Review· 2014
First-in-class cardiolipin-protective compound as a therapeutic agent to restore mitochondrial bioenergetics.
British journal of pharmacology
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Human researchFDA accelerated approval · Barth syndrome
SS-31 / Elamipretide
Elamipretide; mitochondria-targeted tetrapeptide
Also indexed as: Elamipretide · MTP-131
What this evidence does not tell us
Forzinity received accelerated approval in September 2025 for Barth syndrome in patients weighing at least 30 kg. A confirmatory trial is required. This is not evidence for healthy-person longevity.
Terms on this page
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7 glossary terms used in this profile
Terms on this page
Unfamiliar word? Open this panel for simple explanations, right here.
7 glossary terms used in this profile
Select a word to see its meaning. You can keep more than one definition open.
Definitions explain the words—not whether a molecule works or is safe. Research education only, not medical advice.
Overview
SS-31 is a research name for elamipretide, a mitochondria-targeted tetrapeptide. The finished product Forzinity has a narrow accelerated FDA approval for Barth syndrome, not healthy-person longevity.
Mechanism of action
Cardiolipin / mitochondrial membrane
Elamipretide interacts with cardiolipin in the inner mitochondrial membrane. Research examines membrane organization and energy-related function; that mechanism does not by itself demonstrate an anti-aging benefit.
A biological pathway describes a proposed or observed interaction—not necessarily a demonstrated health outcome.
Decode the terminology in our glossaryPut the research in context
Simplified educational maps—not a treatment pathway or a prediction of benefit.
Scientific evidence
How strong is the evidence?
Human evidence is still developing
- Limited evidence
- Early research
- Human researchCurrent category
- Human outcomes
Studies in people exist, but the findings may be small, narrow, mixed or still need confirmation. A hormone or cell marker is not necessarily a health benefit.
For this research: Forzinity received accelerated approval in September 2025 for Barth syndrome in patients weighing at least 30 kg. A confirmatory trial is required. This is not evidence for healthy-person longevity.
An editorial guide—not a validated score, a percentage, a safety rating or an approval badge. Regulatory status is separate. More research does not mean fewer risks.
Cell studies
Mechanistic laboratory evidence is not separately assessed in this selected-source summary; see references and their study types.
Animal experiments
Animal evidence is not separately assessed here. Findings in animals must not be interpreted as demonstrated human benefit.
Human observational studies
Associations, biomarker studies and anecdotes cannot establish treatment causality; no observational result is used here to infer clinical effectiveness.
Human clinical trials
Disease-specific human trials and accelerated approval exist. Confirmation of the predicted Barth syndrome clinical benefit is required.
Regulatory evidence
Forzinity (elamipretide) received accelerated FDA approval in September 2025 for Barth syndrome in patients weighing at least 30 kg. Confirmatory evidence is required. This does not approve longevity use or research-grade SS-31.
Potential research applications
Mitochondrial membrane function and disease-specific outcomes.
These describe scientific questions, not prescribing recommendations. A research grouping does not establish combination safety or clinical effectiveness.
Explore research by health goalSafety considerations
Injection-site reactions are common in trials; serious hypersensitivity reactions have been reported. Refer to the approved product label for full contraindications and warnings.
This is not an exhaustive safety or contraindication list. An absence of reported harm is not proof of safety. Pregnancy, breastfeeding, cancer history, endocrine disease and concurrent medicines can materially change risk. Unregulated preparations add identity, contamination and sterility risks.
Regulatory status · United States
FDA accelerated approval · Barth syndrome
Forzinity (elamipretide) received accelerated FDA approval in September 2025 for Barth syndrome in patients weighing at least 30 kg. Confirmatory evidence is required. This does not approve longevity use or research-grade SS-31.
Read the official regulatory sourceRegulatory status and evidence strength are different. A nomination for compounding, a clinical-trial registration or a “research use only” label is not approval. International rules vary; consult the current regulator and product label.
Selected literature & source transparency
Matched bibliographic records confirm a publication’s identity, not the validity of every claim. Selected sources are not a systematic literature review.
Continue your own source search
These open search results, not additional verified citations. Trial registration is not evidence that a treatment works.
Three questions worth bringing to your clinician
- Which human outcomes—not just biomarkers—support this claim?
- What established options address my actual health concern?
- What do my medical history and current medicines change about the risks?
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