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Warm Autoimmune Hemolytic Anemia Pipeline Analysis Report 2025

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    Report

  • 200 Pages
  • June 2025
  • Region: Global
  • Expert Market Research
  • ID: 6102627
According to the National Organisation for Rare Disorders, warm autoimmune hemolytic anemia (wAIHA) is the most common subtype of autoimmune hemolytic anemia, affecting approximately 1 to 3 per 100,000 people every year. The disease can occur at any age, therefore, there is a significant focus on designing effective drugs that help in successfully managing and treating the disease.

Report Coverage

The Warm Autoimmune Hemolytic Anemia Drug Pipeline Report by the publisher gives comprehensive insights into ongoing warm autoimmune hemolytic anemia clinical trials. It covers various aspects related to the details of warm autoimmune hemolytic anemia drugs under development. The report includes the analysis of over 100 pipeline drugs and 50+ companies. The warm autoimmune hemolytic anemia 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 warm autoimmune hemolytic anemia.

The detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration and ongoing warm autoimmune hemolytic anemia pipeline development activities are covered. Moreover, warm autoimmune hemolytic anemia collaborations and commercial assessments are offered, helping stakeholders to make informed decisions.

Warm Autoimmune Hemolytic Anemia Pipeline Outlook

Warm autoimmune hemolytic anemia is an autoimmune condition that leads to premature death of red blood cells in the body. It is the most common type of autoimmune hemolytic anemia. Normally, red blood cells have a lifespan of 120 days before they are ultimately destroyed by the spleen. However, individuals affected by this condition witness sudden death of RBCs at a rapid pace and to an extent wherein the body cannot compensate for the drastic loss. Symptoms may include tiredness, dizziness, jaundice or heart palpitations.

The first-line warm autoimmune hemolytic anemia treatment involves corticosteroids. These drugs are successful in about 65-70% of the patients. In relapsed cases, splenectomy, rituximab or other immunosuppressive drugs are advised. In December 2023, researchers at the American Journal of Hematology revealed that Fostamatinib, a spleen tyrosine kinase inhibitor, previously used for the treatment of patients with chronic immune thrombocytopenia in the United States can be found successful in managing warm antibody autoimmune hemolytic anemia (wAIHA) effectively. Such initiatives aimed at developing high-efficacy drugs are amongst major trends, impacting the drug pipeline outlook positively.

Warm Autoimmune Hemolytic Anemia - Drug Pipeline Therapeutic Assessment

This section of the report covers the analysis of warm autoimmune hemolytic anemia drug candidates based on several segmentations including:

By Phase

The pipeline assessment report covers 50+ drug analyses based on 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

The warm autoimmune hemolytic anemia therapeutic assessment report covers 50+ drug analyses based on drug classes:

  • Corticosteroids
  • Immunosuppressive Agents
  • Intravenous Immunoglobulins (IVIG)
  • Cytotoxic Agents
  • Monoclonal Antibodies

By Route of Administration

The pipeline assessment report covers 50+ drug analyses based on the route of administration.
  • Oral
  • Parenteral
  • Others

Warm Autoimmune Hemolytic Anemia - 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 warm autoimmune hemolytic anemia. There are around 20 drugs in phase II of warm autoimmune hemolytic anemia drugs.

Warm Autoimmune Hemolytic Anemia - Pipeline Assessment Segmentation, By Drug Classes

The drug molecules categories covered under warm autoimmune hemolytic anemia pipeline analysis include corticosteroids, immunosuppressive agents, intravenous immunoglobulins (IVIG), cytotoxic agents and monoclonal antibodies. These drugs can be used in combination, based on the patient’s response to treatment, symptoms and severity of the condition.

Warm Autoimmune Hemolytic Anemia Clinical Trials Therapeutic Assessment - Competitive Dynamics

The warm autoimmune hemolytic anemia drug pipeline report 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 warm autoimmune hemolytic anemia clinical trials:
  • Zenas BioPharma (USA), LLC
  • Alexion Pharmaceuticals, Inc.
  • Janssen Research & Development, LLC
  • Incyte Corporation
  • Rigel Pharmaceuticals
  • Sanofi
  • Immunovant Sciences GmbH
  • Novartis Pharmaceuticals

Warm Autoimmune Hemolytic Anemia - Emerging Drugs Profile

This section covers the detailed analysis of each drug under multiple phases including phase I, phase II, phase III, phase IV, and emerging drugs for warm autoimmune hemolytic anemia. It covers product description, trial ID, study type, drug class, mode of administration, and recruitment status of warm autoimmune hemolytic anemia (wAIHA) drug candidates.

ALXN1830

Sponsored by Alexion Pharmaceuticals, Inc., the drug is under trials to assess its efficacy and safety in treating warm autoimmune hemolytic anemia (WAIHA). It is currently in Phase 2 of a randomised double-blind study.

M281

As a part of the 24-week double-blind study, M281 is under examination for its efficacy and safety against warm autoimmune hemolytic anemia (wAIHA). It will be administered every 4 weeks during the 24-week double-blind period.

Rilzabrutinib

This oral warm autoimmune hemolytic anemia drug candidate is being evaluated to check the efficacy, safety and pharmacokinetics in patients. Sponsored by Sanofi, Rilzabrutinib is in Phase 2 of an open-label study.

Obexelimab

Zenas BioPharma (USA), LLC is conducting a study to examine the safety and efficacy of obexelimab against warm autoimmune hemolytic anemia (wAIHA) in about 134 participants enrolled in the study.

Reasons To Buy This Report

The Warm Autoimmune Hemolytic Anemia Drug Pipeline Insight Report provides a strategic overview of the latest and future landscape of treatments for warm autoimmune hemolytic anemia. 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 warm autoimmune hemolytic anemia (wAIHA) collaborations, regulatory environments, and potential growth opportunities within the treatment landscape.

Key Questions Answered in the Warm Autoimmune Hemolytic Anemia - Pipeline Insight Report

  • Which companies/institutions are leading the warm autoimmune hemolytic anemia drug development?
  • What is the efficacy and safety profile of warm autoimmune hemolytic anemia pipeline drugs?
  • Which company is leading the warm autoimmune hemolytic anemia pipeline development activities?
  • What is the current warm autoimmune hemolytic anemia commercial assessment?
  • What are the opportunities and challenges present in the warm autoimmune hemolytic anemia drug pipeline landscape?
  • What is the efficacy and safety profile of warm autoimmune hemolytic anemia pipeline drugs?
  • Which company is conducting major trials for warm autoimmune hemolytic anemia drugs?
  • Which companies/institutions are involved in warm autoimmune hemolytic anemia collaborations aimed at providing enhanced therapeutic alternatives for patients?
  • What are the geographies covered for clinical trials in warm autoimmune hemolytic anemia?

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Table of Contents

1 Preface
1.1 Introduction
1.2 Objectives of the Study
1.3 Research Methodology and Assumptions
2 Executive Summary
3 Overview of Warm Autoimmune Hemolytic Anemia
3.1 Signs and Symptoms
3.2 Causes
3.3 Risk Factors
3.4 Diagnosis
3.5 Treatment
4 Patient Profile
4.1 Patient Profile Overview
4.2 Patient Psychology and Emotional Impact Factors
4.3 Risk Assessment and Treatment Success Rate
5 Warm Autoimmune Hemolytic Anemia: Epidemiology Snapshot
5.1 Warm Autoimmune Hemolytic Anemia Incidence by Key Markets
5.2 Warm Autoimmune Hemolytic Anemia- Patients Seeking Treatment in Key Markets
6 Warm Autoimmune Hemolytic Anemia: Market Dynamics
6.1 Market Drivers and Constraints
6.2 SWOT Analysis
7 Warm Autoimmune Hemolytic Anemia: 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 Warm Autoimmune Hemolytic Anemia, 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 Warm Autoimmune Hemolytic Anemia 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 Warm Autoimmune Hemolytic Anemia 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 Obexelimab
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 Drug 2
10.2.3 Other Drugs
11 Warm Autoimmune Hemolytic Anemia 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 ALXN1830
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 RVT-1401 680
11.2.3 Other Drugs
12 Warm Autoimmune Hemolytic Anemia 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 IASO-782 injection
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 Other Drugs
13 Warm Autoimmune Hemolytic Anemia 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 Drug 2
13.2.3 Other Drugs
14 Warm Autoimmune Hemolytic Anemia, Key Drug Pipeline Companies
14.1 Zenas BioPharma (USA), 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 Alexion Pharmaceuticals, 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 Janssen Research & Development, LLC
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 Incyte Corporation
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 Rigel Pharmaceuticals
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 Sanofi
14.6.1 Company Snapshot
14.6.2 Pipeline Product Portfolio
14.6.3 Financial Analysis
14.6.4 Recent News and Developments
14.7 Immunovant Sciences GmbH
14.7.1 Company Snapshot
14.7.2 Pipeline Product Portfolio
14.7.3 Financial Analysis
14.7.4 Recent News and Developments
14.8 Novartis Pharmaceuticals
14.8.1 Company Snapshot
14.8.2 Pipeline Product Portfolio
14.8.3 Financial Analysis
14.8.4 Recent News and Developments
15 Regulatory Framework for Drug Approval, By Region16 Terminated or Suspended Pipeline Products