FDA · United States
venetoclax — FDA regulatory status
venetoclax (VENCLEXTA) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- VENCLEXTA
- Originator
- AbbVie
- Mechanism
- Apoptosis regulator Bcl-2 inhibitor
- Target
- Apoptosis regulator Bcl-2
- Structured fields
- 8
Sponsor / originator context: AbbVie. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Apoptosis regulator Bcl-2 inhibitor. Target: Apoptosis regulator Bcl-2. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 87 published clinical programs and 8 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| 75276617AML3001 | Phase 3 | Janssen-Cilag International N.V | 2024-520154-38-00 |
| ACE-CL-311 (AMPLIFY) | Phase 3 | Anaxis Pharma | 2023-509349-11-00 |
| Azacitidine Combined With Venetoclax and ATRA group | Phase 3 | First People's Hospital | NCT05654194 |
| BGB-11417 for Previously Untreated Chronic Lymphocytic Leukemia | Phase 3 | BEONE MEDICINES AUS | 2023-506948-17-00 |
| BGB-11417-303CLL-RR1 | Phase 3 | BEONE MEDICINES AUS | 2024-517131-52-00 |
| BGB-11417-304 | Phase 3 | BEONE MEDICINES AUS | 2025-524366-21-00 |
| BGB-16673-302 | Phase 3 | BEONE MEDICINES AUS | 2024-518893-15-00 |
| BGB-3111-304 | Phase 3 | BEONE MEDICINES AUS | 2023-509976-40-00 |
| BO25323 | Phase 3 | HOFFMANN-LA ROCHE | 2023-504034-22-00 |
| BO40729 | Phase 3 | HOFFMANN-LA ROCHE | 2023-506184-34-00 |
| CO41685 | Phase 3 | HOFFMANN-LA ROCHE | 2023-504036-17-00 |
| CSET 2025/4132 | Phase 3 | George Institute for | 2025-521634-29-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 2025027051 | INHIBITEURS DE SPHINGOSINE-1-PHOSPHATE LYASE DESTINÉS À ÊTRE UTILISÉS DANS LE TRAITEMENT DE MALADIES NEURODÉGÉNÉRATIVES | WO |
| 2024175803 | COMPOSÉS POUR LE TRAITEMENT DE MALADIES MYÉLOÏDES AVEC DES ANOMALIES CHROMOSOMIQUES | WO |
| 2024146923 | INHIBITEURS DE POLYMÉRISATION DE TUBULINE | WO |
| 2022234069 | NOUVEAUX DÉRIVÉS DE 2-AMINOOXAZOLE ET LEUR UTILISATION POUR LE TRAITEMENT DE MALADIES INFECTIEUSES | WO |
| 3144307 | NEUE OXAZOL DERIVATEN ALS SYK KINASEHEMMER | EP |
| 2016085391 | DÉRIVÉS DE BIS (SULFONAMIDE) ETLEUR UTILISATION COMME INHIBITEURS DE MPGES | WO |
| 2016085392 | DÉRIVÉS DE BIS (SULFONAMIDE) ET LEUR UTILISATION COMME INHIBITEURS DE MPGES | WO |
| 2016071511 | TRAITEMENT DU SYNDROME D'ACTIVATION MASTOCYTAIRE (SAMA) AVEC LE MASINITIB | WO |
Related hubs
FAQ
What is the FDA approval status of venetoclax?
venetoclax currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get venetoclax regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to venetoclax?
This spoke lists 87 published programs associated with venetoclax in our pipeline index.