Venclexta, Venclyxto(venetoclax)
Venclexta, Venclyxto (venetoclax) is a small molecule pharmaceutical. Venetoclax was first approved as Venclexta on 2016-04-11. It is used to treat lymphoid leukemia and myeloid leukemia acute in the USA. It has been approved in Europe to treat b-cell chronic lymphocytic leukemia. The pharmaceutical is active against apoptosis regulator Bcl-2. In addition, it is known to target bcl-2-like protein 1, bcl-2-like protein 2, and induced myeloid leukemia cell differentiation protein Mcl-1.
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Commercial
Trade Name
FDA
EMA
Venclexta
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Venetoclax
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
VENCLEXTA | AbbVie | N-208573 RX | 2016-04-11 | 3 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
venclexta | New Drug Application | 2020-11-23 |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
VENETOCLAX, VENCLEXTA, ABBVIE | |||
2026-05-15 | ODE-239 | ||
2025-11-21 | ODE-211 | ||
2025-06-08 | ODE-185 | ||
2023-10-16 | M-265 | ||
2023-04-11 | ODE-114 |
Patent Expiration
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Venetoclax, Venclexta, Abbvie | |||
9539251 | 2033-09-06 | U-2538 | |
10993942 | 2033-09-06 | U-3114 | |
11110087 | 2033-09-06 | U-3222, U-3223 | |
11413282 | 2033-09-06 | U-3412 | |
11590128 | 2033-09-06 | U-3548 | |
11369599 | 2032-05-23 | DP | |
8722657 | 2032-01-29 | DP | |
10730873 | 2031-11-21 | DP | |
8546399 | 2031-06-27 | DS, DP | |
9174982 | 2030-05-26 | U-2323, U-2445, U-2446, U-2537 |
HCPCS
No data
Clinical
Clinical Trials
456 clinical trials
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Myelodysplastic syndromes | D009190 | D46 | 29 | 27 | 2 | — | — | 44 | |
Non-hodgkin lymphoma | D008228 | C85.9 | 31 | 14 | 1 | — | 1 | 38 | |
Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 16 | 14 | 1 | — | 4 | 27 | |
Mantle-cell lymphoma | D020522 | C83.1 | 11 | 17 | 1 | — | — | 24 | |
Large b-cell lymphoma diffuse | D016403 | C83.3 | 19 | 10 | 1 | — | — | 23 | |
Multiple myeloma | D009101 | C90.0 | 13 | 11 | 2 | — | 1 | 21 | |
Neoplasms | D009369 | C80 | 9 | 4 | 3 | — | 1 | 15 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Myelomonocytic leukemia chronic | D015477 | C93.1 | 13 | 13 | — | — | — | 19 | |
Follicular lymphoma | D008224 | C82 | 13 | 10 | — | — | — | 18 | |
Leukemia | D007938 | C95 | 2 | 8 | — | — | 1 | 10 | |
Hematologic neoplasms | D019337 | 6 | 5 | — | — | — | 9 | ||
Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | 2 | 6 | — | — | — | 7 | |
Lymphoma | D008223 | C85.9 | 7 | 3 | — | — | — | 7 | |
Biphenotypic leukemia acute | D015456 | C95.0 | 2 | 5 | — | — | — | 6 | |
Reactive arthritis | D016918 | EFO_0007460 | M02.3 | 2 | 6 | — | — | — | 6 |
Waldenstrom macroglobulinemia | D008258 | C88.0 | 1 | 6 | — | — | — | 6 | |
Breast neoplasms | D001943 | EFO_0003869 | C50 | 4 | 2 | — | — | — | 5 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Myeloid leukemia | D007951 | C92 | 2 | — | — | — | — | 2 | |
Non-small-cell lung carcinoma | D002289 | 2 | — | — | — | — | 2 | ||
Recurrence | D012008 | 2 | — | — | — | — | 2 | ||
Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | — | — | — | — | 1 |
Anemia | D000740 | EFO_0004272 | D64.9 | 1 | — | — | — | — | 1 |
Hodgkin disease | D006689 | C81 | 1 | — | — | — | — | 1 | |
Sarcoma | D012509 | 1 | — | — | — | — | 1 | ||
Chondrosarcoma | D002813 | 1 | — | — | — | — | 1 | ||
Prolymphocytic leukemia | D015463 | 1 | — | — | — | — | 1 | ||
Male breast neoplasms | D018567 | 1 | — | — | — | — | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | VENETOCLAX |
INN | venetoclax |
Description | Venetoclax is a member of the class of pyrrolopyridines that is a potent inhibitor of the antiapoptotic protein B-cell lymphoma 2. It is used for treamtment of chronic lymphocytic leukemia with 17p deletion. It has a role as an apoptosis inducer, an antineoplastic agent and a B-cell lymphoma 2 inhibitor. It is a member of oxanes, a N-sulfonylcarboxamide, an aromatic ether, a pyrrolopyridine, a member of monochlorobenzenes, a N-arylpiperazine, a N-alkylpiperazine and a C-nitro compound. |
Classification | Small molecule |
Drug class | bcl-2 (B-cell lymphoma 2) inhibitors |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | CC1(C)CCC(CN2CCN(c3ccc(C(=O)NS(=O)(=O)c4ccc(NCC5CCOCC5)c([N+](=O)[O-])c4)c(Oc4cnc5[nH]ccc5c4)c3)CC2)=C(c2ccc(Cl)cc2)C1 |
Identifiers
PDB | — |
CAS-ID | 1257044-40-8 |
RxCUI | 1747556 |
ChEMBL ID | CHEMBL3137309 |
ChEBI ID | — |
PubChem CID | 49846579 |
DrugBank | DB11581 |
UNII ID | N54AIC43PW (ChemIDplus, GSRS) |
Target
Alternate
Variants
Clinical Variant
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Financial
Venclexta - AbbVie
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Additional graphs summarizing 7,905 documents
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Safety
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Adverse Events
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11,525 adverse events reported
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