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Waldenstrom Macroglobulinemia

9
Pipeline Programs
14
Companies
10
Clinical Trials
2 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
0
8
0
0
0
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
873%
Small Molecule
327%
+ 6 programs with unclassified modality

Competitive Landscape

14 companies ranked by most advanced pipeline stage

Prevail Therapeutics
2 programs
2
PirtobrutinibPhase 2Small Molecule
PirtobrutinibPhase 2Small Molecule
AbbVie
AbbVieNORTH CHICAGO, IL
1 program
1
ABT199Phase 21 trial
Active Trials
NCT02677324Completed33Est. Feb 2022
Genmab
GenmabNetherlands - Utrecht
1 program
1
EpcoritamabPhase 2Monoclonal Antibody1 trial
Active Trials
NCT06510491Recruiting20Est. Dec 2027
Kite Pharma
Kite PharmaCA - El Segundo
1 program
1
EpratuzumabPhase 2Monoclonal Antibody1 trial
Active Trials
NCT00113802Terminated31Est. Dec 2006
MSD
MSDIreland - Ballydine
1 program
1
PembrolizumabPhase 2Monoclonal Antibody1 trial
Active Trials
NCT03630042Completed17Est. Feb 2024
Sharp Therapeutics
Sharp TherapeuticsPA - Pittsburgh
1 program
1
PembrolizumabPhase 2Monoclonal Antibody
Pfizer
PfizerNEW YORK, NY
1 program
1
Venetoclax; RituximabPhase 2Monoclonal Antibody
Ascentage Pharma
Ascentage PharmaChina - Beijing
1 program
1
APG2575 400 mgPhase 11 trial
Active Trials
NCT04260217Completed46Est. Aug 2025
BeOne Medicines
BeOne MedicinesCA - San Carlos
2 programs
ZanubrutinibN/ASmall Molecule1 trial
SonrotoclaxPHASE_21 trial
Active Trials
NCT05640102Recruiting111Est. Dec 2027
NCT05952037Active Not Recruiting114Est. Aug 2028
Gilead Sciences
Gilead SciencesFOSTER CITY, CA
2 programs
EpratuzumabPHASE_2Monoclonal Antibody
EpratuzumabPHASE_2Monoclonal Antibody
ETS
ETSMO - Rolla
1 program
MRD and clonal evolutionN/A1 trial
Active Trials
NCT03521596Completed300Est. Oct 2025
Johnson & Johnson
Johnson & JohnsonNEW BRUNSWICK, NJ
1 program
Ibrutinib / Bortezomib / RituximabPHASE_2Monoclonal Antibody
Cellectar Biosciences
Cellectar BiosciencesFLORHAM PARK, NJ
1 program
Iopofosine I 131 single dosePHASE_21 trial
Active Trials
NCT02952508Active Not Recruiting120Est. Dec 2027
Bristol Myers Squibb
1 program
ThalidomidePHASE_21 trial
Active Trials
NCT00083707Completed40Est. Feb 2003

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
GenmabEpcoritamab
BeOne MedicinesSonrotoclax
MSDPembrolizumab
Cellectar BiosciencesIopofosine I 131 single dose
AbbVieABT199
Kite PharmaEpratuzumab
Bristol Myers SquibbThalidomide
Ascentage PharmaAPG2575 400 mg
BeOne MedicinesZanubrutinib
ETSMRD and clonal evolution

Clinical Trials (10)

Total enrollment: 832 patients across 10 trials

Epcoritamab in Previously Treated WM

Start: Dec 2024Est. completion: Dec 202720 patients
Phase 2Recruiting

A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia

Start: Oct 2023Est. completion: Aug 2028114 patients
Phase 2Active Not Recruiting
NCT03630042MSDPembrolizumab

Investigating the Safety and Efficacy of Rituximab and Pembrolizumab in Relapsed/Refractory Waldenström's Macroglobulinaemia

Start: Sep 2019Est. completion: Feb 202417 patients
Phase 2Completed
NCT02952508Cellectar BiosciencesIopofosine I 131 single dose

Study of Iopofosine I-131 (CLR 131) in Select B-Cell Malignancies (CLOVER-1) With Expansion in Waldenstrom

Start: Jul 2017Est. completion: Dec 2027120 patients
Phase 2Active Not Recruiting

Study of ABT-199 (GDC-199) In Patients With Relapsed Or Refractory Waldenström Macroglobulinemia

Start: May 2016Est. completion: Feb 202233 patients
Phase 2Completed

Study of Epratuzumab (hLL2) in Patients With Waldenstrom's Macroglobulinemia

Start: Aug 2004Est. completion: Dec 200631 patients
Phase 2Terminated

Anti-Angiogenesis Therapy Using Thalidomide in Patients With Waldenstrom's Macroglobulinemia

Start: Jan 1999Est. completion: Feb 200340 patients
Phase 2Completed

APG-2575 Single Agent or in Combination With Ibrutinib or Rituximab in Patients With Waldenström Macroglobulinemia

Start: May 2021Est. completion: Aug 202546 patients
Phase 1Completed

Observational Study Evaluating the Efficacy and Safety of Zanubrutinib in Participants With Waldenström Macroglobulinemia

Start: Mar 2023Est. completion: Dec 2027111 patients
N/ARecruiting
NCT03521596ETSMRD and clonal evolution

Non-invasive Diagnostics and Monitoring of MRD and Clonal Evolution in Waldenström's Macroglobulinemia and in IgM-MGUS

Start: Aug 2018Est. completion: Oct 2025300 patients
N/ACompleted

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

2 actively recruiting trials targeting 832 patients
Monoclonal Antibody is the dominant modality (73% of programs)
14 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.