Molecule
Fosdenopterin is a cyclic pyranopterin monophosphate. It is available as powder for injection for intravenous use. MedsAcross supplies Fosdenopterin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
NULIBRY is indicated to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A. NULIBRY is cyclic pyranopterin monophosphate (cPMP) indicated to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A.
Source: US FDA prescribing information
Patients with MoCD Type A have mutations in the MOCS1 gene leading to deficient MOCS1A/B dependent synthesis of the intermediate substrate, cPMP. Substrate replacement therapy with NULIBRY provides an exogenous source of cPMP, which is converted to molybdopterin. Molybdopterin is then converted to molybdenum cofactor, which is needed for the activation of molybdenum-dependent enzymes, including sulfite oxidase (SOX), an enzyme that reduces levels of neurotoxic sulfites.
Source: US FDA prescribing information
Start NULIBRY if known or presumed MoCD Type A. Promptly discontinue if MoCD Type A is not confirmed by genetic testing. NULIBRY is intended for administration by a healthcare provider. If deemed appropriate by a healthcare provider, NULIBRY may be administered at home by the patient's caregiver. See the table below for the recommended dosage in patients less than one year of age. Administer NULIBRY by intravenous infusion once daily. For dose volumes less than 2 mL, consider administering by slow intravenous push.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Potential for Photosensitivity: Advise patients/caregivers to avoid patient exposure to sunlight, and to have the patient wear sunscreen, protective clothing, and sunglasses when exposed to the sun. If photosensitivity occurs, advise caregivers/patients to seek medical attention immediately and consider a dermatological evaluation.
Source: US FDA prescribing information
The most common adverse reactions (>25%) were catheter-related complications, pyrexia, viral infection, pneumonia, otitis media, vomiting, cough/sneezing, viral upper respiratory infection, gastroenteritis, bacteremia, and diarrhea.
Source: US FDA prescribing information
Store NULIBRY frozen between -25°C and -10°C (-13°F and 14°F). Store vial in original carton to protect from light. For storage recommendations for the reconstituted solution.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Fosdenopterin, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Nulibry 9.5 mg powder for injectionIntravenous Cold chain | Sentynl Therapeutics | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Fosdenopterin and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Fosdenopterin, including Nulibry.
Yes. The US FDA first approved Fosdenopterin on 26 February 2021, according to Drugs@FDA.
Yes. Fosdenopterin has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Fosdenopterin must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Fosdenopterin is classified under ATC code A16AX19 (Fosdenopterin).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.