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Waldenstrom's Macroglobulinemia Drug Pipeline Analysis Report 2025

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    Drug Pipelines

  • 200 Pages
  • June 2025
  • Region: Global
  • Expert Market Research
  • ID: 6102628
Waldenstrom macroglobulinemia is considered the most common subtype of lymphoplasmacytic lymphoma, as per the current WHO classification. Although a rare blood cancer, the incidence of Waldenstrom’s macroglobulinemia is strongly influenced by sex, age, race, and ethnicity. It is reported that the incidence of Waldenstrom’s macroglobulinemia is two times higher in men than in women in the United States. Existing treatments for this B-cell lymphoma are often linked to significant side effects, indicating the need for therapies with improved safety profiles and better tolerability.

Report Coverage

Waldenstrom’s Macroglobulinemia Drug Pipeline Insight Report by the publisher gives comprehensive insights into Waldenstrom’s macroglobulinemia drugs currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for Waldenstrom’s macroglobulinemia. The report includes the analysis of over 100 pipeline drugs and 50+ companies. The Waldenstrom’s macroglobulinemia pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials including their adverse effects on patients suffering from Waldenstrom’s Macroglobulinemia.

The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to Waldenstrom’s macroglobulinemia.

Waldenstrom’s Macroglobulinemia Drug Pipeline Outlook

Waldenstrom’s macroglobulinemia refers to a type of non-Hodgkin lymphoma that affects plasma cells and lymphoplasmacytoid cells (types of white blood cells). It is caused by DNA changes in the white blood cells that trigger them to multiply quickly and live longer than healthy cells. Common symptoms of this rare, slow-growing blood cancer include extreme tiredness, nosebleeds, frequent infections, and unintentional weight loss, among others.

Waldenstrom’s macroglobulinemia is treated by a combination of drugs, procedures, and other therapies. Chemotherapy, radiation therapy, and plasmapheresis are common treatment options for this rare disease. Steroids such as dexamethasone or prednisolone are often prescribed to increase the efficiency of chemotherapy agents. However, certain patients develop resistance to current therapies, leading to disease progression or relapse. Thus, there is a critical need to develop novel drugs that target alternative pathways or overcome resistance mechanisms.

Waldenstrom’s Macroglobulinemia - Drug Pipeline Therapeutic Assessment

This section of the report covers the analysis of Waldenstrom’s macroglobulinemia drugs based on several segmentations including:

By Phase

  • Late-Stage Products (Phase 3 and Phase 4)
  • Mid-Stage Products (Phase 2)
  • Early-Stage Products (Phase I)
  • Preclinical and Discovery Stage Products

By Drug Class

  • Recombinant Fusion Proteins
  • Small Molecule
  • Monoclonal Antibody
  • Peptide
  • Polymer
  • Gene Therapy

By Route of Administration

  • Oral
  • Parenteral
  • Others

Waldenstrom’s Macroglobulinemia - Pipeline Assessment Segmentation, By Phases

The report covers phase I, phase II, phase III, phase IV, and early phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to analysis, phase II covers a major share of the total clinical trials for Waldenstrom’s macroglobulinemia.

Waldenstrom’s Macroglobulinemia - Pipeline Assessment Segmentation, By Drug Classes

The drug molecule categories covered under Waldenstrom’s macroglobulinemia pipeline analysis include recombinant fusion proteins, small molecules, monoclonal antibodies, peptides, polymer, and gene therapy. The report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for Waldenstrom macroglobulinemia.

Waldenstrom’s Macroglobulinemia Clinical Trials Therapeutic Assessment - Competitive Dynamics

The report for Waldenstrom’s macroglobulinemia drug pipeline covers the profile of key companies involved in clinical trials and their drugs under development. Below is the list of a few players involved in Waldenstrom’s macroglobulinemia clinical trials:
  • Merck Sharp & Dohme LLC
  • Cellectar Biosciences, Inc.
  • Schrodinger Inc.
  • Eli Lilly and Company
  • Gilead Sciences
  • AstraZeneca

Waldenstrom’s Macroglobulinemia - Emerging Drugs Profile

Major drugs currently in the drug pipeline are as follows:

Drug: Iopofosine I 131 (CLR 131

)
Sponsored by Cellectar Biosciences, Inc., the objective of this Phase 2, open-label, multicenter study is to evaluate Iopofosine I 131 (CLR 131), a targeted radiotherapeutic, in patients with relapsed or refractory (R/R) B-cell cancers and in an expansion group of patients with Waldenstrom macroglobulinemia. The study is expected to be completed by December 2026 and has an estimated 120 participants.

Drug: SGR-1505

Schrödinger, Inc. is conducting a Phase 1 dose-escalation study aimed at evaluating an oral inhibitor of MALT1 called SGR-1505 in participants with B-cell malignancies including Waldenstrom macroglobulinemia. The interventional study has enrolled an estimated 52 subjects and is expected to be completed by March 2026.

Reasons To Buy This Report

The Waldenstrom’s Macroglobulinemia Drug Pipeline Insight Report provides a strategic overview of the latest and future landscape of treatments for Waldenstrom’s macroglobulinemia. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into market trends, regulatory environments, and potential growth opportunities within Waldenstrom’s macroglobulinemia pipeline insights.

Key Questions Answered in the Waldenstrom’s Macroglobulinemia - Pipeline Insight Report

  • What is the current landscape of Waldenstrom’s macroglobulinemia pipeline drugs?
  • How many companies are developing Waldenstrom’s macroglobulinemia drugs?
  • How many phase III and phase IV drugs are currently present in Waldenstrom’s macroglobulinemia pipeline drugs?
  • Which companies/institutions are leading Waldenstrom’s macroglobulinemia drug development?
  • What is the efficacy and safety profile of Waldenstrom’s macroglobulinemia pipeline drugs?
  • What are the opportunities and challenges present in the Waldenstrom’s macroglobulinemia drug pipeline landscape?
  • Which company is conducting major trials for Waldenstrom’s macroglobulinemia drugs?
  • What geographies are covered for Waldenstrom’s macroglobulinemia clinical trials?
  • What are emerging trends in Waldenstrom’s macroglobulinemia clinical trials?

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Table of Contents

1 Preface
1.1 Introduction
1.2 Objectives of the Study
1.3 Research Methodology & Assumptions
2 Executive Summary
3 Overview of Waldenstrom’s Macroglobulinemia
3.1 Signs and Symptoms
3.2 Causes
3.3 Risk Factors
3.4 Diagnosis
3.5 Treatment
4 Patient Profile: Waldenstrom’s Macroglobulinemia
4.1 Patient Profile Overview
4.2 Patient Psychology and Emotional Impact Factors
4.3 Risk Assessment and Treatment Success Rate
5 Waldenstrom’s Macroglobulinemia: Epidemiology Snapshot
5.1 Waldenstrom’s Macroglobulinemia Incidence by Key Markets
5.2 Waldenstrom’s Macroglobulinemia - Patients Seeking Treatment in Key Markets
6 Waldenstrom’s Macroglobulinemia: Market Dynamics
6.1 Market Drivers and Constraints
6.2 SWOT Analysis
7 Waldenstrom’s Macroglobulinemia: Key Facts Covered
7.1 Top Countries Contributing to Clinical Trials in Asia-Pacific
7.2 Top Countries Contributing to Clinical Trials in Europe
7.3 Top Countries Contributing to Clinical Trials in North America
7.4 Top Countries Contributing to Clinical Trials in Other Regions
8 Waldenstrom’s Macroglobulinemia, Drug Pipeline Assessment
8.1 Assessment by Treatment Type
8.2 Assessment by Route of Administration
8.3 Assessment by Drug Class
9 Drug Pipeline Comparative Analysis
9.1 List of Waldenstrom’s Macroglobulinemia Pipeline Drugs
9.1.1 By Company
9.1.2 By Phase
9.1.3 By Indication
9.1.4 By Trial Status
9.1.5 By Funder Type
9.2 Attribute Scoring Analysis of Pipeline Drugs (Top Drugs)
10 Waldenstrom’s Macroglobulinemia Drug Pipeline - Late-Stage Products (Phase III and IV) (Top Drugs)
10.1 Comparative Analysis for Late-Stage Drugs
10.1.1 Study Type
10.1.2 Recruitment Status
10.1.3 Company
10.1.4 Funder Type
10.2 Product Level Analysis*
10.2.1 Drug 1
10.2.1.1 Product Description
10.2.1.2 Trial ID
10.2.1.3 Sponsor Name
10.2.1.4 Study Type
10.2.1.5 Drug Class
10.2.1.6 Eligibility Criteria
10.2.1.7 Study Record Dates
10.2.1.7.1 First Submitted
10.2.1.7.2 First Posted
10.2.1.7.3 Last Update Posted
10.2.1.7.4 Last Verified
10.2.1.8 Indication
10.2.1.9 Study Design
10.2.1.10 Recruitment Status
10.2.1.11 Enrollment (Estimated)
10.2.1.12 Location Countries
10.2.1.13 Recent Results
10.2.2 Other Drugs
11 Waldenstrom’s Macroglobulinemia Drug Pipeline - Mid-Stage Products (Phase II) (Top Drugs)
11.1 Comparative Analysis for Mid-Stage Drugs
11.1.1 Study Type
11.1.2 Recruitment Status
11.1.3 Company
11.1.4 Funder Type
11.2 Product Level Analysis*
11.2.1 Drug: Iopofosine I 131 (CLR 131)
11.2.1.1 Product Description
11.2.1.2 Trial ID
11.2.1.3 Sponsor Name
11.2.1.4 Study Type
11.2.1.5 Drug Class
11.2.1.6 Eligibility Criteria
11.2.1.7 Study Record Dates
11.2.1.7.1 First Submitted
11.2.1.7.2 First Posted
11.2.1.7.3 Last Update Posted
11.2.1.7.4 Last Verified
11.2.1.8 Indication
11.2.1.9 Study Design
11.2.1.10 Recruitment Status
11.2.1.11 Enrollment (Estimated)
11.2.1.12 Location Countries
11.2.1.13 Recent Results
11.2.2 Drug: Pirtobrutinib, Drug: Venetoclax
11.2.3 Drug: Nemtabrutinib
11.2.4 Other Drugs
12 Waldenstrom’s Macroglobulinemia Drug Pipeline - Early-Stage Products (Phase I) (Top Drugs)
12.1 Comparative Analysis for Early-Stage Drugs
12.1.1 Study Type
12.1.2 Recruitment Status
12.1.3 Company
12.1.4 Funder Type
12.2 Product Level Analysis*
12.2.1 Biological: Autologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA Vaccine
12.2.1.1 Product Description
12.2.1.2 Trial ID
12.2.1.3 Sponsor Name
12.2.1.4 Study Type
12.2.1.5 Drug Class
12.2.1.6 Eligibility Criteria
12.2.1.7 Study Record Dates
12.2.1.7.1 First Submitted
12.2.1.7.2 First Posted
12.2.1.7.3 Last Update Posted
12.2.1.7.4 Last Verified
12.2.1.8 Indication
12.2.1.9 Study Design
12.2.1.10 Recruitment Status
12.2.1.11 Enrollment (Estimated)
12.2.1.12 Location Countries
12.2.2 Drug: SGR-1505
12.2.3 Other Drugs
13 Waldenstrom’s Macroglobulinemia Drug Pipeline - Preclinical and Discovery Stage Products (Top Drugs)
13.1 Comparative Analysis for Preclinical and Discovery Stage Drugs
13.1.1 Study Type
13.1.2 Recruitment Status
13.1.3 Company
13.1.4 Funder Type
13.2 Product Level Analysis*
13.2.1 Drug 1
13.2.1.1 Product Description
13.2.1.2 Trial ID
13.2.1.3 Sponsor Name
13.2.1.4 Study Type
13.2.1.5 Drug Class
13.2.1.6 Eligibility Criteria
13.2.1.7 Study Record Dates
13.2.1.7.1 First Submitted
13.2.1.7.2 First Posted
13.2.1.7.3 Last Update Posted
13.2.1.7.4 Last Verified
13.2.1.8 Indication
13.2.1.9 Study Design
13.2.1.10 Recruitment Status
13.2.1.11 Enrollment (Estimated)
13.2.1.12 Location Countries
13.2.2 Other Drugs
14 Waldenstrom’s Macroglobulinemia, Key Drug Pipeline Companies
14.1 Merck Sharp & Dohme LLC
14.1.1 Company Snapshot
14.1.2 Pipeline Product Portfolio
14.1.3 Financial Analysis
14.1.4 Recent News and Developments
14.2 Cellectar Biosciences, Inc.
14.2.1 Company Snapshot
14.2.2 Pipeline Product Portfolio
14.2.3 Financial Analysis
14.2.4 Recent News and Developments
14.3 Schrodinger Inc.
14.3.1 Company Snapshot
14.3.2 Pipeline Product Portfolio
14.3.3 Financial Analysis
14.3.4 Recent News and Developments
14.4 Eli Lilly and Company
14.4.1 Company Snapshot
14.4.2 Pipeline Product Portfolio
14.4.3 Financial Analysis
14.4.4 Recent News and Developments
14.5 Gilead Sciences
14.5.1 Company Snapshot
14.5.2 Pipeline Product Portfolio
14.5.3 Financial Analysis
14.5.4 Recent News and Developments
14.6 AstraZeneca
14.6.1 Company Snapshot
14.6.2 Pipeline Product Portfolio
14.6.3 Financial Analysis
14.6.4 Recent News and Developments
15 Regulatory Framework for Drug Approval, By Region16 Terminated or Suspended Pipeline Products