Nemtabrutinib

Not yet reviewed: Listed from FDA or ClinicalTrials.gov records; an editor has not checked it yetListed from FDA or ClinicalTrials.gov records; an editor has not checked it yet.

Merck & Co., Inc. MRK · Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; CLL; Leukemia, Chronic Lymphocytic; Leukemia, Lymphocytic, Chronic, B-Cell

Key figures

  • Next catalyst

    None scheduled

    Only dates with a source are listed

  • Phase

    Phase 3

    Not recorded

  • Linked trials

    3

    From ClinicalTrials.gov

  • Latest FDA action

    None on record

    From Drugs@FDA

Recalls, shortages, patents and EU status at a glance

Key information

Indications
Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; CLL; Leukemia, Chronic Lymphocytic; Leukemia, Lymphocytic, Chronic, B-Cell Source: Conditions from ClinicalTrials.gov (opens in a new tab)
Designations
None recorded
Next catalyst
None scheduled

Development timeline

  1. Preclinical Completed
  2. Phase 1 Completed
  3. Phase 2 Completed
  4. Phase 3 Current stageFirst trial start 16 Mar 20233 linked trials
  5. Filed Not yet
  6. Approved Not yet

Overview

Mechanism
Not recorded
Route
Not recorded
Modality
Not recorded
Specialties
Not recorded

Overview text is written by HealthTrade editors.

Key dates

No catalysts yet. Editors add each date together with its source.

FDA designations

No FDA designations are on record for Nemtabrutinib. Editors add each one with its source.

Filed application

No filed application is on record for Nemtabrutinib. Approvals are listed under FDA actions.

FDA advisory committees

No FDA advisory committee meetings are on record for Nemtabrutinib.

Clinical trials

Trials linked to Nemtabrutinib
TrialTitlePhaseStatusEnrollmentPrimary completionResults posted
NCT06136559ClinicalTrials.gov record for NCT06136559 (opens in a new tab)A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)Phase 3Recruiting1,200 (estimated)7 Sep 2032 (estimated) No
NCT05947851ClinicalTrials.gov record for NCT05947851 (opens in a new tab)A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010).Phase 3Recruiting735 (estimated)1 Jun 2032 (estimated) No
NCT05624554ClinicalTrials.gov record for NCT05624554 (opens in a new tab)A Study of Nemtabrutinib vs Chemoimmunotherapy for Participants With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Without TP53 Aberrations (MK-1026-008, BELLWAVE-008)Phase 3Active, not recruiting300 (estimated)19 May 2027 (estimated) No

Publications listing NCT05624554 (1), newest first

  1. BRUIN 313 and 314 Trials Open the Door for Noncovalent Bruton Tyrosine Kinase Inhibition as Initial Therapy for Chronic Lymphocytic Leukemia.

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026 Feb 20

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.

Trial quality

About CT-VCA

Loading trial quality…

FDA actions

No FDA approvals on record for this drug.

FDA recalls load here.

FDA drug shortages load here.

Orange Book patents load here.

FAERS adverse event counts load here.

Papers and preprints load here.

Community discussion loads here.

EU status (EMA)

EMA's medicines data lists no human medicine with the same active substance as Nemtabrutinib.

Source: European Medicines Agency (EMA), medicines data download.

Related news

No recent headlines mention this drug.

Sources

Record updated .

Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.