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 9 indications[3], with its most advanced program in Phase 3.[1]

Navitoclax is one of 204 small molecule programs targeting Myelofibrosis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

203

Competitors

Pipeline

Status by Indication[3][1]

Indication

MyelofibrosisActive, not recruiting

Myelodysplastic SyndromeActive, not recruiting

Mantle Cell LymphomaActive, not recruiting

Clinical Stage III Cutaneous Melanoma AJCC V8Active, not recruiting

Myeloproliferative NeoplasmActive, not recruiting

Phase 1Not yet recruiting

Advanced or Metastatic Solid TumorsActive, not recruiting

WomenActive, not recruiting

Myeloid NeoplasmActive, not recruiting

MyelofibrosisPhase 3

Active, not recruiting

Myelodysplastic SyndromePhase 1

Active, not recruiting

Mantle Cell LymphomaPhase 2

Active, not recruiting

Clinical Stage III Cutaneous Melanoma AJCC V8Preclinical

Active, not recruiting

Myeloproliferative NeoplasmPhase 1

Active, not recruiting

Phase 1Phase 2

Not yet recruiting

Advanced or Metastatic Solid TumorsPreclinical

Active, not recruiting

WomenPhase 1

Active, not recruiting

Myeloid NeoplasmPhase 1

Active, not recruiting

Competition

Competitive Landscape

62 competitors in Advanced or Metastatic Solid Tumors

#DrugCompanyPhaseTrials

Keytruda

Merck & Co.

Phase 2

20 2

Navitoclax

AbbVie

Phase 3

26 3

Avastin

Roche

Phase 2

1 4

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 2

6 5

Gemzar

Johnson & Johnson

Phase 1

2 6

Vectibix

Amgen

Phase 1

1 7

Adriamycin

Pfizer

Phase 1

1 8

Taxane

Bristol-Myers Squibb

Phase 2

1 9

MHB036C

MMinghui Pharmaceutical (Hangzhou) Ltd

Phase 2

1 10

Standard Treatment

Boehringer Ingelheim

Phase 2

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

Myeloproliferative Neoplasm

NCT04041050

Phase 1Active, not recruiting

Myeloid Neoplasm

NCT05455294

Q1 2027

Phase 1Active, not recruiting

Myelofibrosis

NCT04454658

PreclinicalActive, not recruiting

Refractory Acute Lymphoblastic Leukemia

NCT05192889

Phase 1Active, not recruiting

Recurrent Acute Myeloid Leukemia

NCT05222984

Clinical

Trials by Indication[1]

Myelofibrosis5 trials

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

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

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

Show 2 more trials

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 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

Acute Lymphoblastic Leukemia1 trial

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

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

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

17 more indications

ESS1 trial

Expanded Access to Navitoclax

No longer available· AbbVie logo

AbbVie··NCT03592576

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

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

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

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

Metabolism1 trial

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

Completed· AbbVie logo

AbbVie·Phase 1·NCT01121133·12 enrolled

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

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

Myeloid Neoplasm1 trial

Combination Navitoclax, Venetoclax and Decitabine for Advanced Myeloid Neoplasms

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

Refractory Acute Lymphoblastic Leukemia1 trial

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

Active, not recruiting·SSt. Jude Children's Research Hospital·Preclinical·NCT05192889·35 enrolled

Recurrent Acute Myeloid Leukemia1 trial

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

Active, not recruiting·CCity of Hope Medical Center·Phase 1·NCT05222984·17 enrolled

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 Leukemia1 trial

Women1 trial

Non-Small Cell Lung Cancer1 trial

Phase 11 trial

ESS1 trial

Relapsed or Refractory1 trial

T-cell acute lymphoblastic leukemia1 trial

Hematological Malignancies1 trial

Myelodysplastic Syndrome1 trial

Myeloproliferative Neoplasm1 trial

Metabolism1 trial

Small Cell Lung Cancer1 trial

Diffuse Large B-Cell Lymphoma1 trial

Mantle Cell Lymphoma1 trial

Refractory Solid Tumors1 trial

Chronic Lymphocytic Leukemia1 trial

Myeloid Neoplasm1 trial

Refractory Acute Lymphoblastic Leukemia1 trial

Recurrent Acute Myeloid Leukemia1 trial

Metastatic Malignant Solid Neoplasm1 trial

Clinical Stage III Cutaneous Melanoma AJCC v81 trial

References

Drug Info

Quick Facts

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