ATTR Amyloidosis Pipeline: 10+ Leading Companies Shaping the Future of Groundbreaking Therapies | DelveInsight

The ATTR amyloidosis therapeutics market is witnessing a significant evolution, driven by trailblazing companies such as Novo Nordisk, Sirnaomics, and Arbor Bio. With the advent of RNA interference therapies, TTR stabilizers, gene-editing platforms, and next-generation silencers, these innovators are transforming the treatment landscape. The focus is sharply on halting disease progression, enhancing quality of life, and extending survival in both hereditary and wild-type ATTR amyloidosis. As targeted approaches gain momentum, the pipeline is poised to usher in a new era of precision medicine for this once-untreatable condition.

DelveInsight's "ATTR Amyloidosis Pipeline Insight, 2025" comprehensively analyzes the current clinical landscape and growth prospects in the ATTR Amyloidosis market. The report covers disease insights, treatment guidelines, and a detailed pipeline assessment from preclinical to marketed stages. It includes drug mechanisms, clinical studies, regulatory progress, and key developments such as collaborations, mergers, funding, and designations.

For emerging ATTR Amyloidosis drugs, the ATTR Amyloidosis pipeline analysis report provides a 360° view of the therapeutic landscape by development stage, product type, route of administration, molecule type, and mechanism of action (MOA). The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.

Key Takeaways from the ATTR Amyloidosis Pipeline Report
• DelveInsight's ATTR amyloidosis pipeline analysis depicts a strong space with 10+ active players working to develop 10+ pipeline drugs for ATTR amyloidosis treatment.
• The leading ATTR amyloidosis companies include Alnylam Pharmaceuticals, Novo Nordisk, Sirnaomics, Arbor Bio, and others are evaluating their lead assets to improve the ATTR amyloidosis treatment landscape.
• Key ATTR amyloidosis pipeline therapies in various stages of development include Vutrisiran, NN-6019, ALN-TTRsc04, STP152G, ABO-102, and others.
• In March 2025, Alnylam Pharmaceuticals announced moderated poster presentations of new data from the HELIOS-B Phase III trial, evaluating vutrisiran for treating ATTR amyloidosis with cardiomyopathy (ATTR-CM) in a patient population representative of today's cases.
• In November 2024, Alnylam Pharmaceuticals (ALNY) announced that the FDA has accepted its supplemental new drug application (sNDA) for review, seeking label expansion of Amvuttra (vutrisiran) to treat ATTR amyloidosis with cardiomyopathy (ATTR-CM).
• In August 2024, Alnylam Pharmaceuticals, Inc., a leader in RNAi therapeutics, announced detailed results from the HELIOS-B Phase III study of vutrisiran, an investigational RNAi therapeutic for ATTR amyloidosis with cardiomyopathy (ATTR-CM).

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ATTR Amyloidosis Overview
Transthyretin amyloidosis (ATTR), also known as cardiac amyloidosis or ATTR-CM, is a condition where misfolded transthyretin (TTR) protein accumulates in tissues, particularly the heart. TTR is normally produced by the liver and carries retinol and thyroxine, but structural changes in TTR lead to misfolding and aggregation. These deposits primarily affect the heart and peripheral nerves, causing a range of symptoms, including nerve damage that leads to loss of movement and temperature sensitivity. The onset of hereditary ATTR (hATTR) symptoms typically occurs between the mid-20s and mid-60s and worsens over time. Diagnosis is confirmed through tissue biopsy with histopathology and immunohistochemistry, though extracardiac tissue samples may have unreliable sensitivity.

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ATTR Amyloidosis Treatment Analysis: Drug Profile
Vutrisiran: Alnylam Pharmaceuticals
Vutrisiran is an investigational RNAi therapeutic, administered subcutaneously, designed to treat both hereditary and wild-type ATTR amyloidosis. It targets and silences specific messenger RNA to block the production of transthyretin (TTR) protein, potentially preventing the formation of TTR amyloid deposits. Administered quarterly or biannually, vutrisiran may help reduce amyloid accumulation and restore function in affected tissues. It uses Alnylam's Enhanced Stabilization Chemistry (ESC)-GalNAc-conjugate delivery platform, offering increased potency and metabolic stability for infrequent injections. The safety and efficacy of vutrisiran have not yet been evaluated by regulatory authorities, and it is currently in Phase III development.

NN-6019: Novo Nordisk
NN-6019 is an investigational humanized monoclonal antibody designed to target and deplete amyloid deposits in hereditary and wild-type ATTR amyloidosis (hATTR and wtATTR) without affecting the normal tetrameric form of TTR. Preclinical studies have shown that NN-6019 promotes the clearance of insoluble amyloid fibrils through antibody-mediated phagocytosis and inhibits amyloid formation. This approach has the potential to benefit ATTR patients at high risk for early mortality due to amyloid accumulation in vital organs. NN-6019 is currently in Phase II clinical trials for the treatment of ATTR amyloidosis.

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ATTR 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
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

By Molecule Type
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Scope of the ATTR Amyloidosis Pipeline Report
• Coverage: Global
• Key ATTR Amyloidosis Companies: Alnylam Pharmaceuticals, Novo Nordisk, Sirnaomics, Arbor Bio, and others.
• Key ATTR Amyloidosis Pipeline Therapies: Vutrisiran, NN-6019, ALN-TTRsc04, STP152G, ABO-102, and others.

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Table of Contents
1. Introduction
2. Executive Summary
3. ATTR Amyloidosis Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. ATTR Amyloidosis Pipeline Therapeutics
6. ATTR Amyloidosis Pipeline: Late-Stage Products (Phase III)
7. ATTR Amyloidosis Pipeline: Mid-Stage Products (Phase II)
8. ATTR Amyloidosis Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

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This release was published on openPR.