FDA product approval
approved product. Forzinity (elamipretide) has accelerated FDA approval for Barth syndrome in patients weighing at least 30 kg. This does not approve other uses or research products.
Longevity · compound · checked 2026-10-09
SS-31 math uses the listed vial sizes on this card and the liquid you type. Concentration in mcg per mL is vial milligrams times 1000, divided by milliliters. A U-100 syringe has 100 marks per milliliter, so each unit is that concentration divided by 100. Example numbers so you can see the math: a 10 mg listing plus 2 mL of liquid. Change any number and the units change. Try the numbers. A research-market vial is not the same material used in a trial.
Last checked Oct 9, 2026 by PepBear. Not medical advice.
U-100 math for listed SS-31 sizes. Each cell is micrograms per syringe mark if you add that much liquid. The table does the same math as the calculator. It does not pick an amount for you.
| Listed vial | 1 mL liquid | 2 mL liquid | 3 mL liquid |
|---|---|---|---|
| 10 mg | 100 | 50 | 33.3 |
Other names in the library: elamipretide, forzinity, SS-31 (10MG). The cited evidence and any approval concern the studied or labeled preparation. Oral, nasal, cosmetic and research-market versions do not inherit product approval or proven efficacy. Listed sizes: 10 mg. A seller title is a listing. It does not prove the vial matches a paper.
Elamipretide acts on mitochondrial cardiolipin; product-specific evidence matters.
FDA product approval
approved product. Forzinity (elamipretide) has accelerated FDA approval for Barth syndrome in patients weighing at least 30 kg. This does not approve other uses or research products.
Compounding
not established. Compounded products do not carry FDA product approval; legal eligibility is not established here.
Research
product specific. Barth syndrome patients meeting the approved Forzinity criteria; accelerated approval uses a surrogate endpoint.
Sport
unknown. Not individually verified; consult your sport authority.
We mark the cited papers as B for Barth syndrome patients meeting the approved Forzinity criteria; accelerated approval uses a surrogate endpoint. and Approved labeled indication only.. Product-label clinical evidence. Risks on the record: Injection-site reactions were the most common adverse reactions reported with the approved Forzinity product. The approved product label warns about hypersensitivity; approval does not establish the safety or quality of research-market preparations.
We mark the cited papers as B. That is our label for how strong those papers are. It does not say the compound works.
The catalog does not record a single hour value. No verified human value is generalized here to research-labeled SS-31 products.
Half-life on file: no single hour value. No verified human value is generalized here to research-labeled SS-31 products. Follow the label on the vial you hold. This page does not set a throw-away date after you add water.
People using PepBear often log: Existing clinician-directed records, symptoms and dated health measurements. Record missing data; trends do not demonstrate causation.
approved product. Forzinity (elamipretide) has accelerated FDA approval for Barth syndrome in patients weighing at least 30 kg. This does not approve other uses or research products.
The calculator turns numbers you type into U-100 units. Trial or label amounts stay as cited facts.
Units = (amount in mcg ÷ (vial mg × 1000 ÷ water mL)) × 100 on a U-100 syringe. Enter the three numbers. The chart shows the same math for each listed vial size and 1, 2 or 3 mL of liquid.
A U-100 barrel is easy to misread below about 5 marks. That is a measuring warning. The page does not tell you to take more.
A licensed clinician must interpret the evidence for your situation. This entry provides education, not treatment instructions. Not medical advice. PepBear does not pick a dose, a cycle, or a seller.