Navitoclax

Phase 3Small molecule

Navitoclax is an experimental drug being studied to treat certain cancers and blood disorders by helping the body's immune system kill cancer cells and remove damaged cells.[1] Navitoclax is currently being investigated across 11 indications[3], with its most advanced program in Phase 3.[1]

Navitoclax is one of 286 small molecule programs targeting Clinical Stage III Cutaneous Melanoma AJCC v8. It is currently in Phase 3.

Indications

Total Trials

Active Trials

285

Competitors

Pipeline

Status by Indication[3][1]

Indication

Clinical Stage III Cutaneous Melanoma AJCC V8Active, not recruiting

WomenActive, not recruiting

Myeloproliferative NeoplasmActive, not recruiting

MyelofibrosisActive, not recruiting

Acute Lymphoblastic LeukemiaActive, not recruiting

Myelodysplastic SyndromeActive, not recruiting

Mantle Cell LymphomaActive, not recruiting

Acute Myeloid LeukemiaActive, not recruiting

Myeloid NeoplasmActive, not recruiting

Advanced or Metastatic Solid TumorsActive, not recruiting

Clinical Stage III Cutaneous Melanoma AJCC V8Preclinical

Active, not recruiting

WomenPhase 1

Active, not recruiting

Myeloproliferative NeoplasmPhase 1

Active, not recruiting

MyelofibrosisPhase 3

Active, not recruiting

Acute Lymphoblastic LeukemiaPhase 2

Active, not recruiting

Myelodysplastic SyndromePhase 1

Active, not recruiting

Mantle Cell LymphomaPhase 2

Active, not recruiting

Acute Myeloid LeukemiaPhase 1

Active, not recruiting

Myeloid NeoplasmPhase 1

Active, not recruiting

Advanced or Metastatic Solid TumorsPreclinical

Active, not recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

255 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

Idamycin

Pfizer

Phase 3

59 2

Xospata

Astellas

Phase 3

24 3

Fludara

Sanofi

Phase 3

17 4

Mylotarg

WWyeth-Lederle Vaccines

Phase 3

38 5

Vepesid

AAvyxa

Phase 3

52 6

Vanflyta

Daiichi Sankyo

Phase 3

14 7

Neupogen

EEastern Cooperative Oncology Group

Phase 3

31 8

Nexavar

Bayer

Phase 3

12 9

Cytoxan

BBaxter Healthcare Corporation

Trexall

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Myelofibrosis

NCT04468984

Phase 1Active, not recruiting

Myeloid Neoplasm

NCT05455294

Phase 1Active, not recruiting

Myeloproliferative Neoplasm

NCT04041050

Q1 2027

Phase 1Active, not recruiting

Myelofibrosis

NCT04454658

Phase 1/2Active, not recruiting

Acute Lymphoblastic Leukemia

NCT05192889

PreclinicalActive, not recruiting

Metastatic Malignant Solid Neoplasm

NCT02079740

Clinical

Trials by Indication[1]

Myelofibrosis5 trials

Safety and Tolerability Study of Mivebresib Tablet Alone or in Combination With Ruxolitinib Tablet or Navitoclax Tablet in Adult Participants With Myelofibrosis

Terminated· AbbVie logo

AbbVie·Phase 1·NCT04480086·1 enrolled

Safety and Tolerability Study of Oral ABBV-744 Tablet Alone or in Combination With Oral Ruxolitinib Tablet or Oral Navitoclax Tablet in Adult Participants With Myelofibrosis

Active, not recruiting· AbbVie logo

AbbVie·Phase 1·NCT04454658·21 enrolled

Study of Oral Navitoclax Tablet in Combination With Oral Ruxolitinib Tablet Versus Best Available Therapy to Assess Change in Spleen Volume in Adult Participants With Relapsed/Refractory Myelofibrosis

Active, not recruiting· AbbVie logo

AbbVie·Phase 3·NCT04468984·330 enrolled

Show 2 more trials

Study of Oral Navitoclax Tablet In Combination With Oral Ruxolitinib Tablet When Compared With Oral Ruxolitinib Tablet To Assess Change In Spleen Volume In Adult Participants With Myelofibrosis

Completed· AbbVie logo

AbbVie·Phase 3·NCT04472598·252 enrolled

A Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Participants With Myelofibrosis

Completed· AbbVie logo

AbbVie·Phase 2·NCT03222609·191 enrolled

Acute Lymphoblastic Leukemia2 trials

A Study of Venetoclax in Combination With Navitoclax and Chemotherapy in Subjects With Relapsed/Refractory Acute Lymphoblastic Leukemia or Relapsed/Refractory Lymphoblastic Lymphoma

Completed· AbbVie logo

AbbVie·Phase 1·NCT03181126·69 enrolled

Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax

Active, not recruiting·SSt. Jude Children's Research Hospital·Phase 1/2·NCT05192889·35 enrolled

Hematological Malignancies1 trial

HEM-iSMART-A: Decitabine / Venetoclax and Navitoclax in Pediatric Patients With Relapsed or Refractory Hematological Malignancies

Withdrawn·PPrincess Maxima Center for Pediatric Oncology·Phase 1/2·NCT05740449

Myelodysplastic Syndrome1 trial

Navitoclax in Relapsed or Refractory High-Risk Myelodysplastic Syndrome

Active, not recruiting·TThomas Jefferson University·Phase 1·NCT05564650·6 enrolled

Metabolism1 trial

A Study to Assess the Effect of Rifampin on the Metabolism of Navitoclax

Completed· AbbVie logo

AbbVie·Phase 1·NCT01121133·12 enrolled

16 more indications

Small Cell Lung Cancer1 trial

Navitoclax and Vistusertib in Treating Patients With Relapsed Small Cell Lung Cancer and Other Solid Tumors

Terminated·NNational Cancer Institute (NCI)·Phase 1/2·NCT03366103·15 enrolled

Diffuse Large B-Cell Lymphoma1 trial

A Study of Navitoclax in Addition to Bendamustine and Rituximab in Patients With Relapsed Diffuse Large B-Cell Lymphoma (NAVIGATE)

Withdrawn· Roche logo

Roche·Phase 2·NCT01423539

Myeloid Neoplasm1 trial

Combination Navitoclax, Venetoclax and Decitabine for Advanced Myeloid Neoplasms

Active, not recruiting·JJacqueline Garcia, MD·Phase 1·NCT05455294·16 enrolled

Phase 11 trial

A Phase 1b-2 Trial to Assess Venetoclax and Navitoclax Consolidation and Post-transplant Maintenance in High-risk Patients With T-ALL

Not yet recruiting·IIsraeli Medical Association·Phase 1/2·NCT05054465·48 enrolled

ESS1 trial

Expanded Access to Navitoclax

No longer available· AbbVie logo

AbbVie··NCT03592576

Myeloproliferative Neoplasm1 trial

A Study Evaluating Safety and Tolerability, and Pharmacokinetics of Navitoclax Monotherapy and in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasm

Active, not recruiting· AbbVie logo

AbbVie·Phase 1·NCT04041050·85 enrolled

Mantle Cell Lymphoma1 trial

Genetically Risk-Stratified Venetoclax, Ibrutinib, Rituximab (± Navitoclax) in Relapsed/Refractory Mantle Cell Lymphoma

Active, not recruiting·PPeter MacCallum Cancer Centre, Australia·Phase 2·NCT05864742·40 enrolled

Refractory Solid Tumors1 trial

Navitoclax and Sorafenib Tosylate in Treating Patients With Relapsed or Refractory Solid Tumors

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT02143401·29 enrolled

Chronic Lymphocytic Leukemia1 trial

Open-label Extension Study of Navitoclax in Subjects With Chronic Lymphocytic Leukemia (CLL)

Completed· AbbVie logo

AbbVie·Phase 2·NCT01557777·17 enrolled

Acute Myeloid Leukemia1 trial

Navitoclax, Venetoclax, and Decitabine for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Previously Treated With Venetoclax

Active, not recruiting·—·Phase 1·NCT05222984·17 enrolled

Women1 trial

Combination of Olaparib and Navitoclax in Women with HGSC and TNBC

Active, not recruiting·SSunnybrook Health Sciences Centre·Phase 1·NCT05358639·36 enrolled

Non-Small Cell Lung Cancer1 trial

Osimertinib and Navitoclax in Treating Patients With EGFR-Positive Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT02520778·27 enrolled

T-cell acute lymphoblastic leukemia1 trial

Adding Targeted Drugs to Usual Chemotherapy for Adults With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LBL)

Withdrawn·NNational Cancer Institute (NCI)·Phase 2·NCT06210750

Relapsed or Refractory1 trial

Expanded Access Program of Venetoclax and Navitoclax for Pediatric Patients with Relapsed or Refractory ALL or LL

No longer available·KKathleen Ludwig··NCT05215405

Metastatic Malignant Solid Neoplasm1 trial

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

Active, not recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT02079740·96 enrolled

Clinical Stage III Cutaneous Melanoma AJCC v81 trial

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

Active, not recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT01989585·75 enrolled

Sources

References

[1]
ClinicalTrials.gov — 26 trial records for Navitoclax. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Navitoclax compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Navitoclax. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — AbbVie company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Apoptosis Regulator Bcl-W Inhibitor; Apoptosis Regulator Bcl-X Inhibitor; Apoptosis Regulator Bcl-2 Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: AbbVie

Navitoclax

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Trials by Indication[1]

Myelofibrosis5 trials

Acute Lymphoblastic Leukemia2 trials

Hematological Malignancies1 trial

Myelodysplastic Syndrome1 trial

Metabolism1 trial

Small Cell Lung Cancer1 trial

Diffuse Large B-Cell Lymphoma1 trial

Myeloid Neoplasm1 trial

Phase 11 trial

ESS1 trial

Myeloproliferative Neoplasm1 trial

Mantle Cell Lymphoma1 trial

Refractory Solid Tumors1 trial

Chronic Lymphocytic Leukemia1 trial

Acute Myeloid Leukemia1 trial

Women1 trial

Non-Small Cell Lung Cancer1 trial

T-cell acute lymphoblastic leukemia1 trial

Relapsed or Refractory1 trial

Metastatic Malignant Solid Neoplasm1 trial

Clinical Stage III Cutaneous Melanoma AJCC v81 trial

References

Drug Info

Quick Facts

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