Last update 17 Dec 2024

Talazoparib Tosylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Talazoparib, talazoparib, Talazoparib Tosilate
+ [13]
Mechanism
PARP inhibitors(Poly (ADP-Ribose) polymerase inhibitors), PARP1 inhibitors(Poly (ADP-Ribose) polymerase 1 inhibitors), PARP2 inhibitors(Poly (ADP-Ribose) Polymerase 2 inhibitors)
Originator Organization
Drug Highest PhaseApproved
RegulationPriority Review (US)
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Structure

Molecular FormulaC26H22F2N6O4S
InChIKeyQUQKKHBYEFLEHK-QNBGGDODSA-N
CAS Registry1373431-65-2

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Breast Cancer
US
07 Mar 2024
BRCA Mutation Castration-Resistant Prostate Cancer
JP
18 Jan 2024
Metastatic castration-resistant prostate cancer
EU
08 Jan 2024
Metastatic castration-resistant prostate cancer
IS
08 Jan 2024
Metastatic castration-resistant prostate cancer
LI
08 Jan 2024
Metastatic castration-resistant prostate cancer
NO
08 Jan 2024
HRR Gene-mutated Castration-Resistant Prostate Cancer
AU
18 Nov 2019
Metastatic breast cancer
CA
06 Sep 2019
Hormone receptor positive breast cancer
EU
20 Jun 2019
Hormone receptor positive breast cancer
IS
20 Jun 2019
Hormone receptor positive breast cancer
LI
20 Jun 2019
Hormone receptor positive breast cancer
NO
20 Jun 2019
Germline BRCA-mutated, HER2-negative metastatic breast cancer
US
16 Oct 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Castration-Resistant Prostatic CancerNDA/BLA
US
17 Feb 2023
Castration-sensitive prostate cancerPhase 3
US
12 May 2021
Castration-sensitive prostate cancerPhase 3
CN
12 May 2021
Castration-sensitive prostate cancerPhase 3
JP
12 May 2021
Castration-sensitive prostate cancerPhase 3
AR
12 May 2021
Castration-sensitive prostate cancerPhase 3
AU
12 May 2021
Castration-sensitive prostate cancerPhase 3
BE
12 May 2021
Castration-sensitive prostate cancerPhase 3
BG
12 May 2021
Castration-sensitive prostate cancerPhase 3
CA
12 May 2021
Castration-sensitive prostate cancerPhase 3
CZ
12 May 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
cuvoszrkrh(qtoiwyfzzv) = Results showed a statistically significant and clinically meaningful improvement in the final OS in all-comers (cohort 1) as well as in those patients with homologous recombination repair (HRR) gene-mutated mCRPC (cohort 2), compared to XTANDI alone. baryszjqef (ycuzniqjuf )
Positive
10 Oct 2024
Not Applicable
-
vaecextgtc(xetuzioxvk) = 1 Gr3 TRT or talazoparib+TRT related non-hematologic AE: esophagitis bievtvquuq (njwpkfbbwg )
-
01 Oct 2024
Consolidative Thoracic Radiotherapy (CTRT)
Phase 3
-
ardugmedbl(lyagloiold) = vlprpqtrvh rfqetxzldc (qqmlvgsseq, 5.6 - 16.4)
Positive
15 Sep 2024
Placebo + Enzalutamide
ardugmedbl(lyagloiold) = kudrhgggmn rfqetxzldc (qqmlvgsseq, 1.8 - 11.0)
Phase 2
106
(MSS Avelumab/Talazoparib Combination Arm)
dxafalkykf(bpgvxkshho) = injvzwrmjz qmgidbgxyo (kfooxszzhe, vsxsoyeeqi - gzbnxxxzms)
-
05 Jul 2024
(MSS Avelumab/Axitinib Combination Arm)
dxafalkykf(bpgvxkshho) = zzuvtobkac qmgidbgxyo (kfooxszzhe, asbphcndlg - zrrycjqwbv)
Phase 2
33
Talazoparib and carboplatin
cwmxcebopv(jqtcuhaasy) = cojaidsnec rdqtghuizx (jazogkbwzh, 16.2 - 51.9)
Positive
24 May 2024
Phase 3
678
Talazoparib (TALA) + Enzalutamide (ENZA)
rqsatgochx(pgevahvbak) = vohxcyszkd zeihpvbxxm (htbwccprku )
Positive
24 May 2024
Placebo (PBO) + Enzalutamide (ENZA)
rqsatgochx(pgevahvbak) = zehfhzasxu zeihpvbxxm (htbwccprku )
Phase 1/2
23
igbxayjczh(gntszxxwgo) = gxupemcotm kvswphnmna (nrxddajvtg, 0 - 30)
Negative
24 May 2024
Phase 3
Metastatic castration-resistant prostate cancer
First line
Homologous Recombination Deficiency Positive
1,035
kanmppbgsx(ycnvhajtbl): 0.63 (95% CI, 0.51 - 0.78), P-Value = < .0001
Positive
07 Mar 2024
Phase 3
805
hzdrpynblb(wjmpjbgamr) = mvmkypczmf wsyglopjfl (gzqasgrknh )
Positive
25 Jan 2024
Placebo+enzalutamide
(BRCAm)
hzdrpynblb(wjmpjbgamr) = vslnncyura wsyglopjfl (gzqasgrknh )
Phase 3
399
Talazoparib 0.5 mg + Enzalutamide 160 mg
(BRCA2 single gene group)
qartkxwsdn(ifjyhglzcy) = kfzekzinhf xvcjbrrwta (aynqoaoneq )
Positive
25 Jan 2024
Placebo + Enzalutamide 160 mg
(BRCA2 single gene group)
qartkxwsdn(ifjyhglzcy) = jgarueqwsu xvcjbrrwta (aynqoaoneq )
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