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Molecule

Venetoclax

BCL-2 Inhibitor
Available on requestOrphanOncology
Presentations
4
Brands
1
Manufacturers
1
Available from stock
0

Venetoclax is a BCL-2 inhibitor indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), among other approved uses. It is available as tablets and kits for oral use. MedsAcross supplies Venetoclax for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
BCL-2 Inhibitor, P-Glycoprotein Inhibitors, Increased Cellular Death
ATC classification
L01XX52 Venetoclax · Cancer medicines (antineoplastics), subgroup L01X, subgroup L01XX
US FDA first approval
11 April 2016
EU status
Authorised
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Tablet, Kit
Identifiers
UNII N54AIC43PWRxCUI 1747556CAS 1257044-40-8DrugBank DB11581Q23671272

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

VENCLEXTA is a BCL-2 inhibitor indicated: For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). 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.

Source: US FDA prescribing information

How it works

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.

Source: US FDA prescribing information

Dosing overview

See Full Prescribing Information for recommended VENCLEXTA dosages. Take VENCLEXTA tablets orally once daily with a meal and water. Provide prophylaxis for tumor lysis syndrome.

Source: US FDA prescribing information

Contraindications

Concomitant use of VENCLEXTA with strong CYP3A inhibitors at initiation and during the ramp-up phase is contraindicated in patients with CLL/SLL due to the potential for increased risk of tumor lysis syndrome. Concomitant use with strong CYP3A inhibitors at initiation and during ramp-up phase in patients with CLL/SLL is contraindicated.

Source: US FDA prescribing information

Warnings and precautions

Tumor Lysis Syndrome (TLS): Anticipate TLS, assess risk in all patients. Premedicate with anti-hyperuricemics and ensure adequate hydration. Employ more intensive measures (intravenous hydration, frequent monitoring, hospitalization) as overall risk increases. Neutropenia: Monitor blood counts. Interrupt dosing and resume at same or reduced dose. Consider supportive care measures. Infections: Monitor for signs and symptoms of infection and treat promptly. Withhold for Grade 3 and 4 infection until resolution and resume at same or reduced dose. Immunization: Do not administer live attenuated vaccines prior to, during, or after treatment with VENCLEXTA until B-cell recovery. Embryo-Fetal Toxicity: May cause embryo-fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

Source: US FDA prescribing information

Side effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Tumor Lysis Syndrome Neutropenia Infections In CLL/SLL, the most common adverse reactions (≥20%) for VENCLEXTA when given in combination with obinutuzumab or rituximab or as monotherapy are neutropenia, thrombocytopenia, anemia, diarrhea, nausea, upper respiratory tract infection, cough, musculoskeletal pain, fatigue, and edema. In CLL/SLL, the most common adverse reactions (≥20%) for VENCLEXTA when given in combination with acalabrutinib are neutropenia, headache, diarrhea, musculoskeletal pain, and COVID-19.

Source: US FDA prescribing information

Interactions

Strong or moderate CYP3A inhibitors or P-gp inhibitors: Adjust dosage of VENCLEXTA. Strong or moderate CYP3A inducers: Avoid co-administration. P-gp substrates: Take at least 6 hours before VENCLEXTA.

Source: US FDA prescribing information

Storage

Store in original container at or below 86°F (30°C). Dispense to patient in original container to protect from moisture.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

4 presentations of Venetoclax, sorted by availability.

MedicineManufacturerRegisterAvailability
Venclexta 100 mg tabletOralAbbVieUS FDAAvailable on request
Venclexta 10 mg tabletOralAbbVieUS FDAAvailable on request
Venclexta 50 mg tabletOralAbbVieUS FDAAvailable on request
Venclexta kitAbbVieUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 11 April 2016Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Venetoclax in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Venetoclax available for export from India?

Yes, on request. MedsAcross lists 4 presentations of Venetoclax and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Venetoclax have?

The catalogue lists 1 brand names for Venetoclax, including Venclexta.

Is Venetoclax approved by the US FDA?

Yes. The US FDA first approved Venetoclax on 11 April 2016, according to Drugs@FDA.

Is Venetoclax authorised in the European Union?

Yes. Venetoclax has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Venetoclax need cold chain shipping?

No listed presentation of Venetoclax is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Venetoclax in?

Venetoclax is classified under ATC code L01XX52 (Venetoclax).

References

  1. Venclexta prescribing information (AbbVie). U.S. National Library of Medicine, DailyMed. Retrieved 20 May 2026
  2. Venclyxto: European public assessment report (EPAR). European Medicines Agency. Retrieved 10 July 2026

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