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Venclexta (venetoclax)
Venclexta (generic name: venetoclax) is a BCL-2 Inhibitor [EPC] drug developed by AbbVie. It is currently FDA-approved (first approved 2014) for Acute myeloid leukemia, disease, Chronic lymphoid leukemia, disease, Malignant lymphoma - small lymphocytic.
Venclexta is a selective and orally bioavailable small-molecule inhibitor of BCL-2, an anti-apoptotic protein.
Venclexta is a medication used to treat adults with acute myeloid leukemia (AML). It works by inhibiting the apoptosis regulator Bcl-2, a small molecule inhibitor of this protein.
At a glance
| Generic name | venetoclax |
|---|---|
| Sponsor | AbbVie |
| Drug class | BCL-2 Inhibitor [EPC] |
| Target | Apoptosis regulator Bcl-2 |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2014 |
| Annual revenue | 2583 |
Mechanism of action
Venetoclax is a medication that works by binding directly to the BCL-2 protein. This binding action displaces pro-apoptotic proteins like BIM, triggering mitochondrial outer membrane permeabilization and the activation of caspases. As a result, venetoclax helps restore the process of apoptosis in cancer cells.
Approved indications
- Acute myeloid leukemia, disease
- Chronic lymphoid leukemia, disease
- Malignant lymphoma - small lymphocytic
Common side effects
- Neutropenia
- Lymphopenia
- Thrombocytopenia
- Anemia
- Headache
- Diarrhea
- Nausea
- Musculoskeletal pain
- Fatigue
- COVID-19
- Bruising
- Rash
Drug interactions
- Strong or moderate CYP3A inhibitors or P-gp inhibitors
- Strong CYP3A inhibitors at initiation and during the ramp-up phase
- Strong or moderate CYP3A inhibitors or P-gp inhibitors
- Strong or moderate CYP3A inducers
- Warfarin
- P-gp substrates
- Grapefruit products, Seville oranges, and starfruit
Key clinical trials
- Venetoclax in Combination With ASTX727 for the Treatment of Chronic Myelomonocytic Leukemia and Other Myelodysplastic Syndrome/Myeloproliferative Neoplasm (PHASE2)
- Testing the Combination of an Anti-Cancer Drug, Iadademstat, With Other Anti-Cancer Drugs (Venetoclax and Azacitidine) for Treating AML (PHASE1)
- Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia (PHASE2)
- The Safety and Tolerability of LBS-007 in Patients With Relapsed or Resistant Acute Leukaemias (PHASE1, PHASE2)
- BLAST MRD AML-2: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 2- A Randomized Phase 2 Study of Anti-PD-1 Pembrolizumab in Combination With Azacitidine and Venetoclax as Frontline Therapy in Unfit Patients With Acute Myeloid Leukemia (PHASE2)
- Venetoclax for the Treatment of Patients With Relapsed Hairy Cell Leukemia (PHASE2)
- Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia (NA)
- Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial) (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Venclexta CI brief — competitive landscape report
- Venclexta updates RSS · CI watch RSS
- AbbVie portfolio CI
Frequently asked questions about Venclexta
What is Venclexta?
How does Venclexta work?
What is Venclexta used for?
Who makes Venclexta?
What is the generic name of Venclexta?
What drug class is Venclexta in?
When was Venclexta approved?
What development phase is Venclexta in?
What are the side effects of Venclexta?
What is Venclexta's annual revenue?
What does Venclexta target?
Related
- Drug class: All BCL-2 Inhibitor [EPC] drugs
- Target: All drugs targeting Apoptosis regulator Bcl-2
- Manufacturer: AbbVie — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Acute myeloid leukemia, disease
- Indication: Drugs for Chronic lymphoid leukemia, disease
- Indication: Drugs for Malignant lymphoma - small lymphocytic
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing