Ozmosi | Navitoclax Drug Profile
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Navitoclax

Pronounced as: nav-i-TOE-klax

Alternative Names: navitoclax, abt-263
Clinical Status: Active
Latest Update: 2026-01-28
Latest Update Note: Clinical Trial Update

Product Description

Navitoclax is a BCL-XL/BCL-2 inhibitor that is being investigated to treat myelofibrosis. (Sourced from: https://www.abbvie.com/our-science/pipeline/navitoclax.html)

Mechanisms of Action: BCL2 Inhibitor

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: AbbVie
Company Location: Eastern America
Company Founding Year: 2013
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Navitoclax

Countries in Clinic: Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Poland, Puerto Rico, Russia, Serbia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States

Active Clinical Trial Count: 12

Recent & Upcoming Milestones

Highest Development Phases

Phase 3: Myelofibrosis

Phase 2: Acute Lymphoid Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma

Phase 1: Acute Myeloid Leukemia|Chronic Lymphoid Leukemia|Lymphocytic Chronic B-Cell Leukemia|Lymphoma, B-Cell|Lymphoma, Non-Hodgkin|Myelodysplastic Syndrome|Myeloproliferative Disorders|Oncology Unspecified

Trial ID

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated

NCT05564650

22P.205

P1

Active, not recruiting

Acute Myeloid Leukemia|Myelodysplastic Syndrome

2024-05-03

50%

2025-12-11

Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments

NCT05054465

ITALLI001

P2

Not yet recruiting

Precursor Cell Lymphoblastic Leukemia-Lymphoma|Acute Lymphoid Leukemia

2025-08-01

2022-08-02

Primary Endpoints|Treatments

NCT00788684

M10-166

P1

Completed

Lymphoma, Non-Hodgkin|Lymphoma, B-Cell|Chronic Lymphoid Leukemia|Lymphocytic Chronic B-Cell Leukemia

2025-02-07

2%

2025-02-21

Primary Endpoints

jRCT2080224824

jRCT2080224824

P1

Completed

Oncology Unspecified

2024-09-08

NCT04468984

TRANSFORM-2

P3

Active, not recruiting

Myelofibrosis

2025-01-29

43%

2025-04-26

Patient Enrollment|Primary Completion Date|Primary Endpoints|Treatments

NCT04041050

M19-753

P1

Active, not recruiting

Myeloproliferative Disorders

2026-12-31

12%

2025-02-15

Primary Endpoints

NCT04472598

TRANSFORM-1

P3

Completed

Myelofibrosis

2023-04-13

29%

2025-02-22

Primary Endpoints|Study Completion Date|Treatments|Trial Status

2023-507274-40-00

M19-753

P1

Active, not recruiting

Myelofibrosis

2025-06-03

2025-05-02

Treatments

NCT05455294

NCT05455294

P1

Active, not recruiting

Acute Myeloid Leukemia|Myelofibrosis|Myeloproliferative Disorders|Myelodysplastic Syndrome

2024-04-17

50%

2026-01-29

Primary Completion Date|Primary Endpoints|Treatments

JapicCTI-194907

JapicCTI-194907

P1

Active

Oncology Unspecified

2021-07-21

2023-507276-53-00

M16-109

P2

Completed

Myelofibrosis

2025-01-28

2025-05-02

Treatments

NCT05192889

RAVEN

P2

Active, not recruiting

Precursor Cell Lymphoblastic Leukemia-Lymphoma|Acute Lymphoid Leukemia

2024-06-13

2%

2024-11-27

Primary Endpoints