Compounds
SS-31 (Elamipretide): Mitochondrial Peptide Benefits, Dosage, Trial Data, Status
SS 31 peptide benefits checked against the trials: how elamipretide works in mitochondria, why FDA approved it only for Barth syndrome, the negative myopathy, heart and eye trials, the studied 40 mg dose versus seller charts, the risks and its 2026 legal status.
Published October 12, 2026 · 15 min read
Key takeaways
- SS-31, now called elamipretide, is a four-amino-acid synthetic peptide that concentrates in the inner membrane of mitochondria and binds cardiolipin, the lipid that holds the energy-making machinery together. In 2025 it became the first disease-specific treatment approved for Barth syndrome.
- The approval is narrow. On September 19, 2025, under accelerated approval, Forzinity (elamipretide) was cleared to improve muscle strength in Barth syndrome, an ultra-rare inherited disease of cardiolipin, in patients weighing at least 30 kg. The evidence was a 12-patient crossover trial that missed both primary endpoints, then strength gains in an open-label extension; a confirmatory trial is required.
- Outside Barth syndrome the controlled trials were negative or missed their primary endpoints: 218 adults with mitochondrial myopathy, about 300 heart-attack patients, 71 people with heart failure and 176 with dry macular degeneration. The aging case rests on mouse studies and one single-infusion study in older adults.
- The studied dose is 40 mg under the skin once a day, the label dose. Seller charts of 1 to 20 mg a day in 4- to 12-week cycles come from no trial. Injection-site reactions occurred in every treated patient in the Barth trial.
- Legally, elamipretide is a prescription drug for one rare disease. Research-labeled SS-31 vials are unapproved drugs, and FDA warned sellers of them on August 24, 2026. We give no purchase guidance.
SS-31 (elamipretide) at a glance
- Also called
- elamipretide, Forzinity (brand name), MTP-131, Bendavia, Szeto-Schiller peptide 31
- Class
- Synthetic tetrapeptide (D-arginine, dimethyltyrosine, lysine, phenylalanine-amide) that concentrates in the inner mitochondrial membrane and binds cardiolipin; one of the Szeto-Schiller peptides
- Route
- Subcutaneous injection once daily (Forzinity is a ready-to-use 80 mg/mL solution); intravenous infusion and eye drops in earlier trials
- FDA status
- Approved for one use only: Forzinity received accelerated approval on September 19, 2025 to improve muscle strength in Barth syndrome in patients weighing at least 30 kg, with a confirmatory trial required. Prescribable for that indication; not approved for aging, longevity, heart failure, mitochondrial myopathy or eye disease. Research-labeled SS-31 vials are unapproved drugs, and FDA warned sellers on August 24, 2026.
- FDA Category 2 (compounding restricted)
- No
- Available by prescription (US)
- Only as the brand Forzinity, for Barth syndrome in patients weighing at least 30 kg; not a compounded or wellness product
- Best-studied use
- Barth syndrome (approved on muscle strength); negative or inconclusive trials in mitochondrial myopathy, heart attack, heart failure and dry macular degeneration; one single-infusion study in healthy older adults
- Typical monthly cost (telehealth, 2026)
- No list price we could verify for Forzinity; we do not price research vials
What SS-31 is and how it works
SS-31 is one of the Szeto-Schiller peptides, a family of short synthetic peptides described in the early 2000s by the laboratories of Hazel Szeto and Peter Schiller to cross cell membranes and collect inside mitochondria. Its sequence is D-arginine, 2',6'-dimethyltyrosine, lysine and phenylalanine-amide (Forzinity label). During development it was called MTP-131 and Bendavia; elamipretide is the generic name and Forzinity the brand.
The target is cardiolipin, a phospholipid found almost only in the inner mitochondrial membrane. Cardiolipin shapes the folds (cristae) where energy is made and holds the respiratory complexes together so electrons pass efficiently. When it is oxidized or depleted, cytochrome c stops acting as an electron carrier and starts acting as a peroxidase that damages cardiolipin further. SS-31 binds cardiolipin through electrostatic and hydrophobic interactions; in cell and animal studies that keeps cytochrome c in its carrier role, protects the cristae and improves ATP production (Szeto 2014). FDA's label describes it more plainly as a mitochondrial cardiolipin binder that improves mitochondrial structure and function.
That mechanism points at one disease above all. In Barth syndrome, mutations in the TAZ gene stop cells from remodeling cardiolipin properly; the disease is X-linked, affects boys and men, and causes heart muscle disease, weak skeletal muscles and fatigue (Thompson 2021) (Shirley 2026). If a cardiolipin binder helps anyone, it should help them.
After an injection under the skin, blood levels peak within 30 to 60 minutes, about 92% of the dose is absorbed, and the drug and its inactive breakdown products leave in the urine within about 48 hours (Forzinity label). That is why every trial dosed it daily or as an infusion.
What the evidence actually shows
| Claim | Grade | What the evidence shows | Sources |
|---|---|---|---|
| Improves muscle strength in Barth syndrome (the approved claim) | B | 12 males aged 12 to 35, 40 mg a day subcutaneously or placebo for 12 weeks each in a crossover: neither primary endpoint (6-minute walk, symptom score) was met and strength did not change (median +4 newtons versus -5). In the open-label extension, knee-extensor strength rose a median 34 newtons at 12 weeks and 63 at 168 weeks from a baseline of 124; walking distance rose 96 meters. No control group in that phase. | Thompson 2021; Thompson 2024; Forzinity label |
| Improves walking and fatigue in primary mitochondrial myopathy | B | Negative. MMPOWER-3: 218 adults, 40 mg a day subcutaneously for 24 weeks; 6-minute walk difference -3.2 meters (P = 0.69), no difference in fatigue. An earlier 5-day intravenous study of 36 adults had shown +64.5 versus +20.4 meters at the top dose (P = 0.053). | Karaa 2023; Karaa 2018 |
| Limits heart damage after a heart attack | B | Negative. EMBRACE STEMI: first anterior heart attack treated with angioplasty, 0.05 mg/kg per hour intravenously for 1 hour or placebo. Infarct size by CK-MB did not differ (5,570 versus 5,785 ng-hours/mL) and MRI, angiographic, ECG and clinical outcomes did not improve. | Gibson 2016 |
| Improves heart function in heart failure | B | Negative. PROGRESS-HF: 71 adults with ejection fraction 40% or less, placebo, 4 mg or 40 mg subcutaneously daily for 28 days. Left ventricular end-systolic volume and ejection fraction did not change versus placebo. | Butler 2020 |
| Slows dry age-related macular degeneration | B | ReCLAIM-2: 176 adults aged 55 or older with geographic atrophy, 40 mg a day subcutaneously for 48 weeks. Both primary endpoints (low-light visual acuity, growth of atrophy) were missed. Secondary analyses showed 43% less progression of photoreceptor-layer loss (nominal P = 0.0034). A phase 3 trial is under way. | Ehlers 2025 |
| Boosts mitochondrial energy in older adults | C | 39 healthy adults aged 60 to 85 with poorly functioning mitochondria: one 2-hour infusion of 0.25 mg/kg per hour raised maximal ATP production in a hand muscle by 27% versus 12% on placebo (P = 0.045), with no difference from placebo by day 7 and no change in muscle fatigue resistance. | Roshanravan 2021 |
| Slows aging or extends lifespan | D | Mouse data only. In old mice, 3 mg/kg a day for 8 weeks slowed frailty and improved heart strain and muscle fatigue resistance, but epigenetic and transcriptomic age showed no detectable change in most groups. No human trial has measured an aging outcome. | Mitchell 2025 |
| Safe and well tolerated | B | Generally well tolerated in trials of up to 48 weeks in hundreds of patients and 168 weeks in 8 men, but injection-site reactions are near universal (redness in 12 of 12 on drug versus 3 of 12 on placebo in the Barth trial), serious hypersensitivity has been reported, and eosinophil counts rise for months. | Forzinity label; Thompson 2024; Karaa 2023 |
Barth syndrome: the approval and what it rests on
TAZPOWER randomized 12 patients to 40 mg a day of elamipretide or placebo under the skin for 12 weeks, then, after a 4-week washout, switched them. Neither primary endpoint, the 6-minute walk and a Barth symptom score, improved in that controlled phase. Ten patients continued on open-label drug; at 36 weeks they walked 95.9 meters farther than at the start of the extension (Thompson 2021), and the 8 who reached 168 weeks kept a cumulative gain of 96.1 meters (Thompson 2024).
The approval did not rest on walking. It rested on knee-extensor strength measured with a handheld dynamometer, a secondary endpoint that did not move in the randomized phase (median +4 newtons on drug, -5 on placebo) but rose during the extension: a median 34 newtons at week 12, 68 at week 24 and 63 at week 168, from a median baseline of 124 (Forzinity label). FDA's cardiovascular and renal drugs advisory committee met to review the application on October 10, 2024, and FDA approved Forzinity on September 19, 2025 (Federal Register 2025) under accelerated approval, which allows a drug for a serious condition to reach patients on an intermediate endpoint, with continued approval contingent on a confirmatory trial (Shirley 2026).
That trial, 4TAZPower, began recruiting in July 2026: about 48 males aged 5 and older, randomized to elamipretide or placebo for 72 weeks, with a composite of walking, timed up-and-go and sit-to-stand tests as the primary endpoint (ClinicalTrials.gov NCT07531251). Until it reports, the honest summary is that elamipretide may help Barth syndrome, that FDA judged the risk-benefit acceptable for a disease with no other specific treatment, and that the controlled evidence is not yet there.
Primary mitochondrial myopathy: the big trial failed
The first signal looked good. In MMPOWER, 36 adults with genetic mitochondrial myopathy received 2-hour intravenous infusions of 0.01, 0.1 or 0.25 mg/kg per hour, or placebo, for five days; at the top dose they walked 64.5 meters farther against 20.4 on placebo, a borderline result (P = 0.053) (Karaa 2018). MMPOWER-3 then tested the subcutaneous product properly: 218 adults, 40 mg a day or placebo for 24 weeks. The difference in walking distance was -3.2 meters (P = 0.69), and fatigue did not improve (Karaa 2023). A subgroup finding in patients with nuclear-DNA defects led to NuPOWER, a 48-week trial of 60 mg a day in 102 patients that finished in 2024; we found no published results. The pattern, a small early signal followed by a null phase 3, is a familiar story in drug development, and it is the closest human test of "mitochondrial rejuvenation" in people whose mitochondria are measurably impaired.
Heart attack and heart failure: negative phase 2 trials
EMBRACE STEMI enrolled 300 patients having a first anterior heart attack treated with emergency angioplasty, infusing elamipretide at 0.05 mg/kg per hour for an hour or placebo. Infarct size did not shrink, and no imaging, ECG or clinical outcome improved; the drug was well tolerated (Gibson 2016). In chronic heart failure, PROGRESS-HF gave 71 adults with a reduced ejection fraction placebo, 4 mg or 40 mg a day under the skin for 28 days; heart volumes and ejection fraction did not change (Butler 2020). Two further phase 2 trials completed in 2017, one in heart failure with preserved ejection fraction and one of intravenous dosing in 308 hospitalized patients; neither has published results we could find. We found no cardiac trial outside Barth syndrome registered since then.
Dry macular degeneration: missed endpoints, a phase 3 under way
After two small open-label studies, ReCLAIM-2 randomized 176 people aged 55 or older with geographic atrophy, the advanced dry form, to 40 mg a day under the skin or placebo for 48 weeks. It missed both primary endpoints, low-light visual acuity and growth of the atrophic area. In secondary analyses, loss of the photoreceptor layer (the ellipsoid zone) progressed 43% more slowly on drug, and 14.6% versus 2.1% gained 10 or more letters of low-light acuity, both nominal results. Adverse events occurred in 86% on drug and 71% on placebo, mostly injection-site reactions (Ehlers 2025). Photoreceptor loss became the agreed primary endpoint of ReNEW, a 96-week phase 3 of 313 patients due to reach its primary completion in 2027. This is the most active program outside Barth syndrome, and it is still unproven.
Aging and older adults: one infusion and mouse data
The only controlled study of elamipretide aimed at aging itself gave 39 healthy adults aged 60 to 85, chosen for poorly functioning muscle mitochondria, a single 2-hour infusion of 0.25 mg/kg per hour or placebo. Maximal ATP production in a hand muscle rose 27% against 12% on placebo immediately afterward, and the difference from placebo was gone by day 7; the muscle did not become more fatigue-resistant (Roshanravan 2021). A 4-week open-label safety pilot of daily injections in 30 adults aged 65 to 80 started in late 2025; no results have been posted.
In mice, the data are more encouraging and more limited. Eight weeks of 3 mg/kg a day, delivered by pumps under the skin, slowed the accumulation of frailty and improved heart strain and muscle fatigue resistance in old animals, yet epigenetic and transcriptomic age showed no detectable change in most treated groups (Mitchell 2025). Function improved; the clocks did not move.
What you are promised versus what is documented
Seller pages present SS-31 as mitochondrial repair: more energy, endurance, faster recovery, fat loss, sharper thinking, better skin, a younger heart and longer life. Sorted by evidence:
- Documented in humans: a strength gain in Barth syndrome during an uncontrolled extension; a transient rise in muscle ATP capacity after one infusion in older adults; slower photoreceptor-layer loss as a secondary finding in macular degeneration.
- Tested in humans and not shown: better walking or less fatigue in mitochondrial myopathy, smaller heart attacks, better heart function in heart failure, slower growth of geographic atrophy.
- Never tested in humans: energy or endurance in healthy people, fat loss, cognition, skin, recovery and lifespan.
The irony is that SS-31 has more controlled human trials than the other mitochondrial peptides sold for longevity, and those trials are what make the marketing hard to sustain.
SS-31 versus MOTS-c, NAD+ and exercise
| SS-31 (elamipretide) | MOTS-c | NAD+ precursors and injections | Exercise training | |
|---|---|---|---|---|
| What it is | Synthetic cardiolipin-binding tetrapeptide | Natural mitochondrial-DNA-encoded peptide, AMPK activator in mice | Vitamin B3 derivatives and NAD+ itself | Regular aerobic and resistance training |
| Human evidence | Approved in Barth syndrome on a strength endpoint; negative or inconclusive trials elsewhere | No human trial; one 4-week trial of an analog | Raise blood NAD+; no aging outcome shown | Decades of outcome data |
| Legal in the US, October 2026 | Prescription for Barth syndrome only; sellers of research vials warned in August 2026 | Not compoundable; research vials are unapproved drugs | Supplements legal; NAD+ injections compounded under an interim policy | Yes |
| Verdict | A rare-disease drug, not a longevity product | Research molecule | Cheap experiment with weak returns | The proven option |
The MOTS-c profile and NAD+ profile carry the detail, and our longevity ranking places all of them side by side.
Dosage: what was studied versus what sellers circulate
| Setting | Dose | Population | Result |
|---|---|---|---|
| Forzinity label | 40 mg subcutaneously once daily for patients weighing at least 30 kg; 20 mg daily in adults with severe kidney impairment not on dialysis | Barth syndrome | Approved on knee-extensor strength (accelerated) |
| TAZPOWER | 40 mg subcutaneously daily, 12 weeks, then open-label up to 168 weeks | 12 males aged 12 to 35 | Controlled phase negative; gains in extension |
| MMPOWER-3 | 40 mg subcutaneously daily, 24 weeks | 218 adults, mitochondrial myopathy | No benefit |
| PROGRESS-HF | 4 mg or 40 mg subcutaneously daily, 28 days | 71 adults, heart failure | No benefit |
| EMBRACE STEMI | 0.05 mg/kg per hour intravenously for 1 hour, once | First anterior heart attack | No benefit |
| ReCLAIM-2 | 40 mg subcutaneously daily, 48 weeks | 176 adults, dry macular degeneration | Primary endpoints missed |
| Older adults | 0.25 mg/kg per hour intravenously for 2 hours, once | 39 healthy adults aged 60 to 85 | Transient rise in muscle ATP capacity |
| Seller charts, October 2026 | 1 to 5, 5 to 10 or 10 to 20 mg daily, or 0.5 to 1 mg three to five times a week, in 4- to 12-week cycles with breaks | Adults buying research vials | Never studied |
The pattern is plain. Every published long-term human study used 40 mg a day, and outside Barth syndrome that dose did not deliver its primary endpoint. The chart doses sit below it, at levels no subcutaneous efficacy trial tested except the 4 mg arm of PROGRESS-HF, which did nothing; the cycles have no source at all. Some charts also misquote the trials, listing EMBRACE STEMI as 0.25 mg/kg when the infusion was 0.05 mg/kg per hour for one hour.
Forzinity is a ready-to-use solution of 80 mg/mL, so a 40 mg dose is 0.5 mL and there is nothing to reconstitute (Forzinity label). Research vials are freeze-dried powders of unverified content, and we do not give a reconstitution example for them; the reconstitution calculator is for medications a pharmacy has dispensed with a labeled concentration. Our SS-31 dosage chart covers every studied dose, and the MOTS-c dosage chart does the same for the other mitochondrial peptide sold alongside it.
Side effects and who should not use it
From the label and trials (Forzinity label):
| Effect | Elamipretide | Placebo |
|---|---|---|
| Any injection-site reaction | 12 of 12 (100%) | 8 of 12 (67%) |
| Injection-site redness | 100% | 25% |
| Injection-site pain | 75% | 42% |
| Hardening or itching at the site | 67% each | 17% each |
| Bruising or hives at the site | 25% each | 0% |
Those figures come from the 12-patient Barth crossover; in the 218-patient myopathy trial most adverse events were mild to moderate (Karaa 2023). The label carries two warnings and one laboratory finding. Hypersensitivity reactions, including rashes, eczema-like dermatitis, cough and serious reactions needing emergency treatment, can appear from minutes to months after starting. The benzyl alcohol preservative makes it unsuitable for newborns. And eosinophil counts rise frequently, peaking around 90 days and returning to baseline within 6 to 12 months, without symptoms in the trials. Overdose would be expected to cause histamine-type effects such as low blood pressure and near-fainting.
Do not use it, or use it only under specialist care, if you:
- have had a serious allergic reaction to elamipretide or its ingredients (the label's only contraindication);
- have severe kidney disease: exposure more than doubles when creatinine clearance is under 30 mL/min, the label halves the dose, and dialysis patients were not studied;
- are pregnant or breastfeeding: there are no human data, because Barth syndrome affects males;
- are considering a research vial: its identity, dose and sterility are unknown, which no trial result can fix.
Legal status in the United States
Elamipretide is an FDA-approved drug for one indication: improving muscle strength in Barth syndrome in patients weighing at least 30 kg, under accelerated approval granted September 19, 2025 (Federal Register 2025). A licensed physician may prescribe it, and in principle any approved drug can be prescribed off label, but no trial supports its use for aging or wellness.
Compounding offers no workaround. Elamipretide is now a component of an approved drug, but under section 503A a pharmacy may not regularly compound what is essentially a copy of a commercially available product, and our legal tracker records no legitimate wellness supply. The vials sold online as SS-31 are unapproved drugs: on August 24, 2026 FDA sent warning letters to five online peptide vendors whose products included SS-31/elamipretide, rejecting their "research use only" disclaimers because dosing guidance, reconstitution calculators and bundled bacteriostatic water showed the products were meant for people (ArentFox Schiff 2026). The letters are addressed to sellers, not buyers; for a buyer the consequence is a product nobody stands behind.
Cost and how it is prescribed
We could not verify a list price for Forzinity. It is a specialty drug for an ultra-rare disease, prescribed through the specialists who manage Barth syndrome. If you have Barth syndrome or care for someone who does, that team is the route. For everyone else there is no legitimate product to buy, and we give no purchase guidance; prices for research vials buy no verified content.
Special populations
- Older adults. No patient aged 65 or older was enrolled in the Barth studies. Older adults took part in the macular degeneration trial (all aged 55 or older), where injection-site reactions were again the most common adverse event, and in the heart failure trial (mean age 65), where drug-related adverse events were as common on placebo; the only aging study used a single infusion. Kidney function, which declines with age, governs exposure.
- Women. Barth syndrome affects males, so the approval data are all male; women made up 64% of the myopathy trial. There are no pregnancy data.
- Children. The label covers children who weigh at least 30 kg; seven patients aged 12 and older supported that. It is not approved below 30 kg or in newborns.
Bottom line
SS-31 is a real drug with a real mechanism, and in Barth syndrome it is the first disease-specific treatment, approved on an intermediate endpoint with a confirmatory trial now recruiting. It is also a drug whose controlled trials in mitochondrial myopathy, heart attack, heart failure and macular degeneration missed their primary endpoints, and whose evidence for aging is a short-lived rise in ATP capacity in a hand muscle and some fitter old mice. The research vials sold as a longevity peptide are the same molecule on paper and an unverified product in fact, and FDA has told their sellers in writing that they are unapproved drugs. For a healthy adult, the evidence offers nothing to inject.
Frequently asked questions
+What are the benefits of SS-31 peptide?
One benefit is documented well enough for FDA approval, and only under accelerated approval: in Barth syndrome, a rare inherited disease of the mitochondrial lipid cardiolipin, patients on elamipretide 40 mg a day gained knee-extensor strength during an open-label extension, although the controlled part of the trial missed its endpoints. Everything else is unproven or negative in people: large trials in mitochondrial myopathy, heart attack, heart failure and dry macular degeneration did not meet their primary endpoints. The energy, endurance and longevity benefits sold online come from mouse studies and one single-infusion study in older adults.
+What is SS-31 peptide?
SS-31 is a synthetic peptide of four amino acids, one of the Szeto-Schiller peptides designed in the early 2000s to enter cells and concentrate in the inner membrane of mitochondria. There it binds cardiolipin, a lipid that holds the energy-producing machinery together, and in laboratory studies it protects that machinery from oxidative damage. Its drug name is elamipretide; it was also called MTP-131 and Bendavia, and it is sold as Forzinity for Barth syndrome.
+Is SS-31 the same as elamipretide?
The molecule is the same: elamipretide is the generic name for SS-31, and Forzinity is the brand of the FDA-approved product. What is not the same is the product. Forzinity is a sterile, labeled solution made under FDA oversight. A vial sold online as 'SS-31' for research is a powder whose identity, purity and sterility nobody has verified, and FDA treats it as an unapproved drug when it is marketed for people.
+Is SS-31 FDA approved?
Yes, for one rare disease. FDA granted elamipretide (Forzinity) accelerated approval on September 19, 2025 to improve muscle strength in adults and children with Barth syndrome who weigh at least 30 kg. Accelerated approval means the decision rested on an intermediate endpoint, knee-extensor strength, and continued approval may depend on a confirmatory trial, which began recruiting in July 2026. It is not approved for aging, energy, heart disease or any other use.
+What is the SS-31 dose per day?
The only labeled dose is 40 mg injected under the skin once a day for patients with Barth syndrome weighing at least 30 kg, halved to 20 mg in adults with severe kidney impairment who are not on dialysis. The same 40 mg daily dose was used in the myopathy, heart failure and macular degeneration trials. The 1 to 20 mg daily cycles on seller charts were not tested in any trial. Our SS-31 dosage chart lays out every studied dose.
+Does SS-31 work for anti-aging?
Not in any human study. In old mice, elamipretide improved frailty scores, heart function and muscle fatigue resistance without a detectable change in measured biological age. In 39 healthy adults aged 60 to 85, one two-hour infusion raised the maximum rate of ATP production in a hand muscle right afterward, with no difference from placebo a week later and no effect on fatigue. No trial has measured an aging outcome, and the largest trial in people with weak mitochondria found no improvement in walking or fatigue.
+Is SS-31 safe?
In trials it was generally well tolerated, but not free of side effects. Injection-site reactions were near universal: in the Barth trial, redness at the injection site occurred in all 12 patients on drug versus 3 on placebo. The label also warns of hypersensitivity reactions, including serious ones needing emergency care, reports a temporary rise in eosinophils, and forbids use in newborns because of the benzyl alcohol preservative. The longest data cover 8 young men treated for at least 168 weeks.
+What are mitochondria peptides?
The phrase covers two different things. Some are made by the body and encoded in mitochondrial DNA, such as MOTS-c and humanin; they have mouse data and human blood-level data but no human treatment trials. Others are synthetic drugs designed to reach mitochondria, of which elamipretide is the only one approved anywhere. Only elamipretide has controlled human trials, and most of them were negative.
+Can I buy SS-31 peptide online?
Vials sold online as SS-31 are research-labeled products, and FDA's position is that they are unapproved drugs when the seller's site shows they are meant for people; it named SS-31 in warning letters to five vendors on August 24, 2026. We give no purchase guidance. The legal product, Forzinity, is a prescription drug for Barth syndrome.
+How much does SS-31 cost?
We could not verify a list price for Forzinity, a specialty drug for an ultra-rare disease. We do not list prices for research vials, which are unapproved drugs with no verified content whatever they cost.
Sources
- LabelStealth BioTherapeutics. Forzinity (elamipretide) injection, for subcutaneous use: prescribing information, sections 1, 2, 3, 5, 6, 8, 11, 12 and 14 (DailyMed setid 146bf34c-76f2-48db-ac07-fb29cce2cd75, SPL version 10, December 12, 2025). (2025)
- RegulatoryFederal Register. Issuance of priority review voucher; rare pediatric disease product; Forzinity (elamipretide), approved September 19, 2025. December 19, 2025. (2025)
- ReviewShirley M. Elamipretide: first approval. Drugs 2026;86:377-83. (2026)
- ReviewSzeto HH. First-in-class cardiolipin-protective compound as a therapeutic agent to restore mitochondrial bioenergetics. Br J Pharmacol 2014;171:2029-50. (2014)
- StudyThompson WR et al. A phase 2/3 randomized clinical trial followed by an open-label extension to evaluate the effectiveness of elamipretide in Barth syndrome (TAZPOWER). Genet Med 2021;23:471-8. (2021)
- StudyThompson WR et al. Long-term efficacy and safety of elamipretide in patients with Barth syndrome: 168-week open-label extension results of TAZPOWER. Genet Med 2024;26:101138. (2024)
- SourceClinicalTrials.gov NCT07531251. Phase 3b/4 randomized, placebo-controlled trial of daily subcutaneous elamipretide in genetically confirmed Barth syndrome (4TAZPower), 72 weeks; confirmatory trial for the accelerated approval. Recruiting from July 2026. (2026)
- StudyKaraa A et al. Randomized dose-escalation trial of elamipretide in adults with primary mitochondrial myopathy (MMPOWER). Neurology 2018;90:e1212-21. (2018)
- StudyKaraa A et al. Efficacy and safety of elamipretide in individuals with primary mitochondrial myopathy: the MMPOWER-3 randomized clinical trial. Neurology 2023;101:e238-52. (2023)
- StudyGibson CM et al. EMBRACE STEMI study: a phase 2a trial to evaluate the safety, tolerability, and efficacy of intravenous MTP-131 on reperfusion injury in patients undergoing primary percutaneous coronary intervention. Eur Heart J 2016;37:1296-303. (2016)
- StudyButler J et al. Effects of elamipretide on left ventricular function in patients with heart failure with reduced ejection fraction: the PROGRESS-HF phase 2 trial. J Card Fail 2020;26:429-37. (2020)
- StudyEhlers JP et al. ReCLAIM-2: a randomized phase II clinical trial evaluating elamipretide in age-related macular degeneration, geographic atrophy growth, visual function, and ellipsoid zone preservation. Ophthalmol Sci 2025;5:100628. (2025)
- StudyRoshanravan B et al. In vivo mitochondrial ATP production is improved in older adult skeletal muscle after a single dose of elamipretide in a randomized trial. PLoS One 2021;16:e0253849. (2021)
- StudyMitchell W et al. The mitochondria-targeted peptide therapeutic elamipretide improves cardiac and skeletal muscle function during aging without detectable changes in tissue epigenetic or transcriptomic age. Aging Cell 2025;24:e70026. (2025)
- NewsArentFox Schiff. RUO-ined: five peptide vendors learn that research use only is not a legal strategy (FDA warning letters of August 24, 2026, covering SS-31/elamipretide among other peptides). September 18, 2026. (2026)
Written by
The Peptide Doctrine Editorial Team
Our editors write from primary sources — peer-reviewed studies, FDA documents and pharmacy records — and grade every claim by the strength of its evidence. See our editorial policy for how articles are researched, reviewed and updated.
Disclosure. The Peptide Doctrine is an independent editorial project. It currently has no sponsor and runs no advertising: we accept no payment for reviews, rankings or placements, we run no affiliate links, and we do not sell or link to "research-use" peptide vendors. Content is educational and is not medical advice.
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