Kuvan(sapropterin)
Kuvan (sapropterin) is a small molecule pharmaceutical. Sapropterin was first approved as Kuvan on 2007-12-13. It is used to treat phenylketonurias in the USA. It has been approved in Europe to treat phenylketonurias. The pharmaceutical is active against phenylalanine-4-hydroxylase.
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Trade Name
FDA
EMA
Kuvan (generic drugs available since 2019-05-10)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| kuvan | New Drug Application | 2021-02-08 |
| sapropterin dihydrochloride | ANDA | 2022-11-03 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Sapropterin Dihydrochloride, Kuvan, Biomarin Pharm | |||
| 9216178 | 2032-11-01 | DP | |
| 7566462 | 2025-11-16 | DP | |
| 8003126 | 2025-11-16 | ||
| RE43797 | 2024-11-17 | U-1156, U-1590 | |
| 7566714 | 2024-11-17 | U-989, U-1589 | |
| 7612073 | 2024-11-17 | U-1010 | |
| 7727987 | 2024-11-17 | DP | |
| 8067416 | 2024-11-17 | U-989, U-1589 | |
| 8318745 | 2024-11-17 | DP | |
| 9433624 | 2024-11-17 | U-1589 | |
HCPCS
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Clinical
Clinical Trials
70 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Phenylketonurias | D010661 | E70.0 | 3 | 7 | 9 | 4 | 11 | 33 | |
| Peripheral arterial disease | D058729 | EFO_0004265 | 1 | — | — | 1 | — | 2 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Autistic disorder | D001321 | EFO_0003758 | F84.0 | — | 2 | 1 | — | — | 2 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 1 | 1 | — | — | 1 |
| Portal hypertension | D006975 | EFO_0000666 | K76.6 | — | 1 | 1 | — | — | 1 |
| Oral manifestations | D009912 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 2 | 1 | — | — | 1 | 4 |
| Hypertension | D006973 | EFO_0000537 | I10 | 2 | 1 | — | — | — | 3 |
| Intermittent claudication | D007383 | EFO_0003876 | I73.9 | 1 | 1 | — | — | — | 2 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | 1 | 2 | — | — | — | 2 |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | 1 | 1 | — | — | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | — | — | — | 1 |
| Albuminuria | D000419 | EFO_0004285 | R80.9 | — | 1 | — | — | — | 1 |
| Coronary artery disease | D003324 | I25.1 | — | 1 | — | — | — | 1 | |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | — | 1 | — | — | — | 1 |
| Chronic renal insufficiency | D051436 | N18 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart failure | D006333 | EFO_0003144 | I50 | 2 | — | — | — | 1 | 3 |
| Pulmonary arterial hypertension | D000081029 | 2 | — | — | — | — | 2 | ||
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | 1 | — | — | — | 1 | 2 |
| Aging | D000375 | GO_0007568 | R41.81 | 1 | — | — | — | — | 1 |
| Menopause | D008593 | EFO_0003922 | N95 | 1 | — | — | — | — | 1 |
| Peripheral vascular diseases | D016491 | EFO_0003875 | I73.9 | 1 | — | — | — | — | 1 |
| Heart disease risk factors | D000082742 | 1 | — | — | — | — | 1 | ||
| Vasoconstriction | D014661 | 1 | — | — | — | — | 1 | ||
| Oxidative stress | D018384 | EFO_1001905 | 1 | — | — | — | — | 1 | |
| Radiodermatitis | D011855 | L58 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Behavior and behavior mechanisms | D001520 | — | — | — | — | 1 | 1 | ||
| Autism spectrum disorder | D000067877 | F84.0 | — | — | — | — | 1 | 1 | |
| Gastroparesis | D018589 | EFO_1000948 | K31.84 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | SAPROPTERIN |
| INN | sapropterin |
| Description | Tetrahydrobiopterin (BH4, THB), also known as sapropterin (INN), is a cofactor of the three aromatic amino acid hydroxylase enzymes, used in the degradation of amino acid phenylalanine and in the biosynthesis of the neurotransmitters serotonin (5-hydroxytryptamine, 5-HT), melatonin, dopamine, norepinephrine (noradrenaline), epinephrine (adrenaline), and is a cofactor for the production of nitric oxide (NO) by the nitric oxide synthases. Chemically, its structure is that of a (dihydropteridine reductase) reduced pteridine derivative (quinonoid dihydrobiopterin).
|
| Classification | Small molecule |
| Drug class | pteridine derivatives |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | C[C@H](O)[C@H](O)[C@H]1CNc2nc(N)[nH]c(=O)c2N1 |
Identifiers
| PDB | — |
| CAS-ID | 17528-72-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201774 |
| ChEBI ID | 59560 |
| PubChem CID | 44257 |
| DrugBank | DB00360 |
| UNII ID | EGX657432I (ChemIDplus, GSRS) |
Target
Variants
Clinical Variant
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Financial
Kuvan - BioMarin Pharmaceutical
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Trends
PubMed Central
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Additional graphs summarizing 1,134 documents
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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267 adverse events reported
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