SS-31 / Elamipretide

Name: SS-31 / Elamipretide
Brand: LyoPep

Also known as SS-31

Elamipretide/SS-31 cardiolipin-binding tetrapeptide reference material

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

Batch COA

MOQ1 kit (10 vials) per SKU

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

Lead time14–21 days

SS-31 / Elamipretide — 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: 1 kit (10 vials) per SKU
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

Follow the storage condition stated on the batch COA or label from receipt onward.

Research context

What researchers study about SS-31 / Elamipretide

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.

Batch documentation

SS-31 / Elamipretide batch COAs

Laboratory: Manufacturer's QC laboratoryTests: HPLC purity · MS identity · endotoxin · fill amount

5 mg
10 mg
50 mg

Previews are blurred on purpose so the documents cannot be reused; third-party reports show their first page only. Sales sends the clear full version for the product and strength you ask about.

Independent test fails? Full refund.

Representative records, refreshed periodically

Published COAs show recent representative batches and may not be the newest. For a quote or shipment, sales confirms the lot and sends its COA.

Third-party reports, added progressively

Previews of the first page of third-party reports are on our Quality page and on the matching product pages; sales sends the full report on request. You can also send any vial from your order to an independent laboratory of your choice. Unless agreed otherwise in writing, the buyer pays for optional testing.

Help reviewing your COA

Need help reading a batch COA or third-party report? Sales can explain the test items, specifications and how the results relate to the lot under discussion.

On every batch COA: HPLC purity · MS identity · endotoxin · fill amount · Verify LyoPep

Third-party reports for SS-31 / Elamipretide

Reports from Qorix (tjqxgd.com), a third-party analytical laboratory in Tianjin, China: HPLC purity and MS identity of the sample tested.

Laboratory: Third-party laboratoryTests: HPLC purity · MS identity

50 mg

Previews are blurred on purpose so the documents cannot be reused; third-party reports show their first page only. Sales sends the clear full version for the product and strength you ask about.

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.

Batch COA for the released lotHPLC purity with method contextMS identity resultEndotoxin resultFill amount (measured content per vial)SDS and handling statement

Available fills

Quote the fill and pack configuration you need

Reference SKUFillBase pack

SS55 mg10 vials

SS1010 mg10 vials

SS5050 mg10 vials

Other format

Also available as a nasal spray (US stock)

Black 10 mL nasal spray bottle with a clear cap — 10 mL nasal spray bottle

Besides lyophilized vials, SS-31 / Elamipretide is also supplied as a nasal spray solution, shipped from our US stock.

Strengths: 5 mg
Bottle sizes: 10 mL or 20 mL
Minimum order: 10 bottles per strength and bottle size
Ships from: Our US stock

Handling

Plan storage before the parcel arrives

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 the destination and timing so receipt can be planned, then move the material into its stated storage condition on arrival.

Buyer FAQ

Terms to settle before the purchase order

Can a buyer arrange third-party testing?+

Yes. You can send any vial from your order to an independent laboratory of your choice. If you want the laboratory, specification, sampling, method and acceptance rule agreed with us before testing, sales confirms them in writing. Unless otherwise agreed in writing, the buyer pays the cost of this optional testing.

What if my own lab test shows the product is out of specification?+

Send any vial from your order to an independent laboratory of your choice. If the report shows the product does not meet the specification on its COA — purity below the stated minimum, or an identity that does not match — share the report with our sales team and we refund that product in full.

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.

How should material be stored after delivery?+

Move it into the storage condition stated on the batch COA or label as soon as it arrives, and record the package condition on receipt.

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 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 / Elamipretide

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.

Evidence before order

SS-31 / Elamipretide

Key benefits

Specifications to confirm against the released lot

Identity, purity and content are separate release questions.

What researchers study about SS-31 / Elamipretide

The question the literature is testing

Research routes and exposure context

Compatibility, limitations and decision context

Interactions reported in the literature

SS-31 / Elamipretide batch COAs

Third-party reports for SS-31 / Elamipretide

Ask for the current packet, not a generic certificate

Quote the fill and pack configuration you need

Also available as a nasal spray (US stock)

Plan storage before the parcel arrives

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 / Elamipretide

Buyer intelligence

Compare adjacent molecules and documentation needs.

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