Drug

Navitoclax

In clinical development

ClassApoptosis regulator Bcl-2 inhibitorEmerging researchLate-stage development

RxNorm1109380 ChEMBLCHEMBL443684 ATCL01XX78UNIIXKJ5VVK2WD

Research papers

Active clinical trials

Protein targets

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Phase I/II Study of Dabrafenib, Trametinib, and Navitoclax in BRAF Mutant Melanoma (Phase I and II) and Other Solid Tumors (Phase I Only)

Clinical trial2026-06-17Results expected Q4 2027 · ClinicalTrials.gov

A Phase II Study of Genetically Risk-Stratified Combination of Venetoclax, Ibrutinib and Rituximab (With and Without Navitoclax) in Patients With Relapsed and Refractory Mantle Cell Lymphoma (AIM2)

Clinical trial2026-06-01Primary completion · ClinicalTrials.gov

An Open Label, Two-Part, Phase Ib/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of the MEK Inhibitor Trametinib and the BCL2-Family Inhibitor Navitoclax (ABT-263) in Combination in Subjects With KRAS or NRAS Mutation-Positive Advanced Solid Tumors

Clinical trial2026-05-28Results posted · ClinicalTrials.gov

A Phase Ib/II Study Evaluating Navitoclax After Failure of Hypomethylating Agent and Venetoclax for Treatment of Relapsed or Refractory High-Risk Myelodysplastic Syndrome

Clinical trial2026-05-08Completed · ClinicalTrials.gov

A Phase Ib Open Label Study of Navitoclax in Combination With Venetoclax + Decitabine in Relapsed/Refractory Acute Myeloid Leukemia Previously Treated With Venetoclax

Clinical trial2026-04-20Results expected Q1 2027 · ClinicalTrials.gov

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Of Navitoclax In Combination With Ruxolitinib Versus Ruxolitinib In Subjects With Myelofibrosis (TRANSFORM-1)

Clinical trial2026-03-23Results posted · ClinicalTrials.gov

A Phase 2 Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Subjects With Myelofibrosis (REFINE)

Clinical trial2026-01-20Results posted · ClinicalTrials.gov

RAVEN: A Phase I/II Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax

Clinical trial2025-09-22Results posted · ClinicalTrials.gov

A Phase 1b-2 Trial to Assess the Safety and Efficacy of a Venetoclax and Navitoclax Consolidation in High-risk Patients With T- Cell Acute Lymphoblastic Leukemia Prior to Allogeneic Transplantation Followed by Venetoclax and Navitoclax Post-transplant Maintenance

Clinical trial2025-08-01Primary completion · ClinicalTrials.gov

A Phase 1b Study Of ABBV-744 Alone Or In Combination With Ruxolitinib Or Navitoclax In Subjects With Myelofibrosis

Clinical trial2025-07-16Results expected Q1 2027 · ClinicalTrials.gov

A Phase I Trial of the Combination of Olaparib and Navitoclax in Women with High Grade Serous Epithelial Ovarian Cancer and Triple Negative Breast Cancer

Clinical trial2025-03-30Primary completion · ClinicalTrials.gov

The Differential Effect of Senolytics on SASP Cytokine Secretion and Regulation of EMT by CAFs.

Research2024-04-04International journal of molecular sciences

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Navitoclax

RxNorm CUI

1109380

ChEMBL ID

CHEMBL443684

ATC codes

L01XX78

UNII

XKJ5VVK2WD

Primary mechanism

Apoptosis regulator Bcl-2 inhibitor

Pharmacology & targets

3 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Apoptosis regulator Bcl-2

BCL2 · P10415

INHIBITORApoptosis regulator Bcl-2 inhibitor

Bcl-2-like protein 1

BCL2L1 · Q07817

INHIBITORApoptosis regulator Bcl-X inhibitor

Bcl-2-like protein 2

BCL2L2 · Q92843

INHIBITORApoptosis regulator Bcl-W inhibitor

Clinical trials

24 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

LATEST COMPLETION 2026

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 24

Phase 111Phase 1 / 26Phase 25Phase 32

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Navitoclax in Combination With Ruxolitinib Versus Best Available Therapy in Subjects With Relapsed/Refractory Myelofibrosis (TRANSFORM-2), Incorporating Extension Arm C - Continued Access for Navitoclax to Roll Over Subjects From Studies M10-166, M16-109, M16-191, and M19-753

Active, not recruitingPH IIIAbbVien=3302026

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Of Navitoclax In Combination With Ruxolitinib Versus Ruxolitinib In Subjects With Myelofibrosis (TRANSFORM-1)

CompletedPH IIIAbbVien=2522025

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase Ib/II Study Evaluating Navitoclax After Failure of Hypomethylating Agent and Venetoclax for Treatment of Relapsed or Refractory High-Risk Myelodysplastic Syndrome

CompletedPH IThomas Jefferson Universityn=62026

A Phase 2 Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Subjects With Myelofibrosis (REFINE)

CompletedPH IIAbbVien=1912025

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Of Navitoclax In Combination With Ruxolitinib Versus Ruxolitinib In Subjects With Myelofibrosis (TRANSFORM-1)

CompletedPH IIIAbbVien=2522025

A Phase I Trial of ABT-263 (Navitoclax), a Bcl-2 Inhibitor, and Sorafenib (Nexavar) in Patients With Relapsed or Refractory Solid Organ Tumors

CompletedPH INational Cancer Institute (NCI)n=292024

A Phase 1B Study of AZD9291 in Combination With Navitoclax in EGFR-Mutant Non-Small Cell Lung Cancer Following Resistance to Initial EGFR Kinase Inhibitor

CompletedPH INational Cancer Institute (NCI)n=272023

A Phase 1 Dose Escalation, Open-Label Study of Venetoclax in Combination With Navitoclax and Chemotherapy in Subjects With Relapsed/Refractory Acute Lymphoblastic Leukemia or Relapsed/Refractory Lymphoblastic Lymphoma

CompletedPH IAbbVien=692020

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

The Differential Effect of Senolytics on SASP Cytokine Secretion and Regulation of EMT by CAFs.

International journal of molecular sciences · 2024 · 20 cites

Related drugs

2 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Dasatinib

Studied across 2 of the same disease areas as Navitoclax in the shared literature.

2 shared diseases1 shared paper

Quercetin

Studied across 2 of the same disease areas as Navitoclax in the shared literature.

2 shared diseases1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials