Last update 19 Dec 2024

Darolutamide

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Darolutamide, Darolutamide (JAN/USAN/INN), BAY-1841788
+ [7]
Target
Mechanism
AR antagonists(Androgen Receptor antagonists)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (US), Fast Track (US), Conditional marketing approval (CN)
Login to view timeline

Structure

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

External Link

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
Metastatic Prostate Carcinoma
JP
24 Feb 2023
Metastatic castration-resistant prostate cancer
US
05 Aug 2022
Prostatic Cancer
BR
01 Jan 2020
Castration-Resistant Prostatic Cancer
US
30 Jul 2019
Developing
10 top R&D records.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
Castration-sensitive prostate cancerNDA/BLA
US
26 Sep 2024
Localized Prostate CarcinomaPhase 3-01 Jan 2025
Recurrent Prostate CarcinomaPhase 3
US
03 Apr 2023
Recurrent Prostate CarcinomaPhase 3
CN
03 Apr 2023
Recurrent Prostate CarcinomaPhase 3
JP
03 Apr 2023
Recurrent Prostate CarcinomaPhase 3
AU
03 Apr 2023
Recurrent Prostate CarcinomaPhase 3
AT
03 Apr 2023
Recurrent Prostate CarcinomaPhase 3
BE
03 Apr 2023
Recurrent Prostate CarcinomaPhase 3
BR
03 Apr 2023
Recurrent Prostate CarcinomaPhase 3
CA
03 Apr 2023
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
669
darolutamide+androgen-deprivation therapy
phaaprrmqu(mfcjirdeaq): HR = 0.54 (95% CI, 0.41 - 0.71), P-Value = <0.0001
Positive
16 Sep 2024
Placebo+androgen-deprivation therapy
Phase 3
669
wibrrkeniu(fpyuydloge) = Has met its primary endpoint of radiological progression-free survival (rPFS). pedwnrxetj (mzzlcuvzgj )
Met
Positive
17 Jul 2024
Not Applicable
10
Darolutamide + Chemotherapy + ADT
dfftccbmmn(jirsvfcawd) = 5 patients (50%) presented asthenia ifwaqgxirw (dkhjnweejd )
Positive
24 May 2024
Phase 3
1,305
oionhzkidk(lyzkxbxqpo) = ibiibdguum hwbvfckzbi (rjpfarslmp )
Positive
24 May 2024
Placebo
oionhzkidk(lyzkxbxqpo) = fynhtzochm hwbvfckzbi (rjpfarslmp )
Not Applicable
550
gafzjajqmy(dewdvascje) = dkpeoyvnzo tcfkzzxylh (ulxvkikhxh )
Positive
01 May 2024
Not Applicable
319
DARO plus ADT (doublet therapy [DT])
tqhwsmaqss(niflzzyefu) = rbphajanhy ztlhjddnio (cbqfxugspj )
Positive
01 May 2024
Phase 3
-
DarolutamiDocetaxeltaxel + ADT
rqkojbfhtj(ppbofiwiml) = okxrighokw hsnhliytti (jbwqjvmlku, 6.54 - 9.14)
Positive
25 Jan 2024
rqkojbfhtj(ppbofiwiml) = ugaryqwipf hsnhliytti (jbwqjvmlku, 4.92 - 6.96)
Phase 3
1,305
Darolutamide 600 mg
xkvkfkooyo(cfqowryuwr): HR = 0.64 (95% CI, 0.41 - 0.99)
Positive
02 Dec 2023
Placebo
Phase 3
1,306
hsievjvpsl(criiovdzke): HR = 0.2 (95% CI, 0.15 - 0.27)
-
22 Oct 2023
Placebo
Phase 2
30
yvnmejflos(wycmtebexv) = psmvhpqhvf yqfwbygoau (cgkpewpfpc, eiwdthhytk - xoobspedff)
-
04 Aug 2023
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Chat with Hiro
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free