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Drug ReportsTalazoparib
Talzenna(talazoparib)
Talzenna (talazoparib) is a small molecule pharmaceutical. Talazoparib was first approved as Talzenna on 2018-10-16. It is used to treat breast neoplasms in the USA. It has been approved in Europe to treat breast neoplasms. The pharmaceutical is active against poly [ADP-ribose] polymerase 2 and poly [ADP-ribose] polymerase 1.
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FDA approval date
EMA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Talzenna
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Talazoparib tosylate
Tradename
Company
Number
Date
Products
TALZENNAMylanN-211651 RX2018-10-16
6 products, RLD, RS
Labels
FDA
EMA
No data
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
breast neoplasmsEFO_0003869D001943C50
Agency Specific
FDA
EMA
Expiration
Code
TALAZOPARIB TOSYLATE, TALZENNA, PFIZER
2026-06-20I-920
Patent Expiration
Patent
Expires
Flag
FDA Information
Talazoparib Tosylate, Talzenna, Pfizer
87353922031-10-20DS, DP
101898372031-10-20DS, DP
80129762029-10-19DS, DP
84206502029-07-27DS, DP
98209852029-07-27U-2437
107800882029-07-27U-3651
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01X: Other antineoplastic agents in atc
— L01XK: Poly (adp-ribose) polymerase (parp) inhibitors
— L01XK04: Talazoparib
HCPCS
No data
Clinical
Clinical Trials
114 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C8021141—433
Breast neoplasmsD001943EFO_0003869C5011151—326
Ovarian neoplasmsD010051EFO_0003893C56862——15
Prostatic neoplasmsD011471—C61781——14
Non-small-cell lung carcinomaD002289——321——6
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Triple negative breast neoplasmsD064726——710———14
Pancreatic neoplasmsD010190EFO_0003860C2542———5
Myeloid leukemia acuteD015470—C92.052———5
Fallopian tube neoplasmsD005185——41———5
Castration-resistant prostatic neoplasmsD064129——32——15
Endometrial neoplasmsD016889EFO_0004230—23———4
Colorectal neoplasmsD015179——32———4
Renal cell carcinomaD002292EFO_0000376—23———3
Lung neoplasmsD008175HP_0100526C34.9011———2
Squamous cell carcinoma of head and neckD000077195——21———2
Show 26 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Small cell lung carcinomaD055752——3————3
LeukemiaD007938—C951————1
Uterine cervical neoplasmsD002583HP_0030159—1————1
Vaginal neoplasmsD014625—C521————1
MesotheliomaD008654—C451————1
Myelodysplastic syndromesD009190—D461————1
B-cell chronic lymphocytic leukemiaD015451—C91.11————1
Mantle-cell lymphomaD020522—C83.11————1
Ovarian epithelial carcinomaD000077216——1————1
Neuroendocrine tumorsD018358EFO_1001901D3A.81————1
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Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTalazoparib
INNtalazoparib
Description
Talazoparib, sold under the brand name Talzenna, is an anti-cancer medication used for the treatment of breast cancer and prostrate cancer. It is an orally available poly ADP ribose polymerase PARP inhibitor marketed by Pfizer for the treatment of advanced breast cancer with germline BRCA mutations. Talazoparib is similar to the first in class PARP inhibitor, olaparib.
Classification
Small molecule
Drug classpoly-ADP-ribose polymerase inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Cn1ncnc1[C@H]1c2n[nH]c(=O)c3cc(F)cc(c23)N[C@@H]1c1ccc(F)cc1
Identifiers
PDB—
CAS-ID1207454-56-5
RxCUI—
ChEMBL IDCHEMBL3137320
ChEBI ID—
PubChem CID—
DrugBankDB11760
UNII ID9QHX048FRV (ChemIDplus, GSRS)
Target
Agency Approved
PARP2
PARP2
PARP1
PARP1
Organism
Homo sapiens
Gene name
PARP2
Gene synonyms
ADPRT2, ADPRTL2
NCBI Gene ID
Protein name
poly [ADP-ribose] polymerase 2
Protein synonyms
ADP-ribosyltransferase (NAD+; poly(ADP-ribose) polymerase)-like 2, ADP-ribosyltransferase diphtheria toxin-like 2, ADPRT-2, ARTD2, DNA ADP-ribosyltransferase PARP2, hPARP-2, NAD(+) ADP-ribosyltransferase 2, pADPRT-2, poly (ADP-ribose) polymerase family, member 2, poly (ADP-ribosyl) transferase-like 2, Poly[ADP-ribose] synthase 2, poly[ADP-ribose] synthetase 2, Protein poly-ADP-ribosyltransferase PARP2
Uniprot ID
Mouse ortholog
Parp2 (11546)
poly [ADP-ribose] polymerase 2 (Q99N29)
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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559 adverse events reported
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