SS-31 Dosage Chart and Calculator: Common Protocol, Trial Doses
SS-31 (elamipretide) dosage chart: units per dose by vial size for the 40 mg daily common protocol, a calculator, and the doses its mitochondrial trials used.
The short version
SS-31 (elamipretide) has a real clinical trial dosing record, unlike most compounds on this site. The protocol most often used is 40 mg by subcutaneous injection once daily, continuously. The subcutaneous trials used the same figure, and it is stated here as common practice. Every dose in the trial record was given to patients with a diagnosed genetic mitochondrial disease under clinical supervision. The largest trial did not improve its primary outcomes at that dose.
- The common protocol is 40 mg by subcutaneous injection once daily, continuously - the same figure used across the subcutaneous trials.
- An earlier trial used intravenous dosing measured in milligrams per kilogram per hour, a different route entirely.
- The trial using the 40 mg daily dose for 24 weeks did not meet its primary walking and fatigue endpoints.
- Every trial dose was given to diagnosed patients under clinical supervision. None of these trials studied healthy adults.
SS-31 dosage chart
SS-31 is FDA-approved only for a specific use; research vials are sold for others. Units on a U-100 insulin syringe across the common off-label range - common practice, not the label dose - by vial size.
10 mg vialwith 2 mL water
| Dose | Units | Volume | Doses per vial |
|---|
Full 10 mg vial page: other water volumes, mixing, storage →
30 mg vialwith 2 mL water
| Dose | Units | Volume | Doses per vial |
|---|
Full 30 mg vial page: other water volumes, mixing, storage →
50 mg vialwith 1 mL water
| Dose | Units | Volume | Doses per vial |
|---|---|---|---|
| 40 mg | 80 units | 0.8 mL | 1 |
Full 50 mg vial page: other water volumes, mixing, storage →
280 mg vialwith 5 mL water
| Dose | Units | Volume | Doses per vial |
|---|---|---|---|
| 40 mg | 71.5 units | 0.715 mL | 7 |
Full 280 mg vial page: other water volumes, mixing, storage →
U-100 insulin syringe (100 units = 1 mL), to the nearest half unit. Arithmetic only. Other numbers: peptide calculator.
SS-31 (elamipretide) has more clinical dosing data behind it than most compounds this site covers. Every milligram of it was given to patients with a diagnosed genetic mitochondrial disease. This page gives the protocol most commonly used, then what each trial used. For the wider evidence and the Phase 3 result, see the main SS-31 guide.
US legal status - FDA-approved · prescription only
Elamipretide is FDA-approved only as Forzinity (accelerated approval, September 2025) to improve muscle strength in Barth syndrome, at 40 mg subcutaneously once daily. Research-chemical vials sold as SS-31 are not the approved product, and no approval covers energy, longevity or use in healthy adults.
SS-31 dosage: the common protocol
The protocol most often used is 40 mg by subcutaneous injection once daily, continuously. The subcutaneous trials below used the same figure from the first dose. It is stated here as common practice, not a dose proven to work in every population.
Common protocol
What is commonly used. For its approved use, the dose is the one on the FDA label.
- Dose per administration
- 40 mg
- How often
- once daily, at a consistent time
- Route
- Subcutaneous injection
- Cycle length
- No set length in common use
- Common vial size
- 280 mg
- Timing
- No set time of day - one injection daily
This is the same 40 mg once-daily dose used throughout the elamipretide Phase 2/3 Barth syndrome trial (SPIBA 201: a 12-week crossover followed by a 36-week open-label extension) and carried into the FDA-approved Forzinity label, which halves the dose to 20 mg daily when eGFR is below 30 mL/min and the patient is not on dialysis.
Plan a cycle in the protocol builder or work out injection volume in the dosage calculator.
SS-31 doses used in human studies
The three subcutaneous trials all used the same regimen: 40 mg once daily. The earliest trial used a different route. It gave a two-hour intravenous infusion dosed by body weight per hour, not a flat daily milligram amount, during dose-escalation testing.
Why this dose does not carry over to a healthy adult
Every dose above was given to patients with a genetically confirmed mitochondrial disease, under clinical trial supervision and monitoring. None of these trials enrolled healthy adults, and none tested the aging or energy uses SS-31 is marketed for online. The longest, best-controlled test of 40 mg in a rare genetic disorder did not meet its primary outcomes. This page does not carry that figure over to a healthy adult buying an unverified vial.
What is not established
- No dose has been tested in a healthy adult. Every trial population above has a diagnosed mitochondrial disease. The population buying SS-31 for aging or energy is the one group nobody has studied at any dose.
- The only approved dose is for a narrow, rare-disease population. The FDA gave elamipretide accelerated approval as Forzinity in September 2025, at 40 mg subcutaneously once daily. It covers only muscle strength in Barth syndrome patients weighing at least 30 kg, not aging, energy or any general-population use.
- No human half-life is established for use in dosing-interval decisions outside these supervised trials.
Reconstitution and injection volume: use the calculator, not a guess
Turning a target amount into an injection volume depends on a specific vial’s concentration and diluent, which this page cannot know. The dosage calculator handles that arithmetic. It does not supply or endorse a dose.
SS-31 side effects and risks
The only FDA-reviewed label is Forzinity’s, for Barth syndrome patients weighing at least 30 kg. It says nothing about anyone outside that population. In the trials above, injection-site reactions were the most commonly reported adverse event and were mostly mild. In one trial they affected 80% of participants receiving the drug. Outside diagnosed patients under clinical monitoring, there is no long-term human safety record. Material sold as a research chemical carries no verified purity, identity or concentration.
Related
SS-31 dosage calculator
Preset to a 280 mg vial and 40,000 mcg, the low end of the common protocol. Enter your own vial size, water and dose to get the syringe units to draw.
Your vial
Printed on the vial. There is no standard size - enter what yours says.
This changes how much you draw - never how many doses the vial holds.
100 units per mL. 1 unit = 0.01 mL. This is what almost every insulin syringe sold is, in every barrel size.
Capacity only. A 1 mL U-100 syringe holds 100 units - the scale decides that, not the barrel.
Draw this much
= 0.29 mL on a 1 mL U-100 syringe
- Concentration
- 140,000 mcg/mL
- Exact volume
- 0.2857 mL
- Dose you actually get(after rounding to the nearest mark)
- 40,600 mcg
- Doses per vial(unaffected by water volume)
- 7
Where to get SS-31 legally
SS-31 is an FDA-approved prescription medicine, so the legal route is a licensed prescriber, in person or by telehealth, and a licensed pharmacy.
It is sold only as Forzinity, for Barth syndrome, through AnovoRx Specialty Pharmacy, and neither AnovoRx nor the maker publishes a price.
How telehealth prescribing works, what it costs and what to check: telehealth peptide prescribing.
Research-labelled SS-31 (not the approved medicine)
These checked vendors sell a research-labelled version. It has not been reviewed by FDA, is labelled not for human use, and is tested only as the seller chooses.
1.Next Level Pharm
10 mg vial
- No FDA warning letter found
- Names its testing lab
- Batch COAs published
- Takes card payment
How research-labelled SS-31 differs, and what FDA has said →
Common questions
What is the usual SS-31 dose?
The protocol most often used is 40 mg by subcutaneous injection once daily, continuously. The subcutaneous trials used the same figure, and it was carried into the FDA-approved Barth syndrome product. It is stated here as common practice, not a dose proven to work in every population. An earlier, smaller trial used intravenous infusions of 0.01, 0.1 or 0.25 milligrams per kilogram per hour over two hours. That is a different route and dosing method entirely.
Did the 40 mg daily dose work?
In the largest and best-controlled trial, a 24-week Phase 3 study in primary mitochondrial myopathy, it did not. The trial states directly that the 40 mg subcutaneous daily dose did not improve the distance walked on a 6-minute walk test. It also did not improve the total fatigue score compared with placebo.
Is there an approved SS-31 dose?
Only for a narrow population. The FDA gave elamipretide accelerated approval as Forzinity in September 2025. The approved dose is 40 mg subcutaneously once daily, to improve muscle strength in Barth syndrome patients weighing at least 30 kg. That is not an approval for aging, energy or general use. Otherwise the 40 mg figure comes from clinical trial protocols in diagnosed patients, not a general-population label.
Can the 40 mg trial dose be used by a healthy adult for aging or energy?
This page does not carry the trial dose over to healthy adults. Every trial that used 40 mg studied patients with a diagnosed genetic mitochondrial disease under clinical monitoring. The trial that ran longest at that dose did not meet its primary outcomes. The evidence does not support applying that number to a different population buying an unverified vial.
How do I work out reconstitution and injection volume?
That is arithmetic about a specific vial and diluent, not a dosing decision, and this page cannot know your vial. The dosage calculator handles concentration and draw-volume math for whatever amount is being discussed. It does not tell you what dose to use.
Who should not use SS-31, and what are the risks?
The only FDA-reviewed label covers Barth syndrome patients of at least 30 kg, so it says nothing about anyone else. In trials, injection-site reactions were the most common side effect. There is no long-term safety data outside diagnosed patients under monitoring, and material sold as a research chemical carries no verified purity or concentration.
References (4 sources)
Bibliographic detail is fetched from PubMed, not written by me - so a citation here cannot drift from the paper it names. Study design comes from PubMed's own tags rather than my judgement.
- 1.Karaa A, Haas R, Goldstein A et al. Randomized dose-escalation trial of elamipretide in adults with primary mitochondrial myopathy. Neurology. 2018;90(14):e1212-e1221.Randomised trialPMID 29500292full text
- 2.Karaa A, Haas R, Goldstein A et al. A randomized crossover trial of elamipretide in adults with primary mitochondrial myopathy. J Cachexia Sarcopenia Muscle. 2020;11(4):909-918.Randomised trialPMID 32096613full text
- 3.Karaa A, Bertini E, Carelli V et al. Efficacy and Safety of Elamipretide in Individuals With Primary Mitochondrial Myopathy: The MMPOWER-3 Randomized Clinical Trial. Neurology. 2023;101(3):e238-e252.Randomised trialPMID 37268435full text
- 4.Thompson WR, Manuel R, Abbruscato A et al. Long-term efficacy and safety of elamipretide in patients with Barth syndrome: 168-week open-label extension results of TAZPOWER. Genet Med. 2024;26(7):101138.Randomised trialPMID 38602181