Talzenna

(Talazoparib)

ApprovedSmall molecule

Talazoparib is used to treat certain types of breast cancer in patients with a specific genetic mutation (BRCA1 or BRCA2) that makes their cancer cells unable to repair DNA damage effectively.[2] Talzenna is currently approved and in use across 28 indications[4].[1]

Talzenna is one of 613 small molecule programs targeting Breast Neoplasm. It is currently in Approved.

Indications

Total Trials

Active Trials

612

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Breast NeoplasmActive, not recruiting

Glioblastoma MultiformeApproved

Neuroendocrine NeoplasmApproved

Hereditary Breast and Ovarian Cancer SyndromeApproved

Urothelial CarcinomaApproved

Metastatic CancerActive, not recruiting

Psoriatic ArthritisApproved

Metastatic Prostate CancerApproved

Prostate CancerActive, not recruiting

Advanced MalignanciesActive, not recruiting

Breast NeoplasmApproved

Active, not recruiting

Glioblastoma MultiformeApproved

Approved

Neuroendocrine NeoplasmApproved

Approved

Hereditary Breast and Ovarian Cancer SyndromeApproved

Approved

Urothelial CarcinomaApproved

Approved

Metastatic CancerPhase 2

Active, not recruiting

Psoriatic ArthritisApproved

Approved

Metastatic Prostate CancerApproved

Approved

Prostate CancerPhase 3

Active, not recruiting

Advanced MalignanciesPhase 3

Active, not recruiting

Showing 10 of 28 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Talzenna

Pfizer

Approved

18 2

Adenocard

Astellas

Preclinical

2 3

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 4

Nubain

AAultman Health Foundation

Preclinical

1 5

Duragesic

CCephalon

Preclinical

1 6

Beta Blocker

WWeill Medical College of Cornell University

Preclinical

1 7

Ablavar

LLantheus Medical Imaging

Preclinical

2 8

Gadolinium-Chelate

MM.D. Anderson Cancer Center

Preclinical

1 9

Metfomin

UUniversity of Texas Southwestern Medical Center

Preclinical

1 10

Calcium Channel Blocker

MMinia University

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2Active, not recruiting

Malignant Solid Neoplasm

NCT05142241

Phase 1Active, not recruiting

Mcrpc

NCT04846478

Q4 2026

Phase 2Active, not recruiting

Metastatic Endometrial Cancer

NCT02912572

Phase 2Active, not recruiting

Metastatic Cancer

NCT02286687

Phase 1/2Recruiting

Ewing Sarcoma

NCT04901702

Phase 3Active, not recruiting

Advanced Malignancies

NCT05059522

Clinical

Trials by Indication[1]

Breast Cancer18 trials

A Study to Evaluate TAlazoparib, Radiotherapy and Atezolizumab in gBRCA 1/2 Negative Patients With PD-L1+ Metastatic Triple Negative Breast Cancer

Terminated·—·Phase 2·NCT04690855·1 enrolled

Talazoparib and HSP90 Inhibitor AT13387 in Treating Patients With Metastatic Advanced Solid Tumor or Recurrent Ovarian, Fallopian Tube, Primary Peritoneal, or Triple Negative Breast Cancer

Withdrawn·NNational Cancer Institute (NCI)·Phase 1·NCT02627430

A Study of ZEN003694 and Talazoparib in Patients With Triple Negative Breast Cancer

Terminated·ZZenith Epigenetics·Phase 2·NCT03901469·115 enrolled

Show 15 more trials

Talazoparib Before Standard Therapy in Treating Patients With Invasive, BRCA-Mutated Breast Cancer

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT02282345·36 enrolled

Study of ASTX727 Plus Talazoparib in Patients With Triple Negative or Hormone Resistant/HER2-negative Metastatic Breast Cancer

Completed·KKathy Miller·Phase 1·NCT04134884·34 enrolled

A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673), in Locally Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (ABRAZO Study)

Terminated· Pfizer logo

Pfizer·Phase 2·NCT02034916·84 enrolled

Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers

Active, not recruiting·KKari Wisinski·Phase 1/2·NCT03911973·37 enrolled

Talazoparib in Advanced Breast Cancer Patients With Homologous Recombinant Deficiency

Recruiting·SSeoul National University Hospital·Phase 2·NCT04892693·70 enrolled

FUnctional Selection of Advanced Breast Cancer Patients for Talazoparib Treatment Using the REpair Capacity (RECAP) Test

Recruiting·EErasmus Medical Center·Phase 2·NCT06193525·66 enrolled

Efficacy of Talazoparib in Asian Metastatic Breast Cancer Patients With a Homologous Recombinant Deficiency (HRD) Signature

Unknown status·UUniversity of Malaya·Phase 2·NCT05288127·55 enrolled

A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study)

Completed· Pfizer logo

Pfizer·Phase 3·NCT01945775·431 enrolled

Talazoparib For Neoadjuvant Treatment Of Germline BRCA1/2 Mutation Patients With Early Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer

Terminated· Pfizer logo

Pfizer·Phase 2·NCT03499353·61 enrolled

Evaluation of Talazoparib, a PARP Inhibitor, in Patients With Somatic BRCA Mutant Metastatic Breast Cancer: Genotyping Based Clinical Trial

Recruiting·MMassachusetts General Hospital·Phase 2·NCT03990896·30 enrolled

Circulating Tumor DNA Enriched, Genomically Directed Post-neoadjuvant Trial for Patients With Residual Triple Negative Breast Cancer

Terminated·—·Phase 2·NCT04849364·52 enrolled

Selinexor & Talazoparib in Advanced Refractory Solid Tumors; Advanced/Metastatic Triple Negative Breast Cancer (START)

Recruiting·NNational University Hospital, Singapore·Phase 1/2·NCT05035745·63 enrolled

Real-World Outcomes of US Talazoparib-Treated Patients With Locally Advanced or Metastatic Breast Cancer

Completed· Pfizer logo

Pfizer··NCT04987931·84 enrolled

TALAVE: A Pilot Trial of Induction Talazoparib Followed by Combination of Talazoparib and Avelumab in Advanced Breast Cancer

Active, not recruiting·GGeorgetown University·Preclinical·NCT03964532·24 enrolled

Phase 1b/2 Study to Evaluate Antibody-Drug Conjugate Sacituzumab Govitecan in Combination With PARP Inhibitor Talazoparib in Patients With Metastatic Breast Cancer

Active, not recruiting·MMassachusetts General Hospital·Preclinical·NCT04039230·75 enrolled

Prostate Cancer9 trials

Talazoparib in Combination With Belinostat for Metastatic Breast Cancer, Metastatic Castration Resistant Prostate Cancer, and Metastatic Ovarian Cancer

Completed·UUniversity of Michigan Rogel Cancer Center·Phase 1·NCT04703920·26 enrolled

Presurgical Phase II Study of Talazoparib in Combination With Enzalutamide in Prostate Cancer

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05873192·30 enrolled

Telaglenastat + Talazoparib In Prostate Cancer

Unknown status·MMassachusetts General Hospital·Phase 2·NCT04824937·30 enrolled

Show 6 more trials

Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer

Recruiting·—·Phase 2·NCT04734730·70 enrolled

Enzalutamide Plus Talazoparib for the Treatment of Hormone Sensitive Prostate Cancer (ZZ-First)

Completed·MMedSIR·Phase 2·NCT04332744·54 enrolled

Pidnarulex and Talazoparib in Patients With Metastatic Castration Resistant Prostate Cancer

Suspended·PPeter MacCallum Cancer Centre, Australia·Phase 1·NCT05425862·48 enrolled

A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer

Completed· Pfizer logo

Pfizer·Phase 2·NCT03148795·128 enrolled

TALAPRO-3: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, STUDY OF TALAZOPARIB WITH ENZALUTAMIDE VERSUS PLACEBO WITH ENZALUTAMIDE IN MEN WITH DDR GENE MUTATED METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER

Active, not recruiting· Pfizer logo

Pfizer·Phase 3·NCT04821622·599 enrolled

A Phase Ib/II Study of Intermittent Talazoparib Plus Temozolomide in Patients With Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair

Terminated·MMemorial Sloan Kettering Cancer Center·Preclinical·NCT04019327·16 enrolled

Patients With Advanced Solid Tumors5 trials

A Study to Evaluate the Effect of Itraconazole and Rifampin on the Pharmacokinetics of Talazoparib in Patients With Advanced Solid Tumors

Completed· Pfizer logo

Pfizer·Phase 1·NCT03077607·36 enrolled

A Study to Assess the Effects of Talazoparib on Cardiac Repolarization in Patients With Advanced Solid Tumors

Completed· Pfizer logo

Pfizer·Phase 1·NCT03042910·38 enrolled

Talazoparib in Combination With Gemcitabine and Cisplatin in Patients With Advanced Solid Tumors

Withdrawn·WWashington University School of Medicine·Phase 1·NCT02537561

Show 2 more trials

A Phase 1 Study Of Talazoparib, PARP Inhibitor, In Japanese Patients With Advanced Solid Tumors

Completed· Pfizer logo

Pfizer·Phase 1·NCT03343054·28 enrolled

A Study of Talazoparib in Patients With Advanced Solid Tumors

Completed· Pfizer logo

Pfizer·Phase 1·NCT03070548·6 enrolled

Advanced or Metastatic Solid Tumors3 trials

Avelumab With Bempegaldesleukin With or Without Talazoparib or Enzalutamide in Advanced or Metastatic Solid Tumors

Terminated· Pfizer logo

Pfizer·Phase 1/2·NCT04052204·3 enrolled

Talazoparib in Treating Patients With Advanced or Metastatic Solid Tumors That Cannot Be Removed by Surgery and Liver or Kidney Dysfunction

Withdrawn·NNational Cancer Institute (NCI)·Phase 1·NCT02567396

A Study of ART4215 for the Treatment of Advanced or Metastatic Solid Tumors

Completed·AArtios Pharma Ltd·Phase 1·NCT04991480·93 enrolled

Patients With Solid Tumors2 trials

Study of CB-839 (Telaglenastat) in Combination With Talazoparib in Patients With Solid Tumors

Terminated·CCalithera Biosciences, Inc·Phase 1/2·NCT03875313·33 enrolled

Comparison of Safety and Clinical Benefit of Injections Subcutaneously Talazoparib Versus Oral Talazoparib in Patients With Solid Tumors

Withdrawn·CCenter Trials & Treatment·Phase 1·NCT03426254

47 more indications

Tics2 trials

An Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800)

Completed· Pfizer logo

Pfizer·Phase 1·NCT02997176·38 enrolled

An Open-Label Pharmacokinetics and Safety Study of Talazoparib

Completed· Pfizer logo

Pfizer·Phase 1·NCT02997163·34 enrolled

Small Cell Lung Cancer2 trials

Talazoparib and Low-Dose Temozolomide in Treating Participants With Relapsed or Refractory Extensive-Stage Small Cell Lung Cancer

Active, not recruiting·JJonsson Comprehensive Cancer Center·Phase 2·NCT03672773·35 enrolled

Testing Maintenance Therapy for Small Cell Lung Cancer in Patients With SLFN11 Positive Biomarker

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04334941·103 enrolled

Advanced Solid Tumors2 trials

STUDY OF TALAZOPARIB MONOTHERAPY IN CHINESE PARTICIPANTS WITH ADVANCED SOLID TUMORS

Completed· Pfizer logo

Pfizer·Phase 1·NCT04635631·15 enrolled

Study of RP-3500, Camonsertib, in Advanced Solid Tumors

Completed·RRepare Therapeutics·Phase 1/2·NCT04497116·276 enrolled

Acute Myeloid Leukemia2 trials

Natural Killer Cell Immunotherapy in Combination With PARP-inhibition in Acute Myeloid Leukemia

Not yet recruiting·GGerman Cancer Research Center·Phase 1/2·NCT05319249·54 enrolled

Talazoparib and Gemtuzumab Ozogamicin for the Treatment of CD33 Positive Relapsed or Refractory Acute Myeloid Leukemia

Completed·RRoswell Park Cancer Institute·Phase 1·NCT04207190·24 enrolled

Lung Cancer2 trials

Lung-MAP: Talazoparib in Treating Patients With HRRD Positive Recurrent Stage IV Squamous Cell Lung Cancer

Completed·SSWOG Cancer Research Network·Phase 2·NCT03377556·51 enrolled

Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer

Completed·SSWOG Cancer Research Network··NCT02154490·1,864 enrolled

Advanced Cancer1 trial

Testing the Addition of the Anti-Cancer Drug Talazoparib to the Combination of Carboplatin and Paclitaxel for the Treatment of Advanced Cancer

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT02317874·43 enrolled

Malignant Mesothelioma1 trial

Efficacy of a Maintenance Treatment With TALAzoparib Following First Line Platinum-based Chemotherapy in Malignant MESOthelioma

Unknown status·HHospices Civils de Lyon·Phase 2·NCT04462809·40 enrolled

Solid Malignancies1 trial

Talazoparib Plus Irinotecan With or Without Temozolomide in Children With Refractory or Recurrent Solid Malignancies

Completed·SSt. Jude Children's Research Hospital·Phase 1·NCT02392793·43 enrolled

PARP Inhibitor1 trial

PARP Inhibitor With 177Lu-DOTA-Octreotate PRRT in Patients With Neuroendocrine Tumours

Recruiting·PPeter MacCallum Cancer Centre, Australia·Phase 1·NCT05053854·24 enrolled

Glioma1 trial

Talazoparib - Carboplatin for Recurrent High-grade Glioma With DDRd

Completed·TThe University of Hong Kong·Phase 2·NCT04740190·33 enrolled

Metastatic Cancer1 trial

Talazoparib in Treating Patients With Recurrent, Refractory, Advanced, or Metastatic Cancers and Alterations in the BRCA Genes

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT02286687·150 enrolled

mCRPC1 trial

Phase Ia/Ib Talazoparib + Tazemetostat for mCRPC

Active, not recruiting·—·Phase 1·NCT04846478·35 enrolled

ESS1 trial

Pre-approval Single-patient Expanded Access for Talazoparib (PF-06944076)

Available· Pfizer logo

Pfizer··NCT05650476

Solid Tumors1 trial

Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors

Terminated· Pfizer logo

Pfizer·Phase 2·NCT03565991·202 enrolled

Immunotherapy1 trial

The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy

Unknown status·FFondazione per la Medicina Personalizzata·Phase 2·NCT04591431·400 enrolled

Renal Cell Carcinoma1 trial

Talazoparib and Avelumab in Participants With Metastatic Renal Cell Carcinoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT04068831·18 enrolled

Advanced or Recurrent Solid Tumors1 trial

Study of Talazoparib, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors

Completed· Pfizer logo

Pfizer·Phase 1·NCT01286987·113 enrolled

Peritoneal Cancer1 trial

A Study Evaluating Talazoparib in Relapsed Ovarian, Fallopian Tube, and Peritoneal Cancer

Withdrawn· Pfizer logo

Pfizer·Phase 2·NCT02836028

Locally Advanced1 trial

A Study of Avelumab, Binimetinib and Talazoparib in Patients With Locally Advanced or Metastatic RAS-mutant Solid Tumors

Terminated· Pfizer logo

Pfizer·Phase 1/2·NCT03637491·36 enrolled

Pilot Study1 trial

Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study

Terminated·PPeter MacCallum Cancer Centre, Australia·N/A·NCT04801966·3 enrolled

Neoadjuvant Treatment1 trial

BrUOG 390: Neoadjuvant Treatment With Talazoparib

Terminated·—·Phase 1·NCT04598321·1 enrolled

Trial1 trial

The Drug Rediscovery Protocol (DRUP Trial)

Recruiting·TThe Netherlands Cancer Institute·Phase 2·NCT02925234·1,550 enrolled

Triple-Negative Breast Cancer1 trial

Talazoparib Maintenance Therapy in Triple-negative Breast Cancer

Unknown status·YYonsei University·Phase 2·NCT04755868·206 enrolled

HER2-Negative1 trial

Treatment Patterns and Clinical Outcomes Among Talazoparib-Treated Adults With HER2-Negative mBC With gBRCA1/2m

Completed· Pfizer logo

Pfizer··NCT05141708·33 enrolled

Malignancies1 trial

Talazoparib and Temozolomide in Treating Younger Patients With Refractory or Recurrent Malignancies

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT02116777·40 enrolled

Untreated AML1 trial

Decitabine and Talazoparib in Untreated AML and R/R AML

Completed·UUniversity of Maryland, Baltimore·Phase 1/2·NCT02878785·25 enrolled

Non-Small Cell Lung Cancer1 trial

Combination Treatment (Talazoparib Plus Avelumab) for Stage IV or Recurrent Non-Squamous Non-Small Cell Lung Cancer With STK11 Gene Mutation (A LUNG-MAP Treatment Trial)

Completed·SSWOG Cancer Research Network·Phase 2·NCT04173507·47 enrolled

Gynecologic Cancers1 trial

Talazoparib and Radiation Therapy in Treating Patients With Locally Recurrent Gynecologic Cancers

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT03968406·24 enrolled

Metastatic Colorectal Cancer1 trial

Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer

Recruiting·OOslo University Hospital·Phase 2·NCT05725200·40 enrolled

Safety and Efficacy1 trial

Study of Talazoparib in Combination With Chemotherapy in Relapsed Pediatric AML to Determine Safety and Efficacy

Recruiting·—·Phase 1·NCT05101551·34 enrolled

Endometrial Cancer1 trial

A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer

Recruiting·AAlliance Foundation Trials, LLC.·Phase 1/2·NCT04486352·148 enrolled

Kidney Cancer1 trial

Talazoparib and Axitinib for People With Previously Treated Advanced Kidney Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1/2·NCT04337970·23 enrolled

Ovarian Cancer1 trial

ZEN003694 Combined With Talazoparib in Patients With Recurrent Ovarian Cancer

Recruiting·—·Phase 2·NCT05071937·33 enrolled

Ewing sarcoma1 trial

Study of Onivyde With Talazoparib or Temozolomide in Children With Recurrent Solid Tumors and Ewing Sarcoma

Recruiting·SSt. Jude Children's Research Hospital·Phase 1/2·NCT04901702·90 enrolled

Phase II1 trial

Phase II Study of Atezolizumab and Tiragolumab With ctDNA for HPV-positive SCC

Withdrawn·MM.D. Anderson Cancer Center·Phase 2·NCT06762808

MDS1 trial

Talazoparib for Cohesin-Mutated AML and MDS With Excess Blasts

Active, not recruiting·—·Phase 1·NCT03974217·13 enrolled

Myeloproliferative Neoplasms1 trial

Pacritinib w/ Talazoparib in Pts w/ Myeloproliferative Neoplasms Unresponsive to JAK2 Inhibition

Recruiting·FFox Chase Cancer Center·Phase 1·NCT06218628·24 enrolled

Melanoma1 trial

Nivolumab in Combination With Talazoparib in Melanoma and Mutations in BRCA or BRCA-ness Genes

Completed·—·Phase 2·NCT04187833·8 enrolled

Breast Neoplasms1 trial

A PROSPECTIVE, SINGLE-ARM, OPEN-LABEL, NON-INTERVENTIONAL, MULTI-CENTRE, POST MARKETING SURVEILLANCE (PMS) STUDY OF TALZENNA(REGISTERED)

Withdrawn· Pfizer logo

Pfizer··NCT04982848

Lymphoma, Non-Hodgkin1 trial

Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Recruiting·AAmerican Society of Clinical Oncology·Phase 2·NCT02693535·4,200 enrolled

Malignant Solid Neoplasm1 trial

Rapid Analysis and Response Evaluation of Combination Anti-Neoplastic Agents in Rare Tumors (RARE CANCER) Trial: RARE 2 Talazoparib and Temozolomide

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05142241·14 enrolled

Prostate Cancer (Adenocarcinoma)1 trial

A Randomized Open-label Phase 2 Study of TALazoparib With or Without ENzaluTamide in Patients With Metastatic Castration-Resistant Prostate Cancer and HRR Mutations After Progression on Abiraterone Acetate or Darolutamide

Recruiting·PProstate Cancer Clinical Trials Consortium·Phase 2·NCT06844383·126 enrolled

Advanced Malignant Solid Neoplasm1 trial

Phase 2 Trial of the Combination of the BET Inhibitor, ZEN003694 (ZEN-3694), and the PARP Inhibitor Talazoparib, in Patients With Molecularly-Selected Solid Tumors (ComBET)

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05327010·88 enrolled

Anatomic Stage III Breast Cancer AJCC v81 trial

A Pharmacodynamics-Driven Trial of Talazoparib, an Oral PARP Inhibitor, in Patients With Advanced Solid Tumors and Aberrations in Genes Involved in DNA Damage Response

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04550494·29 enrolled

Metastatic Endometrial Cancer1 trial

A Phase 2, Two-Group, Two-Stage, Open-Label Study of Avelumab in Patients With MSS, MSI-H and POLE-mutated Recurrent or Persistent Endometrial Cancer, Avelumab / Talazoparib in Patients With MSS Recurrent or Persistent Endometrial Cancer, and Avelumab / Axitinib in Patients With MSS Recurrent or Persistent Endometrial Cancer

Active, not recruiting·DDana-Farber Cancer Institute·Phase 2·NCT02912572·106 enrolled

Advanced Malignancies1 trial

AVELUMAB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM PFIZER-SPONSORED AVELUMAB CLINICAL STUDIES.

Active, not recruiting· Pfizer logo

Pfizer·Phase 3·NCT05059522·77 enrolled

Unspecified2 trials

StrataPATH™ (Precision Indications for Approved Therapies)

Terminated·SStrata Oncology·Phase 2·NCT05097599·11 enrolled

Open-Label Extension and Safety Study of Talazoparib

Completed· Pfizer logo

Pfizer·Phase 2·NCT02921919·120 enrolled

Regulatory

FDA Approval Timeline[5]

Jun 20, 2023

TALZENNA

NDA NDA211651

Mar 7, 2024

TALZENNA

NDA NDA217439

Sources

References

[1]
ClinicalTrials.gov — 90 trial records for Talazoparib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Talzenna drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Talazoparib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Talazoparib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA217439). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Talzenna. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Poly [ADP-Ribose] Polymerase-1 Inhibitor; Poly [ADP-Ribose] Polymerase 2 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Pfizer

Patent Landscape[6]

Patent Cliff

Jul 27, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9820985Jul 27, 2029

10780088Jul 27, 2029

8420650Jul 27, 2029

8012976Jul 27, 2029

10189837Oct 20, 2031

1 more patents

8735392Oct 20, 2031

Talzenna

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Trials by Indication[1]

Breast Cancer18 trials

Prostate Cancer9 trials

Patients With Advanced Solid Tumors5 trials

Advanced or Metastatic Solid Tumors3 trials

Patients With Solid Tumors2 trials

Tics2 trials

Small Cell Lung Cancer2 trials

Advanced Solid Tumors2 trials

Acute Myeloid Leukemia2 trials

Lung Cancer2 trials

Advanced Cancer1 trial

Malignant Mesothelioma1 trial

Solid Malignancies1 trial

PARP Inhibitor1 trial

Glioma1 trial

Metastatic Cancer1 trial

mCRPC1 trial

ESS1 trial

Solid Tumors1 trial

Immunotherapy1 trial

Renal Cell Carcinoma1 trial

Advanced or Recurrent Solid Tumors1 trial

Peritoneal Cancer1 trial

Locally Advanced1 trial

Pilot Study1 trial

Neoadjuvant Treatment1 trial

Trial1 trial

Triple-Negative Breast Cancer1 trial

HER2-Negative1 trial

Malignancies1 trial

Untreated AML1 trial

Non-Small Cell Lung Cancer1 trial

Gynecologic Cancers1 trial

Metastatic Colorectal Cancer1 trial

Safety and Efficacy1 trial

Endometrial Cancer1 trial

Kidney Cancer1 trial

Ovarian Cancer1 trial

Ewing sarcoma1 trial

Phase II1 trial

MDS1 trial

Myeloproliferative Neoplasms1 trial

Melanoma1 trial

Breast Neoplasms1 trial

Lymphoma, Non-Hodgkin1 trial

Malignant Solid Neoplasm1 trial

Prostate Cancer (Adenocarcinoma)1 trial

Advanced Malignant Solid Neoplasm1 trial

Anatomic Stage III Breast Cancer AJCC v81 trial

Metastatic Endometrial Cancer1 trial

Advanced Malignancies1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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