Mitochondrial-related

SS-31 / Elamipretide

An Aliquot catalog identity that names SS-31 with elamipretide. FDA granted accelerated approval to an elamipretide product for a specific labeled use in 2025.

Canonical ID
ss-31
Evidence type
FDA accelerated-approval record and prescribing information
Human PK
Not published

Overview

Aliquot distinguishes the specific approved product from the broader catalog identity and does not extend the label beyond what it supports.

The current FDA label is used for regulatory context. Aliquot withholds a half-life because the label does not publish one.

Human pharmacokinetic context

Not published

Aliquot has not published a route-matched human half-life statement for this entry.

Half-life is descriptive population context, not a dosing interval, a prediction of an individual's response, or a recommendation. Route-mismatched and uncited estimates are withheld.

Limitations

  • Accelerated approval is specific to the named product and labeled population; it does not validate other products or uses.
  • No elimination half-life is published from the current label.

Related calculation tools

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Sources

  1. FDA grants accelerated approval to first treatment for Barth syndrome FDA approval announcement · U.S. Food and Drug Administration · accessed 2026-07-28 Accelerated approval date and narrow regulatory context.
  2. Forzinity (elamipretide) prescribing information FDA prescribing information · U.S. Food and Drug Administration · accessed 2026-07-28 Current prescribing information and PK limitation.
  3. Aliquot compound library methodology Editorial methodology · Aliquot · accessed 2026-07-28 Editorial scope and withholding rules.

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Reviewed by Aliquot editorial review on 2026-07-28. Next scheduled review: 2026-10-26. Methodology and corrections.