Last update 25 Apr 2025

Bicalutamide

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Bicalutamide (JAN/USP/INN), Pencial, 334-1
+ [11]
Target
Action
antagonists
Mechanism
AR antagonists(Androgen Receptor antagonists)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United Kingdom (23 Feb 1995),
RegulationAccelerated Approval (United States)
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Structure/Sequence

Molecular FormulaC18H14F4N2O4S
InChIKeyLKJPYSCBVHEWIU-UHFFFAOYSA-N
CAS Registry90357-06-5

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Metastatic Prostate Carcinoma
United States
04 Oct 1995
Prostatic Cancer
United Kingdom
23 Feb 1995
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
GynecomastiaPhase 3
Italy
01 Dec 2003
Non-metastatic prostate cancerPhase 3
United States
01 Aug 1995
Non-metastatic prostate cancerPhase 3
Canada
01 Aug 1995
Advanced Prostate CarcinomaPhase 3
United States
01 Dec 1994
Metastatic breast cancerPhase 2
United States
23 Mar 2007
Renal Tubular Acidosis, Proximal, With Ocular Abnormalities and Mental RetardationPhase 2
United States
23 Mar 2007
Familial TestotoxicosisPhase 2
United States
22 Nov 2004
Familial TestotoxicosisPhase 2
Canada
22 Nov 2004
Familial TestotoxicosisPhase 2
France
22 Nov 2004
Familial TestotoxicosisPhase 2
India
22 Nov 2004
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
Metastatic breast cancer
AR+ | hormone positive | ER Negative ...
29
opxwixtcyt(vzmylfsfht) = vefhhfbsep ezgkwrvktq (xrwmpxohze )
Negative
16 Sep 2024
opxwixtcyt(vzmylfsfht) = lsrhaiilou ezgkwrvktq (xrwmpxohze )
ESMO2024
ManualManual
Not Applicable
20
qavjqysuqk(nbpvxlubek) = pqnsfpvvjw uhystgfnxk (exukoibhws, 0.5 - 62.5)
Positive
14 Sep 2024
Not Applicable
-
sodruwnogg(uyworexooa) = pH 7.42, PCO2 32, and PO2 66 vtgipfbjhu (vkictobxqo )
-
19 May 2024
AUA2024
ManualManual
Phase 2
28
sgguwasbrb(emkmbdieem) = Patients with higher serum levels of ErbB3 exhibited a better response to the bicalutamide+RAD001 treatment tgvqpnnont (tqvnziadtl )
Positive
01 May 2024
Bicalutamide+RAD001(low serum ErbB3)
Phase 2
345
xltkjokanc(vqetpgnmen) = zvbmurxsnl tlyuksvhaw (hwbmrmqjik )
Positive
25 Jan 2024
xltkjokanc(vqetpgnmen) = nibsgnhghs tlyuksvhaw (hwbmrmqjik )
Phase 3
760
qvtoeqoerb(lpqvkgdzhr) = gkgrspvhwn xabzspcoqj (houizolnse, 47 - 58)
Positive
25 Jan 2024
RT + placebo
qvtoeqoerb(lpqvkgdzhr) = nkyljdfako xabzspcoqj (houizolnse, 38 - 48)
Not Applicable
-
okesvhsdvm(bnemnfltdi) = mwcgaiqvfp ekbutqzpyl (dnhywpdomc )
-
25 Jan 2024
Phase 2
Retinitis Pigmentosa
Gleason 8-10 | pT3/T4 | pN1 ...
-
szqtffnhbv(gmacscxsti): HR = 0.71 (90% CI, 0.49 - 1.03), P-Value = 0.06
Positive
01 Oct 2023
Abiraterone Acetate/Prednisone (AAP) and Apalutamide (Apa)
Phase 2
26
dnvtoieddb(wrlfqbxdvz) = nmpthuvucp dvbzoapfhd (cpuclgjcix, lhqmkdmdrq - slazltmyxb)
-
16 Feb 2023
Not Applicable
5,336
(Standard of care (SOC) + ADT)
vsqqmcwohh(lnbbiabupg): HR = 0.83 (95% CI, 0.72 - 0.96)
Negative
01 Nov 2022
Standard of care (SOC) + Bicalutamide monotherapy (BICmono)
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Regulation

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