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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 diseasesD004700
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
ISTURISARecordatiN-212801 RX2020-03-06
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
isturisaNew Drug Application2020-03-19
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
cushing syndromeEFO_0003099D003480E24
Agency Specific
FDA
EMA
Expiration
Code
OSILODROSTAT PHOSPHATE, ISTURISA, RECORDATI RARE
2027-03-06ODE-286
2025-03-06NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Osilodrostat Phosphate, Isturisa, Recordati Rare
107096912035-10-12U-2770
101436802035-07-06DP
86098622031-01-13U-2770
94347542031-01-13DP
83140972029-03-27DS, DP
88356462026-08-23DS, DP
ATC Codes
H: Systemic hormonal preparations, excl. sex hormones and insulins
— H02: Corticosteroids for systemic use
— H02C: Antiadrenal preparations
— H02CA: Anticorticosteroids
— H02CA02: Osilodrostat
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 hypersecretionD047748EFO_1001110E24.0—42—17
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I10—2———2
Adrenal gland neoplasmsD000310EFO_0003850C74—1———1
Essential hypertensionD000075222I10—1———1
HyperaldosteronismD006929HP_0011736E26—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Renal insufficiencyD051437HP_0000083N191————1
Hepatic insufficiencyD0485501————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameOSILODROSTAT
INNosilodrostat
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 classenzyme inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
N#Cc1ccc([C@H]2CCc3cncn32)c(F)c1
Identifiers
PDB—
CAS-ID928134-65-0
RxCUI2286252
ChEMBL IDCHEMBL3099695
ChEBI ID—
PubChem CID44139752
DrugBankDB11837
UNII ID5YL4IQ1078 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
CYP11B2
CYP11B2
CYP11B1
CYP11B1
Organism
Homo sapiens
Gene name
CYP11B2
Gene synonyms
NCBI Gene ID
1585
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
Q16726
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
Mock data
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17,628 adverse events reported
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