Full Protocol Guide

SS-31 (Elamipretide) 10mg

A mitochondrial research peptide entry focused on cardiolipin, oxidative-stress biology, and clinician review.

SS-31 (Elamipretide) 10mg product vial
SS-31 Elamipretide 10mg vial Performance, Recovery & Muscle
ProductSS-31 (Elamipretide) 10mg
CategoryPerformance, Recovery & Muscle
FormatSS-31 Elamipretide 10mg vial
ReviewSource-linked guide

Contents

Use this guide as a structured review page. The same headings appear for every protocol so clients and the care team can scan the page consistently.

Important Note

This page is informational and does not authorize use. Peptify clients should complete assessment, disclose medications and health history, and follow the clinician-approved plan only.

  • Do not start, stop, combine, or change a protocol based only on website content.
  • Emergency symptoms require urgent medical care, not a website or routine follow-up message.

Quickstart Highlights

SS-31 (elamipretide; also called MTP-131) is a cell-permeable, mitochondria-targeted tetrapeptide that binds cardiolipin in the inner mitochondrial membrane, stabilizing cristae to improve ATP output and reduce reactive oxygen species[1][2]. Elamipretide was FDA-approved in September 2025 (brand Forzinity) — but only for Barth syndrome, via accelerated approval on a surrogate endpoint; it is not approved for heart failure, mitochondrial myopathy, neurodegeneration, anti-aging or performance, which remain investigational. This research-grade vial is not the approved Forzinity drug and is presented for research and educational use only.

  • Add 1.0 mL bacteriostatic water to one 10 mg vial → 10 mg/mL (10,000 mcg/mL), a concentrated dilution that keeps doses in a single syringe.
  • 5–10 mg once daily across an 8-week course. This is well below the ~40 mg/day SC dose used in human trials.
  • At 10 mg/mL, 1 unit = 0.1 mg = 100 mcg; 5 mg = 50 units and 10 mg = 100 units on a U-100 syringe.
  • Lyophilized: store at −20 °C (−4 °F); once reconstituted, refrigerate at 2–8 °C (35.6–46.4 °F) and do not freeze the solution.
  • Important: Start with the Prep & Injection Guide — it covers the preparation and safety basics every protocol on this site assumes.

Dosing & Reconstitution Guide

A single practical dilution with accurate once-daily dosing, step by step

Standard Approach (1 mL = 10 mg/mL)
Phase / Week(s) Dose & Frequency Volume (U-100 units / mL)
Weeks 1–2 5 mg (5,000 mcg) — 1× daily 50 units (0.50 mL)
Weeks 3–8 10 mg (10,000 mcg) — 1× daily 100 units (1.0 mL)
  • Reconstitute: Add 1.0 mL bacteriostatic water to one 10 mg vial → final concentration 10 mg/mL (10,000 mcg/mL).
  • Typical daily range: 5–10 mg once daily over an 8-week course (well below the ~40 mg/day used in human trials).
  • Easy measuring: At 10 mg/mL, 1 unit = 0.01 mL = 0.1 mg = 100 mcg on a U-100 syringe, so every milligram equals 10 units (verify: units = mg ÷ 0.1).
  • Storage: Lyophilized: store at −20 °C (−4 °F); after reconstitution, refrigerate at 2–8 °C (35.6–46.4 °F) and do not freeze the mixed solution.
  • Frequency: one subcutaneous injection each day at a consistent time. The concentrated 1.0 mL dilution keeps each dose within a single insulin syringe (5 mg = 50 units; 10 mg = 100 units)[3]. These figures are an educational reference schedule and are well below the ~40 mg/day SC dose studied in human trials — not approved human dosing.

Reconstitution Steps

Draw 1.0 mL of bacteriostatic water into a sterile syringe.

  • Release it slowly down the vial’s inner wall to limit foaming.
  • Swirl or roll gently until fully dissolved — don’t shake.
  • Label with the date and concentration (10 mg/mL), then refrigerate at 2–8 °C (35.6–46.4 °F), shielded from light; use within 4 weeks.
  • The 1.0 mL dilution gives a clean 10 mg/mL, so each milligram is exactly 10 units on a U-100 syringe and standard doses fit in one fill. Avoid freezing the reconstituted solution, since freeze–thaw can denature the peptide.
  • Important: This guide is for educational purposes only and is not medical advice. For research use only. Not for human consumption.

Supplies Needed

Quantities below assume an 8–16 week course of once-daily injections with gradual titration.

  • At 5–10 mg/day, a 10 mg vial lasts about 1–2 days, so plan multiple vials per week.
  • 8 weeks (5–10 mg/day): ~42–56 vials
  • 4 weeks: ~21–28 vials
  • 2 weeks: ~7–14 vials
  • Per injection: 1 syringe
  • 8 weeks (once daily): ~56 syringes
  • 16 weeks (once daily): ~112 syringes
  • Use 1.0 mL per 10 mg vial for reconstitution.
  • 8 weeks (~42–56 vials): ~42–56 mL → 5–6 bottles
  • 4 weeks (~21–28 vials): ~21–28 mL → 3 bottles
  • One for the vial stopper + one for the injection site each day.
  • Per injection: 2 swabs
  • 8 weeks (once daily): ~112 swabs → 1–2 boxes

Protocol Overview

A concise summary of the once-daily regimen, drawn from commonly cited reference protocols.

  • ▪Goal: Support mitochondrial function by stabilizing cardiolipin to improve ATP output and lower reactive oxygen species — mechanisms shown preclinically; broad human benefits remain investigational[1][2].
  • ▪Schedule: Once-daily subcutaneous injections across an 8-week course (Weeks 1–2 at 5 mg; Weeks 3–8 at 10 mg).
  • ▪Dose Range: 5–10 mg per day — well below the ~40 mg/day SC dose used in human trials.
  • ▪Reconstitution: 1.0 mL bacteriostatic water per 10 mg vial gives 10 mg/mL, so 1 unit = 100 mcg.
  • ▪Storage: Keep the dry vial frozen at −20 °C (−4 °F); once mixed, refrigerate at 2–8 °C and do not freeze the solution.

Dosing Protocol

A suggested daily titration approach based on common reference doses.

  • ▪Start: Begin at 5 mg (50 units) once daily for Weeks 1–2 to gauge tolerability.
  • ▪Titrate: Increase to 10 mg (100 units) once daily from Week 3 if well tolerated.
  • ▪Target: Maintain 10 mg daily through Week 8.
  • ▪Cycle Length: An 8-week course as outlined in the dosing table above.
  • ▪Timing: Inject at a consistent time each day and rotate injection sites systematically.

Storage Instructions

Correct storage is what preserves the peptide’s stability and activity.

  • ▪Lyophilized: Hold the dry vial at −20 °C (−4 °F) in dry, dark conditions and limit moisture exposure[7].
  • ▪Reconstituted: Refrigerate at 2–8 °C (35.6–46.4 °F) and use within about 28 days; do not freeze the mixed solution, as freezing can denature peptides[8].
  • ▪Handling: Let frozen vials warm to room temperature before opening so condensation won’t form, and keep the solution clear of heat and direct light.
  • ▪Freeze–thaw: Avoid repeated freeze–thaw cycles of the reconstituted solution.

Important Notes

Practical points that keep daily administration safe and consistent.

  • ▪Sterile technique: Use a fresh sterile U-100 insulin syringe each time and drop it straight into a puncture-proof sharps container afterward.
  • ▪Site rotation: Move between abdomen, thighs and upper arms to reduce local irritation and lipohypertrophy[9].
  • ▪Slow injection: Push the plunger slowly and pause a few seconds before withdrawing the needle to prevent backflow.
  • ▪Recordkeeping: Log the daily dose, injection site and any observations to keep the protocol consistent.
  • ▪Regulatory note: Elamipretide is FDA-approved (Forzinity) only for Barth syndrome via accelerated approval; this research-grade SS-31 vial is not that approved drug and is not FDA-approved for any other use[3].

How This Works

SS-31 (elamipretide; research code MTP-131) is a cell-permeable, mitochondria-targeted tetrapeptide. Unlike most peptides it concentrates inside mitochondria, where it binds cardiolipin — a signature phospholipid of the inner mitochondrial membrane[1][2].

  • By stabilizing cardiolipin and the curvature of the cristae, SS-31 helps preserve electron-transport-chain organization. The proposed result is more efficient ATP synthesis and lower production of reactive oxygen species (ROS), protecting cells from oxidative and energetic stress[2].
  • Approval status (read carefully): elamipretide received FDA accelerated approval in September 2025 under the brand Forzinity — but only for Barth syndrome (to improve muscle strength in patients weighing ≥30 kg), on a surrogate endpoint, with a confirmatory trial potentially required[3].
  • It is NOT approved for heart failure, mitochondrial myopathy, neurodegeneration, eye disease, anti-aging, fat loss or athletic performance. Several key late-stage trials failed their primary endpoints — including MMPOWER-3 in mitochondrial myopathy[4] and PROGRESS-HF in heart failure[5]. Those uses remain investigational.
  • The research-grade “SS-31” vial described here is not the approved Forzinity drug. Note also that the 5–10 mg/day on this page is well below the ~40 mg/day subcutaneous dose used in human trials. Treat any broad benefits as preliminary and under investigation, never established.

Lifestyle Factors

Habits that may support mitochondrial and metabolic health alongside the protocol.

  • ▪Nutrition: Eat a nutrient-dense diet; antioxidant-rich foods and adequate protein support overall mitochondrial and metabolic health.
  • ▪Activity & rest: Regular aerobic and resistance exercise is one of the strongest stimuli for mitochondrial biogenesis; balance it with genuine recovery.
  • ▪Sleep: Aim for 7–9 hours; sleep supports cellular repair and metabolic regulation.
  • ▪Stress: Manage stress with evidence-based practices, since chronic stress raises oxidative load on cells.

Potential Benefits & Side Effects

What preclinical research and early trials describe; outside Barth syndrome, human efficacy is unproven and individual results vary.

  • ▪Mitochondrial function (preclinical): Models report improved ATP production and reduced ROS via cardiolipin stabilization[1][2].
  • ▪Barth syndrome (approved): Improved muscle strength supported FDA accelerated approval (Forzinity) in this single rare indication[3].
  • ▪Tolerability (trials): Generally well tolerated in clinical trials, most commonly with mild injection-site reactions.
  • ▪Note on humans: Beyond Barth syndrome these benefits are not established — major trials in mitochondrial myopathy (MMPOWER-3) and heart failure (PROGRESS-HF) failed their primary endpoints[4][5].
  • ▪Injection-site reactions: Mild redness, tenderness or soreness can occur; rotating sites helps.
  • ▪Unknown long-term profile: Human safety data is limited, so caution and monitoring are advised.
  • ▪Approval scope: Approved only for Barth syndrome (Forzinity); all other uses are investigational and the long-term profile at these doses is not established.

Injection Technique

General subcutaneous technique, following established clinical best-practice guidance[14][15].

  • ▪Wash your hands well with soap and water.
  • ▪Wipe the vial stopper with an alcohol swab and let it air-dry.
  • ▪Choose a site (abdomen, thigh, or upper arm) and clean it with a fresh alcohol swab, letting it dry fully[15].
  • ▪Draw the intended dose, then check for air bubbles and push any out.
  • ▪Pinch a skinfold at the chosen site between thumb and forefinger.
  • ▪Insert the needle into the pinch at a 45–90-degree angle (use 45 degrees if the fat layer is thin)[14].
  • ▪Skip aspiration for subcutaneous shots — it isn’t needed[14].
  • ▪Press the plunger slowly and steadily until it’s fully down.
  • ▪Wait 5–10 seconds, then pull the needle straight out to prevent leakage.
  • ▪Drop the used syringe straight into a puncture-proof sharps container — never recap a needle.
  • ▪Return the reconstituted vial to the fridge right away.
  • ▪Rotate the injection site each day to prevent irritation and lipohypertrophy[9].
  • ▪Watch the site for excess redness, swelling, or signs of infection.

References

Reference-derived details for SS-31 (Elamipretide) 10mg.

  • SS-31 (10mg Vial) Dosage Protocol Open source
  • 1 Circulation Research (PubMed) SS-31 (elamipretide) binds cardiolipin in the inner mitochondrial membrane and stabilizes cristae structure. View Source ↗ Open source
  • 2 Pharmacological Reviews / J Pharmacol Exp Ther (PubMed) Mechanism of SS peptides: improved ATP synthesis and reduced reactive oxygen species in mitochondria. View Source ↗ Open source
  • 3 U.S. FDA FDA accelerated approval of elamipretide (Forzinity) for Barth syndrome, September 2025. View Source ↗ Open source
  • 4 The Lancet Neurology / ClinicalTrials.gov MMPOWER-3: phase 3 trial of elamipretide in primary mitochondrial myopathy did not meet its primary endpoint. View Source ↗ Open source
  • 5 ClinicalTrials.gov PROGRESS-HF and related cardiac trials of elamipretide in heart failure failed to meet primary endpoints. View Source ↗ Open source
  • 6 Stealth BioTherapeutics Developer background and clinical program for elamipretide (MTP-131). View Source ↗ Open source
  • 7 Peptide Storage Guide Best practices for storing lyophilized peptides (temperature, humidity and light protection). View Source ↗ Open source
  • 8 Peptide Reconstitution & Stability Reconstituted peptides: refrigerate at 2–8 °C and avoid freeze–thaw, which can denature peptides. View Source ↗ Open source
  • 9 Injection Site Rotation (Patient Education) Rotating subcutaneous injection sites to reduce irritation and lipohypertrophy. View Source ↗ Open source
  • 10 U.S. FDA Forzinity Label Approved indication, dosing and safety information for elamipretide (Forzinity). View Source ↗ Open source
  • 11 Aging Cell / GeroScience (PubMed) Preclinical studies of SS-31 on age-related mitochondrial dysfunction and muscle performance. View Source ↗ Open source
  • 12 Free Radical Biology & Medicine (PubMed) SS-31 reduces mitochondrial oxidative stress in preclinical models. View Source ↗ Open source
  • 13 ClinicalTrials.gov Registry of elamipretide trials across indications, including those that did not meet primary endpoints. View Source ↗ Open source
  • 14 Centers for Disease Control and Prevention (CDC) Subcutaneous injection technique: angle, site and no-aspiration guidance. View Source ↗ Open source
  • 15 Subcutaneous Injection Technique (Patient Education) How to administer a subcutaneous injection: clinical technique guidelines. View Source ↗ Open source
  • 16 Prime Lab Peptides Research peptide supplier — purity specifications and certificates of analysis. View Source ↗ Open source