venetoclax Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 5133 | 1257044-40-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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 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.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Sept. 20, 2019 | PMDA | AbbVie GK | |
| Dec. 5, 2016 | EMA | AbbVie Ltd | |
| April 11, 2016 | FDA | ABBVIE INC |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Death | 1018.66 | 52.11 | 320 | 882 | 81148 | 2275735 |
| Intentional product use issue | 720.77 | 52.11 | 135 | 1067 | 3467 | 2353416 |
| Off label use | 514.93 | 52.11 | 190 | 1012 | 73408 | 2283475 |
| Acute myeloid leukaemia | 357.70 | 52.11 | 72 | 1130 | 2638 | 2354245 |
| Neutropenia | 261.83 | 52.11 | 85 | 1117 | 21463 | 2335420 |
| Chronic lymphocytic leukaemia | 196.72 | 52.11 | 34 | 1168 | 521 | 2356362 |
| Febrile neutropenia | 139.95 | 52.11 | 45 | 1157 | 10837 | 2346046 |
| Tumour lysis syndrome | 126.22 | 52.11 | 26 | 1176 | 1049 | 2355834 |
| Disease progression | 120.05 | 52.11 | 45 | 1157 | 17050 | 2339833 |
| Sepsis | 116.62 | 52.11 | 45 | 1157 | 18443 | 2338440 |
| Platelet count decreased | 112.36 | 52.11 | 42 | 1160 | 15771 | 2341112 |
| Hospice care | 107.59 | 52.11 | 21 | 1181 | 641 | 2356242 |
| Richter's syndrome | 106.55 | 52.11 | 15 | 1187 | 50 | 2356833 |
| Pyrexia | 102.71 | 52.11 | 57 | 1145 | 53651 | 2303232 |
| White blood cell count decreased | 92.70 | 52.11 | 38 | 1164 | 18170 | 2338713 |
| Infection | 82.90 | 52.11 | 35 | 1167 | 17994 | 2338889 |
| Thrombocytopenia | 71.17 | 52.11 | 32 | 1170 | 19099 | 2337784 |
| Pneumonia | 69.42 | 52.11 | 43 | 1159 | 49253 | 2307630 |
| Pancytopenia | 65.43 | 52.11 | 26 | 1176 | 11426 | 2345457 |
| Hospitalisation | 58.90 | 52.11 | 26 | 1176 | 14827 | 2342056 |
| Lymphadenopathy | 58.78 | 52.11 | 20 | 1182 | 5678 | 2351205 |
| Haemoglobin decreased | 53.91 | 52.11 | 26 | 1176 | 18125 | 2338758 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Death | 1307.44 | 44.64 | 511 | 1516 | 86932 | 1657822 |
| Intentional product use issue | 1069.03 | 44.64 | 212 | 1815 | 2507 | 1742247 |
| Off label use | 777.05 | 44.64 | 285 | 1742 | 38286 | 1706468 |
| Acute myeloid leukaemia | 451.82 | 44.64 | 107 | 1920 | 2934 | 1741820 |
| Chronic lymphocytic leukaemia | 419.49 | 44.64 | 81 | 1946 | 795 | 1743959 |
| Neutropenia | 301.38 | 44.64 | 118 | 1909 | 18142 | 1726612 |
| Tumour lysis syndrome | 298.48 | 44.64 | 69 | 1958 | 1682 | 1743072 |
| Febrile neutropenia | 241.64 | 44.64 | 88 | 1939 | 11012 | 1733742 |
| Platelet count decreased | 200.98 | 44.64 | 86 | 1941 | 16437 | 1728317 |
| Richter's syndrome | 174.01 | 44.64 | 29 | 1998 | 107 | 1744647 |
| Pneumonia | 168.76 | 44.64 | 107 | 1920 | 46075 | 1698679 |
| Hospice care | 165.37 | 44.64 | 35 | 1992 | 555 | 1744199 |
| Disease progression | 165.21 | 44.64 | 76 | 1951 | 17187 | 1727567 |
| Pyrexia | 141.25 | 44.64 | 96 | 1931 | 46304 | 1698450 |
| White blood cell count decreased | 135.45 | 44.64 | 61 | 1966 | 13088 | 1731666 |
| Infection | 126.19 | 44.64 | 57 | 1970 | 12303 | 1732451 |
| Lymphadenopathy | 121.30 | 44.64 | 41 | 1986 | 4073 | 1740681 |
| Sepsis | 118.44 | 44.64 | 63 | 1964 | 19375 | 1725379 |
| Asthenia | 117.96 | 44.64 | 77 | 1950 | 34593 | 1710161 |
| Haemoglobin decreased | 105.70 | 44.64 | 56 | 1971 | 17058 | 1727696 |
| Pancytopenia | 86.97 | 44.64 | 43 | 1984 | 11314 | 1733440 |
| Blood count abnormal | 82.78 | 44.64 | 24 | 2003 | 1433 | 1743321 |
| General physical health deterioration | 81.11 | 44.64 | 43 | 1984 | 13075 | 1731679 |
| Thrombocytopenia | 73.99 | 44.64 | 48 | 1979 | 21201 | 1723553 |
| Hospitalisation | 68.38 | 44.64 | 38 | 1989 | 12662 | 1732092 |
| Fatigue | 67.69 | 44.64 | 65 | 1962 | 50716 | 1694038 |
| Diarrhoea | 64.46 | 44.64 | 65 | 1962 | 53787 | 1690967 |
| Cytopenia | 55.74 | 44.64 | 16 | 2011 | 920 | 1743834 |
| Septic shock | 54.10 | 44.64 | 28 | 1999 | 8081 | 1736673 |
| Acute myeloid leukaemia recurrent | 53.18 | 44.64 | 12 | 2015 | 258 | 1744496 |
| Atrial fibrillation | 52.19 | 44.64 | 34 | 1993 | 15077 | 1729677 |
| Anaemia | 51.50 | 44.64 | 44 | 1983 | 29413 | 1715341 |
| Splenomegaly | 46.58 | 44.64 | 17 | 2010 | 2103 | 1742651 |
| Mantle cell lymphoma | 45.50 | 44.64 | 11 | 2016 | 322 | 1744432 |
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L01XX52 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Other antineoplastic agents |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| FDA EPC | N0000192515 | BCL-2 Inhibitor |
| FDA PE | N0000009176 | Increased Cellular Death |
| FDA MoA | N0000185503 | P-Glycoprotein Inhibitors |
| MeSH PA | D000970 | Antineoplastic Agents |
Drug Use (View source of the data)
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Chronic lymphoid leukemia, disease | indication | 92814006 |
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 2.0 | acidic |
| pKa2 | 13.01 | acidic |
| pKa3 | 7.73 | Basic |
| pKa4 | 4.24 | Basic |
| pKa5 | 3.47 | Basic |
| pKa6 | 0.56 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 100MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 9174982 | May 26, 2030 | TREATMENT IN COMBINATION WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY |
| 100MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 9174982 | May 26, 2030 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) |
| 100MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 9174982 | May 26, 2030 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 100MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 9174982 | May 26, 2030 | TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 10MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 9174982 | May 26, 2030 | TREATMENT IN COMBINATION WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY |
| 10MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 9174982 | May 26, 2030 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) |
| 10MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 9174982 | May 26, 2030 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 10MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 9174982 | May 26, 2030 | TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 50MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 9174982 | May 26, 2030 | TREATMENT IN COMBINATION WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY |
| 50MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 9174982 | May 26, 2030 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) |
| 50MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 9174982 | May 26, 2030 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 50MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 9174982 | May 26, 2030 | TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 100MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 9539251 | Sept. 6, 2033 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LEUKEMIA (SLL) IN COMBINATION WITH A GA101 ANTIBODY SUCH AS OBINUTUZUMAB FOR ONE OR MORE DOSING PERIODS, WHEREIN THE CLL OR SLL IS A CD20-EXPRESSING CANCER |
| 10MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 9539251 | Sept. 6, 2033 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LEUKEMIA (SLL) IN COMBINATION WITH A GA101 ANTIBODY SUCH AS OBINUTUZUMAB FOR ONE OR MORE DOSING PERIODS, WHEREIN THE CLL OR SLL IS A CD20-EXPRESSING CANCER |
| 50MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 9539251 | Sept. 6, 2033 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LEUKEMIA (SLL) IN COMBINATION WITH A GA101 ANTIBODY SUCH AS OBINUTUZUMAB FOR ONE OR MORE DOSING PERIODS, WHEREIN THE CLL OR SLL IS A CD20-EXPRESSING CANCER |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 100MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | April 11, 2021 | NEW CHEMICAL ENTITY |
| 10MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | April 11, 2021 | NEW CHEMICAL ENTITY |
| 50MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | April 11, 2021 | NEW CHEMICAL ENTITY |
| 100MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | June 8, 2021 | INFORMATION ADDED TO THE PACKAGE INSERT REGARDING THE REVISION OF THE MONOTHERAPY INDICATION OF VENETOCLAX |
| 100MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | June 8, 2021 | REVISIONS TO INDICATION FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 10MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | June 8, 2021 | INFORMATION ADDED TO THE PACKAGE INSERT REGARDING THE REVISION OF THE MONOTHERAPY INDICATION OF VENETOCLAX |
| 10MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | June 8, 2021 | REVISIONS TO INDICATION FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 50MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | June 8, 2021 | INFORMATION ADDED TO THE PACKAGE INSERT REGARDING THE REVISION OF THE MONOTHERAPY INDICATION OF VENETOCLAX |
| 50MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | June 8, 2021 | REVISIONS TO INDICATION FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 100MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | Nov. 21, 2021 | VENETOCLAX IN COMBO WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE FOR THE TX OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY |
| 10MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | Nov. 21, 2021 | VENETOCLAX IN COMBO WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE FOR THE TX OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY |
| 50MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | Nov. 21, 2021 | VENETOCLAX IN COMBO WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE FOR THE TX OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY |
| 100MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | May 15, 2022 | VENETOCLAX IN COMBINATION WITH OBINUTUZUMAB IN PREVIOUSLY UNTREATED PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LYMPHOMA |
| 10MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | May 15, 2022 | VENETOCLAX IN COMBINATION WITH OBINUTUZUMAB IN PREVIOUSLY UNTREATED PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LYMPHOMA |
| 50MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | May 15, 2022 | VENETOCLAX IN COMBINATION WITH OBINUTUZUMAB IN PREVIOUSLY UNTREATED PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LYMPHOMA |
| 100MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | April 11, 2023 | TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION, AS DETECTED BY AN FDA APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 10MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | April 11, 2023 | TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION, AS DETECTED BY AN FDA APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 50MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | April 11, 2023 | TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION, AS DETECTED BY AN FDA APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 100MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | June 8, 2025 | INDICATED FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 10MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | June 8, 2025 | INDICATED FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 50MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | June 8, 2025 | INDICATED FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 100MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | Nov. 21, 2025 | INDICATED IN COMBO WITH AZACITIDINE, OR DECITABINE, OR LOW-DOSE CYTARABINE FOR THE TX OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY |
| 10MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | Nov. 21, 2025 | INDICATED IN COMBO WITH AZACITIDINE, OR DECITABINE, OR LOW-DOSE CYTARABINE FOR THE TX OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY |
| 50MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | Nov. 21, 2025 | INDICATED IN COMBO WITH AZACITIDINE, OR DECITABINE, OR LOW-DOSE CYTARABINE FOR THE TX OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY |
| 100MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | May 15, 2026 | TREATMENT OF PREVIOUSLY UNTREATED ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) |
| 10MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | May 15, 2026 | TREATMENT OF PREVIOUSLY UNTREATED ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) |
| 50MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | May 15, 2026 | TREATMENT OF PREVIOUSLY UNTREATED ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Apoptosis regulator Bcl-2 | Cytosolic other | INHIBITOR | Ki | 11 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
| Bcl-2-like protein 1 | Cytosolic other | INHIBITOR | Ki | 7.32 | SCIENTIFIC LITERATURE | ||||
| Apoptosis regulator Bcl-W | Cytosolic other | INHIBITOR | Ki | 6.61 | SCIENTIFIC LITERATURE |
External reference:
| ID | Source |
|---|---|
| D10679 | KEGG_DRUG |
| 763511000 | SNOMEDCT_US |
| 1747556 | RXNORM |
| 016803 | NDDF |
| 4035629 | VANDF |
| 31601 | MMSL |
| d08429 | MMSL |
| 720491001 | SNOMEDCT_US |
| 49846579 | PUBCHEM_CID |
| CHEBI:133021 | CHEBI |
| N54AIC43PW | UNII |
| 9925 | INN_ID |
| DB11581 | DRUGBANK_ID |
| CHEMBL3137309 | ChEMBL_ID |
| 8318 | IUPHAR_LIGAND_ID |
| C579720 | MESH_SUPPLEMENTAL_RECORD_UI |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Venclexta | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-0561 | TABLET, FILM COATED | 10 mg | ORAL | NDA | 18 sections |
| Venclexta | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-0566 | TABLET, FILM COATED | 50 mg | ORAL | NDA | 18 sections |
| Venclexta | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-0576 | TABLET, FILM COATED | 100 mg | ORAL | NDA | 18 sections |
| Venclexta | HUMAN PRESCRIPTION DRUG LABEL | 4 | 0074-0579 | KIT | 50 mg | None | NDA | 18 sections |
| Venclexta | HUMAN PRESCRIPTION DRUG LABEL | 4 | 0074-0579 | KIT | 100 mg | None | NDA | 18 sections |
| Venclexta | HUMAN PRESCRIPTION DRUG LABEL | 4 | 0074-0579 | KIT | 10 mg | None | NDA | 18 sections |
| Venclexta | HUMAN PRESCRIPTION DRUG LABEL | 4 | 0074-0579 | KIT | 100 mg | None | NDA | 18 sections |