Istradefylline
Nourianz (istradefylline) is a small molecule pharmaceutical. Istradefylline was first approved as Nourianz on 2019-08-27. It is used to treat parkinson disease in the USA. It is known to target adenosine receptor A2a, adenosine receptor A1, adenosine receptor A2b, and adenosine receptor A3.
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FDA Novel Drug Approvals 2019
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
Trade Name
FDA
EMA
Nourianz
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Istradefylline
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| NOURIANZ | Kyowa Kirin | N-022075 RX | 2019-08-27 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| nourianz | New Drug Application | 2020-11-02 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| parkinson disease | EFO_0002508 | D010300 | G20 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ISTRADEFYLLINE, NOURIANZ, KYOWA KIRIN | |||
| 2024-08-27 | NCE | ||
HCPCS
No data
Clinical
Clinical Trials
27 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Parkinson disease | D010300 | EFO_0002508 | G20 | 1 | 9 | 11 | — | 1 | 21 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Restless legs syndrome | D012148 | EFO_0004270 | G25.81 | — | 1 | — | — | — | 1 |
| Sleep wake disorders | D012893 | G47 | — | 1 | — | — | — | 1 | |
| Movement disorders | D009069 | EFO_0004280 | G25 | — | 1 | — | — | — | 1 |
| Spinal cord injuries | D013119 | EFO_1001919 | 1 | 1 | — | — | — | 1 | |
| Spinal cord diseases | D013118 | HP_0002196 | G95.9 | 1 | 1 | — | — | — | 1 |
| Cognitive dysfunction | D060825 | G31.84 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Apathy | D057565 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | ISTRADEFYLLINE |
| INN | istradefylline |
| Description | Istradefylline is an oxopurine. |
| Classification | Small molecule |
| Drug class | theophylline derivatives |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CCn1c(=O)c2c(nc(/C=C/c3ccc(OC)c(OC)c3)n2C)n(CC)c1=O |
Identifiers
| PDB | 8GNG |
| CAS-ID | 155270-99-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL431770 |
| ChEBI ID | — |
| PubChem CID | 5311037 |
| DrugBank | DB11757 |
| UNII ID | 2GZ0LIK7T4 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
0 adverse events reported
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