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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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Study first post date
Last update post 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
TALZENNAPfizerN-211651 RX2018-10-16
6 products, RLD, RS
TALZENNAPfizerN-217439 RX2024-03-07
6 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
talzennaNew Drug Application2024-04-17
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
115 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—C8026171—441
Breast neoplasmsD001943EFO_0003869C5015221—336
Prostatic neoplasmsD011471—C619102—120
Ovarian neoplasmsD010051EFO_0003893C56852——14
Ovarian epithelial carcinomaD000077216——531——9
Non-small-cell lung carcinomaD002289——321——6
Castration-resistant prostatic neoplasmsD064129——321—16
Hereditary breast and ovarian cancer syndromeD061325——131——5
Brca2 genesD024522———11——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Triple negative breast neoplasmsD064726——710———14
CarcinomaD002277—C80.057——112
RecurrenceD012008——55———8
Lung neoplasmsD008175HP_0100526C34.9033——17
Neoplasm metastasisD009362EFO_0009708—42———6
Myeloid leukemia acuteD015470—C92.052——16
AdenocarcinomaD000230——43———6
Small cell lung carcinomaD055752——32———5
Pancreatic neoplasmsD010190EFO_0003860C2542———5
Fallopian tube neoplasmsD005185——41———5
Show 43 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Serous cystadenocarcinomaD018284——3————3
Myelodysplastic syndromesD009190—D461———12
Esophageal neoplasmsD004938—C151————1
Female genital neoplasmsD005833——1————1
Uterine cervical neoplasmsD002583HP_0030159—1————1
Vaginal neoplasmsD014625—C521————1
And serous mucinous cystic neoplasmsD018297——1————1
Hematologic neoplasmsD019337——1————1
B-cell chronic lymphocytic leukemiaD015451—C91.11————1
Mantle-cell lymphomaD020522——1————1
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PancytopeniaD010198HP_0001876D61.81————11
HypertensionD006973EFO_0000537I10————11
PreleukemiaD011289——————11
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
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,092 adverse events reported
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