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Nulibry(fosdenopterin)
Nulibry (fosdenopterin) is a small molecule pharmaceutical. Fosdenopterin was first approved as Nulibry on 2021-02-26. It has been approved in Europe to treat inborn errors metal metabolism.
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FDA Novel Drug Approvals 2021
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
hereditary congenital and neonatal diseases and abnormalitiesD009358
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Nulibry
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fosdenopterin hydrobromide
Tradename
Company
Number
Date
Products
NULIBRYSentynl TherapeuticsN-214018 RX2021-02-26
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
nulibryNew Drug Application2022-10-28
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
FOSDENOPTERIN HYDROBROMIDE, NULIBRY, SENTYNL THERAPS INC
2028-02-26ODE-342
2026-02-26NCE
2025-10-27M-286
Patent Expiration
Patent
Expires
Flag
FDA Information
Fosdenopterin Hydrobromide, Nulibry, Sentynl Theraps Inc
75040952025-01-31DPU-3092
ATC Codes
A: Alimentary tract and metabolism drugs
— A16: Other alimentary tract and metabolism products in atc
— A16A: Other alimentary tract and metabolism products in atc
— A16AX: Various alimentary tract and metabolism products
— A16AX19: Fosdenopterin
HCPCS
No data
Clinical
Clinical Trials
5 clinical trials
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Mock data
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Charcot-marie-tooth diseaseD002607G60.0—11——1
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hemophilia bD002836D671————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Developmental disabilitiesD002658EFO_0003852F89————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFOSDENOPTERIN
INNfosdenopterin
Description
Fosdenopterin (or cyclic pyranopterin monophosphate, cPMP), sold under the brand name Nulibry, is a medication used to reduce the risk of death due to a rare genetic disease known as molybdenum cofactor deficiency type A (MoCD-A).
Classification
Small molecule
Drug classphosphoro-derivatives; pteridine derivatives
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Nc1nc(=O)c2c([nH]1)N[C@@H]1O[C@@H]3COP(=O)(O)O[C@@H]3C(O)(O)[C@@H]1N2
Identifiers
PDB—
CAS-ID150829-29-1
RxCUI—
ChEMBL IDCHEMBL2338675
ChEBI ID60210
PubChem CID135463437
DrugBankDB16628
UNII ID4X7K2681Y7 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 16 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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1,219 adverse events reported
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