SS-31

Elamipretide/SS-31 cardiolipin-binding tetrapeptide reference material

≥ 99.0% · target, verify batch COACAS 736992-21-5RUO

Research statusFDA accelerated approval applies to FORZINITY for a defined Barth-syndrome indication; this RUO material is not an approved drug reference context · supplied material is RUO

Supplied formTetrapeptide (linear, C-terminally amidated, D-amino acid + non-proteinogenic Dmt residue)

Lead time14–21 days

SS-31 — Lyophilized material; confirm released-lot appearance on the COA

Representative packaging image · verify the ordered lot

Decision summary

Key benefits

Research value includes cardiolipin and mitochondrial-membrane binding, mitochondrial morphology and bioenergetics, proteomic interaction mapping, Barth-syndrome translational research and investigation of mixed clinical outcomes across mitochondrial, cardiac and ophthalmic programs
Only FORZINITY's defined Barth-syndrome muscle-strength indication is FDA approved; other proposed benefits remain indication-specific and investigational.

Published research context is presented for literature orientation only. It is not a dosing, treatment or human-use instruction.

Qualification data

Specifications to confirm against the released lot

CAS: 736992-21-5
Formula: C₃₂H₄₉N₉O₅ (free peptide; FORZINITY uses the trihydrochloride salt)
Molecular weight: 639.8 g/mol
Appearance: Lyophilized material; confirm released-lot appearance on the COA
Purity: ≥ 99.0% · target, verify batch COA
Storage: Use this released lot's COA and stability instructions. Confirm whether the material is free peptide or hydrochloride salt and document powder/solution temperature, light, moisture, matrix, concentration, container, freeze-thaw limits and validated hold time. The opened-vial storage rule for ready-to-use FORZINITY must not be transferred to a lyophilized or differently formulated RUO lot.
MOQ: On request
Lead time: 14–21 days

PubChem CID 11764719

Qualification matrix

Identity, purity and content are separate release questions.

Identity

Confirm the stated molecule and supplied form. Start with the matching batch COA; request sequence-level evidence only when the buyer's written procedure requires it and availability or a separate scope has been agreed.

Purity

Review RP-HPLC method conditions, wavelength, integration and related-peak handling. A percentage without the method is not enough.

Content

Net peptide content is not the same as gross lyophilized powder weight. Ask which assay supports the stated amount and whether water/counter-ion is addressed.

Stability

Define long-term storage and transit exposure separately. Cold-chain can be quoted when the buyer’s risk assessment requires it and adds cost.

Research context

What researchers study about SS-31

SS-31 (elamipretide) is a synthetic mitochondria-associated tetrapeptide with sequence D-Arg-2,6-dimethyl-Tyr-Lys-Phe-NH2. FDA granted accelerated approval to the distinct sterile prescription product FORZINITY on September 19, 2025 to improve muscle strength in adults and children with Barth syndrome weighing at least 30 kg. Approval was based on an intermediate knee-extensor-strength endpoint and remains subject to confirmation of clinical benefit. This listing is research material and is not FORZINITY or an FDA-approved substitute.

Approved context: FORZINITY for muscle-strength improvement in Barth syndrome patients weighing at least 30 kg under accelerated approval, with confirmatory benefit required
Research contexts include mitochondrial cardiolipin/membrane biology, primary mitochondrial myopathy, heart failure, ischemia-reperfusion, geographic atrophy and aging-related models
Several indication-specific randomized trials missed prespecified primary endpoints; the Barth-syndrome approval must not be generalized.

Mechanism context

The question the literature is testing

FDA describes elamipretide as a mitochondrial cardiolipin binder that localizes to the inner mitochondrial membrane and improves mitochondrial morphology and function. Mechanistic studies also report membrane partitioning, altered surface electrostatics and interactions with cardiolipin-associated proteins. These mechanisms do not by themselves establish clinical benefit outside the approved indication or verify another supplier's lot.

Evidence map

Research routes and exposure context

Evidence tierApproved finished-product context

Research areaMitochondrial research

Routes reported in sources

SubcutaneousIntravenous

Dose / exposure contextProtocol-specific; verify the cited primary source

Routes and exposure contexts summarize cited studies or approved finished-product labels. They are not instructions for administering this RUO material; no customer dose is provided.

Evidence boundaries

Compatibility, limitations and decision context

Research-use-only material; not for human or veterinary administration
FORZINITY's most common labeled adverse reactions are injection-site reactions, and serious reactions have also been reported
Its accelerated approval requires a confirmatory trial
The approved product's safety database, sterile manufacturing, preservative system and renal dosing do not establish the safety, sterility or equivalence of this RUO material.

Interactions reported in the literature

No peptide-stacking compatibility has been established
Do not infer synergy or safety with NAD+ precursors, MOTS-c, Humanin, GHK-Cu, BPC-157 or thymosin beta-4 from marketing or pathway overlap
The interaction information in the FORZINITY label is formulation- and prescribing-specific and does not validate experimental combinations involving this RUO lot.

Literature context is not a supplier release result or human-use instruction. Follow your institution's approved laboratory risk assessment.

Factory batch documentation

SS-31 factory batch COAs

SS-31 5 mg Factory batch COA protected preview

SS-315 mg · WHJLP-SS5-260611-B

SS-31 10 mg Factory batch COA protected preview

SS-3110 mg · WHJLP-SS10-260611-B

SS-31 50 mg Factory batch COA protected preview

SS-3150 mg · WHJLP-SS50-260611-B

Representative records, refreshed periodically

Published COAs show representative factory batches and may not be the latest available. For a current quote or shipment, our sales team can confirm the applicable lot and provide its COA.

Independent testing, arranged on request

Third-party reports are not routinely published. If independent verification is required, we can agree the laboratory, method, acceptance criteria and remedy before testing. If the agreed specification is not met, an appropriate resolution—including a refund where applicable—can be discussed under the agreed terms. Unless otherwise agreed in writing, the buyer pays the cost of this optional testing.

Help reviewing your COA

Need help reading a factory COA or third-party report? Our sales team can clarify test items, specifications and how the results relate to the lot under discussion.

Ask for the current packet, not a generic certificate

First identify the supplied form: free peptide or defined hydrochloride salt
Require complete stereochemical sequence, C-terminal amidation, intact mass, peptide content, chromatographic related-peptide profile, aggregates, counterion stoichiometry/assay, water and residual solvents
Add validated bioburden, endotoxin and sterility controls only when the research protocol requires them
HPLC area purity, appearance and an unspecified third-party COA do not establish equivalence to FORZINITY.

Released-batch COARP-HPLC result and method contextIdentity result appropriate to the moleculeWater / counter-ion context where relevantSDS and handling statementAdditional testing scoped on request

Available fills

Quote the fill and pack configuration you need

Reference SKUFillBase pack

SS31-05MG5 mg10 vials

SS31-10MG10 mg10 vials

SS31-50MG50 mg10 vials

Handling

Storage in the lab and temperature during transit are different decisions

Use this released lot's COA and stability instructions. Confirm whether the material is free peptide or hydrochloride salt and document powder/solution temperature, light, moisture, matrix, concentration, container, freeze-thaw limits and validated hold time. The opened-vial storage rule for ready-to-use FORZINITY must not be transferred to a lyophilized or differently formulated RUO lot.

State destination, season, acceptable transit exposure and whether your protocol requires insulated or cold-chain service. Additional temperature-control cost is quoted explicitly.

Buyer FAQ

Terms to settle before the purchase order

Can a buyer arrange third-party testing?+

Yes. Testing must be performed by a mutually accepted, established specialist laboratory. Fee allocation, specification, sampling, method and acceptance rule must be agreed before testing; if an agreed independent result shows nonconformance, the remedy follows the signed order terms. Unless otherwise agreed in writing, the buyer pays the cost of this optional testing.

Does HPLC purity prove peptide content?+

No. Chromatographic purity describes the relative peak profile under a stated method. Identity, water, counter-ion, residual solvents and assay/content may require separate methods.

Is cold-chain shipping always required?+

Not always. Heat can accelerate degradation, especially during summer and long transit. Cold-chain reduces exposure but raises cost. State the destination and stability risk so the right service can be quoted.

How are payment terms handled?+

Available methods and milestones depend on order value, destination and project type. The pro forma invoice should state currency, bank details, fees, payment milestones and the release condition.

Why must the testing laboratory understand peptide chemistry?+

Free-base and salt forms, hydrophilic and hydrophobic sequences, aggregation and adsorption can change sample preparation and method suitability. Use a laboratory experienced with the molecule class.

External qualification references

WHO good storage and distribution practices IATA Temperature Control Regulations ISO/IEC 17025 laboratory competence 21 CFR 211.84 component testing and supplier COA controls

These are buyer-qualification references, not claims that this RUO material is regulated, certified or released under those frameworks. Applicability depends on the buyer's workflow and jurisdiction.

Selected sources

Literature behind the research context

Regulatory sources: FDA FORZINITY announcement, approval letter and Integrated Review for NDA 215244, current DailyMed label, FDA Drug Trials Snapshot and ongoing accelerated-approval table. Key clinical evidence includes TAZPOWER (PMID 33077895) and its 168-week open-label extension, MMPOWER-3, the early HFrEF study (PMID 28866242) and ReCLAIM-2 (PMID 39605874). Mechanistic evidence includes Chavez et al. 2020 (PMID 32554501) and Mitchell et al. 2020 (PMID 32273339).

01
A 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
Genetics in Medicine · 2021 · peer-reviewed original research (randomized controlled trial with open-label extension)
Open source
02
Long-term efficacy and safety of elamipretide in patients with Barth syndrome: 168-week open-label extension results of TAZPOWER
Genetics in Medicine · 2024 · peer-reviewed original research (long-term open-label extension)
Open source
03
Efficacy and Safety of Elamipretide in Individuals With Primary Mitochondrial Myopathy: The MMPOWER-3 Randomized Clinical Trial
Neurology · 2023 · peer-reviewed original research (phase 3 randomized controlled trial)
Open source
04
Novel Mitochondria-Targeting Peptide in Heart Failure Treatment: A Randomized, Placebo-Controlled Trial of Elamipretide
Circulation: Heart Failure · 2017 · peer-reviewed original research (randomized, placebo-controlled, ascending-dose trial)
Open source
05
ReCLAIM-2: A Randomized Phase II Clinical Trial Evaluating Elamipretide in Age-related Macular Degeneration, Geographic Atrophy Growth, Visual Function, and Ellipsoid Zone Preservation
Ophthalmology Science · 2025 · peer-reviewed original research (phase 2 randomized, double-masked, placebo-controlled trial)
Open source
06
Mitochondrial protein interaction landscape of SS-31
Proceedings of the National Academy of Sciences (PNAS) · 2020 · peer-reviewed original research (mechanistic/proteomics study)
Open source
07
The mitochondria-targeted peptide SS-31 binds lipid bilayers and modulates surface electrostatics as a key component of its mechanism of action
Journal of Biological Chemistry · 2020 · peer-reviewed original research (biophysical/mechanistic study)
Open source
08
Elamipretide: A Review of Its Structure, Mechanism of Action, and Therapeutic Potential
International Journal of Molecular Sciences · 2025 · peer-reviewed review article
Open source

Product FAQ

Questions buyers ask about SS-31

What exact SS-31 identity and salt form should be specified?+

The FDA elamipretide sequence is D-Arg-2,6-dimethyl-Tyr-Lys-Phe-NH₂; all residues other than arginine have the L configuration. The approved FORZINITY product contains elamipretide trihydrochloride, whereas an RUO lot may be free peptide or a defined salt. The order and COA should state full stereochemistry, terminal amidation, counterion identity and stoichiometry, and whether content is reported as elamipretide equivalent or total salt mass.

How should mitochondrial targeting of SS-31 be described?+

SS-31 is a cationic-aromatic tetrapeptide that partitions into negatively charged membrane interfaces and interacts with cardiolipin-rich inner-mitochondrial membranes. Biophysical work reports surface-charge-dependent binding, changes in membrane packing and electrostatics, and interactions with cardiolipin-associated proteins. This is not adequately described as simple membrane-potential-driven accumulation like a triphenylphosphonium conjugate, and no universal 100- to 1,000-fold enrichment or lower off-target-effect claim should be assigned across models.

SS-31

Key benefits

Specifications to confirm against the released lot

Identity, purity and content are separate release questions.

What researchers study about SS-31

The question the literature is testing

Research routes and exposure context

Compatibility, limitations and decision context

Interactions reported in the literature

SS-31 factory batch COAs

Ask for the current packet, not a generic certificate

Quote the fill and pack configuration you need

Storage in the lab and temperature during transit are different decisions

Terms to settle before the purchase order

Literature behind the research context

A 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

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

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

Novel Mitochondria-Targeting Peptide in Heart Failure Treatment: A Randomized, Placebo-Controlled Trial of Elamipretide

ReCLAIM-2: A Randomized Phase II Clinical Trial Evaluating Elamipretide in Age-related Macular Degeneration, Geographic Atrophy Growth, Visual Function, and Ellipsoid Zone Preservation

Mitochondrial protein interaction landscape of SS-31

The mitochondria-targeted peptide SS-31 binds lipid bilayers and modulates surface electrostatics as a key component of its mechanism of action

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

Questions buyers ask about SS-31

Compare adjacent molecules and documentation needs.

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