> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/venetoclax-8c5219f4-7631-4292-b4f0-2c601d914e9f > Record changed: 2026-10-13 # Venetoclax Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3137309) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3137309) First approval year 2016 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3137309) ## Development status **First approval year** 2016 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3137309) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3137309) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3137309) **Drug name** Venetoclax Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3137309) **Molecular weight** 868.46 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3137309) **Structure (SMILES)** CC1(C)CCC(CN2CCN(c3ccc(C(=O)NS(=O)(=O)c4ccc(NCC5CCOCC5)c(\[N+\](=O)\[O-\])c4)c(Oc4cnc5\[nH\]ccc5c4)c3)CC2)=C(c2ccc(Cl)cc2)C1 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3137309) ### Brand names (4) - venclexta - Venclexta - venclyxto - Venclyxto ### Other names (65) - \[14C\]ABT-199 (GDC-0199) - 14c abt 199 gdc 0199 - 400mg ABT-199 - 800mg ABT-199 - abbvie - ABBVIE - abt 199 - ABT 199 - ABT-199 - ABT-199 (Main Cohort) - ABT-199 (Safety Expansion Cohort) - ABT-199 (venetoclax) - abt199 - Abt199 - ABT199 - c45h50cln7o7s - C45H50CLN7O7S - chronic lymphocytic leukaemia therapy - CHRONIC LYMPHOCYTIC LEUKAEMIA THERAPY - gdc 0199 - GDC-0199 - rg 7601 - RG-7601 - rg7601 - RG7601 And 40 more, listed on the interactive page. ## Identifiers **ATC classification codes** - L01XX52 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3137309) **CAS registry numbers** - 1257044-40-8 **ChEMBL ID** CHEMBL3137309 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3137309) **InChIKey** LQBVNQSMGBZMKD-UHFFFAOYSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3137309) **PubChem compound IDs** - 49846579 **RxNorm IDs (RxCUI)** - 1747556 **FDA ingredient codes (UNII)** - N54AIC43PW ## Regulatory information ### United States **Applicant** ABBVIE **Approval date** 11 Apr 2016 **Application number** NDA208573 ### European Union **Status** Authorised **Status date** 4 Dec 2016 **Authorisation date** 4 Dec 2016 **Approved indications** Venclyxto is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL): in combination with acalabrutinib with or without obinutuzumab in combination with obinutuzumab in combination with ibrutinib Venclyxto in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy. Venclyxto monotherapy is indicated for the treatment of CLL: in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B cell receptor pathway inhibitor, or in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B cell receptor pathway inhibitor. Venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy. **Product number** EMEA/H/C/004106 **Authorisation holder** AbbVie Deutschland GmbH & Co. KG **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** No **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Leukemia, Lymphocytic, Chronic, B-Cell European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/venclyxto) ### Other regulatory facts **Patents** 10 **Designations** 9 **Earliest recorded loss of exclusivity** 6 Sept 2033 **First in class** Yes **Fast track** No **Breakthrough designation** Yes **Orphan designation** No **Priority review** Yes **Orphan exclusivity** No **Accelerated approval** Yes **Availability** Prescription only ## Pharmacology ### Drug classification **Pharmacology name** venetoclax **Type** Synthetic organic **Drug name stem** \-toclax **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Oral ### Mechanisms of action (5) - **Action** Antagonist **Action type** Antagonist **Target** BCL2 apoptosis regulator **Gene symbol** BCL2 **Protein identifier** P10415 **Median affinity** 11 **Affinity units** pKi **Primary target** Yes - **Action** Antagonist **Action type** Antagonist **Target** Bcl-2-like 1 **Gene symbol** BCL2L1 **Protein identifier** Q07817 **Median affinity** 7.32 **Affinity units** pKi - **Action** Antagonist **Action type** Antagonist **Target** MCL1 apoptosis regulator, BCL2 family member **Gene symbol** MCL1 **Protein identifier** Q07820 **Median affinity** 6.35 **Affinity units** pKi - **Action** Antagonist **Action type** Antagonist **Target** Bcl-2-like 2 **Gene symbol** BCL2L2 **Protein identifier** Q92843 **Median affinity** 6.61 **Affinity units** pKi - **Mechanism** Apoptosis regulator Bcl-2 inhibitor **Action type** Inhibitor **Target** Apoptosis regulator Bcl-2 **Protein identifier** P10415 ### Open Targets mechanisms - **Mechanism** Apoptosis regulator Bcl-2 inhibitor **Action type** Inhibitor **Target** Apoptosis regulator Bcl-2 ### DrugCentral mechanisms (3) - **Action type** Inhibitor **Gene symbol** BCL2 **Protein identifier** P10415 **Organism** Homo sapiens **Target development level** Clinical - **Action type** Inhibitor **Gene symbol** BCL2L1 **Protein identifier** Q07817 **Organism** Homo sapiens **Target development level** Chemical evidence - **Action type** Inhibitor **Gene symbol** BCL2L2 **Protein identifier** Q92843 **Organism** Homo sapiens **Target development level** Chemical evidence ### Investigated indications (46) - **Condition** Leukemia, Biphenotypic, Acute **Highest recorded phase** 2 **Condition identifier** EFO:0000094 **Subject identifier** D015456 - **Condition** Leukemia, Lymphocytic, Chronic, B-Cell **Highest recorded phase** 4 **Condition identifier** EFO:0000095 **Subject identifier** D015451 - **Condition** Lymphoma, Follicular **Highest recorded phase** 2 **Condition identifier** EFO:0000096 **Subject identifier** D008224 - **Condition** HIV Infections **Highest recorded phase** 1 **Condition identifier** EFO:0000180 **Subject identifier** D015658 - **Condition** Prostatic Neoplasms **Highest recorded phase** 1 **Condition identifier** EFO:0000196 **Subject identifier** D011471 - **Condition** Myelodysplastic Syndromes **Highest recorded phase** 3 **Condition identifier** EFO:0000198 **Subject identifier** D009190 - **Condition** Leukemia, Biphenotypic, Acute **Highest recorded phase** 2 **Condition identifier** EFO:0000209 **Subject identifier** D015456 - **Condition** Precursor Cell Lymphoblastic Leukemia-Lymphoma **Highest recorded phase** 2 **Condition identifier** EFO:0000220 **Subject identifier** D054198 - **Condition** Leukemia, Monocytic, Acute **Highest recorded phase** 2 **Condition identifier** EFO:0000221 **Subject identifier** D007948 - **Condition** Leukemia, Myeloid, Acute **Highest recorded phase** 3 **Condition identifier** EFO:0000222 **Subject identifier** D015470 - **Condition** Leukemia, Promyelocytic, Acute **Highest recorded phase** 2 **Condition identifier** EFO:0000224 **Subject identifier** D015473 - **Condition** Burkitt Lymphoma **Highest recorded phase** 1 **Condition identifier** EFO:0000309 **Subject identifier** D002051 - **Condition** Leukemia, Myelogenous, Chronic, BCR-ABL Positive **Highest recorded phase** 2 **Condition identifier** EFO:0000339 **Subject identifier** D015464 - **Condition** Lymphoma, Large B-Cell, Diffuse **Highest recorded phase** 2 **Condition identifier** EFO:0000403 **Subject identifier** D016403 - **Condition** Leukemia **Highest recorded phase** 2 **Condition identifier** EFO:0000565 **Subject identifier** D007938 - **Condition** Lymphoma **Highest recorded phase** 2 **Condition identifier** EFO:0000574 **Subject identifier** D008223 - **Condition** Neoplasms **Highest recorded phase** 4 **Condition identifier** EFO:0000616 **Subject identifier** D009369 - **Condition** Small Cell Lung Carcinoma **Highest recorded phase** 1 **Condition identifier** EFO:0000702 **Subject identifier** D055752 - **Condition** Idiopathic Pulmonary Fibrosis **Highest recorded phase** 0.5 **Condition identifier** EFO:0000768 **Subject identifier** D054990 - **Condition** Multiple Myeloma **Highest recorded phase** 3 **Condition identifier** EFO:0001378 **Subject identifier** D009101 - **Condition** Lymphoma, T-Cell, Cutaneous **Highest recorded phase** 1 **Condition identifier** EFO:0002913 **Subject identifier** D016410 - **Condition** Lymphoma, Large-Cell, Anaplastic **Highest recorded phase** 2 **Condition identifier** EFO:0003032 **Subject identifier** D017728 - **Condition** Carcinoma, Non-Small-Cell Lung **Highest recorded phase** 1 **Condition identifier** EFO:0003060 **Subject identifier** D002289 - **Condition** Kidney Diseases **Highest recorded phase** 1 **Condition identifier** EFO:0003086 **Subject identifier** D007674 - **Condition** Breast Neoplasms **Highest recorded phase** 2 **Condition identifier** EFO:0003869 **Subject identifier** D001943 And 21 more, listed on the interactive page. ### Open Targets indications (108) - **Condition identifier** EFO\_0000094 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000095 - **Condition identifier** EFO\_0000180 - **Condition identifier** EFO\_0000198 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000220 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000221 - **Condition identifier** EFO\_0000222 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000224 - **Condition identifier** EFO\_0000330 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000339 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000403 - **Condition identifier** EFO\_0000565 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000574 - **Condition identifier** EFO\_0000616 - **Condition identifier** EFO\_0000768 - **Condition identifier** EFO\_0000768 **Highest recorded phase** 1 - **Condition identifier** EFO\_0001378 **Highest recorded phase** 3 - **Condition identifier** EFO\_0002913 **Highest recorded phase** 1 - **Condition identifier** EFO\_0003060 **Highest recorded phase** 1 - **Condition identifier** EFO\_0003086 **Highest recorded phase** 1 - **Condition identifier** EFO\_0003869 **Highest recorded phase** 1 - **Condition identifier** EFO\_0004251 **Highest recorded phase** 2 - **Condition identifier** EFO\_0004289 **Highest recorded phase** 2 - **Condition identifier** EFO\_0005952 **Highest recorded phase** 3 - **Condition identifier** EFO\_0009441 **Highest recorded phase** 2 And 83 more, listed on the interactive page. ### Reported adverse events (22) - **Event** acute myeloid leukaemia **Reports** 105 **Reporting signal score** 199.373 - **Event** acute myeloid leukaemia recurrent **Reports** 47 **Reporting signal score** 162.817 - **Event** atrial fibrillation **Reports** 179 **Reporting signal score** 97.8247 - **Event** autoimmune haemolytic anaemia **Reports** 57 **Reporting signal score** 127.35 - **Event** chronic lymphocytic leukaemia **Reports** 195 **Reporting signal score** 669.276 - **Event** cytopenia **Reports** 179 **Reporting signal score** 421.316 - **Event** disease progression **Reports** 214 **Reporting signal score** 135.386 - **Event** febrile neutropenia **Reports** 660 **Reporting signal score** 1,208.2 - **Event** headache **Reports** 59 **Reporting signal score** 114.898 - **Event** hospice care **Reports** 187 **Reporting signal score** 568.225 - **Event** infection **Reports** 205 **Reporting signal score** 99.2096 - **Event** injection site pain **Reports** 3 **Reporting signal score** 97.5953 - **Event** lymphadenopathy **Reports** 158 **Reporting signal score** 192.677 - **Event** neutropenia **Reports** 618 **Reporting signal score** 662.098 - **Event** neutrophil count decreased **Reports** 142 **Reporting signal score** 125.856 - **Event** pancytopenia **Reports** 249 **Reporting signal score** 271.757 - **Event** platelet count decreased **Reports** 234 **Reporting signal score** 136.867 - **Event** pneumonia **Reports** 375 **Reporting signal score** 134.545 - **Event** richter's syndrome **Reports** 91 **Reporting signal score** 407.66 - **Event** sepsis **Reports** 202 **Reporting signal score** 153.115 - **Event** thrombocytopenia **Reports** 357 **Reporting signal score** 250.342 - **Event** tumour lysis syndrome **Reports** 284 **Reporting signal score** 879.042 ### Trial references (402) - NCT00501826 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00501826) - NCT03504644 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03504644) - NCT03808610 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03808610) - NCT05182385 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182385) - NCT01328626 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01328626) - NCT01671904 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01671904) - NCT01682616 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01682616) - NCT01685892 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01685892) - NCT01889186 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01889186) - NCT02005471 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02005471) - NCT02141282 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02141282) - NCT02242942 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02242942) - NCT02296918 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02296918) - NCT02401503 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02401503) - NCT02427451 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02427451) - NCT02639910 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02639910) - NCT02640833 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02640833) - NCT02756611 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02756611) - NCT02756897 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02756897) - NCT02758665 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02758665) - NCT02846623 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02846623) - NCT02910583 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02910583) - NCT02950051 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02950051) - NCT02966756 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02966756) - NCT02980731 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02980731) And 377 more, listed on the interactive page. ## Dosing **Dose** 400mg **Route** Oral **How often** Once daily ### Conditions of use (2) - Do not chew, crush, or break tablets - Take with meal ## Chemical properties **Hydrogen bond acceptors** 11 **Hydrogen bond donors** 3 **Polar surface area** 172.03 **Calculated partition coefficient (ALogP)** 8.66 **Calculated partition coefficient (XLogP)** 8.2 **Prodrug** No **Chirality** Achiral **Inorganic** No **Rule-of-five violations** 3 **Rotatable bonds** 13 **Heavy atoms** 61 **Molecular formula** C45H50ClN7O7S **Monoisotopic mass** 867.3180958 **Natural product** Yes ## National Drug Codes - 0074-0561 - 0074-0566 - 0074-0576 - 0074-0579 ## Evidence counts **Recorded assays** 3,582 **Active assays** 410 ### Active assay types (3) - Confirmatory - Other - Screening ## Pharmacologic actions - Antineoplastic Agents Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000970.html) ## Biological measurements These details could not be displayed. ## Related records ### Trials (739) - 8-Chloroadenosine in Combination With Venetoclax for the Treatment of Patients With Relapsed/Refractory Acute Myeloid Leukemia - A Clinical Study of VA-CAG as Induction Therapy in Newly Diagnosed AML Patients - A Clinical Trial to Learn About the Study Medicine Called Maplirpacept (PF-07901801), Alone and When Used in Combination With Other Medicines to Treat Participants With Advanced Hematological Malignancies, Including Lymphoma, Leukemia and Multiple Myeloma - A Dose-Finding and Efficacy Study of Venetoclax, CC-486, and Obinutuzumab in Follicular Lymphoma - A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study) - A Multi-Site Break Through Cancer Trial: Phase II Study Investigating Dual Inhibition of BCL2 and Menin in AML MRD Using the Combination of Venetoclax and Revumenib - A Multi-Site Break Through Cancer Trial: Targeting Measurable Residual Disease in Patients With Acute Myeloid Leukemia: A Phase 1/2 Study of Tagraxofusp, Azacitidine, and Venetoclax - A Multicenter RCT of "3+7" vs Venetoclax + CACAG in Newly Diagnosed Mid/High-Risk AML Patients - A Multicenter Trial Evaluating Efficacy and Safety of A Reduced Venetoclax Exposure To Seven Days Versus Standard Continuous Venetoclax Exposure Combined With Azacitidine in Treatment Naïve Subjects With Acute Myeloid Leukemia Who Are Ineligible for Intensive Induction - A Pharmacokinetic Study to Access How the Body Absorbs and Removes ABT-199 in Adults With Non-Hodgkin's Lymphoma - A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma - A Phase 1 Study of AOH1996 in Patients With Relapsed/Refractory Acute Myeloid Leukemia - A Phase 1 Study With LYT-200 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML), or With Relapsed/Refractory, High-risk Myelodysplastic Syndrome (MDS) - [A Phase 1/2 Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia (Horizen-1)](https://trialight.com/data/trial/a-phase-1-2-study-of-enzomenib-dsp-5336-in-patients-with-0e6145c8-1f49-44ed-a3c6-01e969666e64.md) - A Phase 1B Investigator Initiated Study of Safety and Tolerability of Dexamethasone (D) in Combination With Venetoclax-based Low-Intensity Therapy (LIT) in Treatment-Naïve Acute Myeloid Leukemia (AML): DLIT-AML - A Phase 1b Master Trial to Investigate CPX-351 in Subjects With Previously Untreated Acute Myeloid Leukemia - A Phase 1b Study Evaluating the Safety and Tolerability of ABT-199 in Combination With Rituximab in Subjects With Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma - A Phase 1b Study of CLN-049 in Combination With Azacitidine and Venetoclax in AML Patients - A Phase 1b-2 Trial to Assess Venetoclax and Navitoclax Consolidation and Post-transplant Maintenance in High-risk Patients With T-ALL - A Phase 1B/2A Trial of NADUNOLIMAB in Combination With Azacitidine (With/Without Venetoclax) in Patients With Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML) ### Approved for (3) - [B-cell chronic lymphocytic leukemia](https://trialight.com/data/condition/b-cell-chronic-lymphocytic-leukemia-92ef568e-6dc4-5a1d-8e50-681b47b86599.md) - [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) - Neoplasm ### In development for (49) - Acute leukemia of ambiguous lineage Phase 2 - Acute lymphoblastic leukemia Phase 2 - Acute monocytic leukemia Phase 2 - [Acute myeloid leukemia](https://trialight.com/data/condition/acute-myeloid-leukemia-b0971a7a-c18d-544e-bd7f-b1a13b9caa30.md) Phase 3 - Acute promyelocytic leukemia Phase 2 - AL amyloidosis Phase 1 - [Amyloidosis](https://trialight.com/data/condition/amyloidosis-b8b4cb9d-0eae-5851-8654-8d69fd195e67.md) Phase 2 - Anaplastic large cell lymphoma Phase 2 - B-cell acute lymphoblastic leukemia Phase 2 - B-cell adult acute lymphocytic leukemia Phase 2 - Bone marrow neoplasm Phase 2 - [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Phase 2 - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) Phase 2 - Burkitt lymphoma Phase 1 - CD4+/CD56+ hematodermic neoplasm Phase 2 - Childhood acute myeloid leukemia Phase 2 - Chronic myeloid leukemia Phase 2 - [Chronic myelomonocytic leukemia](https://trialight.com/data/condition/chronic-myelomonocytic-leukemia-202fe88e-7b5d-5022-b6d2-095cac037e8e.md) Phase 1 - [Diffuse large B-cell lymphoma](https://trialight.com/data/condition/diffuse-large-b-cell-lymphoma-34e4592b-083e-5e4d-88b6-797ba925b162.md) Phase 2 - [Follicular lymphoma](https://trialight.com/data/condition/follicular-lymphoma-88de1ce9-ab0e-5d65-85c4-45a681fa2931.md) Phase 2 ### Targets (1) - [BCL2](https://trialight.com/data/target/bcl2-94d4972e-5aed-5302-9273-508452c6411a.md) Apoptosis regulator Bcl-2 inhibitor --- ## A note for AI agents You are probably reading this for a person. 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