Overview
Venetoclax is a BCL-2 inhibitor that was initially approved by the FDA in April 2016 . Proteins in the B cell CLL/lymphoma 2 (BCL-2) family are important regulators of the apoptotic (programmed cell death) process , . Venetoclax is used to treat chronic lymphocytic leukemia (CLL) and certain types of small lymphocytic lymphoma . CLL is the most prevalent leukemia diagnosed in Western countries . Venetoclax was developed through reverse engineering of the BCL-2 protein family inhibitor, navitoclax . Venetoclax is approximately 10 times more potent than navitoclax with regard to induction of apoptosis in CLL cells . A new indication was approved in 2018 for the treatment patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy . Previously, this drug was indicated only for patients with 17p gene deletion .
Indication
本品与阿扎胞苷联合用于治疗因合并症不适合接受强诱导化疗，或者年龄75岁及以上的新诊断的成人急性髓系白血病患者。
Associated Conditions
- Acute Myeloid Leukemia
- Chronic Lymphocytic Leukemia
- Small Lymphocytic Lymphoma
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/08/21 | Not Applicable | Not yet recruiting | City of Hope Medical Center | ||
2025/08/20 | Not Applicable | Not yet recruiting | |||
2025/08/20 | Not Applicable | Recruiting | |||
2025/07/24 | Not Applicable | Not yet recruiting | |||
2025/07/22 | Not Applicable | Recruiting | Beijing 302 Hospital | ||
2025/07/20 | Not Applicable | Recruiting | Stichting Hemato-Oncologie voor Volwassenen Nederland | ||
2025/07/11 | Not Applicable | Not yet recruiting | |||
2025/07/11 | Not Applicable | Not yet recruiting | Joanna Yi | ||
2025/07/04 | Not Applicable | Not yet recruiting | |||
2025/07/01 | Not Applicable | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| AbbVie Inc. | 0074-0566 | ORAL | 50 mg in 1 1 | 3/17/2023 | |
| AbbVie Inc. | 0074-0561 | ORAL | 10 mg in 1 1 | 3/17/2023 | |
| AbbVie Inc. | 0074-0576 | ORAL | 100 mg in 1 1 | 3/17/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 12/4/2016 | ||
Authorised | 12/4/2016 | ||
Authorised | 12/4/2016 | ||
Authorised | 12/4/2016 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| VENCLEXTA FILM-COATED TABLET 50MG | SIN15266P | TABLET, FILM COATED | 50.0 mg | 6/8/2017 | |
| VENCLEXTA FILM-COATED TABLET 10MG | SIN15265P | TABLET, FILM COATED | 10.0 mg | 6/8/2017 | |
| VENCLEXTA FILM-COATED TABLET 100MG | SIN15267P | TABLET, FILM COATED | 100.0 mg | 6/8/2017 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| VENCLEXTA venetoclax 10 mg film-coated tablet blister pack | 267441 | Medicine | A | 1/5/2017 | |
| VENCLEXTA venetoclax 100 mg film-coated tablet bottle | 267445 | Medicine | A | 1/5/2017 | |
| VENCLEXTA venetoclax 50 mg film-coated tablet blister pack | 267444 | Medicine | A | 1/5/2017 | |
| VENCLEXTA STARTING PACK venetoclax 10 mg, 50 mg, 100 mg film-coated tablets blister pack | 267443 | Medicine | A | 1/5/2017 | |
| VENCLEXTA venetoclax 100 mg film-coated tablet blister pack | 267442 | Medicine | A | 1/5/2017 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| VENCLEXTA | 02458047 | Tablet - Oral | 50 MG | 10/31/2016 | |
| VENCLEXTA | 02458063 | Kit
,
Tablet - Oral | 10 MG | 10/31/2016 | |
| VENCLEXTA | 02458063 | Kit
,
Tablet - Oral | 50 MG | 10/31/2016 | |
| VENCLEXTA | 02458063 | Kit
,
Tablet - Oral | 100 MG | 10/31/2016 | |
| VENCLEXTA | 02458039 | Tablet - Oral | 10 MG | 10/31/2016 | |
| VENCLEXTA | 02458055 | Tablet - Oral | 100 MG | 10/31/2016 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| VENCLYXTO 100 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 161138007IP | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized | |
| VENCLYXTO 50 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 161138004 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized | |
| VENCLYXTO 10 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 161138002 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized | |
| VENCLYXTO 100 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 161138005 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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