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, Sapropterin
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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