Fosdenopterin 9.5 mg Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 9.5 mg

Reference Brands: Nulibry (USA/EU)

Category: Critical Care

Fosdenopterin is a Critical Care product available as Injection in strengths 9.5 mg. It corresponds to the reference brand Nulibry (USA/EU). Verified GMP manufacturers and suppliers on PharmaTradz offer it in bulk for import worldwide, with regulatory documentation and dossier support available on request.

Product Description:

Fosdenopterin, also known as cyclic pyranopterin monophosphate (cPMP) and marketed under the brand name Nulibry, is a first-in-class therapy for patients with molybdenum cofactor deficiency (MoCD) type A, a rare and life-threatening genetic metabolic disorder. In MoCD type A, a deficiency in the MOCS1 gene leads to insufficient production of the molybdenum cofactor, resulting in the accumulation of toxic sulfite metabolites that cause severe neurological damage early in life. Fosdenopterin acts as a synthetic replacement for cPMP, restoring the activity of critical molybdenum-dependent enzymes such as sulfite oxidase, xanthine dehydrogenase, and aldehyde oxidase. By replenishing cPMP, fosdenopterin helps normalize metabolic pathways, reduce toxic metabolite accumulation, and improve survival outcomes.

The drug is supplied as a lyophilized powder for intravenous injection, typically in 9.5 mg single-dose vials, and is administered once daily according to patient body weight. Fosdenopterin requires careful clinical supervision, and common side effects may include infusion-related reactions, fever, vomiting, diarrhea, gastroenteritis, and respiratory infections. Approved in the USA in 2021 and in the EU in 2022, fosdenopterin represents the first therapy specifically targeting MoCD type A, offering a life-saving option for affected patients.