Preserved supervised synthesis

Elamipretide synthesis · version 1

This URL preserves the exact reviewed public wording and source set for synthesis version 1.

Supervised synthesis

What do selected human studies report about Elamipretide?

Manually reviewed September 15, 2026 · version 1

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Three selected reports cover the randomized Barth syndrome study, follow-up of the same cohort, and a separate primary mitochondrial myopathy trial. They do not cover every indication or replace the product-specific regulatory record.123

Bottom line from this bounded source set

The randomized Barth syndrome study did not meet its two primary endpoints; later uncontrolled follow-up reported improvements. The larger MMPOWER-3 trial in primary mitochondrial myopathy also missed its primary endpoints. These populations and study designs must be considered separately.123

Reviewed study record

TAZPOWER: randomized and early extension results

Design

A blinded placebo-controlled crossover trial was followed by an open-label extension.1

Population

Twelve participants with Barth syndrome entered the randomized study; ten entered the extension and eight reached 36 weeks.1

Outcomes reported

Neither primary endpoint was met in the randomized period. Walking distance and reported fatigue improved during the uncontrolled extension.1

Limitations

The extension lacks a concurrent placebo group and has attrition. Its changes cannot be interpreted as another randomized treatment effect; the abstract does not provide a detailed harms assessment.1

Reviewed study record

TAZPOWER: longer follow-up of the same cohort

Design

An open-label extension followed participants for up to 168 weeks.2

Population

Ten participants entered the extension; eight reached the week-168 visit.2

Outcomes reported

The authors reported improvements in walking distance and fatigue assessments. Injection-site reactions were the most common adverse events.2

Limitations

This is follow-up of TAZPOWER, not an independent trial. Selection, attrition and absence of concurrent controls limit attribution and generalizability.2

Reviewed study record

MMPOWER-3: primary mitochondrial myopathy

Design

A randomized, blinded, placebo-controlled phase 3 trial assessed 24-week outcomes.3

Population

The study randomized 218 participants with genetically confirmed primary mitochondrial myopathy.3

Outcomes reported

Neither walking distance nor fatigue met the primary efficacy endpoint. Most reported adverse events were mild or moderate.3

Limitations

This is a different disease population from Barth syndrome. Overall null results cannot be replaced by favorable exploratory subgroup findings.3

Reviewed source set

  1. PubMed · 33077895A phase 2/3 randomized clinical trial followed by an open-label extension to evaluate the effectiveness of elamipretide in Barth syndrome, a genetic disorder of mitochondrial cardiolipin metabolism. ↗PubMed PMID 33077895 · EFetch XML reviewed 2026-09-15 · payload SHA-256 7be61a5476f72d7700d76f4e84d64de9269524a305e0f8591b3575519602e747
    No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1038/s41436-020-01006-8. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
  2. PubMed · 38602181Long-term efficacy and safety of elamipretide in patients with Barth syndrome: 168-week open-label extension results of TAZPOWER. ↗PubMed PMID 38602181 · EFetch XML reviewed 2026-09-15 · payload SHA-256 675153339b38b362767882fe96e1930d9d3426f7eb3c18ee3219e019cffb9238
    No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1016/j.gim.2024.101138. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
  3. PubMed · 37268435Efficacy and Safety of Elamipretide in Individuals With Primary Mitochondrial Myopathy: The MMPOWER-3 Randomized Clinical Trial. ↗PubMed PMID 37268435 · EFetch XML reviewed 2026-09-15 · payload SHA-256 ed6e6945e4e878261ab8d7868ae3118cae1354effbbf604ee9aeddfdce7df940
    No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1212/wnl.0000000000207402. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗