Dosing Guide

SS-31 Dosage Chart & Schedule Guide.

SS-31 (Elamipretide) is a mitochondria-targeted tetrapeptide that stabilizes cardiolipin in the inner mitochondrial membrane, improving cellular energy production and reducing oxidative stress. Here are the most commonly used dosing protocols.

⏱️
Half-life~4 h (peak 0.5 – 1 h)
💉
RouteSubcut: abdomen or thigh
🕐
Best timingSame time every day
❄️
Storage2 – 8 °C, never frozen
The short answer

40 mg subcutaneously, once daily, abdomen or outer thigh, same time each day, rotating the site. That is the only FDA-approved dose. Judge it at six months, not six weeks.

Dosage Protocols

Units assume a 50 mg vial mixed with 1 mL of bacteriostatic water (50 mg/mL). Different setup? Use the calculator. The approved product ships ready-to-use, so no official mixing ratio exists.

Tolerance check
10 mgper injection · 20 units
FrequencyOnce daily
Weekly total70 mg / week
Cycle length1 – 2 weeks

A tolerance run, not a therapeutic dose: no human trial has ever used 10 mg/day.

Why this dose+

The lowest subcutaneous dose ever studied was a 4 mg arm in a 28-day heart-failure trial, and nothing in the mitochondrial or Barth programme went below 40 mg. Spend a week or two here to see how daily injections sit with you before you commit to full vials at four times the dose.

FDA LABEL DOSELabel-matched
40 mgper injection · 80 units
FrequencyOnce daily, every day
Weekly total280 mg / week
Cycle lengthContinuous, no rest days

The FDA-approved dose, and the one behind every trial that has produced a positive human result.

Why this dose+

It is the dose in the Barth syndrome trial (TAZPOWER), MMPOWER-3 in 218 people with mitochondrial myopathy, and both ReCLAIM dry-AMD studies; the Barth patients who improved stayed on it for 168 – 192 consecutive weeks. A 50 mg vial lasts barely over a day here, which is why cheaper protocols circulate.

Renal-reduced
20 mgper injection · 40 units
FrequencyOnce daily
Weekly total140 mg / week
Cycle lengthContinuous, renal monitoring

The FDA label halves the dose to 20 mg daily in adults with eGFR under 30 mL/min, not on dialysis.

Why this dose+

Elamipretide and its metabolites clear ~100% renally, and severe impairment raises M1 and M2 metabolite exposure by 280% and 640%. There is no dosing guidance at all for dialysis patients, so that one is a prescriber conversation rather than a number to read off a chart.

Almost every SS-31 protocol online is a quarter of the real dose
  • Research-market guides cluster at 5 – 20 mg/day; no published human trial has used those doses.
  • Every trial behind the FDA approval used 40 mg subcutaneously once daily.
  • The low numbers are economics: at 40 mg/day a 50 mg vial lasts just over a single day, roughly 24 vials a month.
  • The approved 40 mg is free base, equal to 46.8 mg of the hydrochloride: a salt-weight vial holds about 15% less peptide.
40 mg is the approved dose, and nothing above it has beaten it
  • Exposure rises proportionally across 2 – 80 mg with virtually no accumulation.
  • Only two trials went above 40 mg/day, both at 60 mg, and neither published a positive result.
  • 80 mg appears only in pharmacokinetic dose-ranging, never in an outcomes trial.
  • In the approval trial the limiting variable was time, not dose: nothing moved at 12 weeks, strength came at week 24.

Weekly Schedule

Every row is deliberately identical: every subcutaneous trial of SS-31 dosed it once daily, seven days a week. No rest day or cycling pattern has ever been studied.

Weeks 1 – 2 · 10 mg
M
T
W
T
F
S
S
Week 3+ · 40 mg
M
T
W
T
F
S
S
Renal-reduced · 20 mg
M
T
W
T
F
S
S
Inject: every day, no rest days

Missed a dose? The FDA label is explicit: skip it, take the next one at its normal scheduled time, and do not double up. One missed day causes no rebound, but results tracked months of uninterrupted dosing rather than any single injection. Rotate the injection site every day.

SS-31 Reconstitution Calculator

Enter your vial size, how much water you added, and the dose you want; we'll tell you exactly how much to draw. At 50 mg in 1 mL, a 40 mg dose fills 80 units of a U-100 syringe; add more water and the draw stops fitting in one injection.

mg

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mL

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mg

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Your syringe

Standard insulin syringe

Concentration

10.00 mg/mL

1 unit = 100 mcg

Draw volume

1.000 mL

= 10.00 mg ÷ 10.00 mg/mL

Units to draw (1 mL syringe)

100.0 units

1 mL Syringe

100.0 IU
020406080100 IU

From Vial to Injection in 6 Steps

1
Wipe both vial tops

Alcohol swab the SS-31 vial and the bacteriostatic water vial, and let both air-dry before you pierce them.

2
Add the water slowly

For a 50 mg vial, run 1 mL of bacteriostatic water down the inside wall. Never squirt it directly onto the powder cake.

3
Swirl, don't shake

Roll the vial gently until the solution is completely clear. Foaming damages peptides, and elamipretide is described as freely soluble in water; it should not need force.

4
Draw your dose

Use a fresh U-100 insulin syringe. Pull to the unit mark from the calculator and flick out any air bubbles.

5
Inject subcutaneously

Abdomen at least two inches from the navel, or the outer thigh. Rotate the site every single day and avoid tender, bruised or hardened skin.

6
Back in the fridge

Keep the mixed vial at 2 – 8 °C and never freeze it. Inspect before every injection and discard anything cloudy or containing particles.

The 50 mg in 1 mL basis is arithmetic chosen so every tier lands on a U-100 syringe, not an official instruction: the approved product is a ready-to-use 80 mg/mL solution that is never mixed. Vendors claim four weeks refrigerated after reconstitution, but the only validated in-use figure anywhere is the FDA product's 8 days after first puncture.

What to Expect

The first thing SS-31 reliably does is turn your injection site red. The only benefit ever recorded in humans took roughly six months to appear; this is not a compound you judge in a month.

First few injectionsA red welt: this is the drug working normally

Expect redness at the injection site within minutes to hours. In the placebo-controlled trial, 12 of 12 patients on elamipretide developed injection site erythema versus 3 of 12 on placebo, alongside pain (75%), induration (67%) and itching (67%). That is the expected local pharmacology of a highly cationic peptide, not a sign of a bad vial.

Weeks 1 – 4Nothing measurable, and that's expected

Peak blood levels arrive 30 – 60 minutes after injection and clear the same day with essentially no accumulation, so there is no loading phase to feel. No trial has reported a benefit this early on any endpoint. Anything noticed in this window is far more likely to be placebo or the novelty of a new routine than mitochondrial change.

Around day 90Eosinophils rise, usually a non-event

Blood eosinophil counts commonly increase in anyone dosing longer than 30 days, peaking around 90 days at a mean rise of 0.5 – 0.6 ×10³/µL. In trials this was not linked to any symptom or other lab abnormality, and it drifts back to baseline after 6 – 12 months of continued use. Worth knowing before an unrelated blood test alarms you or your doctor.

Week 12The honest checkpoint: still nothing versus placebo

Twelve full weeks of 40 mg/day beat placebo on nothing in the Barth trial: not walking distance, not fatigue, not muscle strength (median +4 newtons on drug versus −5 on placebo). MMPOWER-3 ran 218 people for 24 weeks and also missed both primary endpoints.

Months 6 – 9Where the only positive signal actually appeared

In the open-label extension, knee extensor strength rose a median 68 newtons by week 24 and 57 newtons by week 36 (roughly a 42% gain), with six-minute walk distance up 95.9 metres and a 16% rise in left ventricular stroke volume. The investigators attributed the delay to the time skeletal and cardiac muscle need to remodel. This uncontrolled result is the entire basis of the FDA's accelerated approval.

SS-31 is slow, and its evidence record is mixed. It missed the primary endpoint in its own approval trial, in MMPOWER-3 and in ReCLAIM-2, and its one clear win came from an uncontrolled extension in eight patients. Pick one objective measure before you start (a dynamometer reading, a timed walk, a cycling power number) and set a decision point at six months.

Feeling Something? Check Here

🟢 Normal: keep going
  • Redness at the injection site: 12 of 12 patients on drug vs 3 of 12 on placebo.
  • Injection site pain (75%), firmness or induration (67%), itching (67%).
  • Mild bruising.
  • A symptom-free rise in blood eosinophils peaking around day 90, settling by 6 – 12 months.
  • Manage with daily site rotation, a cool compress, and per the label a topical corticosteroid or an oral antihistamine for mild-to-moderate skin reactions.
🟡 Talk to your prescriber
  • Hives at the injection site (25% in trial), or bruising with no clear cause.
  • Redness spreading well beyond the injection area, or a welt still present after 48 hours.
  • Induration that keeps building despite rotating sites.
  • Any new rash, papular lesions or eczema-like dermatitis anywhere on the body.
  • A new or worsening cough.
  • Reduced urine output, new swelling or any change in kidney function; clearance is ~100% renal.
  • The label advises considering discontinuation for persistent or severe skin reactions.
🔴 Stop and call a doctor
  • Throat tightness, wheezing or difficulty breathing.
  • Swelling of the lips, face or tongue.
  • Widespread hives, faintness or collapse.
  • Seek emergency care; the label calls for epinephrine, antihistamines and corticosteroids as indicated.
  • Serious reactions have started minutes to months after the first dose, and anyone who has had one is never re-exposed.
Do not use SS-31 at all if any of these apply
  • Any prior serious hypersensitivity to elamipretide or product excipients: an absolute contraindication, and rechallenge is prohibited.
  • Neonates and infants: the benzyl alcohol preservative (20 mg/mL) has caused fatal gasping syndrome, metabolic acidosis and neurotoxicity in preterm and low-birth-weight babies.
  • Intravenous administration, which is not approved in any form.
  • Anyone weighing under 30 kg, where safety and efficacy have never been established.
  • Patients on dialysis, where no dosing regimen can be recommended at all.
  • Severe renal impairment (eGFR under 30 mL/min) without halving the dose under medical supervision.
  • Pregnancy or breastfeeding outside direct medical supervision.
  • Any undiagnosed cardiac, renal or muscular symptom that has not been worked up.

FAQ

Is SS-31 the same thing as elamipretide, Bendavia or Forzinity?+

Yes: one molecule, four names, which is a large part of why the literature is so confusing to search. SS-31 is the original academic designation (from Szeto-Schiller, the researchers who developed it). MTP-131 and Bendavia were developmental code and brand names used by Stealth BioTherapeutics. Forzinity is the FDA-approved brand, and elamipretide is the generic name. The peptide itself is a four-amino-acid sequence, D-Arg-2,6-dimethyl-Tyr-Lys-Phe-NH2, with a molecular weight of 749.2 as the trihydrochloride salt. When you search for evidence, use "elamipretide"; that is the term nearly all the clinical literature is indexed under.

Why do vendor guides say 5 – 10 mg when trials used 40 mg?+

Cost, almost certainly. At 40 mg/day a 50 mg vial is consumed in a little over one day, making a label-matched month roughly 24 vials, a price point most of the research market can't sell. No published human study has ever used 5 or 10 mg/day of elamipretide. That doesn't automatically mean low doses do nothing, but it does mean anyone quoting them is extrapolating, and some sites go further and misdescribe 10 mg as the standard clinical trial dose, which is flatly untrue. If you dose low, be clear with yourself that you are running an experiment no one has run, not a validated protocol.

My injection site turned into a red welt. Is my vial contaminated or fake?+

Almost certainly neither. This is the most predictable effect SS-31 has: 100% of patients receiving elamipretide in the placebo-controlled trial developed injection site erythema, compared with 25% on placebo. Pain, firmness and itching affected roughly two-thirds to three-quarters. It reflects the local behaviour of a strongly positively charged peptide in the skin. Rotate sites daily, keep at least two inches from the navel, avoid tender or hardened areas, and use a cool compress or a topical corticosteroid if needed. What is not routine is hives spreading beyond the site, a rash elsewhere on the body, or any breathing symptom; those mean stop and get assessed.

How long before I notice anything?+

Longer than almost any other injectable peptide. In the trial that produced the FDA approval, 12 weeks at the full 40 mg dose beat placebo on nothing at all. The muscle strength signal appeared only in the open-label extension: a median 68 newton gain in knee extensor strength by week 24 and a 96 metre improvement in six-minute walk distance by week 36. The researchers attributed this to the months muscle tissue needs to remodel. Anyone promising a two-week energy transformation is describing something the clinical data does not show.

Do I need to cycle SS-31 or take rest days?+

No, and cycling it has never been tested. Every subcutaneous trial dosed once daily, every day, without interruption; the Barth syndrome patients who improved stayed on continuously for 168 to 192 weeks. There is no evidence of receptor downregulation, tolerance or any other mechanism that would justify a break, and given how slowly benefits appeared, interrupting is more likely to cost you results than protect them. If you miss a dose, skip it entirely and resume at the next scheduled time; never double up.

Can I take it orally or use a nasal spray version?+

Oral and nasal routes have never been studied in humans, and no such product is approved. Elamipretide has been given intravenously in earlier trials (heart failure, STEMI, mitochondrial myopathy) and as a topical eye drop in Leber hereditary optic neuropathy and Fuchs' corneal dystrophy, but the only approved route is subcutaneous, and the approved product is explicitly not approved for intravenous use, partly because the formulation contains benzyl alcohol. Subcutaneous bioavailability is about 92% with peak levels at 30 – 60 minutes, which is why it is the route used clinically. As a peptide it would be broken down in the gut, and oral or nasal products sold as SS-31 have no human pharmacokinetic data behind them whatsoever.

Does SS-31 actually work for anti-aging, energy or athletic performance?+

There is no human trial evidence for any of those uses; the interest comes from mechanism and animal work, not outcomes in people. Its approved indication is narrow: improving muscle strength in Barth syndrome, a rare genetic mitochondrial disorder, in patients weighing at least 30 kg, granted under accelerated approval based on a secondary endpoint in a handful of patients. Its record in larger trials is poor: MMPOWER-3 enrolled 218 people with mitochondrial myopathy and missed both primary endpoints, and ReCLAIM-2 missed its primary endpoint in dry AMD, though it did show a 43% reduction in photoreceptor layer loss. A reasonable reading is that SS-31 does something real to mitochondria, in populations whose mitochondria are genuinely broken, over long periods, which is a much narrower claim than the marketing makes.

How should I store it, and how long is it good for once mixed?+

Keep unopened vials refrigerated at 2 – 8 °C and never freeze the solution; lyophilised research powder is typically kept colder until mixed. Reconstitute gently with bacteriostatic water aimed down the vial wall, then swirl; never shake, since foaming damages peptides. The only validated in-use figure comes from the FDA product, which is discarded 8 days after first opening even with solution remaining; that vial is preserved with benzyl alcohol, so anything you mix yourself should be treated as no more stable than that, not less. Inspect before every injection and discard anything cloudy or containing particles.

Sources

Two figures here are not label-sourced. The ~4 hour half-life comes from secondary summaries; the FDA label gives only Tmax 0.5 – 1 h, ~92% subcutaneous bioavailability and minimal accumulation. The 50 mg/1 mL mixing basis is arithmetic, since the approved product is never reconstituted. The 5 – 20 mg subcutaneous doses sold to the research market have no published human trial behind them.

Disclaimer: This content is for informational and research purposes only and is not medical advice. Elamipretide (Forzinity) is a prescription medicine approved only for Barth syndrome in patients weighing at least 30 kg, under accelerated approval; every other use described here is off-label and unsupported by human outcome data. Always consult a qualified healthcare professional before starting any peptide protocol. PeptideDeck is not responsible for individual use.

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