For research use only. Not for human or veterinary use. Not for diagnostic or therapeutic use.
Menu
Reconstitution calculator

Mitochondrial biology research

SS-31 Dosage, Protocol & Research Guide

Dose source: approved product labelBy Sam, MBA

Label figures describe the approved branded products. The research materials listed on this page are not approved drugs and are not evaluated by any regulator.

  • MW 639.8 g/mol
  • CAS 736992-21-5
Dosage, protocol, reconstitution and storage reference for SS-31, with a reconstitution calculator, vial sizes and cited research.

Dose overview

Every range below is taken from the cited source and carries its evidence grade.

Label figures describe the approved branded products. The research materials listed on this page are not approved drugs and are not evaluated by any regulator.

Human data and community reports

Human data and community reports
SourcePopulationDoseFrequencyRouteDurationEvidence
Forzinity (elamipretide) US label (DailyMed; accelerated approval, Barth syndrome, patients weighing at least 30 kg)[1]40 mg subcutaneously once daily; 20 mg once daily for adults with eGFR below 30 mL/minute and not on dialysishumanpatients with Barth syndrome weighing at least 30 kg (adult and pediatric; labelled indication)40 mg[1]subcutaneous, labelled dose for patients at least 30 kg; 20 mg once daily for adults with eGFR below 30 mL/minute not on dialysisonce dailysubcutaneous— Approved product label
MMPOWER-3 phase 3 trial in primary mitochondrial myopathy (Neurology 2023, doi 10.1212/WNL.0000000000207402)[2]human218 randomized adults with genetically confirmed primary mitochondrial myopathy, phase 3 trial40 mg[2]subcutaneous, trial dose 40 mg per day for 24 weeksdailysubcutaneous— Human clinical trialStudy details from the source: MMPOWER-3 phase 3 trial in primary mitochondrial myopathy (Neurology 2023, doi 10.1212/WNL.0000000000207402): elamipretide 40 mg/d or placebo subcutaneously for 24 weeks

Evidence grades: A approved label, B human trial, C observational, D animal study, E community-reported.

Reconstitution calculator

Sizes in the Pepcore catalogue10 mg50 mg
Concentration
5 mg/mL
Volume to draw
0.05 mL
Units on a U-100 syringe
5 units
Draws per vial
40

0102030405060708090100

Properties

CAS
736992-21-5
Molecular weight
639.8 g/mol
Formula
Not yet recorded
Sequence
D-Arg-Dmt-Lys-Phe-NH2
Aliases
Elamipretide, MTP-131, Bendavia, SS31
Vial sizes (mg)
10, 30, 50

Study duration

24 weeks[2] Human trial

Duration of the cited study. It describes the source and is not a recommended cycle; no off period is stated. Source

Storage notes

Lyophilized
Not yet recorded from a cited source
Reconstituted stability (days)
Not yet recorded from a cited source

Side effects, contraindications and regulatory status

Reported side effects

  • Forzinity (elamipretide) label section 6.1: most common adverse reactions were injection site reactions. In a 12-patient crossover trial vs placebo: any local reaction 100% vs 67%, erythema 100% vs 25%, pain 75% vs 42%.[1] Approved label
  • Same label: injection site induration 67% vs 17% and pruritus 67% vs 17%, bruising 25% vs 0%, urticaria 25% vs 0% (elamipretide vs placebo); eosinophil counts increased, typically peaking around day 90.[1] Approved label
  • Forzinity label warnings: contains benzyl alcohol and is not approved for use in neonates or for intravenous use (5.1); hypersensitivity reactions, including serious allergic reactions needing emergency care, have been reported (5.2).[1] Approved label
  • MMPOWER-3 phase 3 trial (primary mitochondrial myopathy, 40 mg/d subcutaneous for 24 weeks): the authors report elamipretide was well tolerated, with most adverse events mild to moderate (Neurology 2023).[2] Human trial

Contraindications

  • Forzinity label contraindication: serious hypersensitivity to elamipretide or any of the excipients.[1] Approved label

Regulatory status

US label (DailyMed) for Forzinity (elamipretide): accelerated approval in Barth syndrome, patients 30 kg or more; Initial U.S. Approval 2025. Checked 2026-10-20.[1] Source

Report any adverse reaction to a qualified healthcare professional.

What the research says

Summaries of the cited studies, each with its evidence grade.

  • Forzinity (elamipretide) US label (DailyMed; accelerated approval, Barth syndrome, patients weighing at least 30 kg)[1]

    Approved label human

    Forzinity (elamipretide) US label (DailyMed; accelerated approval, Barth syndrome, patients weighing at least 30 kg): 40 mg subcutaneously once daily; 20 mg once daily for adults with eGFR below 30 mL/minute and not on dialysis

    Approved product label

  • MMPOWER-3 phase 3 trial in primary mitochondrial myopathy (Neurology 2023, doi 10.1212/WNL.0000000000207402)[2]

    Human trial human

    MMPOWER-3 phase 3 trial in primary mitochondrial myopathy (Neurology 2023, doi 10.1212/WNL.0000000000207402): elamipretide 40 mg/d or placebo subcutaneously for 24 weeks

    Human clinical trial

Compare vial sizes

Compare vial sizes
SizePriceDoses available from the vial CalculatedCost per dose Calculated
10 mg$44.99——
50 mg$145.99——

Cost per dose uses the listed partner price and the reference dose cited on this page. Prices change; check the product page.

Calculated from a default of 2 mL water (adjustable).

PeptideCheck may earn a commission when you use Pepcore links, at no extra cost to you. Read the disclosure.

Frequently asked questions

What dose figures are published for SS-31?

Cited figures on this page: 40 mg once daily, subcutaneous, labelled dose for patients at least 30 kg; 20 mg once daily for adults with eGFR below 30 mL/minute not on dialysis [1] (Approved product label, evidence grade A); 40 mg daily, subcutaneous, trial dose 40 mg per day for 24 weeks [2] (Human clinical trial, evidence grade B). These are summaries of published sources, not medical advice. Each figure links to its source in the references.

What study duration is cited for SS-31?

The cited duration is 24 weeks, with no off period stated (Human clinical trial). It describes the source, not a recommendation.

What is the regulatory status of SS-31?

US label (DailyMed) for Forzinity (elamipretide): accelerated approval in Barth syndrome, patients 30 kg or more; Initial U.S. Approval 2025. Checked 2026-10-20.

Compound facts

Recorded molecular weight: 639.8 g/mol.
Recorded CAS number: 736992-21-5
Not yet recorded from a cited source.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/11764719
PubMed IDs
32273339, 34302976

References

Numbered sources used on this page. Markers in the text link here.

  1. Forzinity (elamipretide) US label (DailyMed; accelerated approval, Barth syndrome, patients weighing at least 30 kg) dailymed.nlm.nih.gov Approved label
  2. MMPOWER-3 phase 3 trial in primary mitochondrial myopathy (Neurology 2023, doi 10.1212/WNL.0000000000207402) pubmed.ncbi.nlm.nih.gov Human trial

Vial sizes and protocols

  • 10 mgPartner size

  • 50 mgPartner size

Available from Pepcore

Supplied as research material for laboratory use only.

Label figures describe the approved branded products. The research materials listed on this page are not approved drugs and are not evaluated by any regulator.

PeptideCheck may earn a commission when you use Pepcore links, at no extra cost to you. Read the disclosure.