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Waldenstrom Macroglobulinemia

9
Pipeline Programs
14
Companies
11
Clinical Trials
3 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 Molecule1 trial
PirtobrutinibPhase 2Small Molecule1 trial
Active Trials
NCT05734495Recruiting42Est. Jan 2033
NCT07231952Recruiting40Est. Apr 2028
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 Molecule
SonrotoclaxPHASE_21 trial
Active Trials
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
2029
2030
2031
Prevail TherapeuticsPirtobrutinib
GenmabEpcoritamab
BeOne MedicinesSonrotoclax
Prevail TherapeuticsPirtobrutinib
MSDPembrolizumab
Cellectar BiosciencesIopofosine I 131 single dose
AbbVieABT199
Kite PharmaEpratuzumab
Bristol Myers SquibbThalidomide
Ascentage PharmaAPG2575 400 mg
ETSMRD and clonal evolution

Clinical Trials (11)

Total enrollment: 803 patients across 11 trials

NCT07231952Prevail TherapeuticsPirtobrutinib

A Study of Pirtobrutinib, Venetoclax, and Rituximab in People With Waldenström's Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL)

Start: Nov 2025Est. completion: Apr 202840 patients
Phase 2Recruiting
NCT06510491GenmabEpcoritamab

Epcoritamab in Previously Treated WM

Start: Dec 2024Est. completion: Dec 202720 patients
Phase 2Recruiting
NCT05952037BeOne MedicinesSonrotoclax

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
NCT05734495Prevail TherapeuticsPirtobrutinib

Pirtobrutinib and Venetoclax in Waldenström Macroglobulinemia

Start: May 2023Est. completion: Jan 203342 patients
Phase 2Recruiting
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
NCT02677324AbbVieABT199

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

Start: May 2016Est. completion: Feb 202233 patients
Phase 2Completed
NCT00113802Kite PharmaEpratuzumab

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

Start: Aug 2004Est. completion: Dec 200631 patients
Phase 2Terminated
NCT00083707Bristol Myers SquibbThalidomide

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

Start: Jan 1999Est. completion: Feb 200340 patients
Phase 2Completed
NCT04260217Ascentage PharmaAPG2575 400 mg

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
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

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

Key Insights

3 actively recruiting trials targeting 803 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.