SS-31

A mitochondria-targeting aromatic-cationic tetrapeptide developed clinically as elamipretide.

Human trialsPeptide research profile

Also known as: Elamipretide, MTP-131, Bendavia

(how we review)

Dosing & scaling, explained

The calculator records 1 mg daily and 5 mg twice-weekly rows. Clinical elamipretide programs used materially different exposure and formulations. This is educational source context, not a protocol or recommendation.

How sourced amounts are organized

  1. Starting pointNot clinically establishedNo validated titration window

    There is no regulator-approved starting dose for this research use. A low-looking number is not automatically safe.

  2. Recorded preset1 mg daily or 5 mg twice weeklyCalculator library reference

    This is the range represented in the in-app protocol library. It describes the source record; it does not validate the regimen.

  3. Higher exposureNot validated against trial exposureRisk and uncertainty increase

    Higher exposure is not established as more effective. Human pharmacokinetic and long-term safety data may be absent.

“SS-31” research material and clinical elamipretide formulation should not be assumed bioequivalent.

Patterns described in source material

  • Daily or twice weekly in presets

    The cadence represented by the recorded calculator presets.

  • 40 mg daily SC in MMPOWER-3

    Published experiments may use a different route, formulation, timing, or population and should not be treated as interchangeable.

  • No universal schedule

    No single schedule has been validated across products or research contexts.

Clinical context
  • 40 mgDaily subcutaneousMMPOWER-3 phase 3Overall primary endpoints negative

The phase 3 trial directly tested 40 mg/day for 24 weeks and did not meet either primary endpoint in the overall population.

Storage, handling and interpretation

Lyophilized material

Keep cold, dry, and protected from light according to the manufacturer certificate or validated lab SOP.

After reconstitution

Use sterile technique, refrigerate as validated, and avoid repeated freeze-thaw cycles.

Traceability

Record lot, concentration, preparation date, and the identity/purity documentation used by the lab.

Reported protocols for SS-31

What published studies and recent community write-ups report about amounts, timing and course length. 7 clinical, 2 preclinical and 3 community-reported rows, each linked to its source. These are descriptions of what others report, not instructions, and nothing here is medical advice.

ContextDoseFrequencyRouteCourseSource
Clinical7 rows
FDA label, Forzinity (Barth syndrome)Adults and children with genetically confirmed Barth syndrome weighing at least 30 kg40 mg (0.5 mL of an 80 mg/mL solution); 20 mg in adults with eGFR below 30 mL/min who are not on dialysisOnce daily, at the same time each daySubcutaneous, abdomen at least 2 inches from the navel or outer thigh, rotating sites dailyContinuous; the approval covers ongoing treatmentNone; a missed dose is skipped rather than doubledDailyMed, National Library of Medicine2025
The 2025 label gives a single fixed dose with no titration and a half-dose only for severe renal impairment, because exposure rose 125% when creatinine clearance fell below 30 mL/min. Approval was granted under the accelerated pathway on an intermediate endpoint (knee extensor strength) from 12 patients, and injection site erythema occurred in all 12 treated patients versus 3 on placebo.
TAZPOWER randomized crossover trial and open-label extension12 males aged 12-35 with genetically confirmed Barth syndrome40 mgOnce dailySubcutaneous12 weeks on drug and 12 weeks on placebo separated by a 4-week washout, then open-label dosing to 36 weeks and beyond4-week washout between the two blinded periods onlyGenetics in Medicine (PubMed Central)2021
Neither primary endpoint (6-minute walk distance or a Barth fatigue score) was met in the 12-week blinded periods. In the open-label extension, 10 of the 12 continued and 8 reached 36 weeks, by which point walking distance had improved 95.9 m and knee extensor strength had risen, but these are uncontrolled before-and-after comparisons in a handful of patients.
TAZPOWER 168-week open-label extension10 Barth syndrome patients who entered the extension; 8 reached week 16840 mgOnce dailySubcutaneous168 weeks of continuous dosing (3 patients reached 192 weeks per the label)NoneGenetics in Medicine (PubMed)2024
Walking distance was above the extension baseline at every visit, with a cumulative 96.1 m gain at week 168, and 3D echocardiographic volumes and the monolysocardiolipin to cardiolipin ratio moved in the expected direction. Injection site reactions were the most common adverse event; with no placebo arm after week 28, the long-term efficacy figures cannot separate drug effect from time and expectation.
MMPOWER phase 1/2 intravenous dose escalation36 adults with genetically confirmed primary mitochondrial myopathy0.01, 0.10 or 0.25 mg/kg per hour infused over 2 hoursOnce daily for 5 consecutive daysIntravenous infusion5 days, with follow-up testing 2 days after the last doseNot applicableNeurology (PubMed)2018
The highest dose cohort walked a mean 64.5 m farther at day 5 against 20.4 m on placebo, a difference that did not reach significance (p = 0.053), although the dose-response trend did (p = 0.014). Each cohort had only 9 treated and 3 placebo participants, and the 0.25 mg/kg per hour infusion became the reference point for the 40 mg subcutaneous dose used afterwards.
MMPOWER-2 phase 2 crossover trial30 adults with primary mitochondrial myopathy who had completed MMPOWER40 mgOnce dailySubcutaneous4 weeks on drug and 4 weeks on placebo4-week washout between the two periodsJournal of Cachexia, Sarcopenia and Muscle (PubMed)2020
Six-minute walk distance was 398.3 m on elamipretide versus 378.5 m on placebo, a 19.8 m difference that missed significance (p = 0.083), while patient-reported fatigue scores favored the drug. Injection site reactions occurred in 80% of participants, mostly mild, and the authors note that subcutaneous bioavailability was about 90% of the intravenous formulation.
MMPOWER-3 phase 3 trial218 adults (mean age 45.6, 64% women) with genetically confirmed primary mitochondrial myopathy40 mgOnce dailySubcutaneous, self-injected at rotating abdominal or thigh sites24 weeksNoneNeurology (PubMed)2023
The trial missed both primary endpoints: the walking distance difference versus placebo was minus 3.2 m (p = 0.69) and the fatigue score difference was negligible (p = 0.37). Tolerability was good, with 94% completing the double-blind period, but injection site erythema affected 86% of treated participants against 28% on placebo, and a post hoc nuclear-DNA subgroup signal remains a hypothesis.

How a course is commonly described

  1. Day 1: full dose from the startClinical

    The label and every trial began at the full 40 mg subcutaneous dose with no titration, injected at the same time each day in the abdomen or outer thigh. Injection site redness, itching and induration appear early and were the dominant adverse events in all of the trials.

  2. Weeks 1-4Clinical

    Four weeks at 40 mg in MMPOWER-2 produced a 19.8 m walking-distance difference that fell short of significance alongside improved fatigue scores. The label describes peak levels 0.5 to 1 hour after injection and essentially the whole dose recovered in urine within 48 hours, so there is no build-up over the first weeks.

  3. Weeks 12-24Clinical

    Twelve blinded weeks in Barth syndrome and 24 blinded weeks in mitochondrial myopathy showed no advantage over placebo on walking or fatigue. The label's knee-strength data come from the open-label extension, where median gains of 34 newtons at extension week 12 and 68 newtons at week 24 were recorded without a control group.

  4. Weeks 36-168: long-term extensionClinical

    In the TAZPOWER extension, walking distance stayed above baseline at every visit through week 168 and cardiac volumes improved, with 8 of 10 patients still dosing. The approval rests on this uncontrolled long-term experience plus the crossover data, and a placebo-controlled confirmatory trial is a condition of continued approval.

  5. Community blocksCommunity-reported

    Community guides describe 5-10 mg once daily in 4-8 week blocks followed by 2-4 weeks off, or continuous dosing with an optional 8-weeks-on, 4-weeks-off pattern. None of these schedules or doses has been tested in a human trial, and the guides themselves say so.

  • The only regimen with regulatory backing is 40 mg subcutaneously once daily, taken continuously, for Barth syndrome in people weighing at least 30 kg. The same dose and route missed their primary endpoints in a 218-patient mitochondrial myopathy trial and a 176-patient macular degeneration trial.
  • Community doses of 5-10 mg per day are 4 to 8 times lower than any dose studied in humans, and the on-off blocks described online are convention rather than evidence. Rodent work used 3 mg/kg, which does not convert to these figures.
  • Label pharmacokinetics show rapid absorption, no hepatic metabolism, urinary excretion of the whole dose within 48 hours and minimal accumulation, so there is no pharmacological reason to taper or wash out. Forzinity's approval is an accelerated approval contingent on a confirmatory placebo-controlled trial.
Sources for this section (13)
  1. FORZINITY (elamipretide hydrochloride) injection: Prescribing InformationDailyMed, National Library of Medicine2025Clinical
  2. FDA Grants Accelerated Approval to First Treatment for Barth SyndromeU.S. Food and Drug Administration2025Clinical
  3. A phase 2/3 randomized clinical trial followed by an open-label extension to evaluate the effectiveness of elamipretide in Barth syndrome, a genetic disorder of mitochondrial cardiolipin metabolismGenetics in Medicine (PubMed Central)2021Clinical
  4. Long-term efficacy and safety of elamipretide in patients with Barth syndrome: 168-week open-label extension results of TAZPOWERGenetics in Medicine (PubMed)2024Clinical
  5. Randomized dose-escalation trial of elamipretide in adults with primary mitochondrial myopathyNeurology (PubMed)2018Clinical
  6. A randomized crossover trial of elamipretide in adults with primary mitochondrial myopathyJournal of Cachexia, Sarcopenia and Muscle (PubMed)2020Clinical
  7. Efficacy and Safety of Elamipretide in Individuals With Primary Mitochondrial Myopathy: The MMPOWER-3 Randomized Clinical TrialNeurology (PubMed)2023Clinical
  8. ReCLAIM-2: A Randomized Phase II Clinical Trial Evaluating Elamipretide in Age-related Macular Degeneration, Geographic Atrophy Growth, Visual Function, and Ellipsoid Zone PreservationOphthalmology Science (PubMed Central)2025Clinical
  9. Mitochondrial targeted peptide rapidly improves mitochondrial energetics and skeletal muscle performance in aged miceAging Cell (PubMed Central)2013Preclinical
  10. Improving mitochondrial function with SS-31 reverses age-related redox stress and improves exercise tolerance in aged miceFree Radical Biology and Medicine (ScienceDirect)2019Preclinical

Plus 3 community resources (dosing guides, forum threads and vendor write-ups), reported above but not linked.

Overview

SS-31, known generically as elamipretide and by the development codes MTP-131 and Bendavia, is a synthetic four-residue peptide designed by Hazel Szeto and Peter Schiller that concentrates in the inner mitochondrial membrane and binds the phospholipid cardiolipin. Stealth BioTherapeutics took it through trials in primary mitochondrial myopathy, heart failure, reperfusion injury, dry age-related macular degeneration and Barth syndrome, and the large trials in mitochondrial myopathy and macular degeneration both missed their primary endpoints. On September 19, 2025 the FDA granted accelerated approval to Forzinity (elamipretide) injection, 40 mg subcutaneously once daily, to improve muscle strength in people with Barth syndrome weighing at least 30 kg, based on knee extensor strength in a 12-patient trial, with a confirmatory trial required. Powder sold online as SS-31 is a research chemical rather than the approved product, and community guides describe it at a fraction of the labeled dose.

What researchers are exploring

These themes describe recurring questions in published research. They are not claims of effectiveness or recommendations for use.

  • 1

    Mitochondrial myopathy

    MMPOWER trials measure walking capacity, fatigue, symptoms, and safety.

  • 2

    Cardiolipin biology

    Preclinical work explores inner-membrane structure and electron-transport function.

  • 3

    Genotype response

    Post-hoc analyses examine whether nuclear-DNA subgroups differ from mtDNA groups.

  • 4

    Other mitochondrial disorders

    Programs have studied ophthalmic, cardiac, and rare-disease populations.

What the current evidence can support

Study models remain visible so laboratory and animal findings are not mistaken for established human outcomes.

  • Human

    Negative MMPOWER-3 primary endpoints

    In 218 participants, 40 mg/day did not significantly improve six-minute walk distance or fatigue overall.

  • Human

    Earlier dose-escalation trial

    A short phase 1/2 study evaluated IV doses and exercise outcomes.

  • Review

    Post-hoc subgroup caution

    Signals in genotype subgroups require prospective confirmation and do not overturn the overall result.

Amounts recorded for SS-31

These amount records are independent from vial strength, reconstitution volume and measuring device. A recorded source is not the same as study backing, and these values are not recommendations.

  • 1
    Lower recordedSign in for schedule, duration and source context.
    1 mg
  • 2
    Mid recordedSign in for schedule, duration and source context.
    2 mg
  • 3
    Dose · upper endpointSign in for schedule, duration and source context.
    5 mg

Chemistry identifiers

Sequence, synonyms and registry identifiers as recorded in PubChem, the National Library of Medicine's open chemistry database. Formula, mass and CAS number are summarized at the top of the page.

Sequence

D-Arg-Dmt-Lys-Phe-NH2 (Dmt = 2',6'-dimethyl-L-tyrosine)

Also listed as

Elamipretide, Forzinity, Bendavia, MTP-131, SS-31, Ocuvia, RX-31, UNII 87GWG91S09

InChIKey

SFVLTCAESLKEHH-WKAQUBQDSA-N

Origin / design

Designed to associate with the inner mitochondrial membrane/cardiolipin

IUPAC name

(2S)-6-amino-2-[[(2S)-2-[[(2R)-2-amino-5-(diaminomethylideneamino)pentanoyl]amino]-3-(4-hydroxy-2,6-dimethylphenyl)propanoyl]amino]-N-[(2S)-1-amino-1-oxo-3-phenylpropan-2-yl]hexanamide

Limitations and unknowns

Important limitations

  • The 40 mg/day trial dose and investigational formulation differ from small-vial presets.
  • Post-hoc responder analyses are hypothesis-generating.
  • A calculator preset is a recorded research convention, not a recommendation or evidence of clinical benefit.
  • Identity, purity, sterility, and stability can vary substantially outside regulated manufacturing.
  • Route, formulation, and population can make results from one study inapplicable to another use.

Sources

2 curated references, each with its journal, year and study model, plus 3 community resources reported but not linked.

  1. Efficacy and Safety of Elamipretide in Individuals With Primary Mitochondrial MyopathyNeurology2023Human
  2. Randomized dose-escalation trial of elamipretide in adults with primary mitochondrial myopathyNeurology2018Human