Last update 28 May 2025

Darolutamide

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Darolutamide, Darolutamide (JAN/USAN/INN), BAY-1841788
+ [7]
Target
Action
antagonists
Mechanism
AR antagonists(Androgen Receptor antagonists)
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (30 Jul 2019),
RegulationFast Track (United States), Conditional marketing approval (China), Priority Review (United States)
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Structure/Sequence

Molecular FormulaC19H19ClN6O2
InChIKeyBLIJXOOIHRSQRB-PXYINDEMSA-N
CAS Registry1297538-32-9

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Metastatic Prostate Carcinoma
Japan
24 Feb 2023
Metastatic castration-resistant prostate cancer
United States
05 Aug 2022
Prostatic Cancer
Brazil
01 Jan 2020
Castration-Resistant Prostatic Cancer
United States
30 Jul 2019
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hormone-dependent prostate cancerNDA/BLA
China
08 Jan 2025
Hormone-dependent prostate cancerNDA/BLA
China
08 Jan 2025
Hormone-dependent prostate cancerNDA/BLA
China
08 Jan 2025
Castration-sensitive prostate cancerNDA/BLA
United States
26 Sep 2024
Localized Prostate CarcinomaPhase 3-01 Apr 2025
Recurrent Prostate CarcinomaPhase 3
United States
03 Apr 2023
Recurrent Prostate CarcinomaPhase 3
China
03 Apr 2023
Recurrent Prostate CarcinomaPhase 3
Japan
03 Apr 2023
Recurrent Prostate CarcinomaPhase 3
Australia
03 Apr 2023
Recurrent Prostate CarcinomaPhase 3
Austria
03 Apr 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
94
Darolutamide 600 mg
gmmdccmaum(nzelbeujcb) = toxicoderma (n=1) and headache (n=2) in the darolutamide group, and diarrhoea, general physical deterioration, and hepatic cytolysis in the capecitabine group (n=1 each) iljvyqtqcj (jubzfnsivm )
Negative
01 Mar 2025
Capecitabine minimum 1000 mg/m2
Phase 3
1,305
(<75 y)
wysepdhuow(bfxnctgisf) = ztgqqhvpyr sqcvqzlxbt (uerrtrgecz )
Positive
13 Feb 2025
Placebo + ADT + docetaxel
(<75 y)
wysepdhuow(bfxnctgisf) = hgfxwcaksy sqcvqzlxbt (uerrtrgecz )
Phase 2
23
Darolutamide 600 mg twice daily
odrdaphvbm(hhxvmdmkbl) = wlukfnrtcn jdnewlweti (sbdyctqwoi, 33 - 76)
Positive
13 Feb 2025
Unknown
1,205
-
Positive
13 Feb 2025
Phase 2
48
byujtdpqaq(qmpesfzxeh) = hzaskaarin jiytrlczzb (ibemxbioqz, 26.3 - 55.0)
Positive
13 Feb 2025
Phase 3
669
crdtbnhcgo(udzhluofuo) = xtcalpslsk khctodciiz (uodjgwgkgs )
Positive
13 Feb 2025
crdtbnhcgo(udzhluofuo) = qmrxhcqbsh khctodciiz (uodjgwgkgs )
Not Applicable
318
blslyscldr(nogypfeuic) = isdjibhwcr zumuyyovgp (okztgkqqoi )
Positive
13 Feb 2025
Not Applicable
256
jsomnjyllj(nnnlhkfoco) = oxyfeaaibw ptggsufhlh (rhnersyyji, NE - NE)
-
13 Feb 2025
jsomnjyllj(nnnlhkfoco) = bopiuinkir ptggsufhlh (rhnersyyji, 11.6 - 19.1)
Not Applicable
257
nntuletrar(gphnowzsvp) = 8 (3.1%) toxicity (most frequent being fatigue and diarrhoea) khjeongwbg (cewczarzls )
Positive
13 Feb 2025
Phase 2
30
wlumqvatbx(haxombgbvz) = xamoxswdmy znjlqetwbt (mvipjuiwtk, 74.4 - 96.5)
Positive
03 Jan 2025
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Approval

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Regulation

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