AL Amyloidosis Pipeline 2025: FDA Approvals and Clinical Trials Landscape with MOA and ROA Highlights

(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, AL Amyloidosis pipeline constitutes 10+ key companies continuously working towards developing 10+ AL Amyloidosis treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

"AL Amyloidosis Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the AL Amyloidosis Market.

The AL Amyloidosis Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

Some of the key takeaways from the AL Amyloidosis Pipeline Report: https://www.delveinsight.com/sample-request/al-amyloidosis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr
• Companies across the globe are diligently working toward developing novel AL Amyloidosis treatment therapies with a considerable amount of success over the years.
• AL Amyloidosis companies working in the treatment market are HaemaLogiX, Zentalis Pharmaceuticals, Sorrento Therapeutics, Sanofi, Astellas Pharma GmbH, GlaxoSmithKline, Takeda Oncology, Caelum Biosciences, and others, are developing therapies for the AL Amyloidosis treatment
• Emerging AL Amyloidosis therapies in the different phases of clinical trials are- LambdaMab, ZN d5, STI-6129, Isatuximab, Bendamustine, Belantamab mafodotin, Ixazomib, CAEL-101, and others are expected to have a significant impact on the AL Amyloidosis market in the coming years.
• In September 2025, The Phase 1b/2 NEXICART-2 trial (NCT06097832), led by Immix Biopharma and its subsidiary Nexcella, is investigating NXC-201, an experimental autologous BCMA-directed CAR T-cell therapy, for patients with relapsed/refractory (R/R) amyloid light chain (AL) amyloidosis. The study, currently underway in the United States, has surpassed 50% of its targeted enrollment and aims to include a total of 40 participants.
• In July 2025, AstraZeneca's anselamimab did not demonstrate clinical benefit in patients with light chain (AL) amyloidosis in two Phase III trials. The antibody, designed to deplete light chains, was being evaluated under the Cardiac Amyloid Reaching for Extended Survival (CARES) program in patients with Mayo stage IIIa (NCT04512235) and stage IIIb (NCT04504825) AL amyloidosis. In both studies, the drug failed to reach statistical significance for the primary endpoint, which assessed a composite of time to all-cause mortality (ACM) and incidence of cardiovascular hospitalizations (CVH).
• In June 2025, Birtamimab is an experimental monoclonal antibody developed to target and remove amyloid deposits that lead to organ damage in patients with AL amyloidosis by binding to a specific epitope on kappa and lambda AL proteins. The AFFIRM-AL study (NCT04973137), a double-blind, placebo-controlled, time-to-event clinical trial, evaluated the safety and effectiveness of birtamimab in 207 newly diagnosed, treatment-naïve individuals with Mayo Stage IV AL amyloidosis. Participants were randomized in a 2:1 ratio to receive either birtamimab or placebo intravenously every 28 days, alongside standard-of-care treatment with a bortezomib-based chemotherapy regimen.
• In May 2025, Prothena Corporation plc (NASDAQ: PRTA) announced that its Phase 3 AFFIRM-AL clinical trial evaluating birtamimab for AL amyloidosis did not meet its primary endpoint (HR=0.915, p=0.7680). Consequently, the company has decided to discontinue the development of birtamimab and will also end the open-label extension phase of the AFFIRM-AL study.
• In February 2025, Immix Biopharma, Inc. (Nasdaq: IMMX), a clinical-stage biopharmaceutical company developing cell therapies for AL amyloidosis and immune-mediated conditions, announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its sterically-optimized CAR-T therapy, NXC-201, for the treatment of relapsed/refractory AL amyloidosis. As of June 2024, fewer than half of RMAT requests submitted over the past eight years have received approval. The RMAT designation is reserved for advanced regenerative therapies targeting serious illnesses that show potential-through early clinical data-to treat, modify, reverse, or cure disease and address unmet medical needs.
• In January 2025, Attralus, Inc., a clinical-stage biopharmaceutical company developing novel therapies for systemic amyloidosis, in collaboration with Brigham and Women's Hospital in Boston, MA, has announced the enrollment of the first patient in the Phase 3 REVEAL study. This clinical trial is evaluating the investigational diagnostic imaging agent 124I-evuzamitide (AT-01) in individuals suspected of having cardiac amyloidosis. The study aims to determine the sensitivity and specificity of 124I-evuzamitide PET/CT imaging for diagnosing the condition. Dr. Sharmila Dorbala, Principal Investigator and Sponsor of the REVEAL study, emphasized the significance of the research, noting that the imaging technique offers a promising noninvasive approach to detecting amyloid deposits in the heart and other organs. Given the serious nature of cardiac amyloidosis, early and accurate diagnosis is critical. With the availability of FDA-approved treatments, a reliable diagnostic scan could play a crucial role in minimizing diagnostic delays and improving patient outcomes.

AL Amyloidosis Overview
AL amyloidosis (also known as light chain amyloidosis) is a rare and serious condition caused by the buildup of abnormal proteins called amyloid light chains in organs and tissues. These proteins are produced by malfunctioning plasma cells in the bone marrow and can accumulate in the heart, kidneys, liver, and nerves, leading to organ damage. Symptoms vary depending on the organs affected and may include fatigue, swelling, shortness of breath, and irregular heartbeat. Early diagnosis and treatment-often involving chemotherapy or stem cell transplant-are essential to prevent irreversible organ damage and improve outcomes.

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Emerging AL Amyloidosis Drugs Under Different Phases of Clinical Development Include:
• LambdaMab: HaemaLogiX
• ZN d5: Zentalis Pharmaceuticals
• STI-6129: Sorrento Therapeutics
• Isatuximab: Sanofi
• Bendamustine: Astellas Pharma GmbH
• Belantamab mafodotin: GlaxoSmithKline
• Ixazomib: Takeda Oncology
• CAEL-101: Caelum Biosciences

AL Amyloidosis Route of Administration
AL Amyloidosis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as
• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Ophthalmic
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal

AL Amyloidosis Molecule Type
AL Amyloidosis Products have been categorized under various Molecule types, such as
• Oligonucleotide
• Peptide
• Small molecule

AL Amyloidosis Pipeline Therapeutics Assessment
• AL Amyloidosis Assessment by Product Type
• AL Amyloidosis By Stage and Product Type
• AL Amyloidosis Assessment by Route of Administration
• AL Amyloidosis By Stage and Route of Administration
• AL Amyloidosis Assessment by Molecule Type
• AL Amyloidosis by Stage and Molecule Type

DelveInsight's AL Amyloidosis Report covers around 10+ products under different phases of clinical development like
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I)
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Further AL Amyloidosis product details are provided in the report. Download the AL Amyloidosis pipeline report to learn more about the emerging AL Amyloidosis therapies
https://www.delveinsight.com/sample-request/al-amyloidosis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

Some of the key companies in the AL Amyloidosis Therapeutics Market include:
Key companies developing therapies for AL Amyloidosis are - Sorrento Therapeutics, Prothena Therapeutics, Spectrum Pharmaceuticals, Takeda, Millennium Pharmaceuticals, Caelum Biosciences, Astellas Pharma GmbH, Oncopeptides, and others.

AL Amyloidosis Pipeline Analysis:
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 key 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.
The report is built using data and information traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

Download Sample PDF Report to know more about AL Amyloidosis drugs and therapies
https://www.delveinsight.com/sample-request/al-amyloidosis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

AL Amyloidosis Pipeline Market Drivers
• Increase in the number of patients suffering from AL Amyloidosis, increase in awareness about the disease are some of the important factors that are fueling the AL Amyloidosis Market.

AL Amyloidosis Pipeline Market Barriers
• However, high cost of the associated treatment, side effects associated with the treatment and other factors are creating obstacles in the AL Amyloidosis Market growth.

Scope of AL Amyloidosis Pipeline Drug Insight
• Coverage: Global
• Key AL Amyloidosis Companies: HaemaLogiX, Zentalis Pharmaceuticals, Sorrento Therapeutics, Sanofi, Astellas Pharma GmbH, GlaxoSmithKline, Takeda Oncology, Caelum Biosciences, and others
• Key AL Amyloidosis Therapies: LambdaMab, ZN d5, STI-6129, Isatuximab, Bendamustine, Belantamab mafodotin, Ixazomib, CAEL-101, and others
• AL Amyloidosis Therapeutic Assessment: AL Amyloidosis current marketed and AL Amyloidosis emerging therapies
• AL Amyloidosis Market Dynamics: AL Amyloidosis market drivers and AL Amyloidosis market barriers

Contact Us:
Gaurav Bora
gbora@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. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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