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SS-31 (elamipretide)

SS-31, also called elamipretide, is a daily injection approved by the US FDA (as Forzinity) for Barth syndrome, a rare mitochondrial disease. It is not approved for aging.

Approved in the US (accelerated approval): Forzinity, for Barth syndromeNot approved for aging or any other use
OverviewDosingMixingResearchCommunitySafetyFAQSources

SS-31 (elamipretide) quick reference

TypeMitochondria-targeted tetrapeptide
Studied forBarth syndrome, mito disease, eye
EvidenceApproved in US (Barth only)
RouteInjection under the skin
Half-lifePeaks in 0.5-1 hour (label)

What is SS-31 (elamipretide)?

Peptide that binds cardiolipin in mitochondrial membranes.

Used by community for energy and recovery.

FDA-approved only for Barth syndrome (Forzinity).

How SS-31 (elamipretide) works

Cardiolipin binder

Binds a fat in the inner mitochondrial membrane.

Better mitochondria

Label: improves mitochondrial shape and function.

Fast absorption

About 92% absorbed under the skin; peaks in 0.5-1 hour.

Kidney clearance

Cleared in urine within 48 hours.

What SS-31 (elamipretide) is studied for

PeopleBarth syndrome

Knee strength rose over 12 weeks (12 people).

PeopleMitochondrial myopathy

Phase 3 (218 people) missed walk and fatigue goals.

PeopleDry AMD

Phase 2 missed main goals; slowed one retina marker.

PeopleHeart failure

Phase 2 of 20 mg for 7 days is finished.

PeopleHealthy aging

4-week safety trial in adults 65-80 is recruiting.

SS-31 (elamipretide) dosing protocol

WhoDaily amount on the US label
Barth syndrome, 30 kg or more40 mg under the skin once a day
Adults with severe kidney problems (eGFR under 30, not on dialysis)20 mg once a day
Other usesNo label dose

From the Forzinity US prescribing information (openFDA, label effective Dec 2025). Approval is an accelerated approval based on knee muscle strength, so a confirmatory trial is required.

LABEL, BARTH (30 KG+)40 mg under the skin dailyLabel
LABEL, SEVERE KIDNEY20 mg daily (eGFR under 30)Label
TRIAL, MYOPATHY AND AMD40 mg daily for 24 to 48 weeksTrial
COMMUNITY RANGE1-2 mg dailyCommunity

Label and trial amounts come from the sources below. Community amounts are what people report; they have not been tested.

Mixing

Vial10 mg
+
BAC water2 mL
=
Strength5 mg per mL

Label product is ready-made, no mixing. Community vials use saline.

Open the peptide calculator

What the research found

Trial for the approval: 12 males with Barth syndrome, aged 12 to 35, 12 weeks of drug versus 12 weeks of placebo (crossover). Strength is the median change in knee muscle force:

+4 NWeek 12 on drug (placebo: -5 N)
+63 NWeek 168, open-label (8 people)
0 of 2primary goals met versus placebo (6-minute walk, fatigue)

Forzinity US label, Clinical Studies section. The drug was not better than placebo on the two main goals. The strength gains came in the open-label extension without a placebo group.

SS-31 (elamipretide) community experience

What users report. Not tested in trials.

Positive reports

  • Steady energy A functional lift after an adjustment period.
  • Smoother recovery Better training tolerance is a repeat theme.
  • Primes others NAD+ or MOTS-c may feel stronger afterward.

Negative & mixed

  • Injection welts Redness, itching, pain and welts are common.
  • Early tiredness Some feel tired before it improves.
  • Subtle or none Effects can be too small to tell from noise.

SS-31 (elamipretide) stacking

SS-31 + NAD+

Repair first, then fuel. Not studied together.

SS-31 + MOTS-c

Membrane plus AMPK signal. Not studied together.

SS-31 + GLP-1 drug

Mitochondria plus appetite. Not studied together.

SS-31 (elamipretide) side effects & safety

Common

  • Injection-site redness: all 12 on drug.
  • Injection-site pain 75%, hardening 67%.
  • Itching and bruising at the site.
  • Eosinophils rise, then normalize in 6-12 months.
  • Temporary tiredness (community).

Less common

  • Serious allergic reactions have occurred.
  • Hives (community).
  • Vial has benzyl alcohol: not for newborns.

Precautions

  • Serious allergy to elamipretide: contraindicated.
  • Kidney disease: exposure rises; dose cut below eGFR 30.
  • Not for newborns (benzyl alcohol).
  • Do not mix with other drugs in one syringe.
  • Rotate injection sites.

Our verdict on SS-31 (elamipretide)

The only mitochondrial peptide with FDA approval, for Barth syndrome. Anti-aging use is unproven.

SS-31 (elamipretide) FAQ

Is SS-31 approved?

Yes, as Forzinity for Barth syndrome (30 kg or more).

Is it approved for aging?

No.

Does it work for mitochondrial myopathy?

A phase 3 trial of 218 people missed its goals.

Sources

  • Forzinity (elamipretide) US prescribing information via openFDA, effective Dec 2025
  • Karaa A et al. Efficacy and safety of elamipretide in primary mitochondrial myopathy: MMPOWER-3. Neurology 2023, NCT03323749 (PubMed 37268435)
  • ReCLAIM-2: elamipretide in age-related macular degeneration. Ophthalmol Sci 2025, NCT03891875 (PubMed 39605874)
  • ClinicalTrials.gov NCT02914665 (heart failure, 20 mg x 7 days) and NCT07275424 (healthy aging, 4 weeks, recruiting)