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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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
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| endocrine system diseases | D004700 |
Trade Name
FDA
EMA
Isturisa (discontinued: Isturisa)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| isturisa | New Drug Application | 2023-11-03 |
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
16 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cushing syndrome | D003480 | EFO_0003099 | E24 | — | 2 | — | 1 | 3 | 6 |
| Syndrome | D013577 | — | — | — | 2 | — | 1 | 2 | 5 |
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 |
| Acth-secreting pituitary adenoma | D049913 | — | — | — | 2 | 2 | — | — | 4 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | — | 3 | — | — | — | 3 |
| Adrenocortical carcinoma | D018268 | — | — | — | 1 | — | — | — | 1 |
| Adenoma | D000236 | — | — | — | 1 | — | — | — | 1 |
| Adrenocortical adenoma | D018246 | — | — | — | 1 | — | — | — | 1 |
| Adrenal gland neoplasms | D000310 | EFO_0003850 | C74 | — | 1 | — | — | — | 1 |
| Ectopic acth syndrome | D000182 | EFO_1001256 | E24.3 | — | 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 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Adrenal insufficiency | D000309 | — | — | — | — | — | — | 1 | 1 |
| Adrenocortical hyperfunction | D000308 | EFO_1000797 | — | — | — | — | — | 1 | 1 |
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 | 1304733-26-3 |
| RxCUI | — |
| 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
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 348 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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996 adverse events reported
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