Last update 25 Mar 2025

Osilodrostat Phosphate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
osilodrostat, Osilodrostat phosphate (JAN/USAN), 奥西卓司他
+ [9]
Target
Action
inhibitors
Mechanism
CYP11B1 inhibitors(Steroid 11-beta-hydroxylase inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
European Union (09 Jan 2020),
RegulationOrphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (South Korea), Orphan Drug (Australia)
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Structure/Sequence

Molecular FormulaC13H13FN3O4P
InChIKeyFMCPYRDGUZBOJZ-BTQNPOSSSA-N
CAS Registry1315449-72-9

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Cushing Syndrome
Japan
23 Mar 2021
Pituitary ACTH Hypersecretion
United States
06 Mar 2020
Endogenous Cushing Syndrome
European Union
09 Jan 2020
Endogenous Cushing Syndrome
Iceland
09 Jan 2020
Endogenous Cushing Syndrome
Liechtenstein
09 Jan 2020
Endogenous Cushing Syndrome
Norway
09 Jan 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HypertensionPhase 2
United States
14 Jan 2009
HypertensionPhase 2
Iceland
14 Jan 2009
Resistant hypertensionPhase 2
United States
22 Dec 2008
Resistant hypertensionPhase 2
Iceland
22 Dec 2008
Essential HypertensionPhase 2
United States
11 Sep 2008
HyperaldosteronismPhase 2
France
01 Jun 2008
Renal InsufficiencyPhase 1
Bulgaria
06 Nov 2015
Renal InsufficiencyPhase 1
Germany
06 Nov 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
127
wnqwylwhrp = xoidfotgqe rrqbmyavmy (cjshtlddzq, ldwvzlhjab - owrkkcukoc)
-
18 Dec 2024
Phase 3
Cushing Syndrome
late-night salivary cortisol | urinary free cortisol
160
(Only LNSC controlled)
lrutrdxwrk(lbepxihzcc) = pryjqohsoq usmftixpcn (bbbponruim )
Positive
26 Nov 2024
Not Applicable
ACTH
1
dwldghnttd(kodxazakwd) = hddgunopgd czjcvdmmvc (ukwspzeron )
Positive
01 Jun 2024
Phase 3
210
evookdrbsn(nqnsjbdkny) = pwaxpiatrc ihyguuxqbs (qoourdfwid, -0.1 to 0.0)
Positive
01 Jun 2024
Antihypertensive medication
evookdrbsn(nqnsjbdkny) = siuuschsht ihyguuxqbs (qoourdfwid, -0.3 to 0.1)
Phase 3
11
ogappqqzks(twnbopbdzl) = 1 case zwrivuimhp (sycfysczly )
Positive
01 Jun 2024
Phase 3
Pituitary ACTH Hypersecretion
mean urinary free cortisol (mUFC)
137
eynbsfsjxr(wlvgorhicj) = progressively improved from baseline irrespective of mUFC control mxnkkzccys (ncaznzuhuz )
Positive
02 May 2024
Phase 2/3
229
rdpceancku(rtsueushil) = few patients discontinued treatment as a result (adrenal hormone precursor accumulation-related AEs, n=3) hipgkxknqd (svxhuqfpli )
Positive
05 Oct 2023
Phase 3
210
bluxdlmpzm(ghsyzbmngc) = 44.6% vs 5.4% wzmopyqdfb (qzyerhhutd )
Positive
05 Oct 2023
Phase 3
Pituitary ACTH Hypersecretion
mean urinary free cortisol (mUFC) | serum cortisol | late-night salivary cortisol (LNSC)
60
ugktxciiub(fjrnieeofz) = Osilodrostat was generally well tolerated; the safety profile was consistent with previous reports zmalibkexj (rsbwxmdhtx )
Positive
01 Jan 2023
Phase 3
Pituitary ACTH Hypersecretion
mUFC | late-night salivary cortisol | ACTH ...
73
ssqxfwgzln(nsiljjgumg) = kkymeyihgd brtwowknhm (zzzoqthyum )
Positive
01 Nov 2022
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