SS-31 · DOSSIER

SS-31

Elamipretide · Forzinity · Peptide · 4 AS
LEGAL DE · NOT APPROVEDEVIDENCE · EARLY CLINICAL STUDIES3 STUDIES
FIG.01 — SIGNAL CHAIN
D-Arg-Dmt-Lys-Phe-NH₂ · ~639.8 Da
02

Mechanism of action

What SS-31 does in the body — step by step.

01

SS-31 (elamipretide) is a synthetic, cell-permeable tetrapeptide (D-Arg-2′6′-dimethyltyrosine-Lys-Phe-NH₂).

02

It accumulates selectively in the inner mitochondrial membrane, where it binds cardiolipin — a phospholipid found exclusively in mitochondria that stabilises cristae structure and the function of the respiratory chain.

03

Through cardiolipin binding, SS-31 reduces oxidative stress, stabilises the electron transport chain (complexes I–IV), increases ATP production and prevents the release of cytochrome c (an apoptotic signal).

03

Research status

How far along is the evidence?

PRECLINICALEARLY CLINICAL STUDIESCLINICALLY ESTABLISHED
SS-31 is the scientifically most advanced mitochondria-targeted agent.
SS-31 is the scientifically most advanced mitochondria-targeted agent.
On 19 September 2025, the FDA granted elamipretide (Forzinity, Stealth BioTherapeutics) accelerated approval for the treatment of Barth syndrome — a rare paediatric mitochondrial cardiomyopathy.
This is the world's first FDA approval of a mitochondria-targeted therapeutic.
Further clinical studies investigated SS-31 in heart failure (Phase II in Circulation: Heart Failure, 2020), diabetic cardiomyopathy and kidney disease.
An EMA approval does not yet exist.
Anti-aging applications in healthy individuals are not clinically substantiated.
04

Known risks

Without human data, safety statements are limited. What is known:

01
Clinical studies showed an overall favourable safety profile (predominantly local injection-site reactions)
02
Long-term data outside controlled studies are lacking
03
The FDA approval relates to a very specific rare disease — transferability to other indications is not established
04
Quality control not guaranteed from research-chemical sources
05

Cited studies

Chronological — links lead to the source.

2014
The mitochondria-targeted peptide SS-31 prevents mitochondrial membrane potential loss and apoptosis induced by β-amyloid
PubMed 24220033 →
2014
Bendavia, a mitochondria-targeting peptide, is chosen for Phase II clinical study of the treatment of heart failure
PubMed 24476546 →
2020
Elamipretide (SS-31) treatment improves mitochondrial function and reduces oxidative stress in skeletal muscle of heart failure with reduced ejection fraction
PubMed 32386380 →
06

Frequently asked questions

What is SS-31?+

SS-31 (elamipretide) is a synthetic, cell-permeable tetrapeptide (D-Arg-2′6′-dimethyltyrosine-Lys-Phe-NH₂).

What type of peptide is SS-31?+

SS-31 belongs to the Mitochondrial peptide class.

What is SS-31 used for?+

In research, SS-31 has primarily been investigated in the context of: Anti-aging, Recovery. These are research findings (evidence: early clinical studies), not proven benefits in humans and not a usage recommendation.

Is SS-31 legal in Germany?+

SS-31 is not approved as a medicine in Germany. Obtaining it outside clinical studies is legally problematic.

Is SS-31 FDA-approved / legal in the US?+

No. SS-31 is not FDA-approved as a drug in the US; it is mostly sold as a research chemical and not for human consumption.

Is SS-31 legal in Canada?+

No. SS-31 is not authorized by Health Canada and not intended for human consumption.

Where can I buy SS-31?+

Peptica sells nothing and names no sources. SS-31 is "not approved" in Germany; obtaining unapproved substances outside clinical studies is illegal and carries quality and safety risks.

What is the dosage of SS-31?+

Peptica publishes no dosing. There are no approved dosing guidelines for SS-31; figures circulating online stem from animal studies or anecdote, not from validated human protocols. This is not medical advice.

Is SS-31 banned in sport (WADA)?+

SS-31 is currently not on the WADA Prohibited List.

What are the known risks of SS-31?+

Documented risks include: Clinical studies showed an overall favourable safety profile (predominantly local injection-site reactions); Long-term data outside controlled studies are lacking. This is not a complete safety assessment and not medical advice — see the risks section for the full list.

How well researched is SS-31?+

The evidence is classified as “early clinical studies”. 3 studies are cited on this page.

What is the molecular weight of SS-31?+

SS-31 has a molar mass of about 639.8 Da.

Which peptides are related to SS-31?+

Closely related entries: MOTS-c, Epithalon. A direct side-by-side comparison is available via the compare function.

07

Dossier

Legal · Structure · Sources.

LEGAL STATUS BY REGION
Germanynot approved

Elamipretide (Forzinity) has been approved in the USA for Barth syndrome since September 2025 — an EMA approval for the EU does not exist. In Germany, Austria and Switzerland, SS-31 is not an approved medicine. Not on the WADA list. Import for non-scientific purposes is legally unclear.

Legal status varies by country and can change. This is not legal advice.

STRUCTURE & MOLECULE
H₂ND-Arg-Dmt-Lys-Phe-NHCOOH
4
AMINO ACIDS
~639.8
MOL. WEIGHT (Da)
Plasma elimination half-life in humans ~4 hours (animal models ~2 h)
HALF-LIFE
SOURCES & EXTERNAL DATABASES

Methodology: Peptica compiles publicly available studies and regulatory information and assigns each statement an evidence level. Not medical advice. No warranty.

RELATED PEPTIDES & FURTHER READING
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Community notes

Note: These posts are user opinions and not medical advice. Posts containing dosages, therapeutic claims or purchase recommendations are removed. All entries are manually reviewed before publication.
This page is intended solely for factual, scientifically oriented information. No medical advice · no dosage or usage recommendations · no claims of efficacy · no substitute for medical consultation. Peptica sells no substances. Partner links are marked as advertising; Peptica may earn a commission. © 2026 Peptica · Issue 01