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osilodrostat 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| enzyme inhibitors | 5384 | 928134-65-0 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Osilodrostat is a cortisol synthesis inhibitor. It inhibits 11beta-hydroxylase (CYP11B1), the enzyme responsible for the final step of cortisol biosynthesis in the adrenal gland
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 10 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Bocci G, Oprea TI, Benet LZ |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | EIF2AK3,GRK2,PDK1,PDK2,PDK4 | 5 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| March 23, 2021 | PMDA | Recordati Rare Diseases Japan K.K. | |
| March 6, 2020 | FDA | RECORDATI RARE | |
| Jan. 9, 2020 | EMA | Novartis Europharm Limited |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Sulphaemoglobinaemia | 229.15 | 65.53 | 26 | 229 | 507 | 90627685 |
| Adrenal insufficiency | 95.87 | 65.53 | 21 | 234 | 29900 | 90598292 |
| Scleroedema | 91.62 | 65.53 | 10 | 245 | 130 | 90628062 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Adrenal insufficiency | 63.48 | 58.45 | 15 | 174 | 18909 | 42602237 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Sulphaemoglobinaemia | 216.45 | 54.28 | 26 | 418 | 569 | 110588286 |
| Adrenal insufficiency | 131.62 | 54.28 | 31 | 413 | 42359 | 110546496 |
| Scleroedema | 86.22 | 54.28 | 10 | 434 | 157 | 110588698 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | H02CA02 | SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS CORTICOSTEROIDS FOR SYSTEMIC USE ANTIADRENAL PREPARATIONS Anticorticosteroids |
| FDA MoA | N0000182137 | Cytochrome P450 2D6 Inhibitors |
| FDA MoA | N0000182138 | Cytochrome P450 1A2 Inhibitors |
| FDA MoA | N0000182140 | Cytochrome P450 2C19 Inhibitors |
| FDA MoA | N0000182141 | Cytochrome P450 3A4 Inhibitors |
| FDA MoA | N0000190115 | Cytochrome P450 3A5 Inhibitors |
| FDA EPC | N0000193935 | Cortisol Synthesis Inhibitor |
| FDA MoA | N0000193936 | Cytochrome P450 11B1 Inhibitors |
| CHEBI has role | CHEBI:35674 | antihypertensive agent |
| CHEBI has role | CHEBI:231911 | renoprotective agent |
Related Drugs by ATC class:
H02CA Anticorticosteroids 2 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Hypercortisolism | indication | 47270006 | |
| Pituitary-dependent Cushing's disease | indication | 190502001 | DOID:3946 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 6.46 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 10MG BASE | ISTURISA | RECORDATI RARE | N212801 | March 6, 2020 | DISCN | TABLET | ORAL | 8609862 | Jan. 13, 2031 | CUSHINGS DISEASE |
| EQ 1MG BASE | ISTURISA | RECORDATI RARE | N212801 | March 6, 2020 | RX | TABLET | ORAL | 8609862 | Jan. 13, 2031 | TREATMENT OF ENDOGENOUS HYPERCORTISOLEMIA IN ADULTS WITH CUSHINGS SYNDROME FOR WHOM SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE |
| EQ 5MG BASE | ISTURISA | RECORDATI RARE | N212801 | March 6, 2020 | RX | TABLET | ORAL | 8609862 | Jan. 13, 2031 | TREATMENT OF ENDOGENOUS HYPERCORTISOLEMIA IN ADULTS WITH CUSHINGS SYNDROME FOR WHOM SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE |
| EQ 10MG BASE | ISTURISA | RECORDATI RARE | N212801 | March 6, 2020 | DISCN | TABLET | ORAL | 10709691 | Oct. 12, 2035 | CUSHINGS DISEASE |
| EQ 1MG BASE | ISTURISA | RECORDATI RARE | N212801 | March 6, 2020 | RX | TABLET | ORAL | 10709691 | Oct. 12, 2035 | TREATMENT OF ENDOGENOUS HYPERCORTISOLEMIA IN ADULTS WITH CUSHINGS SYNDROME FOR WHOM SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE |
| EQ 5MG BASE | ISTURISA | RECORDATI RARE | N212801 | March 6, 2020 | RX | TABLET | ORAL | 10709691 | Oct. 12, 2035 | TREATMENT OF ENDOGENOUS HYPERCORTISOLEMIA IN ADULTS WITH CUSHINGS SYNDROME FOR WHOM SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 10MG BASE | ISTURISA | RECORDATI RARE | N212801 | March 6, 2020 | DISCN | TABLET | ORAL | March 6, 2027 | INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH CUSHING’S DISEASE FOR WHOM PITUITARY SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE |
| EQ 1MG BASE | ISTURISA | RECORDATI RARE | N212801 | March 6, 2020 | RX | TABLET | ORAL | March 6, 2027 | INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH CUSHING’S DISEASE FOR WHOM PITUITARY SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE |
| EQ 5MG BASE | ISTURISA | RECORDATI RARE | N212801 | March 6, 2020 | RX | TABLET | ORAL | March 6, 2027 | INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH CUSHING’S DISEASE FOR WHOM PITUITARY SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE |
| EQ 10MG BASE | ISTURISA | RECORDATI RARE | N212801 | March 6, 2020 | DISCN | TABLET | ORAL | April 15, 2032 | TREATMENT OF ENDOGENOUS HYPERCORTISOLEMIA IN ADULTS WITH CUSHINGS SYNDROME FOR WHOM SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE, EXCLUDING PATIENTS WITH CUSHINGS DISEASE |
| EQ 1MG BASE | ISTURISA | RECORDATI RARE | N212801 | March 6, 2020 | RX | TABLET | ORAL | April 15, 2032 | TREATMENT OF ENDOGENOUS HYPERCORTISOLEMIA IN ADULTS WITH CUSHINGS SYNDROME FOR WHOM SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE, EXCLUDING PATIENTS WITH CUSHINGS DISEASE |
| EQ 5MG BASE | ISTURISA | RECORDATI RARE | N212801 | March 6, 2020 | RX | TABLET | ORAL | April 15, 2032 | TREATMENT OF ENDOGENOUS HYPERCORTISOLEMIA IN ADULTS WITH CUSHINGS SYNDROME FOR WHOM SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE, EXCLUDING PATIENTS WITH CUSHINGS DISEASE |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Cytochrome P450 11B1, mitochondrial | Enzyme | INHIBITOR | IC50 | 8.60 | DRUG LABEL | DRUG LABEL | |||
| Aromatase | Enzyme | IC50 | 6.07 | CHEMBL | |||||
| Cytochrome P450 11B2, mitochondrial | Enzyme | INHIBITOR | IC50 | 9.15 | SCIENTIFIC LITERATURE | ||||
| Cytochrome P450 11B2, mitochondrial | Enzyme | IC50 | 6.68 | CHEMBL | |||||
| Cytochrome P450 11B1, mitochondrial | Enzyme | IC50 | 6.30 | CHEMBL | |||||
| Cytochrome P450 11B2, mitochondrial | Enzyme | IC50 | 6.96 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 5YL4IQ1078 | UNII |
| 1315449-72-9 | SECONDARY_CAS_RN |
| 4039308 | VANDF |
| C4330903 | UMLSCUI |
| CHEBI:755118 | CHEBI |
| YSY | PDB_CHEM_ID |
| CHEMBL3099695 | ChEMBL_ID |
| 44139752 | PUBCHEM_CID |
| DB11837 | DRUGBANK_ID |
| CHEMBL3707393 | ChEMBL_ID |
| 9818 | INN_ID |
| C553306 | MESH_SUPPLEMENTAL_RECORD_UI |
| D11061 | KEGG_DRUG |
| 8310 | IUPHAR_LIGAND_ID |
| 863916001 | SNOMEDCT_US |
| 863938004 | SNOMEDCT_US |
| 863942001 | SNOMEDCT_US |
| 331593 | MMSL |
| 38191 | MMSL |
| d09521 | MMSL |
| 018295 | NDDF |
| 018296 | NDDF |
| 2286252 | RXNORM |
| 5YL4IQ1078 | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Isturisa | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55292-320 | TABLET, COATED | 1 mg | ORAL | NDA | 32 sections |
| Isturisa | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55292-321 | TABLET, COATED | 5 mg | ORAL | NDA | 32 sections |
| Isturisa | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55292-322 | TABLET, COATED | 10 mg | ORAL | NDA | 32 sections |
| Isturisa | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55292-330 | TABLET, COATED | 1 mg | ORAL | NDA | 32 sections |
| Isturisa | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55292-331 | TABLET, COATED | 5 mg | ORAL | NDA | 32 sections |