Drug · Small Molecule

Talazoparib

CI-DRUG-00000569Explore in graph →NCIt C95733 CHEMBL3137320 CIViC Approved

Regulatory

Approvals (17)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

emaRegulatory1 approval record · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
EU EMA	—	Treatment with Talzenna should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. Patient selection Breast cancer: Patients should be selected for the treatment of breast cancer with Talzenna based on the presence of deleterious or suspected deleterious germline BRCA mutations determined by an experienced laboratory using a validated test method. Genetic counselling for patients with BRCA mutations should be performed according to local regulations, as applicable. Prostate cancer: There is no requirement for tumour mutation testing for selection of patients with mCRPC for treatment with Talzenna.	approved	Jun 20, 2019	ema

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 17 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 3	33	19	2	94	17	CA, EU, US	Oct 16, 2018	Jan 3, 2011
Malignant Breast Neoplasm	Approved	Phase 2	7	4	0	22	2	US	Oct 16, 2018	Feb 4, 2014
Malignant Prostate Neoplasm	Approved	Phase 2	5	3	0	13	2	US	Oct 16, 2018	Jan 3, 2011
Malignant Ovarian Neoplasm	Phase3	Phase 3	4	2	1	13

Curated evidence

Clinical evidence (24)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–24 of 24 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
EMSY Amplification1
Talazoparib	Acral Lentiginous Melanoma

Clinical trials

Trials with this intervention (99)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 51–99 of 99 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT03148795	A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer	completed	Phase 2	128	PfizerINDUSTRY	14	Apr 5, 2024	clinicaltrials
NCT05319249	Natural Killer Cell Immunotherapy in Combination With PARP-inhibition in Acute Myeloid Leukemia(NAKIP-AML)	not yet recruiting

Molecule

Record

Kind: Small Molecule
Mechanism: Poly [ADP-ribose] polymerase 2 inhibitor; Poly [ADP-ribose] polymerase-1 inhibitor
Targets: 2 genes
UNII: 02WK9U5NZC
Aliases: BICALUTAMIDE, BMN 673, BMN673, LT-673, PF-06944076, Talazoparib, TALAZOPARIB (BMN 673), Talazoparib Tosylate, TALAZOPARIB TOSYLATE, TALZENNA

Data updated 20 hours agoSource updated unknown

Identifiers

Codes (12)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01XK04	TALAZOPARIB
DIN (Health Canada)	02492032	TALZENNA
DIN (Health Canada)

CDK12 Loss-of-function2
Olaparib + TalazoparibSubstitutes	Breast Carcinoma	Predictive	D	Supports Sensitivity Response	2	submitted	EID12571 In micropapillary breast carcinoma and a subset of HER2-amplified breast cancers, genomic disruptions of CDK12 (out-of-frame rearrangements and breakpoints within the HER2 amplicon) were associated wi… (full text at CIViC) PMID 24395524 · Natrajan et al., 2014 · Open in CIViC	civic
Olaparib + Rucaparib + Talazoparib + VeliparibSubstitutes	Malignant Prostate Neoplasm	Predictive	D	Supports Sensitivity Response	2	submitted	EID12572 In prostate cancer models, CDK12 loss impaired homologous recombination deficiency and sensitized cells to PARP inhibitors (olaparib, rucaparib, talazoparib, veliparib) in a gene dosage-dependent mann… (full text at CIViC) PMID 39321214 · Chou et al., 2024 · Open in CIViC	civic

CDK12 Loss-of-function2

Olaparib + TalazoparibSubstitutes

Breast Carcinoma

Predictive

Supports Sensitivity Response

submitted

EID12571

In micropapillary breast carcinoma and a subset of HER2-amplified breast cancers, genomic disruptions of CDK12 (out-of-frame rearrangements and breakpoints within the HER2 amplicon) were associated wi… (full text at CIViC)

PMID 24395524 · Natrajan et al., 2014 · Open in CIViC

BRCA1 Loss-of-function2
Talazoparib	Malignant Breast Neoplasm	Predictive	B	Supports Sensitivity Response	4	accepted	EID4838 In part 2 of a two-part dose-escalation phase I trial (NCT01286987), 71 patients with Ewings sarcoma, breast, ovarian, small cell lung, or pancreatic cancers received 1.0 mg/day talazoparib treatment.… (full text at CIViC) PMID 28242752 · de Bono et al., 2017 · Open in CIViC	civic
〃	Malignant Ovarian Neoplasm	Predictive	B	Supports Sensitivity Response	3	accepted	EID4876 In part 2 of a two-part dose-escalation phase I trial (NCT01286987), 71 patients with Ewings sarcoma, breast, ovarian, small cell lung, or pancreatic cancers received 1.0 mg/day talazoparib treatment.… (full text at CIViC) PMID 28242752 · de Bono et al., 2017 · Open in CIViC	civic