Elamipretide / SS-31

Human evidence can mean a controlled clinical study, an observational study, a safety or exposure report, or evidence from a particular finished formulation. Those are different kinds of information.

Limited human evidence. Some human evidence exists, but it is small, early, indirect, or limited to a particular formulation or population.

Preclinical means research in cells, tissues, or animals rather than in people. It can help researchers form a hypothesis, but it cannot establish a human benefit or a complete human safety profile.

Preclinical mitochondrial studies supported the development rationale. Laboratory and animal findings do not establish clinical benefit outside the labeled rare-disease population.[1]

Preclinical findings do not establish outcomes in people.

Risk information may describe the compound, a finished product, a route, a population, or product-quality concerns. The cited material does not replace a current product label or an individual professional assessment.

This section is about the United States only. Status applies to a product, formulation, route, population, and use—not to a name in the abstract. A status shown here is not a recommendation or a statement about another country.

• Source/status dateDec 12, 2025

  FDA-approved medicine

  Forzinity received FDA accelerated approval to improve muscle strength in patients with Barth syndrome who meet the labeled weight criterion. This approval does not extend to other mitochondrial or wellness uses.

  Specific product form or route is not separately published in this status record.

  Open source context

The date above is the date attached to the published status record or source context. It is not necessarily the original approval date.

These prompts help organise a conversation with a qualified professional. They do not create a treatment recommendation, dose, or protocol.

• EvidenceWhich human evidence applies to the exact product, form, route, and use being discussed?
• What remains uncertainWhat is known, and what remains uncertain for this specific context?
• RisksWhich important warnings, common effects, and product-quality concerns should be discussed?
• U.S. statusWhat does the U.S. status cover, and what does it not cover?

Related means that the profiles share a topic, pathway, product context, or research question. It does not mean that they are equivalent.

No related published profiles are available yet.

PeptideGrid review date: Jul 22, 2026. Sources support the specific sections that cite them. Publication does not imply endorsement, equivalence, or individual suitability.

1. 1

   FORZINITY prescribing information

   DailyMed. FORZINITY (elamipretide) prescribing information. Initial U.S. approval 2025.

   National Library of Medicine / Stealth BioTherapeutics · Published Dec 12, 2025 · Accessed Jul 22, 2026 · Prescribing information

   Open source