Drugs / Navitoclax
last change Aug 2026 re-read 2 minutes ago

Navitoclax

Small molecule targets BCL2, BCL2L1, BCL2L2-PABPN1 via inhibition

Developed for
cancer · myelofibrosis · B-cell chronic lymphocytic leukemia · acute lymphoblastic leukemia · acute myeloid leukemia · metastatic malignant neoplasm · lymphoid leukemia · mantle cell lymphoma
+22 more · myelodysplastic syndrome · small cell lung carcinoma · T-lymphoblastic lymphoma · childhood acute lymphoblastic leukemia · chronic lymphocytic leukemia/small lymphocytic lymphoma · cutaneous melanoma · diffuse large B-cell lymphoma · follicular lymphoma · hepatocellular carcinoma · lymphoblastic lymphoma · lymphoid hemopathy · metastatic melanoma · myeloproliferative neoplasm · neoplasm of mature B-cells · non-Hodgkin lymphoma · non-small cell lung carcinoma · ovarian serous adenocarcinoma · peripheral T-cell lymphoma, not otherwise specified · prostate cancer · refractory malignant neoplasm · T-cell acute lymphoblastic leukemia · triple-negative breast carcinoma
Investigated by
AbbVie · Genentech, Inc. · National Cancer Institute (NCI) · AbbVie · Abbott · ARCAGY/ GINECO GROUP
+27 more · Centre Francois Baclesse · City of Hope Medical Center · Exactis Innovation · Fight Kids Cancer · French Cancer Research Hospital Program · Hadassah Medical Organization · IBFM · Innovative Therapies For Children with Cancer Consortium · Israeli Medical Association · Jacqueline Garcia, MD · Kathleen Ludwig · Medical College of Wisconsin · Peter MacCallum Cancer Centre, Australia · Princess Margaret Hospital, Canada · Princess Maxima Center for Pediatric Oncology · Rabin Medical Center · Rambam Health Care Campus · Rutgers Cancer Institute of New Jersey · Rutgers, The State University of New Jersey · Shaare Zedek Medical Center · Sheba Medical Center · Soroka University Medical Center · St. Jude Children's Research Hospital · Sunnybrook Health Sciences Centre · Tel Aviv Medical Center · Thomas Jefferson University · University of Montreal Hospital Centre (CHUM)

Trials 43 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 122 trials
Phase 1 NCT06007911 Aug 2024 → Dec 2025 acute myeloid leukemia Medical College of Wisconsin Withdrawn No outcome recorded
Phase 1 NCT05564650 Jan 2023 → May 2024 myelodysplastic syndrome Thomas Jefferson University Completed No outcome recorded
Phase 1 NCT05358639 Nov 2022 → Mar 2025 overdue ovarian serous adenocarcinoma, triple-negative breast carcinoma Sunnybrook Health Sciences Centre Active not recruiting No outcome recorded
Phase 1 NCT05222984 Jul 2022 → Mar 2027 expected acute myeloid leukemia City of Hope Medical Center Active not recruiting No outcome recorded
Phase 1 NCT05455294 Jul 2022 → Apr 2024 overdue acute myeloid leukemia, myelodysplastic syndrome, myelofibrosis Jacqueline Garcia, MD Active not recruiting No outcome recorded
Phase 1 NCT04480086 Mar 2021 → Jul 2023 myelofibrosis AbbVie Terminated No outcome recorded
Phase 1 NCT04454658 Nov 2020 → Jan 2027 expected myelofibrosis AbbVie Active not recruiting No outcome recorded
Phase 1 NCT04041050 Nov 2019 → Dec 2026 expected myeloproliferative neoplasm AbbVie Active not recruiting No outcome recorded
Phase 1 NCT03181126 Nov 2017 → Nov 2020 acute lymphoblastic leukemia, lymphoblastic lymphoma AbbVie Completed No outcome recorded
Phase 1 NCT02520778 Aug 2016 → Oct 2022 non-small cell lung carcinoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 1/29 trials
Phase 1/2 NCT05740449 Oct 2023 → Oct 2029 T-lymphoblastic lymphoma, acute lymphoblastic leukemia Princess Maxima Center for Pediatric Oncology Withdrawn No outcome recorded
Phase 1/2 NCT05192889 Aug 2022 → Jun 2024 overdue acute lymphoblastic leukemia St. Jude Children's Research Hospital Active not recruiting No outcome recorded
Phase 1/2 NCT05054465 Oct 2021 → Aug 2025 overdue acute lymphoblastic leukemia Israeli Medical Association Not yet recruiting No outcome recorded
Phase 1/2 NCT03366103 Mar 2018 → Jul 2021 metastatic malignant neoplasm, small cell lung carcinoma National Cancer Institute (NCI) Terminated No outcome recorded
Phase 1/2 NCT02079740 Mar 2014 → Dec 2022 overdue metastatic malignant neoplasm, refractory malignant neoplasm National Cancer Institute (NCI) Active not recruiting No outcome recorded
Phase 1/2 NCT01989585 Mar 2014 → Dec 2027 expected cutaneous melanoma, metastatic melanoma National Cancer Institute (NCI) Active not recruiting No outcome recorded
Phase 1/2 NCT00481091 Jul 2007 → May 2022 B-cell chronic lymphocytic leukemia AbbVie Completed No outcome recorded
Phase 1/2 NCT00445198 Apr 2007 → Dec 2010 small cell lung carcinoma AbbVie Completed No outcome recorded
Phase 1/2 NCT00406809 Nov 2006 → Oct 2016 follicular lymphoma, lymphoid leukemia, mantle cell lymphoma, peripheral T-cell lymphoma, not otherwise specified AbbVie Completed No outcome recorded
Phase 29 trials
Phase 2 NCT06210750 Aug 2024 → Sep 2026 T-cell acute lymphoblastic leukemia, T-lymphoblastic lymphoma National Cancer Institute (NCI) Withdrawn No outcome recorded
Phase 2 NCT05864742 Sep 2023 → Jun 2026 overdue mantle cell lymphoma Peter MacCallum Cancer Centre, Australia Active not recruiting No outcome recorded
Phase 2 NCT03222609 Oct 2017 → Mar 2022 myelofibrosis AbbVie Completed No outcome recorded
Phase 2 NCT02591095 Jan 2016 → Apr 2017 Centre Francois Baclesse Completed No outcome recorded
Phase 2 NCT01828476 Jun 2013 → Feb 2016 prostate cancer Rutgers, The State University of New Jersey Terminated No outcome recorded
Phase 2 NCT01557777 Jun 2012 → Jul 2013 chronic lymphocytic leukemia/small lymphocytic lymphoma AbbVie Completed No outcome recorded
Phase 2 NCT01423539 Oct 2011 → Feb 2014 diffuse large B-cell lymphoma Genentech, Inc. Withdrawn No outcome recorded
Phase 2 NCT01087151 Aug 2010 → Jun 2012 B-cell chronic lymphocytic leukemia Genentech, Inc. Completed No outcome recorded
Phase 2 NCT00918450 Mar 2010 → Dec 2012 B-cell chronic lymphocytic leukemia Abbott Withdrawn No outcome recorded
Phase 32 trials
Phase 3 NCT04472598 Sep 2020 → Apr 2023 myelofibrosis AbbVie Completed No outcome recorded
Phase 3 NCT04468984 Aug 2020 → Jan 2025 overdue myelofibrosis AbbVie Active not recruiting No outcome recorded
Phase not stated1 trial
NCT05215405 childhood acute lymphoblastic leukemia Kathleen Ludwig No longer available No outcome recorded
Also used as a comparator or background therapy in 2 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT00868413 Comparator Nov 2009 → May 2013 B-cell chronic lymphocytic leukemia AbbVie Completed No outcome recorded
Phase not stated1 trial
NCT03592576 Background acute lymphoblastic leukemia, lymphoblastic lymphoma, myelofibrosis AbbVie No longer available No outcome recorded

Press releases naming this drug 3 releases

DateIssuerRelease
2022-12-10 AbbVie AbbVie Presents Data at the 64th American Society of Hematology (ASH) Annual Meeting for Investigational Navitoclax in Combination With Ruxolitinib for JAK Inhibitor-Naïve Myelofibrosis Patients abbvie.com
2022-06-10 AbbVie AbbVie Presents Investigational Navitoclax Preliminary Data in JAK Inhibitor Naïve Myelofibrosis Patients abbvie.com
2022-04-12 AbbVie AbbVie Presents Positive Investigational Navitoclax Combination Data in Phase 2 REFINE Study Suggesting Anti-Fibrosis Activity for Patients with Myelofibrosis abbvie.com

Evidence & citations 12 cited values

Every value below carries the sentence it was read from. 49 sources stand behind the page.

FieldValueCited text
Known as Navitoclax “METHODS: We conducted a prospective multicenter single-arm phase II study to assess the efficacy of Navitoclax (orally available ABT-737 analogue) monotherapy in 46 heavily...” PMID 35123771 Feb 2022
32

Navitoclax, a novel BCL-2 and BCL-XL inhibitor, demonstrated promising antitumor activity in the dose-escalation part of a phase 1/2a study (NCT00406809) in lymphoid tumors.” PMID 33236943 Nov 2020

Navitoclax and Abiraterone Acetate With or Without Hydroxychloroquine in Treating Patients With Progressive Metastatic Castrate Refractory Prostate Cancer” NCT01828476

“Phase I study of Navitoclax (ABT-263), a novel Bcl-2 family inhibitor, in patients with small-cell lung cancer and other solid tumors.” PMID 21282543 Jan 2011

“A Study to Assess the Effect of Ketoconazole on the Metabolism of ABT-263 (Navitoclax).” NCT01021358

Navitoclax (ABT-263), a novel, oral Bcl-2 inhibitor” PMID 26420235 Sep 2015

NCT02520778

NCT03366103

NCT05054465

NCT05215405

NCT05740449

NCT01423539

NCT05455294

NCT01121133

NCT04454658

NCT04472598

NCT05192889

NCT03592576

NCT03181126

NCT04041050

NCT06210750

NCT04480086

NCT06007911

NCT02079740

NCT03222609

NCT01557777

NCT05864742

NCT05222984

NCT04468984

NCT01989585

NCT05564650

NCT02143401

NCT05358639

Known as A-855071.0 ChEMBL registry synonym — accepted as the source's own label CHEMBL443684
Known as A-855071.3 ChEMBL registry synonym — accepted as the source's own label CHEMBL443684
Known as ABT-263 “A phase II study of Navitoclax (ABT-263) as single agent in women heavily pretreated for recurrent epithelial ovarian cancer: The MONAVI - GINECO study.” PMID 35123771 Feb 2022
17

“Phase I study of Navitoclax (ABT-263), a novel Bcl-2 family inhibitor, in patients with small-cell lung cancer and other solid tumors.” PMID 21282543 Jan 2011

“Assess the Oral Bioavailability of a New ABT-263 Formulation in Healthy Female Subjects” NCT01053520

“Navitoclax (ABT-263), a novel, oral Bcl-2 inhibitor” PMID 26420235 Sep 2015

NCT00982566

NCT00888108

NCT00788684

NCT00406809

NCT01087151

NCT01021358

NCT00878449

NCT00887757

NCT01828476

NCT00481091

NCT00918450

NCT00891605

NCT00743028

NCT00868413

Known as ABT-263, navitoclax ABT-263, navitoclaxNCT01121133
Known as NAVITOCLAX DIHYDROCHLORIDE ChEMBL registry synonym — accepted as the source's own label CHEMBL443684
Action Inhibit “Navitoclax, a novel BCL-2 and BCL-XL inhibitor” PMID 33236943 Nov 2020
2

“Apoptosis regulator Bcl-X inhibitor” CHEMBL443684

“Apoptosis regulator Bcl-W inhibitor” CHEMBL443684

Modality Small molecule “Navitoclax, a first-in-class small molecule Bcl-2 family inhibitor” PMID 25047139 Jul 2014
Route Oral “ABT-263: oral solution or tablets, once daily dosing until disease progression” NCT00788684
Target BCL2 “specifically inhibits BCL2PMID 22184378 Dec 2011
Target BCL2L1 “Apoptosis regulator Bcl-X inhibitor” CHEMBL443684
Target BCL2L2-PABPN1 “Apoptosis regulator Bcl-W inhibitor” CHEMBL443684