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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Commercial
Therapeutic Areas
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 |
|---|---|---|---|---|
| NULIBRY | Sentynl Therapeutics | N-214018 RX | 2021-02-26 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| nulibry | New Drug Application | 2022-10-28 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
FOSDENOPTERIN HYDROBROMIDE, NULIBRY, SENTYNL THERAPS INC | |||
| 2028-02-26 | ODE-342 | ||
| 2026-02-26 | NCE | ||
| 2025-10-27 | M-286 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Fosdenopterin Hydrobromide, Nulibry, Sentynl Theraps Inc | |||
| 7504095 | 2025-01-31 | DP | U-3092 |
HCPCS
No data
Clinical
Clinical Trials
22 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Inborn errors metal metabolism | D008664 | — | — | 1 | 3 | 1 | — | 1 | 4 |
| Pseudomyxoma peritonei | D011553 | EFO_0007456 | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neuralgia | D009437 | EFO_0009430 | — | — | 4 | — | — | — | 4 |
| Diabetic neuropathies | D003929 | EFO_1000783 | — | — | 4 | — | — | — | 4 |
| Low back pain | D017116 | — | M54.5 | — | 4 | — | — | — | 4 |
| Back pain | D001416 | — | M54 | — | 4 | — | — | — | 4 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | 4 | — | — | — | 4 |
| Chronic pain | D059350 | — | — | — | 1 | — | — | 1 | 2 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hemophilia b | D002836 | — | D67 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics | D010599 | — | — | — | — | — | — | 1 | 1 |
| Developmental disabilities | D002658 | EFO_0003852 | F89 | — | — | — | — | 1 | 1 |
| Musculoskeletal pain | D059352 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Fosdenopterin |
| INN | fosdenopterin |
| 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 class | phosphoro-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-ID | 150829-29-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2338675 |
| ChEBI ID | 60210 |
| PubChem CID | 135894389 |
| DrugBank | DB16628 |
| UNII ID | 4X7K2681Y7 (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Trends
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Safety
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Adverse Events
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