Bleximenib

Phase 3Small molecule

Johnson & Johnson

Bleximenib is one of 80 small molecule programs targeting Acute Myeloid Leukemia. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Acute Myeloid LeukemiaActive, not recruiting

Leukemia, Myeloid, AcuteRecruiting

Acute LeukemiaActive, not recruiting

Acute Myeloid LeukemiaPhase 1

Active, not recruiting

Leukemia, Myeloid, AcutePhase 3

Recruiting

Acute LeukemiaPhase 1/Phase 2

Active, not recruiting

Competition

Competitive Landscape

804 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

Empaveli

Gilead

Phase 3

4 2

Zarnestra

KKura Oncology, Inc.

Phase 3

9 3

Lenograstim

Sanofi

Phase 3

1 4

Valspodar

EEastern Cooperative Oncology Group

Phase 3

3 5

GM-CSF

YY-mAbs Therapeutics

Phase 3

1 6

Homoharringtonine

Ascentage Pharma Group Inc.

Phase 3

1 7

Bleximenib

Johnson & Johnson

Phase 3

1 8

Leukine

Sanofi

Preclinical

7 9

Sprycel

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Preclinical

8 10

Antibiotic

Pfizer

Preclinical

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

Timeline

Expected Milestones

Q1 2027

Phase 1Active, not recruiting

Leukemia, Myeloid, Acute

NCT05453903

Q3 2029

Phase 3Recruiting

Leukemia, Myeloid, Acute

NCT06852222

Q3 2030

PreclinicalRecruiting

Acute Leukemia

NCT04811560

Q4 2033

Phase 3Not yet recruiting

Acute Myeloid Leukemia

NCT07223814

Clinical

Trials by Indication[1]

Acute Leukemia2 trials

A Study of 14C-Bleximenib (Radiolabeled) in Participants With Acute Leukemia

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT07295951·10 enrolled

A Phase 1/2, First-in-Human Study of the Menin-KMT2A (MLL1) Inhibitor Bleximenib in Participants With Acute Leukemia (cAMeLot-1)

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Preclinical·NCT04811560·420 enrolled

Leukemia, Myeloid, Acute2 trials

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Study of Bleximenib, Venetoclax and Azacitidine for the Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia Harboring KMT2A Rearrangements or NPM1 Mutations Who Are Ineligible for Intensive Chemotherapy

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT06852222·600 enrolled

A Phase 1b Study of Bleximenib in Combination With AML-Directed Therapies for Participants With Acute Myeloid Leukemia Harboring KMT2A or NPM1 Alterations

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT05453903·196 enrolled

Acute Myeloid Leukemia1 trial

Bleximenib in Combination With Standard Induction and Consolidation Therapy Followed by Maintenance for Treatment of Patients With Acute Myeloid Leukemia (AML)

Not yet recruiting·SStichting Hemato-Oncologie voor Volwassenen Nederland·Phase 3·NCT07223814·875 enrolled

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for Bleximenib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Bleximenib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Bleximenib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Johnson & Johnson company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Johnson & Johnson

Bleximenib

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q3 2029

Q3 2030

Q4 2033

Trials by Indication[1]

Acute Leukemia2 trials

Leukemia, Myeloid, Acute2 trials

Acute Myeloid Leukemia1 trial

References

Drug Info

Quick Facts

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