SS31

SS-31

A synthetic tetrapeptide, D-Arg-2',6'-dimethyltyrosine-Lys-Phe-NH2, carrying alternating aromatic and basic residues. It does not act at a cell-surface receptor: the published mechanism is direct binding to cardiolipin in the inner mitochondrial membrane, which is unusual among the compounds tracked here.

SS-31 has 21 registered human studies on ClinicalTrials.gov, reaching phase 4, covering 1,869 planned or enrolled participants across the 20 studies that published a figure. An FDA-approved product contains SS-31 — FORZINITY (NDA215244). 200 papers naming it were published in the last ten years.

Collected 2026-08-02 from ClinicalTrials.gov and Drugs@FDA. Counts include only trials whose registered intervention names SS-31; the registry search is fuzzy, so every match is re-checked. None of this says whether SS-31 works or is safe.

FDA status

Approved

Human studies

21

Furthest phase

Phase 4

Papers, 10 yr

200

Readership

1,883

monthly average, Feb–Jul 2026

Tracking since 2026-07-29 · About this data

What has actually been tested in humans

A

An approved product exists

21

Registered human studies

Phase 4

Furthest phase reached

1,869

Planned or enrolled participants, across 20 studies that published a figure

Approved

FDA-approved product — FORZINITY

Registered means registered — not that the study finished, and not that it found anything. The grade is mechanical: it is computed from the registry and the FDA record alone, and it grades how much is known, never whether a compound is good or safe. Collected 2026-08-02 from ClinicalTrials.gov and Drugs@FDA. Check the query.

What SS-31 is, and what it has been studied for

SS-31 is classified by ChEMBL as a protein, and appears in trial registrations under MTP 131 and MTP-131. Its FDA substance identifier is 87GWG91S09.

Across 21 registered trials, it has been studied in Barth Syndrome, Mitochondrial Diseases, Primary Mitochondrial Disease and Heart Failure. A condition here is what a sponsor registered the trial under — it records what was investigated, not what was shown.

The trials were run by Stealth BioTherapeutics Inc. and David Marcinek among others. A named commercial sponsor means a compound is in formal development; its absence does not mean the opposite, only that no company has registered a trial under its own name.

How far it got

SS-31 reached Phase 4 across 21 registered trials.Phase 1First given to peoplePhase 2Looking for an effectPhase 3Tested at scalePhase 4Studied after approval

SS-31 reached Phase 4 across 21 registered trials.

An FDA-approved product contains SS-31. Approval covers a specific product for a specific use — it is not a verdict on the molecule.

Is anyone studying SS-31?

Papers published each year that name SS-31 in the title or abstract, with the clinical trials that started in the same year marked beneath. Ten calendar years.

01325385017181920212223242526trials
Vertical axis: papers published that year. Bar for 2026 is hatched because that year is still running.
Publications and trials naming SS-31, by year
YearPublicationsTrials startedComplete year
201792Yes
2018140Yes
2019161Yes
2020170Yes
2021190Yes
2022272Yes
2023190Yes
2024271Yes
2025431Yes
2026351No

200 papers and 8 registered trials between 2017 and 2026. A paper counts when “elamipretide” appears in its title or abstract — phrase-matched, so a paper mentioning the words separately is not counted. The total is a single query over the whole window, which is why it does not equal the bars added together: PubMed files a paper under both its electronic and its print publication date, so one paper can appear in two years. Publication volume measures scientific attention, not whether a compound works: a well-studied compound can be well-studied and ineffective. Sources: PubMed and ClinicalTrials.gov · collected 2026-08-02.

Published research on SS-31

200 indexed papers name SS-31 in their title or abstract. These are the 8 PubMed ranks most relevant. Listing a paper is not a judgement about it, and none of these is summarised here — follow the link and read what it says.

  1. Elamipretide: A Review of Its Structure, Mechanism of Action, and Therapeutic Potential

    Tung C, Varzideh F, Farroni E, et al.International journal of molecular sciences2025

    PMID 3994071210.3390/ijms26030944

  2. Elamipretide (SS-31) improves mitochondrial dysfunction, synaptic and memory impairment induced by lipopolysaccharide in mice

    Zhao W, Xu Z, Cao J, et al.Journal of neuroinflammation2019

    PMID 3174790510.1186/s12974-019-1627-9

  3. Efficacy and Safety of Elamipretide in Individuals With Primary Mitochondrial Myopathy: The MMPOWER-3 Randomized Clinical Trial

    Karaa A, Bertini E, Carelli V, et al.Neurology2023

    PMID 3726843510.1212/WNL.0000000000207402

  4. Elamipretide: First Approval

    Shirley MDrugs2026

    PMID 4133537210.1007/s40265-025-02269-8

  5. Potential Therapeutic Candidates for Age-Related Macular Degeneration (AMD)

    Nashine SCells2021

    PMID 3457213110.3390/cells10092483

  6. Genotype-specific effects of elamipretide in patients with primary mitochondrial myopathy: a post hoc analysis of the MMPOWER-3 trial

    Karaa A, Bertini E, Carelli V, et al.Orphanet journal of rare diseases2024

    PMID 3957415510.1186/s13023-024-03421-5

  7. Elamipretide Hydrochloride

    American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists2026

    PMID 4120666210.1093/ajhp/zxaf303

  8. Long-term efficacy and safety of elamipretide in patients with Barth syndrome: 168-week open-label extension results of TAZPOWER

    Thompson WR, Manuel R, Abbruscato A, et al.Genetics in medicine : official journal of the American College of Medical Genetics2024

    PMID 3860218110.1016/j.gim.2024.101138

Collected 2026-08-02from PubMed, phrase-matched on “elamipretide” in title and abstract. Run the same search.

About SS-31

A synthetic tetrapeptide, D-Arg-2',6'-dimethyltyrosine-Lys-Phe-NH2, carrying alternating aromatic and basic residues. It does not act at a cell-surface receptor: the published mechanism is direct binding to cardiolipin in the inner mitochondrial membrane, which is unusual among the compounds tracked here.

Also known as
Elamipretide · MTP-131

Structure and mechanism only. Nothing above describes what this compound is for, and no dose appears anywhere on this page.

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