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.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Kuvan, Sapropterin, Zelvysia
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 | 2024-10-22 |
| kuvan | New Drug Application | 2024-08-26 |
| sapropterin dihydrochloride | ANDA | 2025-06-10 |
| zelvysia | ANDA | 2025-04-30 |
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
91 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
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 | 4 | 1 | — | — | 7 |
| Fibrosis | D005355 | — | — | — | 2 | 1 | — | — | 2 |
| Autistic disorder | D001321 | EFO_0003758 | F84.0 | — | 2 | 1 | — | — | 2 |
| Traumatic brain injuries | D000070642 | — | S06 | — | 1 | 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 |
| 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 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | 1 | 2 | — | — | — | 2 |
| Psychotic disorders | D011618 | — | F20.81 | 1 | 2 | — | — | — | 2 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | 1 | 1 | — | — | — | 1 |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | 1 | 1 | — | — | — | 1 |
| Rheumatic diseases | D012216 | — | M79.0 | 1 | 1 | — | — | — | 1 |
| Diffuse scleroderma | D045743 | EFO_0000404 | — | 1 | 1 | — | — | — | 1 |
Show 20 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart failure | D006333 | EFO_0003144 | I50 | 3 | — | — | — | 1 | 4 |
| Pulmonary arterial hypertension | D000081029 | — | — | 2 | — | — | — | — | 2 |
| Familial primary pulmonary hypertension | D065627 | — | I27.0 | 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 |
| Heart disease risk factors | D000082742 | — | — | 1 | — | — | — | — | 1 |
| Vasoconstriction | D014661 | — | — | 1 | — | — | — | — | 1 |
| Oxidative stress | D018384 | EFO_1001905 | — | 1 | — | — | — | — | 1 |
| Dermatitis | D003872 | — | L30.9 | 1 | — | — | — | — | 1 |
Show 9 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 |
| Behavior and behavior mechanisms | D001520 | — | — | — | — | — | — | 1 | 1 |
| Developmental disabilities | D002658 | EFO_0003852 | F89 | — | — | — | — | 1 | 1 |
| Autism spectrum disorder | D000067877 | — | F84.0 | — | — | — | — | 1 | 1 |
| Gastroparesis | D018589 | EFO_1000948 | K31.84 | — | — | — | — | 1 | 1 |
| Essential hypertension | D000075222 | — | I10 | — | — | — | — | 1 | 1 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | — | — | — | 1 | 1 |
| Obstructive lung diseases | D008173 | — | — | — | — | — | — | 1 | 1 |
| Healthy volunteers/patients | — | — | — | — | — | — | — | 1 | 1 |
| Acute kidney injury | D058186 | — | N17 | — | — | — | — | 1 | 1 |
Show 6 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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) |
Target
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Kuvan – BioMarin Pharmaceutical
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 17,549 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
5,572 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use