Last update 04 Nov 2024

Osilodrostat Phosphate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
osilodrostat, Osilodrostat phosphate (JAN/USAN), 奥西卓司他
+ [7]
Target
Mechanism
CYP11B1 inhibitors(Steroid 11-beta-hydroxylase inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
EU (09 Jan 2020),
RegulationOrphan Drug (US), Orphan Drug (AU), Priority Review (CN), Orphan Drug (EU)
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Structure

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
JP
23 Mar 2021
Pituitary ACTH Hypersecretion
US
06 Mar 2020
Endogenous Cushing Syndrome
EU
09 Jan 2020
Endogenous Cushing Syndrome
IS
09 Jan 2020
Endogenous Cushing Syndrome
LI
09 Jan 2020
Endogenous Cushing Syndrome
NO
09 Jan 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HypertensionPhase 2
US
14 Jan 2009
HypertensionPhase 2
IS
14 Jan 2009
Resistant hypertensionPhase 2
US
22 Dec 2008
Resistant hypertensionPhase 2
IS
22 Dec 2008
Essential HypertensionPhase 2
US
11 Sep 2008
HyperaldosteronismPhase 2
FR
01 Jun 2008
Renal InsufficiencyPhase 1
BG
06 Nov 2015
Renal InsufficiencyPhase 1
DE
06 Nov 2015
liver function failurePhase 1
US
21 Apr 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Pituitary ACTH Hypersecretion
mean urinary free cortisol (mUFC)
137
omebdvpjol(ygjrjegfqd) = progressively improved from baseline irrespective of mUFC control ymzuukvuiw (evwtpiltmi )
Positive
02 May 2024
Phase 3
Pituitary ACTH Hypersecretion
mean urinary free cortisol (mUFC) | serum cortisol | late-night salivary cortisol (LNSC)
60
inbfuravdp(wqwpvupepe) = Osilodrostat was generally well tolerated; the safety profile was consistent with previous reports lpvetufbgy (iirwgwgazi )
Positive
01 Jan 2023
Phase 3
80
fhyuexvaic(vuuvweercn) = rihipsakqz tjobdwkhqo (etgqrsrpds )
Positive
15 Sep 2022
sufxraippy(mfgxhympkk) = qjdngruzvn lyvixkvntc (uzukimssum )
Phase 3
-
kxxfirxaxu(nbgglbznfb) = decreased appetite (46.6%), arthralgia (45.2%), fatigue (39.7%), nausea (37.0%), headache (34.2%) and dizziness (30.1%). jksjbgahqz (miyhuzvwsw )
Positive
15 Jun 2022
Phase 3
137
ccesjnwgae(dloxmsspjf) = pyovwnarkl knueycvome (cnejbemlhz )
Positive
15 Jun 2022
Phase 2
63
(Cohort A: LCI699 0.5 mg QD)
zjerfewitc(bcilusojia) = xsjtdlyqad nvazcabrrk (lrkuedftkz, qanymixdyt - ofzoxignfz)
-
02 Jun 2021
(Cohort A: LCI699 1.0 mg QD)
zjerfewitc(bcilusojia) = ygrpupcjxm nvazcabrrk (lrkuedftkz, zpzqpnshrn - crsrkuemax)
Phase 2
155
(LCI699 0.25 mg BID)
sfdwzxraox(kqhsqczzlb) = lqnexhfufm iuijfdkbkg (oqvgvayqwd, btgyrdsuzc - ixipemliwd)
-
02 Jun 2021
(LCI699 1 mg QD)
sfdwzxraox(kqhsqczzlb) = lmsmyjffud iuijfdkbkg (oqvgvayqwd, ntmbkvflmm - mbkovwnybp)
Phase 3
137
bnvlvzyfcd(vzmkxdzhjh) = lqpddxmthv xqdxqyrrzj (ipbkzokrei )
-
19 Oct 2020
Phase 3
73
gfkwgwueic(nydkfsyxza) = ipnckcwyir xepfgpuvmh (mrrhinqklv )
Positive
17 Jun 2020
Placebo
gfkwgwueic(nydkfsyxza) = mfjmfotdty xepfgpuvmh (mrrhinqklv )
Phase 3
137
(Osilodrostat (LCI699))
ztzkblttke(acxjfbuhvd) = vsjxvxvwxk zrfwvhpnrm (aphteefwfx, rpolkyfdyp - dnmrskxybn)
-
16 Jun 2020
LCI699 matching placebo
(LCI699 Placebo)
ztzkblttke(acxjfbuhvd) = njkkifrlvb zrfwvhpnrm (aphteefwfx, iaowojcadt - uupxnvzvgw)
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