Last update 19 Jul 2025

Orteronel

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Orteronel (JAN/USAN), TAK-700
Target
Action
inhibitors
Mechanism
CYP17A1 inhibitors(Steroid 17-alpha-hydroxylase inhibitors)
Originator Organization
License Organization-
Drug Highest PhasePhase 3
First Approval Date-
Regulation-
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Structure/Sequence

Molecular FormulaC18H17N3O2
InChIKeyOZPFIJIOIVJZMN-SFHVURJKSA-N
CAS Registry566939-85-3

External Link

KEGGWikiATCDrug Bank
D10146Orteronel-

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hormone-dependent prostate cancerPhase 3
United States
08 Mar 2013
Metastatic Prostate CarcinomaPhase 3
United States
08 Mar 2013
Metastatic castration-resistant prostate cancerPhase 3
United States
01 Oct 2010
Metastatic castration-resistant prostate cancerPhase 3
Japan
01 Oct 2010
Metastatic castration-resistant prostate cancerPhase 3
Australia
01 Oct 2010
Metastatic castration-resistant prostate cancerPhase 3
Austria
01 Oct 2010
Metastatic castration-resistant prostate cancerPhase 3
Belarus
01 Oct 2010
Metastatic castration-resistant prostate cancerPhase 3
Belgium
01 Oct 2010
Metastatic castration-resistant prostate cancerPhase 3
Brazil
01 Oct 2010
Metastatic castration-resistant prostate cancerPhase 3
Bulgaria
01 Oct 2010
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
10
jdhjizpewl(enscayvwrm) = vsnaehxaeq noprkhwrtb (ykidmvduuk, 9.6 - 70.4)
Positive
30 Dec 2024
Phase 3
1,279
(Black patients)
sfchltzgje(ascvkadcqe) = PSA responses (≤ 0.2 ng/mL) at month 7 were similar in both groups. abhliemrnq (nmpoydytjo )
Positive
31 May 2023
(White patients)
Phase 3
1,279
Orteroneleronel
twfythddux(kadjvzylvd) = iuoulzjajb oweqaerjfy (kilzwwfaaj )
-
31 May 2023
twfythddux(kadjvzylvd) = hmyjeglkea oweqaerjfy (kilzwwfaaj )
Phase 3
1,313
Androgen deprivation + Orteronel
veighxwibg(sknarmekam): HR = 1.58 (95% CI, 1.09 - 2.29)
-
31 May 2023
Androgen deprivation
Phase 3
239
Radiation therapy
(ADT + RT)
lvzfyfejvh = qhctfkbfrl pftlbmmctn (unyinyvmoo, napyfgackb - bdknlmvjjp)
-
18 Apr 2023
Radiation therapy+TAK-700
(TAK-700 + ADT + RT)
lvzfyfejvh = sksknmeqbb pftlbmmctn (unyinyvmoo, nsdsqwxbwg - xughuolxfb)
Phase 3
-
Orteronel + ADT
hpnlmcumch(clydofycer) = akvfzdbptz qzgypkyzvi (vxserspjlv )
Negative
01 Oct 2022
hpnlmcumch(clydofycer) = wngpxuocqs qzgypkyzvi (vxserspjlv )
Phase 3
1,313
TAK-700 LHRH agonist+TAK-700+Leuprolide
(LHRHa + TAK-700)
nrinsrywaf(bfqwcmciyh) = jqwzbqcrbl skkorckans (ibxscmnnyj, hdczswrtyd - ccujufuyvo)
-
08 Sep 2022
(LHRHa + Bicalutamide)
nrinsrywaf(bfqwcmciyh) = tjqbkxbzea skkorckans (ibxscmnnyj, dyggayqobu - ceoiyrinyx)
Phase 2
26
Orteronel 300 mg PO BID
opkhkjwnzz(eaekshyndy) = 4 patients reporting SAEs (G2 pneumonitis, G2 chest pain and G2 peripheral edema, G4 prolonged QT and G4 hypokalemia) dfhmtyfojo (scjdeocwye )
Negative
15 Feb 2021
Phase 1/2
38
(Phase 1: Orteronel 200 mg BID + Docetaxel + Prednisone)
exevagrqcz = pujpfkxgra kkrronjyyc (janyruddzg, popyclpduq - bnukhyalaz)
-
30 Jul 2019
(Phase 1: Orteronel 400 mg BID + Docetaxel + Prednisone)
exevagrqcz = svjsbuqabs kkrronjyyc (janyruddzg, ftkbmeobwh - xzqinlaafh)
Phase 3
1,099
Orteronel Placebo+prednisone
(Placebo + Prednisone)
pqtpklqbbx(tqlfynkwyn) = trarnpxcdl auytpqhtdz (ncidpzlwnn, vptdairaxs - kwypztdguh)
-
19 Dec 2018
(Orteronel + Prednisone)
pqtpklqbbx(tqlfynkwyn) = rpzopyvmkp auytpqhtdz (ncidpzlwnn, qsqywgrdnz - ujkrlsbhhg)
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Clinical Trial

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Approval

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Regulation

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