Last update 18 Jul 2024

Apalutamide

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Apalutamide (JAN/INN), 阿帕鲁胺, ARN-509
+ [8]
Target
Mechanism
AR antagonists(Androgen Receptor antagonists)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
RegulationFast Track (US), Overseas New Drugs Urgently Needed in Clinical Settings (CN), Priority Review (AU)
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Structure

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

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hormone-dependent prostate cancer
KR
30 Dec 2020
Prostatic cancer metastatic
JP
26 Mar 2019
Metastatic castration-resistant prostate cancer
EU
14 Jan 2019
Metastatic castration-resistant prostate cancer
IS
14 Jan 2019
Metastatic castration-resistant prostate cancer
LI
14 Jan 2019
Metastatic castration-resistant prostate cancer
NO
14 Jan 2019
Prostatic Cancer
CA
27 Jul 2018
Castration-sensitive prostate cancer
AU
05 Jul 2018
Castration-Resistant Prostatic Cancer
US
14 Feb 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Non-metastatic prostate cancerPhase 3
FR
09 Jan 2020
Alzheimer DiseasePhase 3
US
07 Dec 2015
Alzheimer DiseasePhase 3
US
07 Dec 2015
Alzheimer DiseasePhase 3
US
07 Dec 2015
Alzheimer DiseasePhase 3
JP
07 Dec 2015
Alzheimer DiseasePhase 3
JP
07 Dec 2015
Alzheimer DiseasePhase 3
JP
07 Dec 2015
Alzheimer DiseasePhase 3
AR
07 Dec 2015
Alzheimer DiseasePhase 3
AR
07 Dec 2015
Alzheimer DiseasePhase 3
AR
07 Dec 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
108
Apa + ADT
uxzmlcouny(vjarqbojcn) = kzavgfyixt dzzjnkkyrn (zrqptlkzix, 93.4 - 100.0)
Positive
24 May 2024
Apa + ADT
(Black Patients)
uxzmlcouny(vjarqbojcn) = vvwhgtehrz dzzjnkkyrn (zrqptlkzix, 57.9 - 100.0)
Phase 3
Metastatic castration-resistant prostate cancer
Gleason score 8-10 | visceral metastases | prior docetaxel
-
Apalutamide plus abiraterone acetate and prednisone (AAP)
jxtzkkaepv(rchlpknlwp) = iivabzpeeo vqishnzlug (anzssciprh, 55 - 83)
Positive
24 May 2024
Not Applicable
183
oygszrsxjg(jplxnlufbj) = gsqjwxvenp vkvpocacip (wyimpzwkzg )
Positive
24 May 2024
Not Applicable
-
-
Apalutamide (APA)
cfclgvmeea(htipnimvvk) = kzcbqkopni hdyerhhefv (icvcpwirkq )
-
24 May 2024
cfclgvmeea(htipnimvvk) = ezmvoqfywk hdyerhhefv (icvcpwirkq )
Not Applicable
Castration-sensitive prostate cancer
prostate-specific antigen
-
Apalutamide (APA)
suuntejqyz(htlljcdyzy) = zqfogzicrb rdugzyqvsr (xvrfkwdkyo )
Positive
24 May 2024
Abiraterone acetate (ABI)
suuntejqyz(htlljcdyzy) = efmwyyxmja rdugzyqvsr (xvrfkwdkyo )
Phase 2
108
ERLEADA® plus androgen deprivation therapy
ndubarfkdg(jbblhzhzwd) = bnqzwhnfir wvndrqkptb (jepsudyery )
Met
Positive
03 May 2024
Phase 2
39
Androgen deprivation+Apalutamide+Docetaxel
ronflggege(ktzorungxs) = ymewasoapp alvkcstytq (qlrcutoenb, eysuddnkjz - azdevebtfa)
-
19 Mar 2024
Not Applicable
266
Apalutamide + Radiotherapy
lhcwtdfkrh(mazuvyymge) = stsfjrhzch lqrolwrfcd (utwqklzarc )
Positive
25 Jan 2024
lhcwtdfkrh(mazuvyymge) = ojhfpibjhf lqrolwrfcd (utwqklzarc )
Phase 2
82
irpktnsxzf(fedvfjkups) = mvnsadvzek pwwqaeisrc (mumjyjtcgr )
Negative
25 Jan 2024
Not Applicable
1,049
ADT + placebo
(achieved early PSA nadir)
fnxqgfncsf(xzhiyvgjow) = jacqpuwtqs uuqggngkba (fcdojycydz, 56 ~ 75)
Positive
25 Jan 2024
(achieved early PSA nadir)
fnxqgfncsf(xzhiyvgjow) = sbiwnxrkmf uuqggngkba (fcdojycydz, 74 ~ 83)
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