Peptimes

Track SS-31 in Peptimes

SS-31 (elamipretide) is a peptide of four amino acids, written D-Arg-2,6-dimethyl-Tyr-Lys-Phe-NH2. As elamipretide hydrochloride, it is the active ingredient in Forzinity, an FDA-approved prescription injection. (Source: DailyMed label.)

Is SS-31 FDA-approved?

Yes, as a specific product: Forzinity (elamipretide) injection is FDA-approved, by prescription, under accelerated approval for the use in its label. Continued approval may depend on a confirmatory trial.

Checked 25 Oct 2026. The sources are below.

SS-31

Also: elamipretide, elamipretide hydrochloride, Forzinity, MTP-131, Bendavia

Status label in the Peptimes Library
FDA Approved
Routes in Peptimes
Subcutaneous
Updated
25 Oct 2026

US regulatory status

FDA approval belongs to the product below, for its route and the uses in its label. Label uses are shortened unless quoted.

  • Forzinity (elamipretide) injection

    Subcutaneous

    Approved under accelerated approval, for the use in its label in adult and pediatric patients with Barth syndrome, as the label defines them. Continued approval may depend on a confirmatory trial.

    Source: DailyMed label, checked 25 Oct 2026

  • Prescription

    Prescription only. Drugs@FDA lists Forzinity as "Prescription", and its label is marked "Rx Only".

    Source: Drugs@FDA, checked 25 Oct 2026

  • Investigational

    No, for the product and uses above.

    Source: Drugs@FDA, checked 25 Oct 2026

How to track it in Peptimes

Add SS-31 in My Protocols and set the schedule you already follow: days of the week, times of day and a start date. Peptimes never suggests an amount when you log or schedule a dose. Its Library entry shows the status label “FDA Approved”; the entry above gives the product it applies to. Other elamipretide products don’t share Forzinity’s approval.

  • Logging: the amount you took and how you feel.
  • Injection sites: each dose records the site, and Insights shows where you’ve injected and how recently. It never suggests where to inject next.
  • Reminders and history: reminders at your times, Dose History, the Calendar and CSV or JSON export work as described on the peptide tracker app page.

Peptimes is a tracking app, not medical advice. Talk to a licensed clinician about your treatment. Peptimes doesn’t sell SS-31 or any other compound.

More sources

  • FDA, Drugs@FDA, NDA 215244 (Forzinity), checked 25 Oct 2026: product, route, marketing status and the original approval on 19 Sep 2025.
  • FDA, Global Substance Registration System, Elamipretide, checked 25 Oct 2026: the names SS-31, MTP-131 and Bendavia, and elamipretide hydrochloride as a separate record.

Peptide tracker appInjection-site history in PeptimesWhat FDA status terms mean

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