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sapropterin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| pteridine derivatives | 2612 | 62989-33-7 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Hosey CM, Chan R, Benet LZ |
| S (Water solubility) | 2 mg/mL | Bocci G, Oprea TI, Benet LZ |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2A,ACVR2B,AXL,BRAF,CAMK2D,CDK5,CDK9,DYRK1B,EIF2AK3,ERBB2,GRK2,ITK,MAP3K21,MAPK7,NTRK2,PDK1,PDK2,PRKDC,TEK | 19 | |||
| kinase-selectivity-class | AXL,GRK2,MAP2K6,MAP3K14,MAP3K21,MAPK7,TEK | 7 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 2, 2008 | EMA | ||
| Dec. 13, 2007 | FDA | BIOMARIN PHARM |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Amino acid level increased | 368.43 | 41.15 | 47 | 1328 | 410 | 90626662 |
| Maternal exposure during pregnancy | 190.64 | 41.15 | 97 | 1278 | 359966 | 90267106 |
| Abortion spontaneous | 71.95 | 41.15 | 28 | 1347 | 54028 | 90573044 |
| Product prescribing error | 67.75 | 41.15 | 23 | 1352 | 30122 | 90596950 |
| Amino acid level decreased | 61.61 | 41.15 | 8 | 1367 | 80 | 90626992 |
| Anxiety | 42.36 | 41.15 | 36 | 1339 | 309736 | 90317336 |
| Psychomotor hyperactivity | 41.89 | 41.15 | 13 | 1362 | 12800 | 90614272 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Amino acid level increased | 186.32 | 45.13 | 27 | 818 | 486 | 42620004 |
| Product prescribing error | 61.28 | 45.13 | 22 | 823 | 26090 | 42594400 |
| Amino acid level decreased | 54.03 | 45.13 | 8 | 837 | 166 | 42620324 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Amino acid level increased | 140.80 | 41.18 | 21 | 1242 | 815 | 110587221 |
| Maternal exposure during pregnancy | 119.67 | 41.18 | 58 | 1205 | 254825 | 110333211 |
| Product prescribing error | 73.44 | 41.18 | 26 | 1237 | 51305 | 110536731 |
| Abortion spontaneous | 63.19 | 41.18 | 21 | 1242 | 34261 | 110553775 |
| Product dose omission issue | 54.92 | 41.18 | 38 | 1225 | 321744 | 110266292 |
| Amino acid level decreased | 48.38 | 41.18 | 6 | 1257 | 55 | 110587981 |
| Overdose | 43.12 | 41.18 | 29 | 1234 | 233765 | 110354271 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | A16AX07 | ALIMENTARY TRACT AND METABOLISM OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS Various alimentary tract and metabolism products |
| FDA MoA | N0000185503 | P-Glycoprotein Inhibitors |
| FDA MoA | N0000190113 | Breast Cancer Resistance Protein Inhibitors |
| FDA MoA | N0000190482 | Phenylalanine Hydroxylase Activators |
| FDA EPC | N0000190483 | Phenylalanine Hydroxylase Activator |
| CHEBI has role | CHEBI:23354 | coenzyme |
| CHEBI has role | CHEBI:33295 | diagnostic agent |
| CHEBI has role | CHEBI:35476 | antipsychotic agent |
| CHEBI has role | CHEBI:35554 | cardiovascular drug |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:35674 | antihypertensive agent |
| CHEBI has role | CHEBI:75835 | anti-anaemic agent |
| CHEBI has role | CHEBI:23357 | cofactor |
| CHEBI has role | CHEBI:50177 | dermatologic drug |
| CHEBI has role | CHEBI:62868 | hepatoprotective agent |
| CHEBI has role | CHEBI:77746 | human metabolite |
| CHEBI has role | CHEBI:231911 | renoprotective agent |
Related Drugs by ATC class:
A16AX Various alimentary tract and metabolism products 23 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Classical phenylketonuria | indication | 7573000 | |
| Tetrahydrobiopterin deficiency | indication | 68724006 | |
| Neutropenic disorder | contraindication | 303011007 | DOID:1227 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 11.23 | acidic |
| pKa2 | 5.42 | Basic |
Orange Book patent data (new drug applications)
None
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Phenylalanine-4-hydroxylase | Enzyme | ACTIVATOR | Ki | 5.40 | IUPHAR | CHEMBL | |||
| Nitric oxide synthase, brain | Enzyme | Kd | 5.95 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4027166 | VUID |
| N0000176128 | NUI |
| D01798 | KEGG_DRUG |
| 69056-38-8 | SECONDARY_CAS_RN |
| 4027166 | VANDF |
| 4027167 | VANDF |
| C0048897 | UMLSCUI |
| CHEBI:59560 | CHEBI |
| THB | PDB_CHEM_ID |
| CHEMBL1201774 | ChEMBL_ID |
| CHEMBL1201775 | ChEMBL_ID |
| DB00360 | DRUGBANK_ID |
| C003402 | MESH_SUPPLEMENTAL_RECORD_UI |
| 5276 | IUPHAR_LIGAND_ID |
| 6553 | INN_ID |
| EGX657432I | UNII |
| 135398654 | PUBCHEM_CID |
| 751628 | RXNORM |
| 129793 | MMSL |
| 24913 | MMSL |
| 339312 | MMSL |
| d07068 | MMSL |
| 007099 | NDDF |
| 012473 | NDDF |
| 012474 | NDDF |
| 432857000 | SNOMEDCT_US |
| 432859002 | SNOMEDCT_US |
| 434239009 | SNOMEDCT_US |
| EGX657432I | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| sapropterin dihydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0054-0906 | TABLET | 100 mg | ORAL | ANDA | 29 sections |
| sapropterin dihydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 31722-045 | TABLET | 100 mg | ORAL | ANDA | 25 sections |
| Sapropterin dihydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 31722-047 | POWDER, FOR SOLUTION | 100 mg | ORAL | ANDA | 26 sections |
| Sapropterin dihydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 31722-048 | POWDER, FOR SOLUTION | 500 mg | ORAL | ANDA | 26 sections |
| Sapropterin Dihydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42571-509 | POWDER, FOR SOLUTION | 100 mg | ORAL | ANDA | 25 sections |
| Sapropterin Dihydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42571-510 | POWDER, FOR SOLUTION | 500 mg | ORAL | ANDA | 25 sections |
| JAVYGTOR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-096 | TABLET | 100 mg | ORAL | ANDA | 25 sections |
| JAVYGTOR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-097 | POWDER, FOR SOLUTION | 100 mg | ORAL | ANDA | 25 sections |
| JAVYGTOR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-162 | POWDER, FOR SOLUTION | 500 mg | ORAL | ANDA | 25 sections |
| sapropterin dihydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 49884-720 | TABLET | 100 mg | ORAL | ANDA | 22 sections |
| SAPROPTERIN DIHYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 49884-873 | POWDER, FOR SOLUTION | 500 mg | ORAL | ANDA | 26 sections |
| SAPROPTERIN DIHYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 49884-948 | POWDER, FOR SOLUTION | 100 mg | ORAL | ANDA | 27 sections |
| Sapropterin Dihydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52817-850 | POWDER, FOR SOLUTION | 100 mg | ORAL | ANDA | 19 sections |
| Sapropterin Dihydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52817-851 | POWDER, FOR SOLUTION | 500 mg | ORAL | ANDA | 19 sections |
| Sapropterin Dihydrochloride | Human Prescription Drug Label | 1 | 59651-574 | TABLET | 100 mg | ORAL | ANDA | 26 sections |
| Kuvan | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68135-300 | TABLET | 100 mg | ORAL | NDA | 27 sections |
| Kuvan | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68135-301 | POWDER, FOR SOLUTION | 100 mg | ORAL | NDA | 27 sections |
| Kuvan | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68135-482 | POWDER, FOR SOLUTION | 500 mg | ORAL | NDA | 27 sections |
| sapropterin dihydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72603-191 | TABLET | 100 mg | ORAL | ANDA | 25 sections |
| Sapropterin dihydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72603-193 | POWDER, FOR SOLUTION | 100 mg | ORAL | ANDA | 26 sections |
| Sapropterin dihydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72603-194 | POWDER, FOR SOLUTION | 500 mg | ORAL | ANDA | 26 sections |
| ZELVYSIA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73289-0070 | POWDER, FOR SOLUTION | 100 mg | ORAL | ANDA | 27 sections |
| ZELVYSIA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73289-0071 | POWDER, FOR SOLUTION | 500 mg | ORAL | ANDA | 27 sections |