Venclexta
An oral medication used to treat chronic lymphocytic leukemia and acute myeloid leukemia.
Where Venetoclax is approved
All regulators →Of the three regulators tracked here, the first to approve Venetoclax was the US, on 11 Apr 2016. It is approved in 3 of the 3 regulators tracked here.
- 4 EU orphan designations, most recently for treatment of mantle cell lymphoma (12 Dec 2017, withdrawn)
- 1 EU safety letter (DHPC), latest: type ii variation for Venclyxto, 10 Jun 2021
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Venetoclax patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Venetoclax, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 10 listed patents; the last listed expires 6 Sep 2033 (US 9539251).
- Latest patent on the drug substance itself: 29 Jan 2032 (US 8722657).
Reproduced from the FDA Orange Book and Purple Book (checked 12 Oct 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Venetoclax
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Venetoclax works
All drug targets →- Apoptosis regulator Bcl-2 inhibitor InhibitorTarget: BCL2 BCL2 apoptosis regulator✓ In ChEMBL and the Guide to Pharmacology
- T-cell acute lymphoblastic leukemiaPhase 3
- T-cell adult acute lymphocytic leukemiaPhase 3
- Acute leukemiaPhase 3
- Acute lymphoblastic leukemiaPhase 3
- Acute myeloid leukemiaPhase 3
- LeukemiaPhase 3
- Mantle cell lymphomaPhase 3
- Myelodysplastic syndromePhase 3
- Plasma cell myelomaPhase 3
- Myeloid neoplasmPhase 2/3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL3137309, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 8318, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Venetoclax
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 7 technology appraisals of Venetoclax. 6 are current, and 6 of these recommend it for at least some patients. 1 older appraisal was replaced or withdrawn.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Venetoclax with obinutuzumab for untreated chronic lymphocytic leukaemia NICE TA1119 | Recommended | 7 Jan 2026 | Current |
| Venetoclax for treating chronic lymphocytic leukaemia NICE TA796 | Recommended | 15 Jun 2022 | Current |
| Venetoclax with low dose cytarabine for untreated acute myeloid leukaemia when intensive chemotherapy is unsuitable NICE TA787 | Optimised | 27 Apr 2022 | Current |
| Venetoclax with azacitidine for untreated acute myeloid leukaemia when intensive chemotherapy is unsuitable NICE TA765 | Recommended | 2 Feb 2022 | Current |
| Venetoclax with obinutuzumab for untreated chronic lymphocytic leukaemia NICE TA663 | Optimised Recommended (Cancer Drugs Fund) | 9 Dec 2020 | Current |
| Venetoclax with rituximab for previously treated chronic lymphocytic leukaemia NICE TA561 | Recommended | 27 Feb 2019 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Venetoclax
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 3 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: VenclyxtoEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Venetoclax
- ATC code
- L01XX52
- ChEMBL
- CHEMBL3137309
- DrugBank
- DB11581
- PubChem CID
- 49846579
- CAS number
- 1257044-40-8
- FDA UNII
- N54AIC43PW
- Wikidata
- Q23671272
- Wikipedia
- Venetoclax
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
What Venclexta is used for
VENCLEXTA is a BCL-2 inhibitor indicated: For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). ( 1.1 ) In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. ( 1.2 ) 1.1 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma VENCLEXTA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). 1.2 Acute Myeloid Leukemia VENCLEXTA is indicated in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction ch…
How it works
12.1 Mechanism of Action Venetoclax is a selective and orally bioavailable small-molecule inhibitor of BCL-2, an anti-apoptotic protein. Overexpression of BCL-2 has been demonstrated in CLL and AML cells where it mediates tumor cell survival and has been associated with resistance to chemotherapeutics. Venetoclax helps restore the process of apoptosis by binding directly to the BCL-2 protein, displacing pro-apoptotic proteins like BIM, triggering mitochondrial outer membrane permeabilization and the activation of caspases. In nonclinical studies, venetoclax has demonstrated cytotoxic activity in tumor cells that overexpress BCL-2.
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How this page is built
The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.
- FDA Drug Label (openFDA) ↗ Indications, mechanism of action and pharmacologic class
- Drugs@FDA ↗ First FDA approval date and the company holding the application
- FDA Drug Shortage Database ↗ Current US supply / shortage status
Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 12 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.