Press release
AL Amyloidosis Clinical Pipeline | 10+ Companies Advancing the Next Breakthroughs
AL Amyloidosis Clinical Pipeline
DelveInsight's 'AL Amyloidosis Pipeline Insight 2024' report provides comprehensive global coverage of pipeline AL Amyloidosis therapies in various stages of clinical development. Major pharmaceutical companies are working to advance the pipeline space and future growth potential of the AL Amyloidosis pipeline domain.
For AL Amyloidosis emerging drugs, the AL Amyloidosis pipeline analysis report provides a 360° view of the therapeutics landscape by development point, product type, route of administration, molecule type, and MOA. The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.
Key Takeaways from the AL Amyloidosis Pipeline Report
• DelveInsight's AL Amyloidosis Pipeline analysis depicts a robust space with 10+ active players working to develop 10+ pipeline drugs for AL Amyloidosis treatment.
• The leading AL Amyloidosis companies include Caelum Biosciences, Nexcella, Inc., HaemaLogiX Ltd., Prothena, Zentalis Pharmaceuticals, Sorrento Therapeutics, Inc., and others are evaluating their lead assets to improve the AL Amyloidosis treatment landscape.
• Key AL Amyloidosis pipeline therapies in various stages of development include Daratumumab, Birtamimab, CAEL-101, Melflufen, Elotuzumab, NXC-201, and others.
• In February 2025, Immix Biopharma, Inc., a clinical-stage biopharmaceutical company focused on cell therapies for AL amyloidosis and immune-mediated diseases, announced that the FDA granted RMAT designation to sterically-optimized CAR-T NXC-201 for treating relapsed/refractory AL amyloidosis.
• In January 2025, Life Molecular Imaging (LMI) announced that the FDA granted Fast Track Designation to [18F]florbetaben for diagnosing cardiac amyloid light-chain (AL) and amyloid transthyretin-related (ATTR) amyloidosis.
Request a sample and discover the recent breakthroughs happening in the AL Amyloidosis pipeline landscape @ https://www.delveinsight.com/report-store/al-amyloidosis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr
AL Amyloidosis Overview
AL amyloidosis, also known as primary systemic amyloidosis, is a rare but serious disorder caused by the abnormal buildup of amyloid protein fibrils in various tissues and organs. It results from the overproduction of defective immunoglobulin light chains by abnormal plasma cells in the bone marrow. These misfolded proteins accumulate in critical organs such as the heart, kidneys, liver, nerves, and gastrointestinal tract, leading to progressive dysfunction. As the disease advances, patients may experience symptoms like fatigue, shortness of breath, swelling, easy bruising, weight loss, and neurological impairments.
Diagnosing AL amyloidosis requires a comprehensive approach, including clinical assessments, specialized laboratory tests, imaging studies, and tissue biopsy to confirm amyloid deposits. Early detection is crucial to initiating treatment and preventing irreversible organ damage. The primary goal of therapy is to reduce the production of abnormal light chains while managing complications. Treatment options may include chemotherapy, immunomodulatory drugs, stem cell transplantation, and supportive care tailored to specific organ involvement.
Due to its chronic and progressive nature, AL amyloidosis requires long-term management and close monitoring. A multidisciplinary team of specialists-including hematologists, nephrologists, cardiologists, and neurologists-plays a vital role in delivering personalized care. Despite the challenges associated with the disease, advances in diagnostic techniques and therapeutic approaches have significantly improved patient outcomes. Ongoing research continues to drive the development of innovative treatments, offering hope for more effective disease management in the future.
Find out more about AL Amyloidosis medication @ https://www.delveinsight.com/report-store/al-amyloidosis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr
AL Amyloidosis Treatment Analysis: Drug Profile
CAEL-101: Caelum Biosciences
CAEL-101 is a fibril-reactive monoclonal antibody (mAb) currently in Phase III clinical development for the treatment of AL amyloidosis. The Cardiac Amyloid Reaching for Extended Survival (CARES) clinical program consists of two parallel Phase III studies-one targeting patients with Mayo stage IIIa disease and another for those with Mayo stage IIIb disease. Together, these studies aim to enroll approximately 370 patients worldwide, primarily evaluating overall survival. CAEL-101 has been granted Orphan Drug Designation by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), underscoring its potential as a promising therapy for AL amyloidosis patients.
NXC-201: Nexcella, Inc.
NXC-201 (formerly HBI0101) is an investigational BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy in development for relapsed or refractory multiple myeloma and AL amyloidosis. This novel CAR-T therapy features a proprietary BCMA-targeting design, engineered to minimize toxicity, as demonstrated in the ongoing NEXICART-1 clinical study. With its differentiated structural profile, NXC-201 is being explored as a potential outpatient treatment option. Currently, the therapy is in Phase I of the NEXICART-1 study, evaluating its efficacy and safety in patients with relapsed or refractory multiple myeloma and AL amyloidosis.
Key AL Amyloidosis Therapies and Companies
• Daratumumab: Janssen Pharmaceutical
• Birtamimab: Prothena
• CAEL-101: Alexion Pharmaceuticals
• Melflufen: Oncopeptides AB
• Elotuzumab: Bristol-Myers Squibb
• NXC-201: Nexcella, Inc.
Learn more about the novel and emerging AL Amyloidosis pipeline therapies @ https://www.delveinsight.com/report-store/al-amyloidosis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr
AL Amyloidosis Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.
By Stage
• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
By Route of Administration
• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Ophthalmic
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal
By Molecule Type
• Oligonucleotide
• Peptide
• Small molecule
Scope of the AL Amyloidosis Pipeline Report
• Coverage: Global
• Key AL Amyloidosis Companies: Caelum Biosciences, Nexcella, Inc., HaemaLogiX Ltd., Prothena, Zentalis Pharmaceuticals, Sorrento Therapeutics, Inc., and others.
• Key AL Amyloidosis Pipeline Therapies: Daratumumab, Birtamimab, CAEL-101, Melflufen, Elotuzumab, NXC-201, and others.
Dive deep into rich insights for drugs used for AL Amyloidosis treatment; visit @ https://www.delveinsight.com/report-store/al-amyloidosis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr
Table of Contents
1. Introduction
2. Executive Summary
3. AL Amyloidosis Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. AL Amyloidosis Pipeline Therapeutics
6. AL Amyloidosis Pipeline: Late-Stage Products (Phase III)
7. AL Amyloidosis Pipeline: Late-Stage Products (Phase III)
8. AL Amyloidosis Pipeline: Mid-Stage Products (Phase II)
9. AL Amyloidosis Pipeline: Early Stage Products (Phase I)
10. Therapeutic Assessment
11. Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Key Companies
14. Key Products
15. Unmet Needs
16. Market Drivers and Barriers
17. Future Perspectives and Conclusion
18. Analyst Views
19. Appendix
Contact Us:
Jatin Vimal
jvimal@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services
About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.
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