synthetic tetrapeptide

SS-31 (elamipretide)

US: Not on the registerEU: Not on the registerUK: Not on the registerCA: Not on the registerAU: Status unknownCH: Not on the registerBR: Not on the registerRS: Not on the registerSG: Not on the registerTR: Not on the register

Answer

SS-31 (elamipretide) is not authorised on any of the 10 registers read, and 1 of them holds no reading for it. No trial states a phase. It has 30 registered trials, 3 of them running.

RegulatorTrial register10 regulators' registers, read 2026-08-31 to 2026-10-03 · ClinicalTrials.gov, read 2026-08-31

Not medical, legal or regulatory advice.

Registered trials30Trial register ClinicalTrials.gov

Running now3Trial register recruiting, active or enrolling

Results posted0Trial register with results on the register

Stopped early13.3%Trial register all peptides: 10%

30 trials by status

Trial register

Running 3Completed 22Stopped early 4Other or not stated 1

ClinicalTrials.gov · read 2026-08-31 · 0 trials have posted results

Trials first submitted per year

Trial register

22014

52015

72016

22017

12019

12020

22021

12024

12025

12026

ClinicalTrials.gov first-submitted date, last 10 years · read 2026-08-31. 2026 is not complete. 7 trials carry no first-submitted date (EU CTIS publishes none, or the year is outside this range).

Status by jurisdiction

World map

CAISNOUSUKEUUACNKRJPMXCHLIRSTRINTHBREGILSAAESGARZAAUNZ

Authorised or registeredNot on the register, or withdrawnNot read yet, or status unknown

Where	Status	Register	Read
United States	Not on the register	FDA, openfda	2026-10-03
European Union	Not on the register	EMA, ema	2026-08-31
United Kingdom	Not on the register	MHRA, uk-mhra	2026-09-03
Canada	Not on the register	Health Canada, ca-dpd	2026-09-03
Australia	Status unknown	TGA, au-artg	not read
Switzerland	Not on the register	Swissmedic, ch-swissmedic	2026-09-03
Brazil	Not on the register	ANVISA, br-anvisa	2026-09-03
Serbia	Not on the register	ALIMS, rs-alims	2026-09-03
Singapore	Not on the register	HSA, sg-hsa	2026-09-03
Turkey	Not on the register	TITCK, tr-titck	2026-09-03

An EU decision applies in the 30 territories the EU register covers: its member states, and Iceland, Liechtenstein and Norway. A dashed tile has no register read for this peptide.

Side effects

Trial register

5 placebo-controlled trials · 546 people on SS-31 (elamipretide) · grey is placebo

Injection site erythema63.8% 44.7%

Injection site pain29.4% 21.8%

Nasopharyngitis5.5% 2.4%

Nausea4.8% 4.7%

Headache4.4% 3.4%

ClinicalTrials.gov posted results · read 2026-10-03All side effects

CHANGE ALERTS

Get an email when this changes

One email when the status of SS-31 (elamipretide) changes on the register. You confirm your address first.

ENFORCEMENT AND OFFICIAL ACTIONS

1 action by named authorities

Enforcement actions, board positions and payer rules that name SS-31 (elamipretide), quoted from the source document. These are not approval decisions. This list shows the actions found so far. It is not a complete list: no authority publishes one.

US-OHenforcement

Ohio Board of Pharmacy, 2026-04-16

During the inspection, [redacted] was found to possess multiple vials of the following illegal dangerous drugs, in either a white powder, purple powder, or clear liquid form, intended for injection, which were obtained from an unlicensed, foreign source: f. SS-31 10mg, 4 vials;

State of Ohio Board of Pharmacy, Order, Case No. A-2026-0037, Findings of Fact paragraph 2(f) · quoted with the party redacted

REGISTERED TRIALS

Newest 10 of 30 trials

All 30 trials

NCT07531251	Clinical Trial in Patients With Barth Syndrome- 4TAZPower currently recruiting participants · register updated 2026-07-13
NCT06373731	ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Rel running, but no longer enrolling · register updated 2026-05-20
NCT05168774	FRDA Investigator Initiated Study (IIS) With Elamipretide completed · register updated 2025-12-12
NCT07275424	Study of Healthy Aging and Physical Function With Elamipretide currently recruiting participants · register updated 2025-12-10
NCT05162768	Study to Evaluate Efficacy and Safety of Elamipretide in Subjects With Primary Mitochondrial Disease From Nuclear DNA Mutations (n completed · register updated 2025-10-24
NCT04689360	An Intermediate Size Expanded Access Protocol of Elamipretide available · register updated 2025-02-14
NCT03891875	ReCLAIM-2 Study to Evaluate Safety,Efficacy & Pharmacokinetics of Elamipretide in Subjects With AMD With Non-central GA completed · register updated 2024-07-12
NCT03098797	A Trial to Evaluate Safety, Tolerability and Efficacy of Elamipretide in Subjects With Barth Syndrome completed · register updated 2024-04-16
NCT03323749	A Trial to Evaluate Safety and Efficacy of Elamipretide Primary Mitochondrial Myopathy Followed by Open-Label Extension terminated before completion · register updated 2022-01-24
NCT02976038	Open-Label Extension Trial to Characterize the Long-term Safety and Tolerability of Elamipretide in Subjects With Genetically Conf terminated before completion · register updated 2021-12-17

All peptides · Method

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New trials, approvals and enforcement actions. One email a week.