Amyotrophic Lateral Sclerosis Pipeline Shows Strong Momentum as 80+ Pharma Companies in the Race | DelveInsight

DelveInsight's, "Amyotrophic Lateral Sclerosis Pipeline Insight 2026" report provides comprehensive insights about 80+ companies and 100+ pipeline drugs in Amyotrophic Lateral Sclerosis pipeline landscape. It covers the Amyotrophic Lateral Sclerosis pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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Key Takeaways from the Amyotrophic Lateral Sclerosis Pipeline Report
• In August 2026, Clene Inc. announced plans to submit a New Drug Application (NDA) for CNM-Au8 in ALS in early Q4 2026, following discussions with the U.S. FDA regarding the potential accelerated approval pathway.
• In August 2026, NeuroSense Therapeutics Ltd. announced completion of the Pre-NDS process with Health Canada for PrimeC, its investigational ALS therapy, and is targeting a December 2026 New Drug Submission.
• DelveInsight's Amyotrophic Lateral Sclerosis pipeline report depicts a robust space with 80+ active players working to develop 100+ pipeline therapies for Amyotrophic Lateral Sclerosis treatment.
• The leading Amyotrophic Lateral Sclerosis Companies such as Ionis Pharmaceuticals, 1ST Biotherapeutics, Scholar Rock, Revalesio, QurAlis Corporation, Sanofi, MediciNova, Helixmith, Verge Genomics, UCB and others.
• Promising Amyotrophic Lateral Sclerosis Pipeline Therapies such as Dazucorilant 300 mg, AP-101, Fasudil (WP-0512), RT001, ARGX-119, AMX0035, ION363, ANX005, and others.

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Amyotrophic Lateral Sclerosis Overview
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 the 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. The exact cause of ALS remains unknown, but it is believed to result from a combination of genetic and environmental factors. Approximately 5-10% of cases are familial and are linked to mutations in genes such as SOD1, C9orf72, TARDBP, and FUS, while the majority of cases are sporadic.

Amyotrophic Lateral Sclerosis Emerging Drugs Profile
• Debamestrocel: Brainstorm-Cell Therapeutics
Debamestrocel (MSC-NTF, also known as NurOwn®) is an investigational, autologous cell therapy being developed for amyotrophic lateral sclerosis (ALS). 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 neuro inflammation. Currently, the drug is in Phase III stage of its development for the treatment of Amyotrophic Lateral Sclerosis.

• SLS-005: Seelos Therapeutics, Inc.
SLS-005 is an investigational therapy for Amyotrophic Lateral Sclerosis (ALS) 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 (e.g., TDP-43, SOD1), it aims to slow ALS progression. Currently, the drug is in Phase II/III stage of its development for the treatment of Amyotrophic Lateral Sclerosis.

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

• HK-001: Everfront Biotech
HK-001 is an investigational small-molecule therapy developed by Everfront Biotech, Inc. for the treatment of amyotrophic lateral sclerosis. Designed as an oral soft-gel capsule formulation, HK-001 is being evaluated in early-phase clinical studies to determine its safety, tolerability, and pharmacokinetic profile in healthy volunteers and ultimately in ALS patients. Through targeted inhibition of mTOR and suppression of excessive autophagy, it aims to delay the progression of ALS in patients. Currently, HK-001 is being evaluated in the Phase I for ALS.

• QRL-201: QurAlis Corporation
QRL-201, developed by QurAlis Corporation, is therapy for amyotrophic lateral sclerosis (ALS) that specifically targets stathmin-2 (STMN2) loss, a key driver of motor neuron degeneration in ALS. The therapy is designed to restore STMN2 expression, which is disrupted due to TDP-43 protein pathology a hallmark of most ALS cases. By re-establishing normal STMN2 levels, QRL-201 aims to stabilize axons, support neuronal repair, and preserve motor function. As per the company pipeline the drug is in Phase I stage of its clinical trial for the treatment of amyotrophic lateral sclerosis.

The Amyotrophic Lateral Sclerosis Pipeline report provides insights into
• The report provides detailed insights about companies that are developing therapies for the treatment of Amyotrophic Lateral Sclerosis 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 Amyotrophic Lateral Sclerosis Treatment.
• Amyotrophic Lateral Sclerosis Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• Amyotrophic Lateral Sclerosis 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 Amyotrophic Lateral Sclerosis market.

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Amyotrophic Lateral Sclerosis Companies
Ionis Pharmaceuticals, 1ST Biotherapeutics, Scholar Rock, Revalesio, QurAlis Corporation, Sanofi, MediciNova, Helixmith, Verge Genomics, UCB and others.

Amyotrophic Lateral Sclerosis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as
• Intravenous
• Subcutaneous
• Oral
• Intramuscular

Amyotrophic Lateral Sclerosis Products have been categorized under various Molecule types such as
• Monoclonal antibody
• Small molecule
• Peptide

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Scope of the Amyotrophic Lateral Sclerosis Pipeline Report
• Coverage- Global
• Amyotrophic Lateral Sclerosis Companies- Ionis Pharmaceuticals, 1ST Biotherapeutics, Scholar Rock, Revalesio, QurAlis Corporation, Sanofi, MediciNova, Helixmith, Verge Genomics, UCB and others.
• Amyotrophic Lateral Sclerosis Pipeline Therapies- Dazucorilant 300 mg, AP-101, Fasudil (WP-0512), RT001, ARGX-119, AMX0035, ION363, ANX005, and others.
• Amyotrophic Lateral Sclerosis Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
• Amyotrophic Lateral Sclerosis Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

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Table of Contents
1. Introduction
2. Executive Summary
3. Amyotrophic Lateral Sclerosis: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. Amyotrophic Lateral Sclerosis- DelveInsight's Analytical Perspective
7. Late Stage Products (Phase III)
8. Drug name: Company name
9. Drug profiles in the detailed report.....
10. Mid Stage Products (Phase II/III)
11. MN-166: MediciNova
12. Drug profiles in the detailed report.....
13. Early Stage Products (Phase I)
14. QRL-201: QurAlis Corporation
15. Drug profiles in the detailed report.....
16. Preclinical and Discovery Stage Products
17. Drug name: Company name
18. Drug profiles in the detailed report.....
19. Inactive Products
20. Amyotrophic Lateral Sclerosis Key Companies
21. Amyotrophic Lateral Sclerosis Key Products
22. Amyotrophic Lateral Sclerosis- Unmet Needs
23. Amyotrophic Lateral Sclerosis- Market Drivers and Barriers
24. Amyotrophic Lateral Sclerosis- Future Perspectives and Conclusion
25. Amyotrophic Lateral Sclerosis Analyst Views
26. Amyotrophic Lateral Sclerosis Key Companies
27. Appendix

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