SS-31 (elamipretide): research

A peptide approved for Barth syndrome muscle strength; benefit needs confirmation and broader energy benefits remain unproven.

Also called: Elamipretide, SS31, SS 31, MTP-131, Bendavia, Forzinity.

Mitochondria-targeted peptides · Mitochondrial cardiolipin-binding tetrapeptide · Evidence: Approved drug.

45 human records include ongoing trials: 28 registered treatment studies, 9 other FDA studies, 7 case reports or series and 1 historical comparison. Records can share participants.

Studies

TAZPOWER: Barth crossover. crossover-rct, n=12, 12 males aged 12–35 with genetically confirmed Barth syndrome. The randomized phase failed; later uncontrolled muscle-strength gains supported accelerated approval. (source)
TAZPOWER: long extension. open-label, n=10, TAZPOWER participants continuing treatment. Walking gains persisted among eight long-term completers. (source)
MMPOWER: IV dose finding. rct, n=36, Adults with genetically confirmed primary mitochondrial myopathy. The unadjusted main comparison narrowly missed significance. (source)
MMPOWER-2: daily injections. crossover-rct, n=30, Adults with genetically confirmed primary mitochondrial myopathy. The walking endpoint missed; several fatigue measures improved. (source)
MMPOWER-3: phase 3. rct, n=218, People aged 16–80 with primary mitochondrial myopathy. Neither walking distance nor fatigue improved versus placebo. (source)
MMPOWER-3: genetic subgroups. cohort, n=218, Genetic subgroups of the 218 MMPOWER-3 participants. Post hoc genetic signals led to NuPOWER. (source)
PROGRESS-HF: 4 or 40 mg. rct, n=71, Stable heart failure with ejection fraction ≤40%. Neither dose improved the main heart-volume endpoint. (source)
Heart failure: one IV infusion. rct, n=36, Heart failure with ejection fraction ≤35%. A short-lived heart-volume signal did not establish long-term benefit. (source)
EMBRACE: heart attack. rct, n=300, First anterior heart attack undergoing emergency artery opening. It did not reduce the main measure of heart damage. (source)
Kidney-artery stent pilot. rct, n=14, Adults with atherosclerotic renal-artery narrowing. Small mechanistic signals require confirmation. (source)
MOTION: older muscle energy. rct, n=39, Healthy adults aged 60–85 selected for low muscle mitochondrial function. A brief energy-production signal did not improve fatigue resistance. (source)
ReCLAIM: high-risk drusen. open-label, n=21, Adults ≥55 with intermediate macular degeneration and high-risk drusen. Vision scores improved without a placebo comparison. (source)
ReCLAIM: retinal atrophy. open-label, n=19, Adults ≥55 with dry macular degeneration and noncentral geographic atrophy. Uncontrolled vision gains led to the randomized program. (source)
ReCLAIM-2: dry macular degeneration. rct, n=176, Adults ≥55 with dry macular degeneration and geographic atrophy. Both primary outcomes failed; exploratory retinal imaging favored active drug. (source)
ReSIGHT: inherited optic neuropathy. rct, n=12, Adults aged 18–50 with m.11778G>A Leber hereditary optic neuropathy. The eye drops did not improve the main sharp-vision endpoint. (source)
MMPOWER-2: long extension. open-label, n=28, Primary Mitochondrial Disease. Walking gains were not sustained in this uncontrolled extension. (source)
Heparin interaction. pk-study, n=12, Healthy Volunteers. A public dose record exists; clinical outcomes are not posted. (source)
ReNEW: phase 3 retina. rct, n=313, Age Related Macular Degeneration (ARMD). Ongoing as of the review date; no clinical result can be inferred. (source)
NuPOWER: nuclear-DNA disease. rct, n=102, Mitochondrial Myopathies; Mitochondrial Pathology; Mitochondrial DNA Mutation; Mitochondrial Diseases; Mitochondrial DNA Deletion; Mitochondrial DNA Depletion; Mitochondrial Met…. A public dose record exists; clinical outcomes are not posted. (source)
ReVEAL: corneal dystrophy. rct, n=22, Fuchs' Corneal Endothelial Dystrophy (FCED). Small paired-eye safety study; it did not establish a corneal benefit. (source)
Mitochondrial expanded access. cohort, Mitochondrial Diseases; Barth Syndrome. A public dose record exists; clinical outcomes are not posted. (source)
Friedreich ataxia: vision pilot. open-label, n=20, Friedreich Ataxia. This unmasked pilot does not establish a dose-response benefit. (source)
SHAPE: aging and function. open-label, n=30, Aging, Healthy. Ongoing as of the review date; no clinical result can be inferred. (source)
First oral dose study. pk-study, n=30, Healthy. A public dose record exists; clinical outcomes are not posted. (source)
Hospitalized heart failure. rct, n=308, Heart Failure. A public dose record exists; clinical outcomes are not posted. (source)
Seven-day oral dosing. pk-study, n=30, Healthy Volunteers. A public dose record exists; clinical outcomes are not posted. (source)
Kidney impairment: repeated IV. pk-study, n=23, Normal and Impaired Renal Function. A public dose record exists; clinical outcomes are not posted. (source)
First IV dose study. pk-study, n=40, Healthy. A public dose record exists; clinical outcomes are not posted. (source)
4TAZPower: confirmatory trial. rct, n=48, Barth Syndrome. Ongoing as of the review date; no clinical result can be inferred. (source)
Smoking and blood-vessel function. pk-study, n=6, Healthy Volunteers. A public dose record exists; clinical outcomes are not posted. (source)
Heart failure with preserved pumping. rct, n=46, Chronic Heart Failure. A public dose record exists; clinical outcomes are not posted. (source)
ReVIEW: early eye-drop study. open-label, n=20, Diabetic Macular Edema; Age-related Macular Degeneration. Sponsor-reported safety exposure does not establish benefit. (source)
EMBRACE: registry safety. rct, n=297, Safety population of the EMBRACE trial. Registry safety includes a numerical death imbalance; causation is unproven. (source)
MMPOWER-3: extension safety. open-label, n=196, Participants continuing after the masked MMPOWER-3 phase. The extension adds exposure information, not a placebo comparison. (source)
Kidney stent: registry endpoint. rct, n=16, 16 enrolled; 14 completed the renal-stent pilot. The registered main filtration endpoint did not show a clear active-arm advantage. (source)
Healthy adults: SC dose finding. pk-study, n=82, Healthy volunteers: 47 single-dose and 35 repeated-dose participants. Healthy-adult low-dose exposure data exist; they do not establish a longevity benefit. (source)
Healthy adults: 40 and 80 mg. pk-study, n=51, Healthy volunteers: 26 single-dose and 25 repeated-dose participants. 80 mg daily was tested briefly; this is not a long-term regimen. (source)
Healthy adults: repeated same-day doses. pk-study, n=8, Healthy adult volunteers. A one-day stress-exposure study cannot support repeated 300 mg days. (source)
Kidney impairment: single IV. pk-study, n=24, Normal, mild, moderate or severe kidney impairment; 6 per group. Reduced kidney function raises exposure. (source)
Kidney impairment: FDA dose details. pk-study, n=23, Normal (6), mild (6), moderate (6), severe (5) kidney impairment. These data underlie the severe-kidney-impairment dose reduction. (source)
Aspirin interaction. crossover-rct, n=8, Healthy adult volunteers. No interaction signal appeared with this specific single-dose IV schedule. (source)
Clopidogrel interaction. crossover-rct, n=8, Healthy adult volunteers. No interaction signal appeared with this specific single-dose IV schedule. (source)
Formulations and injection sites. pk-study, n=40, 32 randomized single-dose and 8 nonrandomized repeated-dose healthy volunteers. Controlled formulations had similar exposure; this does not validate unknown powders. (source)
Heart-rhythm safety study. crossover-rct, n=39, 39 analyzed healthy adult participants. A short high-exposure test found no heart-rhythm signal. (source)
Injection-reaction mitigation study. open-label, Healthy adults in an injection-reaction study. Some local interventions changed reactions; antihistamine sedation was substantial. (source)
Barth: natural-history comparison. cohort, n=27, 8 TAZPOWER extension participants and 19 untreated historical controls. Historical controls favored treatment, but cannot replace a randomized comparison. (source)
Three pediatric expanded-access cases. case-series, n=3, Infants with Barth or Sengers syndrome; child with MEGDEL syndrome. These cases describe specialist dosing, with major confounding and two deaths. (source)
Adult MPAN expanded access. case-report, n=1, Woman evaluated at 17; elamipretide started at age 21 for MPAN. One adult reported functional gains without a control. (source)
CPEO and NARP expanded access. case-series, n=2, Two adults with progressive mitochondrial disease and eye symptoms. An adult 40-to-60 mg schedule has been clinician-published in expanded access. (source)
Barth infant on heart support. case-report, n=1, 11-month-old with Barth syndrome, severe heart failure and mechanical support. Recovery occurred during intensive combined care; the drug’s contribution is unknown. (source)
Newborn Barth expanded access. case-report, n=1, Newborn with Barth syndrome and severe heart weakness. Heart function improved in a newborn receiving several treatments. (source)
Barth neonatal cardiomyopathy case. case-report, n=1, Prenatally identified Barth syndrome with severe LV noncompaction. A further neonatal case was published; complete dose details were not accessible. (source)
French preschool Barth case. case-report, n=1, 5-year-old with Barth syndrome and advanced heart failure. A child improved on combined care; the report cannot isolate the drug’s effect. (source)
Mitochondrial antioxidants review. meta-analysis, n=884, 19 trials, 884 participants, across elamipretide, MitoQ and MitoTEMPO. Pooled results from different compounds cannot be attributed to SS-31. (source)
Heart-failure mitochondrial-drug review. meta-analysis, 31 clinical studies of different mitochondrial-targeted agents. This is not proof that elamipretide prevents death or hospital admission. (source)
Cardiolipin mechanism. animal, Cell experiments, isolated mitochondria and rats with kidney ischemia. This supports the mechanism, not a human dose or clinical benefit. (source)
Barth: FDA strength endpoint. open-label, n=12, Barth crossover trial and its extension. Follow-up strength gains without placebo supported accelerated approval; benefit needs confirmation. (source)

SS-31 (elamipretide) dosage

Typical reported dose: 40 mg once a day

Forzinity: labelled daily dose: 40 mg subcutaneously once daily once daily, under the skin. Drug label. Studied in: Barth syndrome, body weight at least 30 kg. (source)
Forzinity: severe kidney impairment: 20 mg subcutaneously once daily once daily, under the skin. Drug label. Studied in: Adults with Barth syndrome, ≥30 kg, eGFR <30 mL/minute and not on dialysis. (source)
MMPOWER: low IV dose: 0.01 mg/kg/hour IV for 2 hours daily; 0.02 mg/kg total per day once daily as a 2-hour infusion, into a vein. Studied in a trial. Studied in: Adults with genetically confirmed primary mitochondrial myopathy. (source)
MMPOWER: middle IV dose: 0.1 mg/kg/hour IV for 2 hours daily; 0.2 mg/kg total per day once daily as a 2-hour infusion, into a vein. Studied in a trial. Studied in: Adults with genetically confirmed primary mitochondrial myopathy. (source)
MMPOWER: high IV dose: 0.25 mg/kg/hour IV for 2 hours daily; 0.5 mg/kg total per day once daily as a 2-hour infusion, into a vein. Studied in a trial. Studied in: Adults with genetically confirmed primary mitochondrial myopathy. (source)
MMPOWER-2: 40 mg: 40 mg SC once daily once daily, under the skin. Studied in a trial. Studied in: Adults with genetically confirmed primary mitochondrial myopathy. (source)

These are doses reported in labels, trials or user reports, not a personal plan. Check the source behind each one.

Work out syringe units with the dosing calculator

SS-31 (elamipretide) side effects and risks

Reported side effects

Injection-site redness: Barth label: 12/12 (100%) active vs 3/12 (25%) placebo., mild. Rotate sites daily; avoid inflamed skin. (source)
Injection-site pain: Barth label: 9/12 (75%) vs 5/12 (42%)., mild. Persistent or worsening reactions need review. (source)
Injection-site firmness or itch: Each: 8/12 (67%) active vs 2/12 (17%) placebo., mild (source)
Injection-site bruising or hives: Each: 3/12 (25%) active vs 0 placebo., moderate (source)
Increased eosinophils, white blood cells: ReCLAIM 2: 7/117 (6.0%) vs 0/59 placebo. Label: frequent rises in studies lasting at least 30 days., mild (source)
Serious allergic reaction: Can start minutes to months after treatment begins; frequency unknown., serious. Stop further doses and seek emergency care. (source)
Flushing, dizziness or low blood pressure: Label overdose symptoms may be histamine related; community flushing has no reliable rate., moderate (source)
Anxiety, stimulation or worsened fatigue: Personal reports only; frequency and causation are unknown., moderate (source)

Stop and get help if

Trouble breathing, throat swelling, widespread hives or fainting after a dose: Stop further doses and seek emergency care now; a serious allergic reaction can need epinephrine.
Marked lightheadedness, collapse or suspected overdose: Hold further doses and seek urgent medical assessment; overdose may cause low blood pressure.
New severe or persistent abdominal pain, especially with vomiting: Seek urgent assessment; a pediatric report described pancreatic-enzyme elevation, but causation is uncertain.
Cloudy vial, particles, fever or spreading hot, painful injection-site redness: Do not use the vial; seek prompt care for possible infection or product contamination.

Who should avoid it

pregnant: No human pregnancy data. the FDA label does not list pregnancy as a formal contraindication.
breastfeeding: No human milk or infant-effect data.
tryingToConceive: Human reproductive safety is unknown.
under18: The FDA label separately allows Barth syndrome patients weighing at least 30 kg.
other: Do not restart after a serious allergy to elamipretide or a product ingredient.
other: Safety and effectiveness below 30 kg are not established; no approved dose exists for this weight group.
kidneyDisease: Kidney disease raises drug levels. Adults with estimated filtration below 30 mL/min need dosing review; dialysis dosing is unknown.
heartCondition: Heart-failure trials do not establish general benefit. New chest pain, fainting or worsening breathlessness need prompt care.
liverDisease: No liver dosing study was found. The label expects little change in drug levels; severe disease needs review.
testedAthlete: Elamipretide is not named in the 2026 list. Its post-approval classification is unconfirmed; ask the sport’s anti-doping authority.

Interactions

Aspirin and clopidogrel: Single-dose IV studies found no significant change in drug levels or blood-thinning effects. Other blood thinners remain uncertain.
Unfractionated heparin: The IV study found no significant change in clotting tests, aPTT and anti-Xa. Continue usual monitoring.
Metformin and other MATE1 substrates: In lab tests, elamipretide blocks MATE1, a protein that moves medicines. Effects on metformin in people remain unknown.
Duplicate elamipretide products: These names mean the same peptide. Combining them can duplicate the dose. Do not mix products in one syringe.
MOTS-c and other experimental energy stacks: No controlled human combination trial was found. Multiple changes make side effects and benefits hard to trace.

Product quality risks

FDA documented mislisting and quality-control failures in an API supply chain that included elamipretide acetate; this did not measure all retail SS-31 vials.
Unknown powders can have the wrong identity, amount or impurities; HPLC purity alone does not prove sterility or absence of bacterial toxins.
No independent SS-31 retail-vial assay survey or confirmed SS-31 counterfeit-product series was located. Generic peptide warnings are not SS-31 incidence data.

How SS-31 (elamipretide) works

SS-31 binds cardiolipin, a fat in mitochondria, where cells make energy. Lab and animal studies suggest it supports energy production and limits damage. This does not prove better energy or health in people.

Cardiolipin in the inner mitochondrial membrane: Helps stabilize mitochondrial structure and energy-making machinery.
Cytochrome c–cardiolipin interaction: Lab work suggests less damaging peroxide activity while preserving electron transport.

Half-life: After one injection under the skin, mean 3.16 hours in 32 healthy volunteers and 1.48 hours in 7 Barth syndrome patients.

Gaps: The Barth approval rests on a tiny open-label strength dataset; the confirmatory trial has no results yet. NuPOWER is complete but has no registry efficacy results. Conference announcements do not supply a full analyzable dataset. Some early FDA studies have no paper or registry match; detailed safety tables and some cohort doses remain unavailable. Several publications and registries disagree on counts or statistics. Specific discrepancies are retained in study limitations and notes. Clinical-practice schedules come from rare-disease case reports, not an independent wellness or anti-aging dosing guideline. Community frequency labels describe this convenience sample, not measured popularity. Route and exact titration timing are often incomplete. No human SS-31/MOTS-c combination trial, validated cycling schedule, or controlled ME/CFS/long-COVID trial was identified. No reliable powder stability study was found for community diluents, concentrations or storage. Approved-vial storage cannot be transferred. EU, UK, Canadian and Australian authorization searches remain incomplete; Australian scheduling and an athlete-specific WADA ruling were not verified. Long-term cancer risk is unknown; the label states carcinogenicity studies have not been conducted.

Related to SS-31 (elamipretide)

Tirzepatide: A weekly GIP/GLP-1 injection with strong diabetes and weight-loss evidence and common stomach side effects.
NAD+ and precursors: NAD+ helps cells use energy; wellness injection benefits remain unproven.
MOTS-c: A peptide the body makes; injection benefits and safety remain unproven.

SS-31 (elamipretide): the short version

Sources

503B Bulk Drug Substances List, FDA · FDA · 2026
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, FDA · FDA · 2026
Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act, FDA · FDA · 2026
July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee - 07/23/2026, FDA · FDA · 2026
MHRA-101705-PIP01-24 | MHRA, 2026
Peptide products, Therapeutic Goods Administration · TGA · 2026
Pyrogen and Endotoxins Testing: Questions and Answers, FDA · 2026
TGA warning on the risks of importing unapproved peptide products, Therapeutic Goods Administration · 2026
The 2026 Prohibited List, World Anti-Doping Agency · WADA · 2026
The Prohibited List, World Anti-Doping Agency · World Anti-Doping Agency · 2026
Darmerica, LLC - 716152 - 12/08/2025, FDA · FDA · 2025
FORZINITY (elamipretide) injection, for subcutaneous use, U.S. Food and Drug Administration · FDA · 2025
NDA 215244 Forzinity (elamipretide): Integrated Review, 2025
EU/3/21/2430 - orphan designation for treatment of Barth syndrome | European Medicines Agency (EMA), 2021
Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances, FDA · FDA · 2000

Sources checked: 2026-10-18.

Information only, not medical advice. Peptifacts does not sell anything and does not link to sellers.