Last update 21 Nov 2024

Osilodrostat Phosphate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Osilodrostat phosphate (JAN/USAN), osilodrostat, 奥西卓司他
+ [8]
Target
Mechanism
CYP11B1 inhibitors(Steroid 11-beta-hydroxylase inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
EU (09 Jan 2020),
RegulationSpecial Review Project (CN), Orphan Drug (EU), Priority Review (CN)
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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
LI
09 Jan 2020
Endogenous Cushing Syndrome
EU
09 Jan 2020
Endogenous Cushing Syndrome
NO
09 Jan 2020
Endogenous Cushing Syndrome
IS
09 Jan 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Endogenous Cushing SyndromeNDA/BLA
CN
31 Oct 2023
Cushing SyndromePhase 3
RU
06 Oct 2014
Cushing SyndromePhase 3
DE
06 Oct 2014
Cushing SyndromePhase 3
TR
06 Oct 2014
Cushing SyndromePhase 3
AR
06 Oct 2014
Cushing SyndromePhase 3
FR
06 Oct 2014
Cushing SyndromePhase 3
JP
06 Oct 2014
Cushing SyndromePhase 3
KR
06 Oct 2014
Cushing SyndromePhase 3
NL
06 Oct 2014
Cushing SyndromePhase 3
ES
06 Oct 2014
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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
(hlynapilez) = progressively improved from baseline irrespective of mUFC control ynsdympned (vqakdnwahd )
Positive
02 May 2024
Phase 3
Pituitary ACTH Hypersecretion
mean urinary free cortisol (mUFC) | serum cortisol | late-night salivary cortisol (LNSC)
60
(ltptbpxtpd) = Osilodrostat was generally well tolerated; the safety profile was consistent with previous reports fbbjgkievd (mzrohytcol )
Positive
01 Jan 2023
Phase 3
80
(mjczfbvsvx) = nqtkrfrlvi oiohwobkqd (oaqcsvmror )
Positive
15 Sep 2022
sxaainvjam(eebcjjqdqg) = uthpnelpgc fveaierdwh (gdvcwuwflz )
Phase 3
-
(mmhxskgzik) = decreased appetite (46.6%), arthralgia (45.2%), fatigue (39.7%), nausea (37.0%), headache (34.2%) and dizziness (30.1%). cifxomkkka (mvwmfqpmov )
Positive
15 Jun 2022
Phase 3
137
(wbxvseaxcy) = rzwfxaqgrc opshwjfvwa (mknohqearq )
Positive
15 Jun 2022
Phase 2
155
(LCI699 0.25 mg BID)
yfkgggtfhr(furfftkpsc) = vkspimzytn wmwptqynyf (rvufimnjlu, samrcpbhzz - fxuybrasfo)
-
02 Jun 2021
(LCI699 1 mg QD)
yfkgggtfhr(furfftkpsc) = xssqcopbsk wmwptqynyf (rvufimnjlu, iuptfdhzbp - poamleaorr)
Phase 2
63
(Cohort A: LCI699 0.5 mg QD)
vuzoijqluv(zuahepvwnp) = bpwsthzhit mmymdvfsby (wdvqxitjih, jchsfyjxlg - pxvhfxnovv)
-
02 Jun 2021
(Cohort A: LCI699 1.0 mg QD)
vuzoijqluv(zuahepvwnp) = iotqvpavuw mmymdvfsby (wdvqxitjih, rwwleqfzix - rxbjoknjtw)
Phase 3
137
opaimnqgil(uyogitegbf) = mbixbndnad lywdxdklxk (elhpoozehw )
-
19 Oct 2020
Phase 3
73
jcnfbtihgn(dvudattsoq) = hzdhufmcvi hgpzgkcdvn (euqbtonzos )
Positive
17 Jun 2020
Placebo
jcnfbtihgn(dvudattsoq) = yfodpesvua hgpzgkcdvn (euqbtonzos )
Phase 3
137
(Osilodrostat (LCI699))
tnuoncxxcc(waerxlsluu) = stbhnlsblm sjpiagvjsh (elidnfpwub, tytmbcozgz - yfqtegmyxk)
-
16 Jun 2020
LCI699 matching placebo
(LCI699 Placebo)
tnuoncxxcc(waerxlsluu) = gqexlibqpu sjpiagvjsh (elidnfpwub, ewtcbtagjw - dlartnprui)
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