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Waldenström's Macroglobulinemia

3
Pipeline Programs
3
Companies
3
Clinical Trials
1 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
0
0
2
1
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
3100%
+ 1 programs with unclassified modality

On Market (1)

Approved therapies currently available

AbbVie
IMBRUVICAApproved
ibrutinib
AbbVie
Kinase Inhibitor [EPC]oral2013
2.4B Part D

Competitive Landscape

3 companies ranked by most advanced pipeline stage

AbbVie
AbbVieNORTH CHICAGO, IL
1 program
1
1
IbrutinibPhase 3Small Molecule1 trial
Active Trials
NCT02165397Completed181Est. Nov 2019
BeiGene
BeiGeneChina - Beijing
1 program
1
BGB-3111Phase 31 trial
Active Trials
NCT03053440Completed201Est. Jun 2022
BeOne Medicines
BeOne MedicinesCA - San Carlos
2 programs
ZanubrutinibN/ASmall Molecule1 trial
ZanubrutinibPHASE_4Small Molecule
Active Trials
NCT05326308Recruiting705Est. Aug 2028

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
BeiGeneBGB-3111
AbbVieIbrutinib
BeOne MedicinesZanubrutinib

Clinical Trials (3)

Total enrollment: 1,087 patients across 3 trials

NCT03053440BeiGeneBGB-3111

A Study Comparing BGB-3111 and Ibrutinib in Participants With Waldenström's Macroglobulinemia (WM)

Start: Jan 2017Est. completion: Jun 2022201 patients
Phase 3Completed
NCT02165397AbbVieIbrutinib

Ibrutinib With Rituximab in Adults With Waldenström's Macroglobulinemia

Start: Jul 2014Est. completion: Nov 2019181 patients
Phase 3Completed
NCT05326308BeOne MedicinesZanubrutinib

Zanubrutinib in Patients With Waldenström's Macroglobulinemia, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma and Follicular Lymphoma

Start: Apr 2022Est. completion: Aug 2028705 patients
N/ARecruiting

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

2 late-stage (Phase 3) programs, potential near-term approvals
1 actively recruiting trials targeting 1,087 patients
Small Molecule is the dominant modality (100% of programs)
3 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.