Last update 27 Jan 2026

Apalutamide

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Apalutamide (JAN/INN), 阿帕鲁胺, ARN-509
+ [9]
Target
Action
antagonists
Mechanism
AR antagonists(Androgen Receptor antagonists)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (14 Feb 2018),
RegulationFast Track (United States), Overseas New Drugs Urgently Needed in Clinical Settings (China), Priority Review (Australia)
Login to view timeline

Structure/Sequence

Molecular FormulaC21H15F4N5O2S
InChIKeyHJBWBFZLDZWPHF-UHFFFAOYSA-N
CAS Registry956104-40-8

External Link

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
Metastatic Prostate Carcinoma
Japan
29 May 2020
Metastatic castration-resistant prostate cancer
United States
17 Sep 2019
Hormone-dependent prostate cancer
European Union
14 Jan 2019
Hormone-dependent prostate cancer
Iceland
14 Jan 2019
Hormone-dependent prostate cancer
Liechtenstein
14 Jan 2019
Hormone-dependent prostate cancer
Norway
14 Jan 2019
Prostatic Cancer
Canada
27 Jul 2018
Castration-sensitive prostate cancer
Australia
05 Jul 2018
Castration-Resistant Prostatic Cancer
United States
14 Feb 2018
Developing
10 top R&D records.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
Metastatic Castration-Sensitive Prostate CarcinomaPhase 3
United States
31 Aug 2023
Metastatic Castration-Sensitive Prostate CarcinomaPhase 3
China
31 Aug 2023
Metastatic Castration-Sensitive Prostate CarcinomaPhase 3
Australia
31 Aug 2023
Metastatic Castration-Sensitive Prostate CarcinomaPhase 3
Brazil
31 Aug 2023
Metastatic Castration-Sensitive Prostate CarcinomaPhase 3
Canada
31 Aug 2023
Metastatic Castration-Sensitive Prostate CarcinomaPhase 3
France
31 Aug 2023
Metastatic Castration-Sensitive Prostate CarcinomaPhase 3
Germany
31 Aug 2023
Metastatic Castration-Sensitive Prostate CarcinomaPhase 3
Mexico
31 Aug 2023
Metastatic Castration-Sensitive Prostate CarcinomaPhase 3
Poland
31 Aug 2023
Adenocarcinoma of prostatePhase 3
Hong Kong
20 Jul 2020
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
26
(Arm A (Apalutamide Monotherapy))
pabqqjmzei = qrdrhdifmw julucleykl (zhkywgpaml, ycbcyrqsbn - eweogoqkpb)
-
21 Jan 2026
Stereotactic Body Radiation Therapy+Apalutamide
(Arm B (Apalutamide, SBRT))
pabqqjmzei = obihjfhtid julucleykl (zhkywgpaml, dukiwxowtp - emcdlfnzoy)
Not Applicable
Prostatic Cancer
Neoadjuvant
24
dkgpixjqiu(pvqhcysvac) = byqixjjhdp haugppwqxr (gbhdddwkar )
Positive
05 Dec 2025
Phase 4
102
vlilqxzouf(ukweofalup) = ucbgendope uspdnnebsk (eajotkoxyv )
Positive
05 Dec 2025
Phase 3
420
Apalutamide + continuous androgen deprivation therapy (cADT)
qpwhxkmfzv(trqktukbgo) = rkcqsyvghq fhbfkixlvg (zhzxzyqrbp )
Negative
17 Oct 2025
Apalutamide + intermittent androgen deprivation therapy (iADT)
qpwhxkmfzv(trqktukbgo) = pdtxwrncxj fhbfkixlvg (zhzxzyqrbp )
Phase 2
10
nophynspel(kezljzyebo) = Adverse events were consistent with previous studies of carotuximab and included grade 1-2 headache (88%), epistaxis (50%), fatigue (50%), and nausea (50%). ckrrnoehpt (xxawssrwmn )
Positive
17 Oct 2025
Not Applicable
455
wajdfiyfgb(qbnpqiyerx) = ybjmufidob bmawdagmsc (tuchdtfkgk )
Positive
17 Oct 2025
wajdfiyfgb(qbnpqiyerx) = idzxjhrgnq bmawdagmsc (tuchdtfkgk )
Phase 2
93
uwayudblxd = cingebaxhc lrwqqgrlyh (wlkneaygjn, iyqsogvvri - ypwkxybxpp)
-
12 Sep 2025
uwayudblxd = mklezzmweh lrwqqgrlyh (wlkneaygjn, aypmqmsnyt - pytnhwxkdw)
Phase 2
34
(Cohort 1)
epxexaajon = jzzydtfigb apesmcmjzy (wqhlrjrypu, mvffrmtcrb - werifegpcx)
-
29 Aug 2025
(Cohort 2)
epxexaajon = fmaxkplryy apesmcmjzy (wqhlrjrypu, jrkmeyhwcv - bnwvalcyci)
Phase 2
28
stereotactic body radiotherapy+apalutamide+Abiraterone+Leuprolide
ikwyqpkquz = wmzgwxwcfb hudcxmyorv (asgttqwrsm, mjppfiewlr - qhawyuulcs)
-
01 Aug 2025
Phase 2
45
tqdmremssv = colzfymfwp wpqhraalxz (gbdrfrudfr, hfujxvyyrc - tissaupchn)
-
03 Jul 2025
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.
AI Agents Built for Biopharma Breakthroughs
Accelerate discovery. Empower decisions. Transform outcomes.
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