NHD Global
Mitochondrial research · Elamipretide / SS-31
Scientific Product Dossier
Elamipretide is a mitochondrial cardiolipin-binding tetrapeptide. FDA granted accelerated approval to the finished drug Forzinity in September 2025 for improving muscle strength in Barth syndrome patients weighing at least 30 kg. The supporting randomized trial enrolled 12 patients and missed its two primary endpoints; catalog SS-31 is not the approved finished drug.
Shared values below are consolidated from the current catalog record. They are not independent verification or lot results; the current product specification and lot COA control.
Product identity
Literature reference parameters
Identity safeguard Reference identifiers above describe the literature compound record. The supplied form, formula, molecular weight, purity and storage conditions must be verified against the product-specific specification and lot COA.
A target-to-pathway view grounded in the linked research records.
Reported research findings
Reported outcomes are paired with their experimental model and evidence boundary.
The 12-patient randomized portion did not show superiority on 6-minute walk distance or the Barth syndrome fatigue score.
All participants were male; one US site; extremely small rare-disease dataset.
Read the primary studyFDA based accelerated approval on knee-extensor strength observed during longer open-label follow-up and required a post-approval randomized trial.
Approved indication: Barth syndrome in patients weighing at least 30 kg.
Read the primary studyCatalog options
Pack-level catalog data; lot-level controls remain document-specific.
Single-component peptide · 10 mg/vial nominal · 10-vial pack · supplied form and release limits controlled by lot specification.
Request by lot: CoA, HPLC purity and MS identity
Single-component peptide · 50 mg/vial nominal · 10-vial pack · supplied form and release limits controlled by lot specification.
Request by lot: CoA, HPLC purity and MS identity
Document availability is stated honestly and can vary by catalog variant or lot.
Analytical interpretation
Use the source-reviewed guide to separate chromatographic area purity, quantitative assay, LC-MS identity, composition and stability evidence before comparing variants or requesting a lot record.
Open the Quality & Documentation HubHPLC area ≠ assayA dominant peak does not establish target mass fraction.
Intact mass ≠ full sequenceIdentity strength depends on resolution and orthogonal evidence.
Counterions affect contentWater, salt form and solvents change the as-is composition.
Storage needs a data basisShipping practice is not the same as stability evidence.
Evidence map
Published studies and regulatory records, not customer testimonials or usage guidance.
U.S. FDA. Approval date September 19, 2025; SPIBA-201 population and endpoint record.
View primary recordReid Thompson W, et al. Genetics in Medicine. 2021. PMID 33077895.
View primary recordThird-party publications selected for direct relevance.
U.S. FDA. Approval date September 19, 2025; SPIBA-201 population and endpoint record.
Reid Thompson W, et al. Genetics in Medicine. 2021. PMID 33077895.
Concise answers for researchers comparing identity, evidence and catalog variants.
SS-31 and elamipretide refer to the peptide research lineage; Forzinity is a specific FDA-approved finished drug. A catalog SS-31 lot is not automatically that drug.
The 12-patient randomized crossover portion did not meet its 6-minute-walk or fatigue primary endpoints.
Family-level identifiers organize the catalog, while the applicable product specification and lot-specific COA control the supplied form, identity and release results.
A lot-specific COA, product specification sheet and analytical method summary can be requested where applicable.
Store at -20 °C, protected from light and moisture. After reconstitution, aliquot and avoid repeated freeze-thaw cycles. Confirm the applicable storage statement on the product-specific specification and lot documentation.
Knowledge center
Owned educational content connected to this family.
Elamipretide now has an FDA-approved finished product for a narrow Barth syndrome indication, but the approval rests on an unusual rare-disease dataset. The randomized…
Updated August 28, 2026
SS-31 and elamipretide are names used around the same mitochondrial-targeted peptide, but Forzinity is a specific FDA-approved finished drug with an approved application, formulation,…
Updated August 28, 2026Knowledge tools
Move from this dossier into canonical evidence maps, verified status records, analytical interpretation and laboratory calculations.
Published-study results are tied to the linked records and kept separate from catalog-lot claims. Imported purity, storage and document-availability templates have been removed pending product- and lot-specific confirmation.
Technical procurement
Selected: 2S10 · 10 mg × 10 vials
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