menin inhibitor · small molecule

bleximenib

4 active trials, targeting menin. Not approved for any biomarker on marked.bio yet.

Also known as JNJ-75276617.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
NPM1 mutation 4 4 Phase 3

Sponsors

Industry sponsors leading active biomarker-selected trials of bleximenib.

  1. Johnson & Johnson 3

Trials

Status

4 of 4 trials shown

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

    Recruiting Phase 3 Stichting Hemato-Oncologie voor Volwassenen Nederland Started 2026Primary completion 2030-06 NCT07223814

    bleximenibcytarabinedaunorubicinidarubicin

    New diagnosis of AML (≥10% blasts in BM or peripheral blood) with mutated NPM1 or with recurring rearrangements involving KMT2A according to ICC 2022 criteria.

    NPM1 mutationAcute Myeloid Leukemia

  2. A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

    Recruiting Phase 3 Johnson & Johnson Started 2025Primary completion 2029-06 NCT06852222

    bleximenibvenetoclaxazacitidine

    …d lysine N-methyltransferase 2A gene rearranged (KMT2Ar) or nucleophosmin 1 gene mutated (NPM1m) acute myeloid leukemia (AML) with greater than or equal to (\> or =) 10% bone marrow bla…

    NPM1 mutationLeukemia, Myeloid, Acute

  3. A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1)

    Recruiting Phase 1/2 Johnson & Johnson Started 2021Primary completion 2027-02 NCT04811560

    bleximenib

    AML harboring KMT2A-r (gene rearrangement/translocation) or NPM1 mutations only

    NPM1 mutationAcute Leukemia

  4. A Study of Bleximenib in Combination With Acute Myeloid Leukemia (AML) Directed Therapies

    Active, not recruiting Phase 1 Johnson & Johnson Started 2022Primary completion 2026-10 NCT05453903

    bleximenibvenetoclaxazacitidinecytarabinedaunorubicinidarubicin

    c) harboring KMT2A, NPM1, NUP98, or NUP214 alterations

    NPM1 mutationLeukemia, Myeloid, Acute