On this page
- Quick reference
- Dosage chart and four steps
- Supplies needed
- Vial and research context
- SS-31 10 mg Vial Protocol Overview
- SS-31 Dosage in Human Research
- Storage and Handling
- How to Read an SS-31 Peptide Dosage Chart
- Elamipretide Clinical Trial Dose and Schedule Evidence
- How SS-31 Targets Mitochondrial Function
- SS-31 Research Findings, Safety, and Limitations
- Subcutaneous Measurement and Injection Context
- SS-31 Dosage Questions
- SS-31 Peptide Research Questions and Evidence Boundaries
- Important Research Note
- References
- Related research, protocols, and guides
SS-31 Quick Reference (10 mg Vial)
- Vial contents
- 10 mg SS-31
- Final volume
- 1 mL
- Concentration
- 10 mg/mL
- One U-100 unit
- 100 mcg in 0.01 mL
Research context: For evidence on mechanisms, human and preclinical research, limitations, and safety, read SS-31 Peptide: Benefits, Uses, Side Effects, Dosage, and Research.
SS-31 Dosage Chart
Dosing & Reconstitution Guide
Educational guide for reconstitution and daily dosing
Standard / Gradual Approach (1 mL = 10 mg/mL)
| Week | Daily Dose (mg) | Units (per injection) (mL) |
|---|---|---|
| Weeks 1–2 | 5 mg (5000 mcg) | 50 units (0.50 mL) |
| Weeks 3–8 | 10 mg (10,000 mcg) | 100 units (1.0 mL) |
Frequency: Inject once daily subcutaneously at a consistent time. This concentrated dilution (1.0 mL per 10 mg vial) keeps standard doses within a single insulin syringe for convenience and accuracy.
Reconstitution Steps
- Draw 1.0 mL bacteriostatic water with a sterile syringe.
- Inject slowly down the vial wall; avoid vigorous shaking to prevent foaming.
- Gently swirl/roll until fully dissolved (clear solution).
- Label with reconstitution date and refrigerate at 2–8 °C (35.6–46.4 °F), protected from light; follow product-specific use-by and sterile-handling requirements.
Advanced / Aggressive Approach (1 mL = 10 mg/mL)
| Week | Daily Dose (mg) | Units (per injection) (mL) |
|---|---|---|
| Weeks 1–2 | 5 mg (5000 mcg) | 50 units (0.50 mL) |
| Weeks 3–4 | 10 mg (10,000 mcg) | 100 units (1.0 mL) |
| Weeks 5–8 | 15 mg (15,000 mcg) | Split: 2 × 75 units (0.75 mL each) |
| Optional Weeks 9–12 | 20 mg (20,000 mcg) | Split: 2 × 100 units (1.0 mL each) |
Note: Advanced dosing (15–20 mg/day) is based on short‑term clinical trial protocols[4][5] for severe mitochondrial conditions and should only be pursued under medical supervision. Doses above 10 mg require splitting into two separate subcutaneous injections at different sites. Clinical trials have not extensively evaluated SS‑31 beyond 12 weeks; extended use requires careful monitoring.
Supplies Needed
Plan based on an 8–12 week daily protocol with gradual titration.
-
Peptide Vials (SS‑31, 10 mg each):
- 8 weeks (Standard: 5–10 mg/day): approximately 50 vials required
- 12 weeks (Standard maintenance at 10 mg/day): approximately 77 vials required
- 12 weeks (Advanced: escalating to 15 mg/day): approximately 105 vials required
-
Insulin Syringes (U‑100, 1 mL capacity):
- Per week (standard dosing): 7 syringes (1/day)
- 8 weeks: 56 syringes
- 12 weeks: 84 syringes
- Advanced protocols with split injections may require 2 syringes per day for higher doses
-
Bacteriostatic Water (30 mL bottles): Use 1.0 mL per vial for reconstitution.
- 8 weeks (50 vials): 50 mL — 2 bottles required (30 mL each)
- 12 weeks (77 vials): 77 mL — 3 bottles required (30 mL each)
- 12 weeks (105 vials, advanced): 105 mL — 4 bottles required (30 mL each)
-
Alcohol Swabs: One for the vial stopper + one for the injection site each day.
- Per week: 14 swabs (2/day)
- 8 weeks: 112 swabs — 2 boxes required (100 swabs each)
- 12 weeks: 168 swabs — 2 boxes required (100 swabs each)
SS-31 Vial and Research Context
- Reconstitute: Add 1.0 mL bacteriostatic water → 10 mg/mL concentration for single‑syringe convenience.
- Typical daily range: 5–10 mg once daily (gradual titration); advanced protocols may reach 15–20 mg/day under supervision.
- Easy measuring: At 10 mg/mL, 1 unit = 0.01 mL = 100 mcg on a U‑100 insulin syringe.
- Storage: Lyophilized: freeze at −20 °C (−4 °F); after reconstitution, refrigerate at 2–8 °C (35.6–46.4 °F); follow product-specific use-by and sterile-handling requirements.
SS-31, also called elamipretide, MTP-131, or Bendavia, is a mitochondria-targeted tetrapeptide studied for its interaction with cardiolipin in the inner mitochondrial membrane[1][2]. Research examines how this interaction can influence cristae structure, electron transport, mitochondrial function, ATP production, and oxidative stress. Elamipretide received FDA accelerated approval in 2025 as Forzinity for Barth syndrome in patients weighing at least 30 kg, but that approved 40 mg daily product and indication must not be confused with a third-party 10 mg research vial[3][21].
SS-31 10 mg Vial Protocol Overview
The 10 mg vial changes concentration and syringe-volume calculations. It does not establish a clinical dose.
- Compound names: SS-31, elamipretide, MTP-131, and Bendavia refer to the same mitochondria-targeted peptide discussed in the research literature[1].
- Calculation basis: Adding 1.0 mL to a 10 mg vial produces 10 mg/mL. On a U-100 syringe, 1 unit equals 0.01 mL, or 100 mcg at this concentration.
- Research status: Human studies used protocol-specific formulations and doses. They did not validate a general 10 mg vial dosing protocol[4][5].
- Approved product distinction: Forzinity is FDA-approved for a narrow Barth syndrome population at 40 mg subcutaneously once daily. Its concentration, labeling, and handling instructions are product-specific[21][22].
SS-31 Dosage in Human Research
Published elamipretide studies used different doses, durations, populations, and endpoints. The numbers below describe research designs, not a recommended protocol.
- Heart failure: PROGRESS-HF compared 4 mg and 40 mg subcutaneous doses once daily for 28 days. The study did not show a significant improvement in its primary cardiac-structure outcomes[4][24].
- Primary mitochondrial myopathy: MMPOWER-2 evaluated 40 mg subcutaneously once daily for four weeks. The primary six-minute walk outcome was not statistically significant, although selected patient-reported outcomes favored elamipretide[5][25].
- Barth syndrome: TAZPOWER studied 40 mg once daily. The initial crossover phase did not meet its primary endpoints, while longer open-label follow-up reported improvements that require the study-design limitations to remain visible[6][17].
- Later myopathy trial: MMPOWER-3 also used 40 mg once daily for 24 weeks and did not meet its primary efficacy endpoints[16].
Storage and Handling
Storage instructions should come from the exact product label or laboratory stability documentation.
- Do not transfer FDA-label instructions: Forzinity is a finished prescription solution with its own packaging and handling directions. Those directions do not establish stability for a lyophilized research vial[21].
- Research vial: Follow the supplier’s written storage, light-protection, sterility, and use-by information for the specific lot[15].
- After reconstitution: Record the preparation date, minimize contamination risk, and discard the vial if its appearance changes or the supplier’s documented use period has elapsed.
How to Read an SS-31 Peptide Dosage Chart
An SS-31 peptide dosage chart combines two different kinds of information: a mass amount in milligrams or micrograms and a liquid volume in milliliters or U-100 syringe units. The vial strength controls the conversion between those values. It does not determine which dose is appropriate.
For the 10 mg vial shown on this page, a final volume of 1.0 mL produces a 10 mg/mL concentration. One U-100 unit is 0.01 mL, so each unit contains 0.1 mg, or 100 mcg, of SS-31. A 5 mg amount occupies 0.50 mL, which is 50 units. A 10 mg amount occupies 1.0 mL, which is 100 units. These are arithmetic conversions only.
Published elamipretide dose selection cannot be inferred from vial math. Clinical trials used manufactured study formulations and protocol-defined eligibility criteria. The FDA-approved Forzinity dose is also tied to its specific drug product and Barth syndrome indication[21][22].
Elamipretide Clinical Trial Dose and Schedule Evidence
The human research record is broader than a single SS-31 dosage per day. Investigators have used subcutaneous dosing and short intravenous infusions across different conditions. Results have varied by population and endpoint.
Subcutaneous research schedules
- PROGRESS-HF randomized participants with heart failure and reduced ejection fraction to 4 mg, 40 mg, or placebo once daily for 28 days. The trial reported no significant improvement in left ventricular end-systolic volume, end-diastolic volume, or ejection fraction[4].
- MMPOWER-2 used 40 mg once daily for four weeks in primary mitochondrial myopathy. The prespecified six-minute walk comparison did not reach statistical significance[5].
- MMPOWER-3 used 40 mg once daily for 24 weeks in a larger primary mitochondrial myopathy trial. Primary six-minute walk and fatigue endpoints were not met[16].
- TAZPOWER used 40 mg once daily in Barth syndrome. Interpretation requires separating the randomized crossover phase from longer open-label follow-up[6][17].
Other administration formats
A heart failure study evaluated short intravenous elamipretide infusions rather than a daily subcutaneous vial protocol[18]. ReCLAIM and ReCLAIM-2 examined elamipretide in dry age-related macular degeneration using study-specific procedures and endpoints[19][20]. These studies help define the evidence base, but their dosing formats should not be converted into a 10 mg vial schedule.
How SS-31 Targets Mitochondrial Function
SS-31 is designed to concentrate at the inner mitochondrial membrane. It associates with cardiolipin, a phospholipid that helps organize cristae and respiratory-chain proteins[1][2]. Experimental research suggests that the peptide can influence cardiolipin-protein interactions, mitochondrial membrane structure, electron transport, ATP production, and reactive oxygen species signaling[7][8].
Mechanistic studies also describe effects on mitochondrial protein interactions and bioenergetics under cellular stress[21][22]. These findings explain why SS-31 appears in research on mitochondrial dysfunction, but a plausible mechanism does not prove a clinical benefit for every condition. A separate evidence profile summarizes the peptide’s preclinical and clinical development history[9].
SS-31 Research Findings, Safety, and Limitations
Human research has produced a mixed evidence picture. Several trials found acceptable short-term tolerability, while multiple randomized studies did not meet their primary efficacy endpoints[4][5][16]. Barth syndrome research contributed to accelerated approval, which relies on a specific disease population and continuing confirmatory obligations[3][22].
What has been observed
- Injection-site reactions: Local redness, itching, pain, or discomfort were common in subcutaneous studies and are also described in the approved label[5][6][21].
- Variable efficacy: Negative primary endpoints in heart failure and mitochondrial myopathy limit broad claims about performance, fatigue, or cardiac outcomes[4][16].
- Population specificity: Evidence from Barth syndrome, primary mitochondrial myopathy, heart failure, or retinal-disease research cannot automatically be generalized to healthy people or other conditions.
- Product specificity: A third-party lyophilized 10 mg vial is not the same drug product as Forzinity. Concentration, excipients, sterility assurance, and stability documentation may differ.
Subcutaneous Measurement and Injection Context
When a research protocol uses the subcutaneous route, syringe markings represent liquid volume, not peptide international units. CDC, Johns Hopkins, NCBI, and pharmacology references describe general subcutaneous technique, site selection, aseptic preparation, and rotation principles[11][12][13][14].
- Use a new sterile syringe for each preparation and administration.
- Clean the vial stopper and selected site according to appropriate aseptic procedure.
- Rotate sites when repeated subcutaneous administrations are part of a supervised protocol.
- Place used needles and syringes directly into an appropriate sharps container.
SS-31 Dosage Questions
What is SS-31 peptide?
SS-31 is the research name commonly used for elamipretide, a mitochondria-targeted tetrapeptide. It is also described as MTP-131 or Bendavia in parts of the scientific literature[1].
What does a 10 mg SS-31 vial mean?
It means the vial contains 10 mg of peptide before reconstitution. The final concentration depends on the liquid volume added. A 10 mg vial mixed to 1.0 mL equals 10 mg/mL.
How many U-100 units are in 1 mg at 10 mg/mL?
One milligram occupies 0.10 mL at 10 mg/mL. On a U-100 syringe, 0.10 mL is 10 units. This is a concentration conversion, not a dose recommendation.
Is SS-31 the same as Forzinity?
Elamipretide is the active ingredient in Forzinity, but an unlabeled research vial is not interchangeable with the FDA-approved finished drug. Forzinity has product-specific concentration, manufacturing, labeling, indication, and handling requirements[21].
Is there one established SS-31 peptide dosage for every use?
No. Research schedules vary by formulation, route, population, study duration, and endpoint. A vial calculator can convert mass to volume, but it cannot select or validate a dose.
SS-31 Peptide Research Questions and Evidence Boundaries
How have clinical studies on SS-31 selected a dose?
Each trial of elamipretide in adults defined its own dose range, route, cycle length, eligibility criteria, and clinical endpoints. Research in adults with primary mitochondrial myopathy used a different protocol from research in patients with heart failure with reduced ejection fraction[4][5][16]. Those designs do not establish a universal dose of SS-31, SS-31 administration schedule, or SS-31 treatment plan.
How does the peptide target mitochondrial membranes?
As a synthetic peptide, SS-31 concentrates near the inner mitochondrial membrane. Experimental work describes how SS-31 binds cardiolipin and can influence the electron transport chain, mitochondrial reactive oxygen species, cellular energy production, redox signaling, and the mitochondrial permeability transition pore[1][2][21]. Calling it only an antioxidant SS-31 compound would oversimplify the proposed mechanism of SS-31.
Is SS31 peptide established for every mitochondrial disease?
No. The terms SS31 and SS31 peptide appear frequently in search and research summaries, but evidence remains condition-specific. Barth syndrome is an X-linked mitochondrial disease, while primary mitochondrial myopathy includes different disorders and patient groups[10]. Results from one mitochondrial disease cannot be transferred to another without direct study.
Do preclinical findings prove mitochondrial support or longevity benefits?
No. Protective effects of SS-31 in cells or animal models can guide research hypotheses, but they do not prove mitochondrial support, reversing mitochondrial dysfunction, slower mitochondrial decline, or greater longevity in people. The human clinical evidence and its negative primary endpoints must remain part of the interpretation[4][16].
What does reconstituted SS-31 change?
Reconstitution changes concentration and liquid volume. It does not change the evidence for a dose range. Any reconstituted SS-31 calculation should state the vial mass, final volume, concentration, syringe volume, and whether the number is a research example or a published study amount.
Important Research Note
References
- 1International Journal of Molecular Sciences (2025) – Elamipretide: structure, mechanism, and therapeutic research review.
- 2British Journal of Pharmacology – Cardiolipin-binding and mitochondrial membrane mechanism of SS-31.
- 3U.S. Food and Drug Administration – Accelerated approval announcement for elamipretide in Barth syndrome.
- 4Journal of Cardiac Failure (2020) – PROGRESS-HF randomized study of 4 mg and 40 mg daily elamipretide.
- 5Neurology (2020) – MMPOWER-2 trial in primary mitochondrial myopathy.
- 6Genetics in Medicine (2021) – TAZPOWER trial of elamipretide in Barth syndrome.
- 7Biochimica et Biophysica Acta – Cardiolipin remodeling, cristae structure, and mitochondrial function.
- 8Journal of Cardiovascular Pharmacology – SS-31, oxidative stress, and mitochondrial bioenergetics.
- 9Alzheimer’s Drug Discovery Foundation – SS-31 preclinical and clinical evidence overview.
- 10Orphanet Journal of Rare Diseases – Barth syndrome clinical presentation and emerging therapies.
- 11Centers for Disease Control and Prevention – General subcutaneous administration guidance.
- 12Johns Hopkins Arthritis Center – Subcutaneous injection procedure guide.
- 13NCBI Bookshelf – Best practices for injection preparation and administration.
- 14Pharmacologic Considerations of Subcutaneous Drug Administration – Site rotation and absorption considerations.
- 15Pure Lab Peptides – SS-31 10 mg research-vial supplier page.
- 16Neurology (2023) – MMPOWER-3 phase 3 trial of elamipretide in primary mitochondrial myopathy.
- 17Journal of the American College of Cardiology (2024) – Long-term open-label elamipretide outcomes in Barth syndrome.
- 18Circulation: Heart Failure (2017) – Intravenous elamipretide study in heart failure.
- 19Ophthalmology Science (2022) – ReCLAIM phase 1 study in dry age-related macular degeneration.
- 20Ophthalmology Science (2024) – ReCLAIM-2 study of elamipretide in geographic atrophy.
- 21FASEB Journal (2020) – Experimental study of elamipretide and mitochondrial bioenergetics.
- 22Scientific Reports (2020) – Mitochondrial protein interactions associated with elamipretide.
Related research, protocols, and guides
Explore the available research context, protocol variants or comparisons, and practical guides. When vial-strength variants exist, they remain separate because vial strength, concentration, and syringe-unit calculations can differ. Related compounds and blends are comparisons only, not interchangeable.
Research overview
Other vial-strength protocols
Related protocols and comparisons