Elamipretide Hydrochloride 80 mg/mL Suppliers & Bulk Manufacturers
Available Forms: Injection
Available Strengths: 80 mg/mL
Reference Brands: Forzinity (USA)
Category: Critical Care
Elamipretide Hydrochloride is a Critical Care product available as Injection in strengths 80 mg/mL. It corresponds to the reference brand Forzinity (USA). Verified GMP manufacturers and suppliers on PharmaTradz offer it in bulk for import worldwide, with regulatory documentation and dossier support available on request.
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Product Description:
Elamipretide, also known by its development codes SS-31 and MTP-131, and marketed under the brand name Forzinity, is a mitochondria-targeting therapeutic peptide used for the treatment of Barth syndrome. It is administered as a hydrochloride salt via subcutaneous injection and is indicated to improve muscle strength in patients with Barth syndrome weighing at least 30 kilograms (66 lb).
Elamipretide works by selectively binding to cardiolipin, a phospholipid located in the inner mitochondrial membrane, stabilizing mitochondrial structure and improving bioenergetic function. By enhancing mitochondrial efficiency and reducing oxidative stress, elamipretide helps patients with Barth syndrome gain better skeletal muscle performance, improved stamina, and overall physical function.
Barth syndrome is a rare, serious, and life-threatening mitochondrial disorder that primarily affects males. It often presents with severe heart failure in infancy and can lead to premature death. Survivors into adolescence and adulthood frequently experience fatigue, poor stamina, and exercise intolerance, significantly affecting their quality of life and daily functioning.
How Elamipretide Hydrochloride is supplied today, and licensing ahead of patent expiry
Where elamipretide is approved
Checked 3 Oct 2026| Market | Status | Brand · regulator · date |
|---|---|---|
| United States | Approved | Forzinity · FDA · Sep 2025 (accelerated) |
| Generic / biosimilar | None | None approved as of the check date |
Not approved in your country? A hospital or doctor can often still import it for a named patient, through a special-access, import-permit or compassionate-use route. We confirm which route applies in your country and the documents needed before quoting. Ask about named-patient supply →
Frequently Asked Questions
Elamipretide hydrochloride is used to treat Barth syndrome by improving mitochondrial function, physical performance, and skeletal and cardiac muscle strength in affected patients.
Elamipretide hydrochloride is a synthetic peptide designed to selectively target mitochondria and bind cardiolipin, enhancing mitochondrial structure and bioenergetic function.
The trade name of elamipretide hydrochloride is Forzinity.
Elamipretide hydrochloride (Forzinity) is manufactured by Stealth BioTherapeutics in the USA.
The generic name is elamipretide hydrochloride.
The brand name is Forzinity.
Elamipretide hydrochloride is manufactured in the USA by GMP-compliant facilities for specialized use in rare disease treatment programs.
Forzinity (Elamipretide) is developed and sold by Stealth BioTherapeutics. PharmaTradz handles enquiries for authorised supply of the originator product, named-patient import where it is not registered, and licensing or development work ahead of patent expiry.
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