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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Commercial
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 |
|---|---|---|---|---|
| TALZENNA | Mylan | N-211651 RX | 2018-10-16 | 4 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| talzenna | New Drug Application | 2021-10-06 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| breast neoplasms | EFO_0003869 | D001943 | C50 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
TALAZOPARIB TOSYLATE, TALZENNA, PFIZER | |||
| 2023-10-16 | NCE | ||
HCPCS
No data
Clinical
Clinical Trials
108 clinical trials
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Indications Phases 4
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Triple negative breast neoplasms | D064726 | 7 | 10 | — | — | — | 14 | ||
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 4 | 2 | — | — | — | 5 |
| Myeloid leukemia acute | D015470 | C92.0 | 5 | 2 | — | — | — | 5 | |
| Fallopian tube neoplasms | D005185 | 4 | 1 | — | — | — | 5 | ||
| Castration-resistant prostatic neoplasms | D064129 | 3 | 2 | — | — | 1 | 5 | ||
| Endometrial neoplasms | D016889 | EFO_0004230 | 2 | 3 | — | — | — | 4 | |
| Colorectal neoplasms | D015179 | 3 | 2 | — | — | — | 4 | ||
| Renal cell carcinoma | D002292 | 2 | 3 | — | — | — | 3 | ||
| Lung neoplasms | D008175 | C34.90 | 1 | 1 | — | — | — | 2 | |
| Squamous cell carcinoma of head and neck | D000077195 | 2 | 1 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Small cell lung carcinoma | D055752 | 3 | — | — | — | — | 3 | ||
| Leukemia | D007938 | C95 | 1 | — | — | — | — | 1 | |
| Uterine cervical neoplasms | D002583 | 1 | — | — | — | — | 1 | ||
| Vaginal neoplasms | D014625 | C52 | 1 | — | — | — | — | 1 | |
| Mesothelioma | D008654 | C45 | 1 | — | — | — | — | 1 | |
| Myelodysplastic syndromes | D009190 | D46 | 1 | — | — | — | — | 1 | |
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | 1 | — | — | — | — | 1 | |
| Mantle-cell lymphoma | D020522 | C83.1 | 1 | — | — | — | — | 1 | |
| Ovarian epithelial carcinoma | D000077216 | 1 | — | — | — | — | 1 | ||
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | TALAZOPARIB |
| INN | talazoparib |
| Description | Talazoparib, sold under the brand name Talzenna, is an orally available poly ADP ribose polymerase (PARP) inhibitor developed by Pfizer for the treatment of advanced breast cancer with germline BRCA mutations. Talazoparib is similar to the first in class PARP inhibitor, olaparib. It was approved in October 2018, in the United States and June 2019, in the European Union for germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer.
|
| Classification | Small molecule |
| Drug class | poly-ADP-ribose polymerase inhibitors |
| Image (chem structure or protein) | |
| 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-ID | 1207456-01-6 |
| RxCUI | 2099704 |
| ChEMBL ID | CHEMBL3137320 |
| ChEBI ID | — |
| PubChem CID | 135565082 |
| DrugBank | DB11760 |
| UNII ID | 9QHX048FRV (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
Clinical Variant
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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176 adverse events reported
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