Amyotrophic Lateral Sclerosis (ALS) Clinical Trial Pipeline Analysis: 80+ Key Companies Shaping the Future of ALS Therapeutics | DelveInsight

DelveInsight's Amyotrophic Lateral Sclerosis (ALS) Pipeline Insight 2026 report provides comprehensive global coverage of available, marketed, and pipeline ALS therapies in various stages of clinical development. The report provides insights into 80+ companies and 100+ pipeline drugs in the ALS pipeline landscape, covering clinical and nonclinical stage products, therapeutic assessments, and inactive pipeline products.

Key takeaways from the ALS Clinical Trial Landscape Report

• DelveInsight's ALS pipeline report depicts a robust space with 80+ companies working to develop 100+ pipeline therapies for ALS treatment.
• Key ALS companies such as Brainstorm-Cell Therapeutics, Zhimeng Biopharma, Clene Inc., AbbVie, Calico Life Sciences LLC, Collaborative Medicinal Development, LLC, Eledon Pharmaceuticals, PhenoNet, Inc., Kadimastem, Corcept Therapeutics Incorporated, Zydus Lifesciences Limited, Novartis, Spinogenix, Seelos Therapeutics, Inc., Coya Therapeutics, Inc., Cellenkos, Everfront Biotech, Xalud Therapeutics, QurAlis Corporation, Alchemab, Eli Lilly, ProMIS Neurosciences, Time Therapeutics, AKAVA Therapeutics, Nevrargenics, and Biogen.
• Promising ALS pipeline therapies in various stages of development include Debamestrocel-MSC-NTF, CB03-154, CNM-Au8, Fosigotifator, Cu(II)ATSM, Tegoprubart, PHENOGENE-1A, AstroRx cell product, Dazucorilant, ZYIL-1, VHB937, SPG302, SLS-005, COYA 302, CK0803, HK-001, XT-150, QRL-201, QRL-101, ATLX-1282, PMN267, TTM-003, AKV9, NVG645, and EPH101.

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What is Amyotrophic Lateral Sclerosis (ALS)?

Amyotrophic Lateral Sclerosis (ALS) is a progressive and fatal neurodegenerative disorder that primarily affects motor neurons in the brain and spinal cord. It is characterized by degeneration of upper motor neurons in the motor cortex and lower motor neurons in the brainstem and spinal cord, leading to progressive muscle weakness and paralysis.
ALS occurs in both sporadic and familial forms, with the sporadic type accounting for approximately 90-95% of cases. Approximately 5-10% of cases are familial and are associated with mutations in genes such as SOD1, C9orf72, TARDBP, and FUS.
Early manifestations commonly include muscle weakness, stiffness, cramps, and fasciculations, often affecting the limbs or bulbar muscles. As the disease progresses, patients may develop dysarthria, dysphagia, difficulty chewing, and respiratory muscle weakness that can ultimately result in respiratory failure.
Diagnosis is primarily clinical and supported by electrophysiological and imaging studies. Electromyography helps demonstrate widespread denervation and reinnervation, while nerve conduction studies help exclude peripheral neuropathies. MRI is commonly used to exclude structural lesions, and genetic testing may be considered in familial or early-onset cases.
There is currently no cure for ALS. Disease-modifying therapies include riluzole and edaravone, while symptomatic management focuses on spasticity, pain, sialorrhea, nutritional deficits, and respiratory complications. A multidisciplinary approach is essential for maintaining quality of life.

Emerging ALS Drug Profiles

Debamestrocel-MSC-NTF: Brainstorm-Cell Therapeutics
Debamestrocel (MSC-NTF, also known as NurOwn®) is an investigational autologous cell therapy being developed for Amyotrophic Lateral Sclerosis. It uses a patient's own mesenchymal stromal cells (MSCs), modified to secrete high levels of neurotrophic factors (NTFs) that support neuron survival and reduce inflammation in the nervous system.
The therapy is administered by intrathecal injection to deliver these protective factors directly to the spinal fluid. Debamestrocel aims to slow or stabilize ALS progression by enhancing neuronal health and modulating neuroinflammation. Currently, the drug is in Phase III stage of development for the treatment of ALS.

SLS-005: Seelos Therapeutics, Inc.
SLS-005 is an investigational therapy for Amyotrophic Lateral Sclerosis whose active ingredient is the disaccharide trehalose. It is formulated for intravenous infusion and designed to cross the blood-brain barrier, stabilize misfolded proteins, and activate the cellular cleanup process known as autophagy.
By enhancing autophagy and promoting clearance of toxic protein aggregates in motor neurons, including TDP-43 and SOD1, SLS-005 aims to slow ALS progression. Currently, the drug is in Phase II/III stage of development for the treatment of ALS.

COYA 302: Coya Therapeutics, Inc.
COYA 302 is an investigational biologic combination therapy designed to treat Amyotrophic Lateral Sclerosis. It comprises proprietary low-dose interleukin-2 (LD IL-2) and CTLA-4 Ig (abatacept) and is administered subcutaneously.
The therapy is designed to enhance regulatory T-cell (Treg) anti-inflammatory activity while simultaneously suppressing activated monocytes/macrophages. This dual-mechanism approach aims to rebalance immune dysregulation and reduce chronic neuroinflammation believed to contribute to ALS progression. As per the company pipeline, the drug is in Phase II clinical development for the treatment of ALS.

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Scope of the ALS Pipeline Report

• Coverage: Global
• Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination
• Therapeutic Assessment By Clinical Stages: Phase III, Phase II, Phase I, Preclinical, Discovery
• Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical
• Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy
• Key ALS Companies: Brainstorm-Cell Therapeutics, Zhimeng Biopharma, Clene Inc., AbbVie, Calico Life Sciences LLC, Collaborative Medicinal Development, LLC, Eledon Pharmaceuticals, PhenoNet, Inc., Kadimastem, Corcept Therapeutics Incorporated, Zydus Lifesciences Limited, Novartis, Spinogenix, Seelos Therapeutics, Inc., Coya Therapeutics, Inc., Cellenkos, Everfront Biotech, Xalud Therapeutics, QurAlis Corporation, Alchemab, Eli Lilly, ProMIS Neurosciences, Time Therapeutics, AKAVA Therapeutics, Nevrargenics, Biogen
• Key ALS Pipeline Therapies: Debamestrocel-MSC-NTF, CB03-154, CNM-Au8, Fosigotifator, Cu(II)ATSM, Tegoprubart, PHENOGENE-1A, AstroRx cell product, Dazucorilant, ZYIL-1, VHB937, SPG302, SLS-005, COYA 302, CK0803, HK-001, XT-150, QRL-201, QRL-101, ATLX-1282, PMN267, TTM-003, AKV9, NVG645, EPH101.

Dive deep into rich insights for new drugs for ALS treatment, visit https://www.delveinsight.com/sample-request/amyotrophic-lateral-sclerosis-als-pipeline-insight?utmsource=openpr&utm_medium=pressrelease&utm_campaign=kspr

Table of Contents

1. ALS Pipeline Report Introduction
2. ALS Pipeline Report Executive Summary
3. ALS Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. ALS Pipeline Therapeutics
6. ALS Pipeline: Late Stage Products (Phase III)
7. ALS Pipeline: Mid Stage Products (Phase II)
8. ALS Pipeline: Early Stage Products (Phase I)
9. ALS Pipeline: Preclinical and Discovery Stage Products
10. ALS Pipeline Therapeutics Assessment
11. Inactive Products in the ALS Pipeline
12. Key Companies
13. Key Products in the ALS Pipeline
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

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