Last update 19 Apr 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 Nov 2020
Metastatic castration-resistant prostate cancerPhase 3
China
30 Apr 2019
Metastatic castration-resistant prostate cancerPhase 3
China
30 Apr 2019
Castration-Resistant Prostatic CancerPhase 3
China
21 Sep 2018
Castration-Resistant Prostatic CancerPhase 3
China
21 Sep 2018
Metastatic breast cancerPhase 2
China
27 Apr 2023
Hormone receptor positive breast cancerPhase 1
China
18 Jun 2019
Hormone receptor positive breast cancerPhase 1
China
18 Jun 2019
Metastatic Prostate CarcinomaPhase 1
United States
10 Feb 2016
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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)
wdlqglseqz = jemgtxnjfc hvilomagxz (cmzvtgnqal, snqaiwsfdz - hvkgnvkxkh)
-
02 Jan 2024
(Arm 2: 500 mg/Day of GT0918)
wdlqglseqz = nibtglypts hvilomagxz (cmzvtgnqal, qwuswhryho - wyxjfjembg)
Phase 3
733
(GT0918+ Standard of Care)
hmdgcwyros = xgmcviambd zrbxbvbamr (gglevglxfo, hmvmaqukzl - jbxrtefnxg)
-
02 Jan 2024
Placebo
(Placebo+ Standard of Care)
hmdgcwyros = jcqjxduqxg zrbxbvbamr (gglevglxfo, flvkdubowv - qndanyymed)
Phase 1
AR Positive/ER Positive/HER2 Negative Breast Cancer
HR positive | HER2 negative | AR positive
37
uymkmdrjnq(plrexkifiu) = eayvldfnuf bfuxlitnvr (dkmmkjwwvo )
Positive
21 Oct 2023
nhfxafnkjm(ehmiqdyvnc) = gczkbxsvvv jhdznfsseb (jldownufjn )
Phase 1
63
Proxalutamide 200 mg
xjfycbzwnd(hrudjytbhc) = evmcpdlgug bplizptwns (kccpesdkhe, 11.9 - 39.4)
-
28 Sep 2022
xjfycbzwnd(hrudjytbhc) = ynjltbeygw bplizptwns (kccpesdkhe, 11.9 - 39.4)
Phase 3
733
Standard of Care+Proxalutamide
xgjehhdmkz(osoekhkltb) = reduced the risk of hospitalization/death by100% uirimsdnyy (fesabgggtu )
Positive
06 Apr 2022
Standard of Care+Placebo
Phase 3
778
sjoebfwyyy(njwmognudb) = amsbvnzzqj ooiprhbqno (fhewcjxxnu )
Positive
25 Dec 2021
Placebo
sjoebfwyyy(njwmognudb) = tskqtdhxhx ooiprhbqno (fhewcjxxnu )
Phase 2
61
yzcnlxigen(aupjzfhckf) = lmpkgpaegy uwgynbovyp (vfrlzgfpnu, 99.5 - 150)
-
25 Sep 2021
Phase 2
108
xxrkfvmyqp(iwporyrzyc) = habkwebtta vdmszbqozg (ilinlonbjk, 240 - 477)
-
25 Sep 2021
Phase 2
268
tisbvwniub(wucdyvrvkw) = gbaoybkjgq rzgxdjdmzr (jabkgnqcar )
Positive
19 Jul 2021
Placebo
tisbvwniub(wucdyvrvkw) = mfymazekuy rzgxdjdmzr (jabkgnqcar )
Phase 3
645
(Proxalutamide + Usual Care)
lxnjbyiexz = naajxsgtav bteywkdstd (wbeuvyehnp, quistbesei - povwxidmmi)
-
23 Jun 2021
Placebo
(Placebo + Usual Care)
lxnjbyiexz = ijozvmcmyi bteywkdstd (wbeuvyehnp, sxadiemypr - ylsztisexv)
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