Isturisa(osilodrostat)
Isturisa (osilodrostat) is a small molecule pharmaceutical. Osilodrostat was first approved as Isturisa on 2020-01-09. It is used to treat cushing syndrome in the USA. It has been approved in Europe to treat cushing syndrome. It is known to target cytochrome P450 11B2, mitochondrial and cytochrome P450 11B1, mitochondrial.
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FDA Novel Drug Approvals 2020
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| endocrine system diseases | D004700 |
Trade Name
FDA
EMA
Isturisa
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Osilodrostat phosphate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ISTURISA | Recordati | N-212801 RX | 2020-03-06 | 3 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| isturisa | New Drug Application | 2020-03-19 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| cushing syndrome | EFO_0003099 | D003480 | E24 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
OSILODROSTAT PHOSPHATE, ISTURISA, RECORDATI RARE | |||
| 2027-03-06 | ODE-286 | ||
| 2025-03-06 | NCE | ||
HCPCS
No data
Clinical
Clinical Trials
14 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 |
|---|---|---|---|---|---|---|---|---|---|
| Pituitary acth hypersecretion | D047748 | EFO_1001110 | E24.0 | — | 4 | 2 | — | 1 | 7 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | — | 2 | — | — | — | 2 |
| Adrenal gland neoplasms | D000310 | EFO_0003850 | C74 | — | 1 | — | — | — | 1 |
| Essential hypertension | D000075222 | I10 | — | 1 | — | — | — | 1 | |
| Hyperaldosteronism | D006929 | HP_0011736 | E26 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | OSILODROSTAT |
| INN | osilodrostat |
| Description | Osilodrostat, sold under the brand name Isturisa, is a medication for the treatment of adults with Cushing's disease who either cannot undergo pituitary gland surgery or have undergone the surgery but still have the disease. It is taken by mouth.
|
| Classification | Small molecule |
| Drug class | enzyme inhibitors |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | N#Cc1ccc([C@H]2CCc3cncn32)c(F)c1 |
Identifiers
| PDB | — |
| CAS-ID | 928134-65-0 |
| RxCUI | 2286252 |
| ChEMBL ID | CHEMBL3099695 |
| ChEBI ID | — |
| PubChem CID | 44139752 |
| DrugBank | DB11837 |
| UNII ID | 5YL4IQ1078 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
CYP11B2
CYP11B2
CYP11B1
CYP11B1
Organism
Homo sapiens
Gene name
CYP11B2
Gene synonyms
NCBI Gene ID
Protein name
cytochrome P450 11B2, mitochondrial
Protein synonyms
ALDOS, Aldosterone synthase, Aldosterone-synthesizing enzyme, Corticosterone 18-monooxygenase, CYP11B2, CYPXIB2, Cytochrome P-450Aldo, Cytochrome P-450C18, cytochrome P450, family 11, subfamily B, polypeptide 2, cytochrome P450, subfamily XIB (steroid 11-beta-hydroxylase), polypeptide 2, mitochondrial cytochrome P450, family 11, subfamily B, polypeptide 2, Steroid 11-beta-hydroxylase, CYP11B2, steroid 11-beta-monooxygenase, steroid 11-beta/18-hydroxylase, Steroid 18-hydroxylase, steroid 18-hydroxylase, aldosterone synthase, P450C18, P450aldo
Uniprot ID
Mouse ortholog
Cyp11b2 (13072)
cytochrome P450 11B2, mitochondrial (Q64661)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 172 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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17,628 adverse events reported
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