Press release
AL Amyloidosis Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies
Discover the latest drugs and treatment options in the AL Amyloidosis Pipeline. Dive into DelveInsight's comprehensive report today! @ AL Amyloidosis Pipeline Outlook [https://www.delveinsight.com/sample-request/al-amyloidosis-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]
Key Takeaways from the AL Amyloidosis Pipeline Report
* In April 2025, AbbVie conducted a study to determine adverse events and change in disease activity in adult participants with AL amyloidosis treated with ABBV-383. Etentamig (ABBV-383) is an investigational drug being developed for the treatment of AL amyloidosis. This study in broken into 2 parts (dose escalation and safety expansion) with 5 arms.
* In April 2025, Janssen Research & Development LLC announced a study is to characterize cardiac safety of Daratumumab, Cyclophosphamide, Bortezomib, and Dexamethasone (D-VCd) treatment regimens (Arm A: daratumumab + immediate VCd treatment and Arm B: daratumumab + deferred VCd) in newly diagnosed systemic amyloid light chain (AL) amyloidosis with cardiac involvement and to identify potential mitigation strategies for cardiac toxicity (cohort 1); to characterize the pharmacokinetics of subcutaneous (SC) daratumumab, among racial and ethnic minorities, including Black or African American, with newly diagnosed AL amyloidosis treated with D-VCd (cohort 2).
* In April 2025, Regeneron Pharmaceuticals organized a phase 1/2 Study of Linvoseltamab in Patients With Relapsed or Refractory Systemic Light Chain Amyloidosis. In Phase 1, linvoseltamab will be given to a small number of participants to study the side effects of the study drug and to determine the recommended doses of the study drug to be given to participants in Phase 2. In Phase 2, linvoseltamab will be given to more participants to continue to assess the side effects of the study drug and to evaluate the ability of linvoseltamab to treat AL amyloidosis.
* DelveInsight's AL Amyloidosis pipeline report depicts a robust space with 10+ active players working to develop 10+ pipeline therapies for AL Amyloidosis treatment.
* The leading AL Amyloidosis Companies such as Caelum Biosciences, Nexcella, Inc., HaemaLogiX Ltd., Prothena, ZENTALIS PHARMACEUTICALS, Sorrento Therapeutics, Inc. , and others.
* Promising AL Amyloidosis Therapies such as Belantamab mafodotin, CAEL-101, Daratumumab SC, Pomalidomide, Dexamethasone , and others.
Stay ahead with the most recent pipeline outlook for AL Amyloidosis. Get insights into clinical trials, emerging therapies, and leading companies with DelveInsight @ AL Amyloidosis Treatment Drugs [https://www.delveinsight.com/sample-request/al-amyloidosis-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]
AL Amyloidosis Emerging Drugs
* CAEL-101: Caelum Biosciences
CAEL-101 is a fibril-reactive monoclonal antibody (mAb) that is currently in Phase III clinical development for the treatment of patients with amyloid light chain ("AL") amyloidosis. The Cardiac Amyloid Reaching for Extended Survival (CARES) clinical program includes two parallel Phase III studies - one in patients with Mayo stage IIIa disease and one in patients with Mayo stage IIIb disease - and will collectively enroll approximately 370 patients globally. The primary objective of the clinical program is to assess overall survival. CAEL-101 has received Orphan Drug Designation from both the US Food and Drug Administration and European Medicine Agency as a therapy for patients with AL amyloidosis.
* NXC-201: Nexcella, Inc.
NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and AL amyloidosis. The design consists of a structurally differentiated CAR-T, with the proprietary BCMA-targeting CAR, which has demonstrated reduced toxicity in NEXICART-1, supporting investigating NXC-201 as an outpatient therapy. It is currently in Phase I NEXICART-1 study of its novel, autologous, BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy for the treatment of patients with relapsed or refractory multiple myeloma and light chain amyloidosis (AL).
AL Amyloidosis Market Drivers
* Increase in the number of patients suffering from AL Amyloidosis
* Increase in awareness about the disease
AL Amyloidosis Market Barriers
* High cost of the associated treatment
* Side effects associated with the treatment
The AL Amyloidosis pipeline report provides insights into
* The report provides detailed insights about companies that are developing therapies for the treatment of AL Amyloidosis with aggregate therapies developed by each company for the same.
* It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for AL Amyloidosis Treatment.
* AL Amyloidosis Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
* AL Amyloidosis Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
* Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the AL Amyloidosis market.
Explore groundbreaking therapies and clinical trials in the AL Amyloidosis Pipeline. Access DelveInsight's detailed report now! @ New AL Amyloidosis Drugs [https://www.delveinsight.com/sample-request/al-amyloidosis-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]
AL Amyloidosis Companies
Caelum Biosciences, Nexcella, Inc., HaemaLogiX Ltd., Prothena, ZENTALIS PHARMACEUTICALS, Sorrento Therapeutics, Inc., and others.
AL Amyloidosis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration
* Intra-articular
* Intraocular
* Intrathecal
* Intravenous
* Ophthalmic
* Oral
* Parenteral
* Subcutaneous
* Topical
* Transdermal
AL Amyloidosis Products have been categorized under various Molecule types such as
* Oligonucleotide
* Peptide
* Small molecule
Unveil the future of AL Amyloidosis Treatment. Learn about new drugs, pipeline developments, and key companies with DelveInsight's expert analysis @ AL Amyloidosis Market Drivers and Barriers [https://www.delveinsight.com/sample-request/al-amyloidosis-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]
Scope of the AL Amyloidosis Pipeline Report
* Coverage- Global
* AL Amyloidosis Companies- Caelum Biosciences, Nexcella, Inc., HaemaLogiX Ltd., Prothena, ZENTALIS PHARMACEUTICALS, Sorrento Therapeutics, Inc., and others.
* AL Amyloidosis Therapies- Belantamab mafodotin, CAEL-101, Daratumumab SC, Pomalidomide, Dexamethasone, and others.
* AL Amyloidosis Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* AL Amyloidosis Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
Get the latest on AL Amyloidosis Therapies and clinical trials. Download DelveInsight's in-depth pipeline report today! @ AL Amyloidosis Companies, Key Products and Unmet Needs [https://www.delveinsight.com/sample-request/al-amyloidosis-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]
Table of Content
* Introduction
* Executive Summary
* AL Amyloidosis: Overview
* AL Amyloidosis Pipeline Therapeutics
* AL Amyloidosis Pipeline Therapeutic Assessment
* AL Amyloidosis- DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* CAEL-101: Caelum Biosciences
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* Drug Name: Company Name
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I)
* NXC-201: Nexcella, Inc.
* Drug profiles in the detailed report.....
* Preclinical and Discovery Stage Products
* LambdaMab 10B3 & 7F11: HaemaLogiX Ltd.
* Drug profiles in the detailed report.....
* Inactive Products
* AL Amyloidosis Key Companies
* AL Amyloidosis Key Products
* AL Amyloidosis- Unmet Needs
* AL Amyloidosis- Market Drivers and Barriers
* AL Amyloidosis- Future Perspectives and Conclusion
* AL Amyloidosis Analyst Views
* AL Amyloidosis Key Companies
* Appendix
About Us
DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.
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Company Name: DelveInsight Business Research LLP
Contact Person: Yash Bhardwaj
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