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
Therapeutic Areas
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EMA
Venclexta
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| venclexta | New Drug Application | 2024-07-12 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| lymphoid leukemia | — | D007945 | C91 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
VENETOCLAX, VENCLEXTA, ABBVIE | |||
| 2026-05-15 | ODE-239 | ||
| 2025-11-21 | ODE-211 | ||
| 2025-06-08 | ODE-185 | ||
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
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Clinical
Clinical Trials
768 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloid leukemia acute | D015470 | — | C92.0 | 28 | 18 | 8 | 2 | 11 | 60 |
| Leukemia | D007938 | — | C95 | 16 | 15 | 11 | 1 | 21 | 60 |
| Myeloid leukemia | D007951 | — | C92 | 12 | 6 | 6 | 1 | 10 | 33 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 5 | 13 | 9 | — | 13 | 38 |
| Neoplasms | D009369 | — | C80 | 12 | 6 | 4 | — | 4 | 25 |
| Lymphoid leukemia | D007945 | — | C91 | 3 | 3 | 6 | — | 10 | 22 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 15 | 4 | 1 | — | 1 | 19 |
| Multiple myeloma | D009101 | — | C90.0 | 6 | 7 | 3 | — | 1 | 14 |
| Myelodysplastic syndromes | D009190 | — | D46 | 9 | 2 | 1 | — | — | 10 |
| Plasma cell neoplasms | D054219 | — | — | 4 | 6 | 2 | — | — | 10 |
| Recurrence | D012008 | — | — | 7 | 4 | 1 | — | — | 10 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 6 | 2 | 1 | — | 2 | 9 |
| Preleukemia | D011289 | — | — | 4 | 1 | 1 | — | — | 5 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 12 | 7 | — | — | — | 16 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 4 | 2 | — | — | — | 5 |
| Biphenotypic leukemia acute | D015456 | — | C95.0 | 4 | 2 | — | — | — | 5 |
| B-cell lymphoma | D016393 | — | — | 5 | 2 | — | — | — | 5 |
| Mantle-cell lymphoma | D020522 | — | C83.1 | 1 | 4 | — | — | — | 5 |
| Lung neoplasms | D008175 | — | C34.90 | 3 | 1 | — | — | — | 3 |
| Waldenstrom macroglobulinemia | D008258 | — | C88.0 | — | 3 | — | — | — | 3 |
| Precursor t-cell lymphoblastic leukemia-lymphoma | D054218 | — | — | 2 | 2 | — | — | — | 3 |
| Lymphoproliferative disorders | D008232 | Orphanet_2442 | D47.9 | 1 | 2 | — | — | — | 2 |
| Small cell lung carcinoma | D055752 | — | — | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Hematologic neoplasms | D019337 | — | — | 4 | — | — | — | — | 4 |
| Healthy volunteers/patients | — | — | — | 3 | — | — | — | — | 3 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | — | — | — | — | 2 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 2 | — | — | — | — | 2 |
| Non-small-cell lung carcinoma | D002289 | — | — | 2 | — | — | — | — | 2 |
| Prostatic neoplasms | D011471 | — | C61 | 2 | — | — | — | — | 2 |
| Primary myelofibrosis | D055728 | — | D47.4 | 1 | — | — | — | 1 | 2 |
| Neuroblastoma | D009447 | EFO_0000621 | — | 1 | — | — | — | — | 1 |
| Colorectal neoplasms | D015179 | — | — | 1 | — | — | — | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Plasma cell leukemia | D007952 | — | C90.1 | — | — | — | — | 1 | 1 |
| Patient preference | D057240 | — | — | — | — | — | — | 1 | 1 |
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 | — |
| ChEMBL ID | CHEMBL3137309 |
| ChEBI ID | — |
| PubChem CID | 49846579 |
| DrugBank | DB11581 |
| UNII ID | N54AIC43PW (ChemIDplus, GSRS) |
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Venclexta – AbbVie
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Safety
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53,921 adverse events reported
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