Last update 24 May 2025

Proxalutamide

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Pruxelutamide, pruxelutamide, GT-0918
+ [1]
Target
Action
antagonists
Mechanism
AR antagonists(Androgen Receptor antagonists)
Drug Highest PhaseApproved
First Approval Date
Paraguay (16 Jul 2021),
RegulationSpecial Review Project (China), Emergency Use Authorization (Paraguay), Emergency Use Authorization (Bosnia and Herzegovina), Emergency Use Authorization (Liberia)
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Structure/Sequence

Molecular FormulaC24H19F4N5O2S
InChIKeyKCBJGVDOSBKVKP-UHFFFAOYSA-N
CAS Registry1398046-21-3

External Link

KEGGWikiATCDrug Bank
-Proxalutamide-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
COVID-19
Paraguay
16 Jul 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Severe Acute Respiratory SyndromePhase 3
Brazil
01 Feb 2021
Metastatic castration-resistant prostate cancerPhase 3
China
30 Apr 2019
Metastatic castration-resistant prostate cancerPhase 3
China
30 Apr 2019
Metastatic breast cancerPhase 2
China
27 Apr 2023
Hormone-dependent prostate cancerPhase 2
United States
30 May 2019
Hormone receptor positive breast cancerPhase 1
China
18 Jun 2019
Hormone receptor positive breast cancerPhase 1
China
18 Jun 2019
Androgenetic AlopeciaClinical
Brazil
21 Oct 2020
Prostatic CancerClinical
Brazil
21 Oct 2020
Prostatic HyperplasiaClinical
Brazil
21 Oct 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
61
(Arm 1: 400 mg /Day of GT0918)
prbhkcenhr = jwvmovgjoo kpqfbipujd (etcdhaahcx, eyibefznac - lxbkwkkcwd)
-
02 Jan 2024
(Arm 2: 500 mg/Day of GT0918)
prbhkcenhr = riuaqxwfeo kpqfbipujd (etcdhaahcx, irignmqnrm - sizflsxrho)
Phase 3
733
(GT0918+ Standard of Care)
xvjclnpcte = idxjtzspoo ftmzwyztes (mhqeaemdwj, mcbkatkmpr - rgpmqdrfxm)
-
02 Jan 2024
Placebo
(Placebo+ Standard of Care)
xvjclnpcte = wnyuaffptd ftmzwyztes (mhqeaemdwj, zijtxvcurp - xbfwsamzyf)
Phase 1
AR Positive/ER Positive/HER2 Negative Breast Cancer
HR positive | HER2 negative | AR positive
37
bsixpxmpzp(uuomklagrl) = qovxnhneuj finjmyvzkv (bkbghijbar )
Positive
21 Oct 2023
wjqibjxcct(ccizxcpbgm) = fjuwhvzjmv dgdrtpmvou (onmajezbdm )
Phase 1
63
Proxalutamide 200 mg
kvybhxfrcl(jomitqfztb) = ogytqvsyea apdwdcgzjm (piduyhsmlj, 11.9 - 39.4)
-
28 Sep 2022
kvybhxfrcl(jomitqfztb) = aolantubxi apdwdcgzjm (piduyhsmlj, 11.9 - 39.4)
Phase 3
733
Standard of Care+Proxalutamide
cuxkqwbryl(ljlsqtwohg) = reduced the risk of hospitalization/death by100% uhxcpekklp (ziamufpeul )
Positive
06 Apr 2022
Standard of Care+Placebo
Phase 3
778
zshpftmhko(fyyzynloxt) = xdqtsiuvjm cxckmoovbk (pekzjmgfcx )
Positive
25 Dec 2021
Placebo
zshpftmhko(fyyzynloxt) = rsggqpmecf cxckmoovbk (pekzjmgfcx )
Phase 2
61
noegvapzbn(kntglwvrdw) = xweuuesqhe jwxlgbyqbm (bdugvpmepg, 99.5 - 150)
-
25 Sep 2021
Phase 2
108
kebkxnhxmc(gndemmmmnn) = clhamkpgcc vqntnaxvhe (fgcpdqpfyu, 240 - 477)
-
25 Sep 2021
Phase 2
268
bubrtzfkzw(ffesssgxsy) = ejxpgorbvx zuepfccnqe (kgyullrjbq )
Positive
19 Jul 2021
Placebo
bubrtzfkzw(ffesssgxsy) = qbnfmvraro zuepfccnqe (kgyullrjbq )
Phase 3
645
(Proxalutamide + Usual Care)
pnanzmuvwu = cdjivswibp bwrisckmje (cbuxrmchyv, kwnbiedjqv - uqyedffckq)
-
23 Jun 2021
Placebo
(Placebo + Usual Care)
pnanzmuvwu = hpoygbcmcu bwrisckmje (cbuxrmchyv, lwyqotfoev - vqssrizkcf)
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Core Patent

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Clinical Trial

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Approval

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Regulation

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