement
- Healthy longevity
- Athletic mitochondrial optimization
- Benefit in people without Barth syndrome
Evidence grade: High for approved indication. For an approved drug, “high” refers only to its labeled indication—not every off-label or wellness claim.
DOSAGE CONTEXT
Best available dosing range.
FDA-APPROVED LABELThe approved Forzinity dose is 40 mg subcutaneously once daily for adult and pediatric patients with Barth syndrome weighing at least 30 kg.
- Route
- Subcutaneous injection
- Duration
- Chronic specialist therapy with confirmatory evidence obligations
- Men & women
- No routine sex-based dose; the label is diagnosis and weight based.
Clinician verification required. Always double-check the exact molecule or salt, concentration, route, volume, schedule, indication, patient-specific contraindications, interactions and applicable law with the prescribing clinician and dispensing pharmacy. A disclaimer does not make an unapproved product FDA-approved, and a reported-use range is not a prescription.
MONITORING
What should be tracked.
- Muscle strength and functional outcomes
- Injection-site reactions
- Hypersensitivity
- Disease-specific cardiology and metabolic care
SAFETY
Risks, red flags and reasons to avoid it.
- Injection-site reactions
- Hypersensitivity
- Limited approval population and evidence base
- Unknown benefit-risk for wellness use
- Off-label wellness sourcing
- Products not supplied through the approved prescription chain
- Assuming mitochondrial targeting equals anti-aging
Stop and seek careGet urgent medical help for trouble breathing, facial or throat swelling, chest pain, fainting, severe persistent abdominal pain, neurologic changes, severe hypoglycemia, uncontrolled vomiting or a prolonged painful erection.
CLINICIAN VISIT CHECKLIST
Six questions worth bringing with you.
Molecule or analog, salt, concentration, route, manufacturer or compounder, lot and beyond-use date.
Name the diagnosis or target, how it will be measured and the realistic time to reassess.
Ask how it compares with FDA-approved, lower-risk or better-studied alternatives.
Label, human trial, specialty guideline or clinic convention—and whether that route and formulation match.
Baseline checks, follow-up measures, interactions, pregnancy considerations and symptoms that mean stop.
Pharmacy license, prescription, identity/potency testing, sterility controls and who handles a product complaint.
Do not improvise reconstitution or convert “units” without the exact concentration. Mixing, storage and beyond-use instructions are product-specific; confirm them with the dispensing pharmacy.
PRIMARY SOURCES
Read the record yourself.
We prioritize official prescribing information, FDA regulatory material, registered trials and indexed biomedical literature. A source supports the specific statement beside it—not every claim made about the molecule.
PRODUCTS & TREATMENT ACCESS
Use a verified prescription pathway.
Specialty prescription product for eligible Barth syndrome patients.
This 2025 approval changed elamipretide's status, but only for a rare disease. It did not validate the broader longevity market built around SS-31.
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