Mitochondrial Research

SS-31 (Elamipretide)

6.0/10

BioHarmony verdict

Worth trying

SS-31 (elamipretide) is a mitochondria-targeting tetrapeptide that binds cardiolipin. Karaa 2023 found no broad PMM benefit in MMPOWER-3, while FDA granted accelerated Forzinity approval for Barth syndrome in patients weighing at least 30 kg.

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What is SS-31 (Elamipretide)?

SS-31, now known clinically as elamipretide and marketed as Forzinity for Barth syndrome, is a mitochondria-targeting tetrapeptide designed to bind cardiolipin in the inner mitochondrial membrane. Cardiolipin helps organize mitochondrial cristae, the folds where electron transport chain complexes sit and ATP is produced. Birk 2013 showed SS-31 interacting with cardiolipin in ischemic mitochondria, while Szeto 2014 framed the compound as the lead cardiolipin-protective peptide in the Szeto-Schiller class.

From the BioHarmony report, reviewed 2026-09-08.

How it is thought to work

Binds cardiolipin on the inner mitochondrial membrane, supports cristae architecture and electron transport chain supercomplex organization, and reduces mitochondrial ROS leak.

Safety watch-outs

  • Injection-site infection
  • New severe weakness or muscle pain

Full risk profile in the BioHarmony report.

Dosing as published

Approved labelFORZINITY prescribing information for Barth syndrome
PopulationPatients weighing at least 30 kg with Barth syndrome
Dose40 mg
RouteSubcutaneous injection
FrequencyOnce daily
DurationAs directed in the approved prescribing information
PreparationReady-to-use 80 mg/mL solution in a multi-dose vial; no reconstitution. The label directs discarding an opened vial after 8 days.
Source: Dosage and Administration sections 2.2-2.4; Dosage Forms and Strengths section 3

More reported protocols

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Educator coverage (6)

Attributed viewpoints, separate from primary research.

Trust & sourcing

US approvalFDA-approved product exists
CompoundingApproved product exists; compounded copies are not FDA approved
Last checked2026-07-13
Next review2026-10-11

FDA approved elamipretide as Forzinity in 2025 for improving muscle strength in adults and pediatric patients with Barth syndrome who weigh at least 30 kg.

Primary sources

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