Kuvan(sapropterin)
Kuvan, Sapropterin (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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Commercial
Therapeutic Areas
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)
Sapropterin dihydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| KUVAN | BioMarin Pharmaceutical | N-022181 RX | 2007-12-13 | 1 products, RLD, RS |
| KUVAN | BioMarin Pharmaceutical | N-205065 RX | 2013-12-19 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| javygtor | ANDA | 2024-04-30 |
| kuvan | New Drug Application | 2024-08-26 |
| sapropterin dihydrochloride | ANDA | 2024-08-23 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| phenylketonurias | — | D010661 | E70.0 |
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
No data
Clinical
Clinical Trials
87 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 | 4 | 8 | 9 | 5 | 20 | 44 |
| Peripheral arterial disease | D058729 | EFO_0004265 | — | 1 | 1 | — | 1 | — | 3 |
| Peripheral vascular diseases | D016491 | EFO_0003875 | I73.9 | 1 | 1 | — | 1 | — | 3 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | 3 | 3 | 1 | — | — | 6 |
| Fibrosis | D005355 | — | — | — | 2 | 1 | — | — | 2 |
| Autistic disorder | D001321 | HP_0000717 | 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 |
| Lesch-nyhan syndrome | D007926 | Orphanet_510 | E79.1 | — | 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 |
| Obstructive lung diseases | D008173 | HP_0006536 | — | 1 | 1 | — | — | 1 | 3 |
| Chronic renal insufficiency | D051436 | — | N18 | — | 2 | — | — | — | 2 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 2 | — | — | — | 2 |
| Intermittent claudication | D007383 | EFO_0003876 | I73.9 | 1 | 1 | — | — | — | 2 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | 2 | — | — | — | 2 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | — | 1 | — | — | 1 | 2 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | 1 | 2 | — | — | — | 2 |
| Psychotic disorders | D011618 | — | F20.81 | 1 | 2 | — | — | — | 2 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34.0 | 1 | 1 | — | — | — | 1 |
Show 22 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart failure | D006333 | HP_0001635 | I50 | 2 | — | — | — | 1 | 3 |
| Pulmonary arterial hypertension | D000081029 | — | — | 2 | — | — | — | — | 2 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | 1 | — | — | — | 1 | 2 |
| Aging | D000375 | GO_0007568 | R41.81 | 1 | — | — | — | — | 1 |
| Menopause | D008593 | EFO_0003922 | N95 | 1 | — | — | — | — | 1 |
| Vascular diseases | D014652 | EFO_0004264 | I77 | 1 | — | — | — | — | 1 |
| Familial primary pulmonary hypertension | D065627 | — | I27.0 | 1 | — | — | — | — | 1 |
| Heart disease risk factors | D000082742 | — | — | 1 | — | — | — | — | 1 |
| Vasoconstriction | D014661 | — | — | 1 | — | — | — | — | 1 |
| Oxidative stress | D018384 | EFO_1001905 | — | 1 | — | — | — | — | 1 |
Show 8 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | — | — | — | — | 2 | 2 |
| Eclampsia | D004461 | HP_0100601 | O15 | — | — | — | — | 2 | 2 |
| Behavior and behavior mechanisms | D001520 | — | — | — | — | — | — | 1 | 1 |
| Developmental disabilities | D002658 | EFO_0003852 | F89 | — | — | — | — | 1 | 1 |
| Autism spectrum disorder | D000067877 | HP_0000729 | F84.0 | — | — | — | — | 1 | 1 |
| Gastroparesis | D018589 | EFO_1000948 | K31.84 | — | — | — | — | 1 | 1 |
| Essential hypertension | D000075222 | — | I10 | — | — | — | — | 1 | 1 |
| Healthy volunteers/patients | — | — | — | — | — | — | — | 1 | 1 |
| Acute kidney injury | D058186 | HP_0001919 | N17 | — | — | — | — | 1 | 1 |
| Pregnancy complications | D011248 | — | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Sapropterin |
| INN | sapropterin |
| Description | Sapropterin is a tetrahydropterin that is 2-amino-5,6,7,8-tetrahydropteridin-4(3H)-one in which a hydrogen at position 6 is substituted by a 1,2-dihydroxypropyl group (6R,1'R,2'S-enantiomer). It has a role as a coenzyme, a diagnostic agent, a human metabolite and a cofactor. |
| 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 | 135398654 |
| DrugBank | DB00360 |
| UNII ID | EGX657432I (ChemIDplus, GSRS) |
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Kuvan – BioMarin Pharmaceutical
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Trends
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Safety
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Adverse Events
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5,663 adverse events reported
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