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Zanubrutinib

Phase 2

Follicular Lymphoma | Small molecule | Oncology |Genmab A/S|Last Updated: Feb 19, 2026

Target and mechanism

Molecular targetBTK
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

Clinical trial landscape

Zanubrutinib · 1 trial · 6 indications

Phase 2 1
NCT06563596Epco, Zanu, Ritux for R/R FL or MZLFollicular Lymphoma
RECRUITING45 Analytics
PHASE2RECRUITING
Epco, Zanu, Ritux for R/R FL or MZL
Follicular LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Complete Metabolic Response (CMR) Rate among patients with R/R FL
6 months

CMR rate is defined as the proportion of participants who achieved CMR during study. CMR assessed by PET/CT is defined using Lugano criteria.

Complete Metabolic Response (CMR) Rate among patients with R/R MZL
6 months

CMR rate is defined as the proportion of participants who achieved CMR during study. CMR assessed by PET/CT or CT is defined using Lugano criteria.

Secondary Endpoints

Objective Response Rate (ORR)
12 months
Partial Response Rate (PRR)
12 months
End-of-treatment Objective Response Rate (EOT ORR)
Up to 12 months - End-of treatment visit occurs 4 weeks after cycle 12 day 1. Each cycle is 4 weeks. Participants who discontinue therapy due to toxicity would also undergo an EOT evaluation approximately 4 weeks after the last dose of study treatment.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Rituxan + Zanubrutinib + Epcoritamab for FLEXPERIMENTALEnrolled participants will complete: * Baseline visit with imaging and bone marrow biopsy * Imaging on cycles 3, 6, 9 * Up to 1 year of treatment with study drugs * End of Treatment visit with imaging and bone marrow biopsy * Follow up visits every 6 months for up to 10 years
Rituxan + Zanubrutinib + Epcoritamab for MZLEXPERIMENTALEnrolled participants will complete: * Baseline visit with imaging and bone marrow biopsy * Imaging on cycles 3, 6, 9 * Up to 1 year of treatment with study drugs * End of Treatment visit with imaging and bone marrow biopsy * Follow up visits every 6 months for up to 10 years

Interventions

NameTypeDescription
ZanubrutinibDRUGBruton tyrosine kinase inhibitor, 80 mg immediate-release capsule, taken orally per protocol.
RituximabDRUGChimeric anti-CD20 monoclonal antibody, 10 or 50 mL single-use vials, via intravenous infusion per institutional standard.
EpcoritamabDRUGBispecific antibody, 5 or 60 mg/mL vials, via subcutaneous (under the skin) injection per protocol.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Histologically confirmed diagnosis of CD20+ FL (grade 1-3A) or CD20+ MZL (any subtype) (at time of trial entry) with review of the diagnostic pathology specimen at one of the participating institutions. Patients with current histologic transformation are excluded. * Receipt of...

Countries:United States
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Recent Changes (Last 90 Days)

LOWMay 24, 2026NCT06563596studyFirstPostDate: changed

Frequently asked questions about Zanubrutinib

What is Zanubrutinib used for in Follicular Lymphoma?

Zanubrutinib is an investigational small molecule being studied for the treatment of relapsed or refractory Follicular Lymphoma. It is currently in Phase 2 clinical development for this indication, with an ongoing trial evaluating its use in combination with other agents.

What does Zanubrutinib target?

Zanubrutinib targets Bruton's tyrosine kinase (BTK) and acts as an inhibitor of this enzyme. By inhibiting BTK, it is designed to interfere with B-cell receptor signaling, which plays a role in the growth and survival of certain lymphoma cells.

Who is developing Zanubrutinib?

Zanubrutinib is being developed by Genmab A/S, a biopharmaceutical company listed on the stock exchange under the ticker symbol GMAB. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with relapsed or refractory Follicular Lymphoma.

What phase is Zanubrutinib in?

Zanubrutinib is currently in Phase 2 clinical development for Follicular Lymphoma. It is an investigational drug, meaning it has not yet been approved by regulatory authorities and is still being studied in clinical trials to assess its safety and effectiveness.

What clinical trials is Zanubrutinib in?

Zanubrutinib is being evaluated in a Phase 2 clinical trial with the identifier NCT06563596. This trial is recruiting patients with relapsed or refractory Follicular Lymphoma, Marginal Zone Lymphoma, and other non-Hodgkin lymphomas. The study is enrolling approximately 45 participants in the United States.

Is Zanubrutinib the same as Epco or Ritux?

No, Zanubrutinib is not the same as Epco or Ritux. In the clinical trial NCT06563596, Zanubrutinib is being studied in combination with Epco and Ritux for the treatment of relapsed or refractory Follicular Lymphoma and Marginal Zone Lymphoma. Each of these agents has a distinct mechanism of action.