Venetoclax
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2016
- First approval year
- 2016
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Venetoclax
- Molecular weight
- 868.46
- 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
- venclexta
- Venclexta
- venclyxto
- Venclyxto
- [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.
- ATC classification codes
- L01XX52
Sources for recorded values
- CAS registry numbers
- 1257044-40-8
- ChEMBL ID
- CHEMBL3137309
- InChIKey
- LQBVNQSMGBZMKD-UHFFFAOYSA-N
- PubChem compound IDs
- 49846579
- RxNorm IDs (RxCUI)
- 1747556
- FDA ingredient codes (UNII)
- N54AIC43PW
- Applicant
- ABBVIE
- Approval date
- 11 Apr 2016
- Application number
- NDA208573
- 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
- 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 name
- venetoclax
- Type
- Synthetic organic
- Drug name stem
- -toclax
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- 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
- 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
- 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.
- 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.
- 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
- NCT00501826
- NCT03504644
- NCT03808610
- NCT05182385
- NCT01328626
- NCT01671904
- NCT01682616
- NCT01685892
- NCT01889186
- NCT02005471
- NCT02141282
- NCT02242942
- NCT02296918
- NCT02401503
- NCT02427451
- NCT02639910
- NCT02640833
- NCT02756611
- NCT02756897
- NCT02758665
- NCT02846623
- NCT02910583
- NCT02950051
- NCT02966756
- NCT02980731
And 377 more, listed on the interactive page.
- Dose
- 400mg
- Route
- Oral
- How often
- Once daily
- Do not chew, crush, or break tablets
- Take with meal
- 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
- 0074-0561
- 0074-0566
- 0074-0576
- 0074-0579
- Recorded assays
- 3,582
- Active assays
- 410
- Confirmatory
- Other
- Screening
- Antineoplastic Agents
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)
- 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)
In development for (49)
- Acute leukemia of ambiguous lineage Phase 2
- Acute lymphoblastic leukemia Phase 2
- Acute monocytic leukemia Phase 2
- Acute myeloid leukemia Phase 3
- Acute promyelocytic leukemia Phase 2
- AL amyloidosis Phase 1
- Amyloidosis 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 Phase 2
- Breast neoplasm 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 Phase 1
- Diffuse large B-cell lymphoma Phase 2
- Follicular lymphoma Phase 2
Targets (1)
- BCL2 Apoptosis regulator Bcl-2 inhibitor