Peptides
SS-31 (Elamipretide)
Also called Elamipretide · Bendavia
SS-31, also called elamipretide, attracts interest for energy, fatigue and mitochondrial health. It now has a specific US medicine, Forzinity, for muscle strength in Barth syndrome—but that approval does not establish an energy boost or anti-aging benefit for otherwise healthy people.
Dosage & duration
US Forzinity label for Barth syndrome in patients weighing at least 30 kg.
Forzinity labelled dose
Product label- Dose
- 40 mg
- How often
- Once daily, under the skin
- How long
- Ongoing disease-specific treatment
Adults with severe renal impairment need a reduced label dose; dialysis and pediatric renal disease have additional evidence gaps.
Sources: 1
This is not a longevity cycle. MMPOWER-3 tested the same daily amount for 24 weeks in a different disease without meeting its primary endpoints.
The practical difference
Does the approval mean more everyday energy?
SS-31 is also called elamipretide. Its named medicine, Forzinity, has a specific use that does not establish a general energy boost.
| Question | Forzinity in Barth syndrome | General energy or anti-aging use |
|---|---|---|
| Goal | Improving muscle strength | Less fatigue or better exercise tolerance |
| Evidence | Specific accelerated US approval | No general benefit established |
| Product | A defined prescription medicine | A research vial is not established as equivalent |
Why people look at mitochondrial treatment
Mitochondria help cells use energy, so SS-31 is often discussed when someone feels fatigued or wants better exercise tolerance. A plausible energy mechanism does not show that a person’s fatigue is caused by the problem this drug targets.
What the approval actually covers
Forzinity is indicated for muscle strength in adults and children with Barth syndrome weighing at least 30 kg. Accelerated approval was based on knee-extensor strength, with confirmatory benefit still required. It is not a broad approval for aging, gym recovery or unexplained fatigue.
Why the fatigue evidence is mixed
The larger MMPOWER-3 trial in primary mitochondrial myopathy did not improve walking distance or fatigue versus placebo at 24 weeks. Different mitochondrial diseases are not interchangeable, so the Barth indication should not erase that negative result.
Product and follow-up matter
The branded injection has a defined formulation and disease-specific monitoring. Injection-site reactions are common and serious allergic reactions are possible. A research vial called SS-31 should not be assumed equivalent to Forzinity.
Dose references and context Existing reported protocols; not personal dosing instructions
This older catalog material includes research and community reports. It has not all been source-checked in this page update and should not be treated as a dosing recommendation.
FORZINITY labeled Barth syndrome use
40 mg · Subcutaneous · Once daily
For patients weighing at least 30 kg. The label reduces dosage in adults with severe renal impairment; this is disease-specific prescribing context, not a research protocol.
Model details: SS-31 (Elamipretide)
How to read this chart
This is a study-based example of how elamipretide levels change over time. Try different doses or timing to compare the curves.
The calculation uses the same assumptions for everyone. It can't predict your own blood levels or tell you what dose to take.
Study setup and sources
elamipretide: drug concentration in plasma (ng/mL).
Published fixed-parameter elamipretide model with the reported absorption delay.
Fixed reference profile: Fixed tabulated SPICP-105 parameters from 41 healthy participants; no particular reference age or weight is asserted. Elamipretide hydrochloride solution, 40 mg active moiety in 0.5 mL in the source comparator.; Subcutaneous abdomen.
Changing dose or schedule explores a scenario; it does not personalize the reference profile or establish a studied regimen.
Input dose basis: Milligrams of active elamipretide. The 40 mg active dose corresponds to 46.8 mg hydrochloride salt; enter active mass only.
Source exposure scope: Same-product comparator: a single 40 mg active elamipretide hydrochloride-formulation injection into the abdomen. Other doses and repeated schedules are model scenarios.
Elamipretide fixed source model
elamipretide-fda-2025-spicp105 · version 1
- Applicant SPICP-105 column in FDA Table 129; covariate multipliers fixed at one and no random effects. This is not a claimed population-average or personalized curve.
- The 2.63-minute absorption delay is included. No acetate or thigh-injection adjustment is applied.
- CL/F,Vc/F,Q/F,Vp/F are apparent; do NOT multiply by label92%F. No acetate1.05 or thigh0.957 factor for HCl/abdomen reference.
- Model structure
- Two compartments with absorption
- Apparent clearance (CL/F)
- 10.04167 L/hour
- Apparent central volume (Vc/F)
- 1.96 L
- Absorption rate (ka)
- 0.5541667 /hour
- Absorption delay
- 0.04383333 hours
- Apparent intercompartmental clearance (Q/F)
- 1.895833 L/hour
- Apparent peripheral volume (Vp/F)
- 8.89 L
- Input mass conversion
- 1 mg modelled mass per mg entered
- Fixed tabulated typical values are used without person-specific covariates. The inspected table does not expose the centering age/weight; do not label this as a 70 kg person.
- Different formulation/site and population exposure summaries must not be pooled as one cohort.
- Requires implementing the reported absorption lag for faithful timing.
- Table 129 covariate continuation lists acetate 1.05,thigh 0.957,age 0.994 andweight 0.995 effects onKa, fixed weight allometry; tabulated values are used only without individual adjustments, not a personalized model.
- The source-model 40 mg peak is about 1470 ng/mL and AUC 3983 ng·h/mL; separate same-product observed geometric means were 1440 and 3950. Similarity does not make these identical study statistics.
- Only parent elamipretide is modeled; the M1 and M2 metabolites are excluded.
- FDA Forzinity integrated review — Tables 124 and 129
Table 129 applicant SPICP-105 column: CL/F 241 L/day, Vc/F 1.96 L, Q/F 45.5 L/day, Vp/F 8.89 L, Ka 13.3/day and 2.63-minute lag. Table 124 gives the separate 40 mg HCl/abdomen comparator.
- Forzinity prescribing information — active mass and formulation
Section 11 distinguishes 40 mg active elamipretide from 46.8 mg hydrochloride salt. The label is not the source of Table 129 model coefficients.
Common questions
Is SS-31 still entirely unapproved?
Elamipretide has a US approved product, Forzinity, for a specific Barth syndrome population. That does not approve other products or wellness uses.
Does it reliably improve fatigue?
No. MMPOWER-3 did not improve fatigue or walking distance versus placebo in primary mitochondrial myopathy.
Sources Labels, studies and notes behind this guide
Catalog evidence: Human clinical trials. This describes the type of evidence, not a clinical review of every claim.
Summary and fact source checks: 2026-10-07. This records source checking, not medical review of the whole page.
Notes on the quick facts
- Common interest
- Benefits are not established for general wellness.
- Approved use
- Specific patients and accelerated-approval conditions.
- Important trial result
- MMPOWER-3 missed walking and fatigue endpoints.
- 1. Forzinity US prescribing information
Barth syndrome ≥30 kg, accelerated approval based on knee-extensor strength; 40 mg SC daily, adult severe-renal modification. Injection reactions and hypersensitivity.
- 2. MMPOWER-3 randomized trial
Primary mitochondrial myopathy, 40 mg SC daily 24 weeks; no improvement versus placebo in six-minute walk or fatigue.
- 3. FDA Forzinity approval announcement
September 2025 accelerated approval; disease-specific rather than general energy/longevity approval.
- 4. FDA Forzinity integrated review — Tables 124 and 129
Table 129 applicant SPICP-105 column: CL/F 241 L/day, Vc/F 1.96 L, Q/F 45.5 L/day, Vp/F 8.89 L, Ka 13.3/day and 2.63-minute lag. Table 124 gives the separate 40 mg HCl/abdomen comparator.
- 5. Forzinity prescribing information — active mass and formulation
Section 11 distinguishes 40 mg active elamipretide from 46.8 mg hydrochloride salt. The label is not the source of Table 129 model coefficients.
- 6. FORZINITY FDA prescribing information, September 2025
Accelerated approval for muscle strength in Barth syndrome at weight ≥30 kg; 40 mg SC daily, renal adjustment, 0.5–1-hour Tmax and approximately 92% SC bioavailability.
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