SS-31

Quickstart Highlights

SS-31 (elamipretide) is a cell-permeable tetrapeptide that concentrates in the inner mitochondrial membrane and binds cardiolipin, stabilizing cristae structure and electron-transport efficiency. It received FDA accelerated approval in September 2025 as Forzinity for Barth syndrome at a flat 40 mg subcutaneous daily dose, and has been studied in primary mitochondrial myopathy and acute cardiac injury. This educational protocol presents the research-community convention instead: once-daily subcutaneous injections at 5 mg for 2 weeks and then 10 mg, with 15 mg and 20 mg as upper reference points, over a 4–12 week course. The 50 mg vial is reconstituted with 2.0 mL for 25 mg/mL.

• Reconstitute: Add 2 mL bacteriostatic water → 25 mg/mL concentration.
• Dose range: 5–20 mg once daily, subcutaneously (research-community convention; 4–12 week course, then 2–4 weeks off).
• Easy measuring: At 25 mg/mL, 1 unit = 0.01 mL = 250 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) and use within 28 days.
• Label: Forzinity (elamipretide) is approved at a flat 40 mg subcutaneously once daily for Barth syndrome (20 mg with severe renal impairment); the 5–10 mg schedule on this page is research convention with no trial basis.

Protocol Overview

Concise summary of the once-daily regimen.

• Goal: Support mitochondrial energy production and exercise capacity through cardiolipin stabilization in the inner mitochondrial membrane.
• Schedule: Daily subcutaneous injections for 4–12 weeks, followed by a 2–4 week break; the label product is used continuously without cycling.
• Dose Range: 5 mg (5000 mcg) daily for 2 weeks, then 10 mg (10,000 mcg) daily; 15 mg and 20 mg daily are shown as the upper research reference and research ceiling, all well below the 40 mg label dose.
• Reconstitution: 2 mL per 50 mg vial (25 mg/mL) for accurate unit measurements on standard insulin syringes.
• Storage: Lyophilized frozen at −20 °C (−4 °F); reconstituted refrigerated at 2–8 °C (35.6–46.4 °F); use within 28 days; avoid repeated freeze–thaw cycles.
• Evidence: FDA label plus multiple human RCTs (TAZPOWER, MMPOWER-3, ReCLAIM-2) support the subcutaneous route, once-daily frequency and the 40 mg clinical dose with high confidence; the 5–10 mg research-community dose presented here is convention with no trial support, at one-quarter to one-eighth of every clinical dose, so confidence for the schedule itself is low.

Dosing Protocol

Suggested daily approach based on research-community convention, with the FDA label dose shown as context.

• Weeks 1–2: 5 mg (5000 mcg) once daily as the conservative introduction used by most research sites.
• Week 3 onward: 10 mg (10,000 mcg) once daily as the working research dose for the rest of the course.
• Upper research reference: 15 mg once daily is cited by some research sites for performance-focused protocols and is not part of the standard schedule.
• Research ceiling: 20 mg once daily is the top of the community range and still half the 40 mg Forzinity label dose; it is shown for reference, not as a target.
• Frequency: Once per day (subcutaneous injection), at the same time each day; a missed dose is skipped rather than doubled.
• Timing: Morning or pre-workout is common in community sources; no meal timing applies. Rotate injection sites daily.
• Cycle: 4–12 weeks on, then 2–4 weeks off (community convention); the label is continuous, and effects are exposure-dependent with no carry-over once dosing stops.

Storage Instructions

Proper storage preserves product quality and efficacy.

• Lyophilized (powder): Store at −20 °C (−4 °F) protected from light; 2–8 °C (35.6–46.4 °F) refrigeration is acceptable for several months.
• Reconstituted (solution): Refrigerate at 2–8 °C (35.6–46.4 °F) and do not freeze. Research sources allow 28 days; the ready-to-use label product is discarded 8 days after first opening, so a shorter window is the conservative choice.
• SS-31 is light-sensitive: keep the reconstituted vial in an amber or dark container and out of direct light. The solution should be clear and colorless.
• Allow vials to reach room temperature before opening to minimize condensation uptake.

Important Notes

Practical considerations for consistency and safety.

• Use new sterile insulin syringes for each injection; dispose in a proper sharps container.
• Rotate injection sites systematically (abdomen, outer thighs, upper arms) with every daily injection; in the placebo-controlled trial, injection-site erythema occurred in 100% of treated participants, with pain in 75% and induration and pruritus in 67%.
• The 5–10 mg daily schedule is a research-community convention with no trial basis. Every clinical trial (TAZPOWER, MMPOWER-3, ReCLAIM-2) and the Forzinity label used 40 mg subcutaneously once daily, so the community dose is one-quarter to one-eighth of every clinical dose and its effect size is unknown.
• Regulatory status: FDA-approved (Forzinity, Stealth BioTherapeutics, accelerated approval 19 September 2025) for Barth syndrome only; not approved by Health Canada; research-grade SS-31 is an unapproved product sold for research use only.
• Stop and seek medical attention for throat tightness, wheezing, facial, lip or tongue swelling, or widespread hives; the label contraindicates use after any prior serious hypersensitivity reaction.
• Blood eosinophil counts rose in trial participants, peaking around 90 days; the label also reduces the dose to 20 mg daily with severe renal impairment (eGFR under 30 mL/min).
• At 25 mg/mL the four reference doses are 20, 40, 60 and 80 units, all within a 1 mL syringe and the V1 pen’s 80-unit setting; 20 mg (80 units) is the pen’s maximum, and a larger dose would need two injections.
• At 10 mg daily a 50 mg vial lasts 5 days, well inside the 28-day reconstituted window, and a 4-week block at a steady 10 mg uses about 6 vials (5 in the first 4 weeks, which include the 5 mg introduction). Benefits are exposure-dependent and stop when dosing stops; trial endpoints were measured at 24 weeks and beyond, while community reports describe subjective changes after 2–4 weeks.

How This Works

SS-31 is a four-amino-acid, cell-permeable tetrapeptide that concentrates more than 1000-fold in the inner mitochondrial membrane, where it binds cardiolipin, the phospholipid that anchors the electron-transport chain. Stabilizing cardiolipin preserves cristae architecture and supercomplex organization, improving ATP output and reducing electron leak and reactive oxygen species. The FDA label describes it simply as a mitochondrial cardiolipin binder that improves mitochondrial morphology and function. Although plasma half-life is only 2–4 hours, mitochondrial residence time is far longer, which is why once-daily dosing is used in every trial. Human evidence sits entirely at 40 mg daily: in Barth syndrome, accelerated approval rested on improved knee extensor strength at 24 weeks, with open-label gains in six-minute walk distance, while the larger MMPOWER-3 trial in primary mitochondrial myopathy (n=218) missed its co-primary walking and fatigue endpoints. Intravenous infusions have been tested for acute cardiac injury. The 5–10 mg daily research dose has no trial data of its own.

Potential Benefits & Side Effects

Observations from the FDA label, clinical trials and research-community reports.

Potential Benefits:

• Improved knee extensor muscle strength in Barth syndrome, the label endpoint, with a median gain of 68 N at week 24 in the open-label extension.
• Six-minute walk distance improvement of about 96 m in the Barth syndrome open-label extension; the larger MMPOWER-3 mitochondrial myopathy trial did not meet its walking or fatigue endpoints.
• Restoration of mitochondrial bioenergetics and ATP production with reduced reactive oxygen species in mechanistic and preclinical studies.
• Cardioprotection in acute injury models using intravenous infusion (investigational).
• Community-reported reductions in fatigue and improvements in exercise endurance and recovery after 2–4 weeks (anecdotal, at doses below any trial dose).

Potential Side Effects:

• Injection-site reactions dominate the trial data: erythema in 100% of treated participants versus 25% with placebo, pain 75%, induration 67%, pruritus 67%, with bruising and hives also reported.
• Headache, dizziness and mild nausea.
• Blood eosinophil increase, peaking around 90 days of treatment.
• Hypersensitivity reactions including throat tightness, wheezing, facial, lip or tongue swelling and anaphylaxis; contraindicated after any prior serious hypersensitivity.
• Effects are exposure-dependent and cease when dosing stops; one research site’s claim of no significant side effects contradicts the label’s injection-site data.

Lifestyle Factors

Complementary strategies for mitochondrial and exercise-capacity goals.

• Pair the course with regular aerobic and resistance training, since the measurable trial endpoints were muscle strength and walking distance.
• Keep injection timing consistent from day to day and log injection sites, since reactions at the site are the most common adverse effect.
• Prioritize 7–9 hours of sleep and adequate recovery between training sessions to support energy metabolism.
• Maintain a balanced diet with sufficient protein and micronutrients to support muscle and mitochondrial function.
• Track resting fatigue, exercise tolerance and recovery weekly so that any change over a 4–12 week course can be assessed against baseline.
• Review any planned use with a healthcare provider, particularly where kidney function is reduced or there is a history of allergic reactions.

Injection Technique

General subcutaneous injection guidance from clinical best-practice resources.

• Clean the vial stopper and chosen skin site with separate alcohol swabs; allow both to dry completely before proceeding.
• Pinch a fold of skin between your fingers; insert the needle at a 45–90° angle into the subcutaneous tissue (fatty layer, not muscle).
• Do not aspirate (pull back the plunger) when giving a subcutaneous injection.
• Inject the solution slowly and steadily; wait at least 6 seconds after injection before withdrawing the needle to ensure complete delivery and minimize leakage.
• Withdraw the needle and apply light pressure with a clean swab; avoid rubbing vigorously.
• Rotate injection sites systematically (abdomen, thighs, upper arms) to prevent lipohypertrophy and maintain consistent absorption.
• Dispose of used syringes and needles immediately in a proper sharps container.

Recommended Source

We recommend Amino Labs for high-purity SS-31 (50 mg vials).

Note: Product availability and specifications subject to change. Verify current product details on supplier website.

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