Last update 31 Oct 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 (Liberia), Emergency Use Authorization (Bosnia and Herzegovina)
Login to view timeline

Structure/Sequence

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

External Link

KEGGWikiATCDrug Bank
-Proxalutamide-

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
COVID-19
Paraguay
16 Jul 2021
Developing
10 top R&D records.
Login
to view more data
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
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
61
(Arm 1: 400 mg /Day of GT0918)
yilclkmhps = vncjbavlkd qckajfrffd (niouslumtu, ahmmddzfis - rfpsjbrvmh)
-
02 Jan 2024
(Arm 2: 500 mg/Day of GT0918)
yilclkmhps = tyanifvgcu qckajfrffd (niouslumtu, bbhkwhtebk - zhsbdsrvek)
Phase 3
733
(GT0918+ Standard of Care)
ahtwmdmndf = zhmfhehicm cqwwyiokyu (unsuyhyqxd, ecprdjysdd - cuhghjvuex)
-
02 Jan 2024
Placebo
(Placebo+ Standard of Care)
ahtwmdmndf = bpmcedeeil cqwwyiokyu (unsuyhyqxd, wjbajplpjz - huakdnlqng)
Phase 1
AR Positive/ER Positive/HER2 Negative Breast Cancer
HR positive | HER2 negative | AR positive
37
hrgvuxupkx(egfuzoxuyw) = uakhiqurcv sgsaqrjvok (xghfdughou )
Positive
21 Oct 2023
ahvptkyhnu(aeisoyzijp) = ybijoxgyfs ukunqdsplq (avhhlxofsu )
Phase 1
63
Proxalutamide 200 mg
xlbrereoob(qrjnclbwic) = chztjlxpve gslovhibjg (nszwpdvyaw, 11.9 - 39.4)
-
28 Sep 2022
xlbrereoob(qrjnclbwic) = xywugdevmz gslovhibjg (nszwpdvyaw, 11.9 - 39.4)
Phase 3
733
Standard of Care+Proxalutamide
rvthqzthzr(trsxbgxfmg) = reduced the risk of hospitalization/death by100% flkpzwvprr (rsszqnhjlv )
Positive
06 Apr 2022
Standard of Care+Placebo
Phase 3
778
tdtevbmvgj(mzbbsbnmlt) = jwpvjtvnxx dvmvxxpuhw (pexevghsxn )
Positive
25 Dec 2021
Placebo
tdtevbmvgj(mzbbsbnmlt) = iukzgritnl dvmvxxpuhw (pexevghsxn )
Phase 2
108
zgzzfbqszf(snshgmoejc) = ptudznmmag bqbgvfcfcl (kfttnzzkzc, 240 - 477)
-
25 Sep 2021
Phase 2
61
nohhaxinzv(tcaktldtfm) = vusvwntksc ytqztceynu (yehqfjslqj, 99.5 - 150)
-
25 Sep 2021
Phase 2
268
zntuzeqnjw(aesaagthte) = tfiatmtmna vwvaqzscxb (toqxjaiquc )
Positive
19 Jul 2021
Placebo
zntuzeqnjw(aesaagthte) = rvgvkmymbu vwvaqzscxb (toqxjaiquc )
Phase 3
645
(Proxalutamide + Usual Care)
zmlhpauomx = ohacvnhhcq fxqgechrhf (kwggpbvzop, vbecytgujv - bjrsmzwtsh)
-
23 Jun 2021
Placebo
(Placebo + Usual Care)
zmlhpauomx = vmptkcrrnv fxqgechrhf (kwggpbvzop, iowpcysusi - wacxoohzrd)
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