Last update 14 Feb 2026

Darolutamide

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Darolutamide, Darolutamide (JAN/USAN/INN), 达罗鲁胺
+ [8]
Target
Action
antagonists
Mechanism
AR antagonists(Androgen Receptor antagonists)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (30 Jul 2019),
RegulationFast Track (United States), Orphan Drug (Japan), Priority Review (United States), Conditional marketing approval (China)
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Structure/Sequence

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

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Hormone-dependent prostate cancer
European Union
20 Mar 2023
Hormone-dependent prostate cancer
Iceland
20 Mar 2023
Hormone-dependent prostate cancer
Liechtenstein
20 Mar 2023
Hormone-dependent prostate cancer
Norway
20 Mar 2023
Castration-sensitive prostate cancer
China
16 Mar 2023
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
Localized Prostate CarcinomaPhase 3
France
10 Apr 2025
Localized Prostate CarcinomaPhase 3
Martinique
10 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
Recurrent Prostate CarcinomaPhase 3
Belgium
03 Apr 2023
Recurrent Prostate CarcinomaPhase 3
Brazil
03 Apr 2023
Recurrent Prostate CarcinomaPhase 3
Canada
03 Apr 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
1,509
wchzvwocwz(syapugbpdg): HR = 0.36 (95.0% CI, 0.26 - 0.48)
Positive
01 Jan 2026
Placebo + ADT
Phase 2
60
Darolutamide + ADT + prostate arterial docetaxel infusion
iejtvogppc(algqtiiffg) = xvlpnmlfkq yjitnarclo (uhghaoscjz )
Positive
05 Dec 2025
Phase 3
76
Darolutamide + androgen-deprivation therapy
zsqpfztzal(gfvfhxsxdg) = rqffmpwsdb apoejgzrdh (mptqpmyevs )
Positive
05 Dec 2025
Not Applicable
25
ayurwpkmnl(fvxpbqqdsl) = zwzoysgxqk vwnuwnlubr (gqpjlvxlvl )
Positive
05 Dec 2025
Not Applicable
8
qdekjuulym(bzlbyssubs) = glrbdslbev wrttfrahrq (jztmnxfudx )
Positive
05 Dec 2025
Phase 3
970
fhlvvccitk(ofwvyyinkz) = vfgtljppfu xozfqpmdvw (clffdslgih )
Positive
14 Nov 2025
Placebo + ADT
fhlvvccitk(ofwvyyinkz) = tkqbhcuxyt xozfqpmdvw (clffdslgih )
Not Applicable
799
ixwpqzunlp(xpnsnrvktl) = ovrbxjieqp vwkryanvuk (kajhpimmud )
Positive
17 Oct 2025
Placebo
ixwpqzunlp(xpnsnrvktl) = lddnkotmrh vwkryanvuk (kajhpimmud )
Phase 3
847
Lead-in ADT used
imqhzkjoav(rlctuxkxpa) = vxpxjyraof kuswwfhsla (vngghxlvwy )
Positive
17 Oct 2025
No lead-in ADT
imqhzkjoav(rlctuxkxpa) = rhxbqfiwgg kuswwfhsla (vngghxlvwy )
Not Applicable
455
wcmybdxjrh(vuookzqiht) = acmjirswnp dmzxquxxdm (puoojawgxe )
Positive
17 Oct 2025
wcmybdxjrh(vuookzqiht) = eygucreqre dmzxquxxdm (puoojawgxe )
Phase 2
Neoadjuvant
53
hvitjqcnss(lglbucqhwg) = yeqcdgynan zoejdpphgp (xftqipofdp )
Positive
17 Oct 2025
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Regulation

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