fosdenopterin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| insecticides, anthelminthics, pesticides etc., phosphorous derivatives | 5444 | 150829-29-1 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Fosdenopterin provides an exogenous source of cPMP. cPMP is converted to molybdopterin, which is then converted to molybdenum cofactor (MoCo) and restores molybdenum cofactor biosynthesis. In MOCD Type A, mutations in MOCS1 lead to deficient MOCS1A/B-dependent synthesis of cPMP, which subsequently results in deficient molybdenum-dependent enzyme activity (e.g., sulfite oxidase).
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Sept. 15, 2022 | EMA | COMHARSA LIFE SCIENCES LTD | |
| Feb. 26, 2021 | FDA | ORIGIN |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | A16AX19 | ALIMENTARY TRACT AND METABOLISM OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS Various alimentary tract and metabolism products |
| FDA EPC | N0000193919 | Cyclic Pyranopterin Monophosphate |
| FDA EXT | N0000193920 | Cyclic Pyranopterin Monophosphate |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Molybdenum cofactor deficiency type A | indication | 29692004 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 9.5MG BASE/VIAL | NULIBRY | SENTYNL THERAPS INC | N214018 | Feb. 26, 2021 | RX | POWDER | INTRAVENOUS | 7504095 | Jan. 31, 2025 | METHOD OF TREATING MOLYBDENUM COFACTOR DEFICIENCY TYPE A |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 9.5MG BASE/VIAL | NULIBRY | SENTYNL THERAPS INC | N214018 | Feb. 26, 2021 | RX | POWDER | INTRAVENOUS | Oct. 27, 2025 | INFORMATION ADDED TO CLINICAL PHARMACOLOGY SECTION TO INCLUDE RESULTS FROM STUDY ORGN001-102 |
| EQ 9.5MG BASE/VIAL | NULIBRY | SENTYNL THERAPS INC | N214018 | Feb. 26, 2021 | RX | POWDER | INTRAVENOUS | Feb. 26, 2026 | NEW CHEMICAL ENTITY |
| EQ 9.5MG BASE/VIAL | NULIBRY | SENTYNL THERAPS INC | N214018 | Feb. 26, 2021 | RX | POWDER | INTRAVENOUS | Feb. 26, 2028 | INDICATED TO REDUCE THE RISK OF MORTALITY IN PATIENTS WITH MOLYBDENUM COFACTOR DEFICIENCY (MOCD) TYPE A |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Molybdenum cofactor biosynthesis protein 1 | Enzyme | UNKNOWN | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| D11779 | KEGG_DRUG |
| 4X7K2681Y7 | UNII |
| 2301083-34-9 | SECONDARY_CAS_RN |
| C2934004 | UMLSCUI |
| CHEMBL2338675 | ChEMBL_ID |
| 135463437 | PUBCHEM_CID |
| DB16628 | DRUGBANK_ID |
| CHEMBL4594300 | ChEMBL_ID |
| 018652 | NDDF |
| 018656 | NDDF |
| 1149378000 | SNOMEDCT_US |
| 1153617008 | SNOMEDCT_US |
| 1179070005 | SNOMEDCT_US |
| 4040183 | VANDF |
| 2531287 | RXNORM |
| 343975 | MMSL |
| 39338 | MMSL |
| d09717 | MMSL |
| C549445 | MESH_SUPPLEMENTAL_RECORD_UI |
| 11150 | INN_ID |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Nulibry | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42358-295 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 9.50 mg | INTRAVENOUS | NDA | 27 sections |
| Nulibry | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73129-001 | INJECTION, POWDER, FOR SOLUTION | 9.50 mg | INTRAVENOUS | NDA | 27 sections |
| Nulibry | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73129-001 | INJECTION, POWDER, FOR SOLUTION | 9.50 mg | INTRAVENOUS | NDA | 27 sections |