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SS-31
research guide
SS-31, known by the drug name elamipretide, is a mitochondria-targeted peptide that binds cardiolipin in the inner mitochondrial membrane. Per the literature reviewed, elamipretide (brand name Forzinity) received accelerated FDA approval in the United States in September 2025 specifically to improve muscle strength in Barth syndrome patients weighing at least 30 kg, and remains under phase 3 investigation for other conditions. This is a distinct, regulated pharmaceutical entity, not the same as an unapproved research-labeled SS-31 vial.
Evidence depends on population and formulation. Literature summary, not clinical peer review.
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Jorge Abreu is not a doctor. This is an educational research summary, not a prescription or a personal dosing plan. Study results do not establish that a supplier product is safe or effective for people. Consult a licensed clinician about medical decisions.
01 · Start with identity
What is SS-31?
Elamipretide is the approved drug name for the specific pharmaceutical formulation of SS-31 developed by Stealth BioTherapeutics and reviewed by FDA for a narrow, ultra-rare disease indication under a specific dose, route, and manufacturing process. A research-labeled SS-31 vial sold outside that regulatory pathway is not verified to be the same formulation, purity, or clinical entity as the approved drug, even if the peptide sequence is intended to be identical.
Also searched as: Elamipretide
02 · Read the evidence
What the studies reported
01
FDA-approved indication is narrow and accelerated
The FORZINITY (elamipretide) prescribing information states it is indicated to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg, approved under accelerated approval based on improvement in knee extensor muscle strength, an intermediate clinical endpoint, with continued approval contingent on a confirmatory trial. [1]
02
Mechanism centers on cardiolipin binding in mitochondria
A mechanism review describes elamipretide as targeting the inner mitochondrial membrane through cardiolipin binding, discussing evolving understanding of how this interaction affects mitochondrial bioenergetics across several disease models under investigation. [3]
03
First disease-specific approval for Barth syndrome
A 2026 approval summary states elamipretide received accelerated FDA approval in September 2025 for improving muscle strength in Barth syndrome patients weighing 30 kg or more, becoming the first disease-specific treatment for this ultra-rare X-linked disorder, and remains under phase 3 development for other conditions. [2]
03 · Numbers in context
What does dosing evidence actually support?
The FORZINITY label specifies a recommended dosage of 40 mg subcutaneously once daily for patients weighing 30 kg and greater, with dose reduction specified for adults with severe renal impairment, as part of the approved product's official prescribing information for the Barth syndrome indication only. This is regulatory prescribing information for a specific approved drug in a specific ultra-rare disease population, not general information transferable to unapproved research material or to any other condition.
A study dose is not a personal dose. Population, route, formulation and supervision are part of the result. Online community schedules are not treated here as established clinical protocols.
04 · Safety and limits
What not to overlook
- Elamipretide's FDA approval is narrow, limited to Barth syndrome patients meeting a specific weight threshold; it is not an approval for general mitochondrial support or wellness use.
- A research-labeled SS-31 vial is not confirmed equivalent to the approved pharmaceutical formulation, and its purity and manufacturing are not FDA-reviewed.
- Other investigated uses of elamipretide remain in phase 3 development and are not yet approved indications as described in the sources reviewed.
- Regulatory status and label details can change; readers should verify the current FDA-approved label directly (via DailyMed or FDA) rather than relying on this summary for clinical decisions.
05 · Product distinctions
Names are not interchangeable
The approved drug Forzinity (elamipretide) is a specific, FDA-reviewed pharmaceutical product with its own manufacturing and delivery specifications for the Barth syndrome indication. Research-labeled SS-31 sold as lyophilized powder for laboratory use is a different, non-approved product category, and no formulation equivalence to the approved drug should be assumed.
06 · Handling and storage
Follow validated product instructions
A single water volume, refrigerator temperature or expiry window cannot be assumed for every compound and formulation. Use the exact manufacturer documentation and a validated laboratory procedure. If stability, solvent compatibility or microbiological quality is not documented, those properties remain unverified.
Refrigeration, clear appearance and bacteriostatic water do not make an unverified research product suitable for injection. This guide does not provide a mixing or administration procedure.
The existing concentration calculator checks arithmetic only. It cannot choose a safe dose or establish compatibility, sterility or shelf life.
Reign Peptide · Business disclosure
Research product listings
Jorge Abreu is involved in Reign Peptide. Links to Reign are a business connection, not an independent endorsement. Reign lists these products for laboratory research, not human consumption.
Use the listing to check the labeled identity, amount and available batch documentation. A purity result alone does not verify sterility, clinical suitability or equivalence to a medicine used in a trial.
Names and sizes are product labels, not dosing recommendations. Confirm current details with the seller.
Supplies and accessories
Compare the actual specifications
Jorge's supply directory includes syringes, alcohol pads, storage cases, travel refrigeration and electrolytes, with separate links for the two travel refrigeration options. Accessory availability is not a recommendation to administer a research compound.
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Peptide fridge case
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Peptide travel case
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View on Amazon ↗Questions still worth asking
What remains unresolved?
- Will phase 3 trials in other mitochondrial-dysfunction-related conditions confirm the benefit signal seen in the Barth syndrome program?
- How does the pharmacokinetic and safety profile of the approved formulation compare with unapproved research-grade material, a comparison not addressed in the approval literature reviewed?
Check the source
References and evidence scope
- Official label · 2025FORZINITY (elamipretide) prescribing information, NDA 215244 ↗
- Review · 2026Elamipretide: First Approval ↗
- Review · 2025Contemporary insights into elamipretide's mitochondrial mechanism of action and therapeutic effects ↗
These are the sources reviewed for this page, not an exhaustive systematic review. Related compound research is identified as such. Product links are not scientific references.
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