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
- On April 13, 2026- Vector Y Therapeutics conducted a Phase 1/2, multicenter, open-label, ascending dose, uncontrolled, first-in-human study that will evaluate the safety, tolerability and effects on clinical and biomarker endpoints of intracisternal administration of Vtx-002 in participants with Amyotrophic Lateral Sclerosis (ALS).
- On April 08, 2026- argenx initiated a phase 2a study aims to evaluate the safety of ARGX-119 in adults with ALS. The study will also assess the impact of ARGX-119 on ALS disease outcomes, including muscle function. The study consists of 2 periods: a treatment period when participants will receive one of three ARGX-119 doses or placebo and an extension period when all participants will receive the same dose of ARGX-119. Participation in the study will last up to approximately 100 weeks.
- On April 01, 2026- PhenoNet Inc. announced a Phase IIB, randomized, double-blind, placebo-controlled study designed to assess the effects of PHENOGENE-1A (oral inhalation via dry powder inhaler [DPI]) in subjects with mild to moderate ALS disease. Eligible subjects will be randomized to receive either low dose PHENOGENE-1A (34.2 mg per day: in 2 doses of 17.1 mg and matching placebo BID), high dose PHENOGENE-1A (68.4 mg per day: 34.2 mg BID), or placebo (2 matching placebo capsules BID) (see table below), in a 2:2:1 ratio. Subjects will receive treatment for a duration of 24 weeks. All subjects must be on a stable dose of Riluzole 50 mg BID (100 mg daily) for at least 4 weeks prior to randomization and must continue their Riluzole regimen, 50 mg BID (100 mg daily), as standard-of-care treatment, throughout the 24 week treatment period.
- 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
- 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.
Learn more about Amyotrophic Lateral Sclerosis Drugs opportunities in our groundbreaking Amyotrophic Lateral Sclerosis research and development projects @ Amyotrophic Lateral Sclerosis Unmet Needs
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
For a detailed overview of our latest research findings and future plans, read the full details of Amyotrophic Lateral Sclerosis Pipeline on our website, @ Amyotrophic Lateral Sclerosis Emerging Drugs and Companies
Table of Contents
- Introduction
- Executive Summary
- Amyotrophic Lateral Sclerosis: Overview
- Pipeline Therapeutics
- Therapeutic Assessment
- Amyotrophic Lateral Sclerosis– DelveInsight’s Analytical Perspective
- Late Stage Products (Phase III)
- Drug name: Company name
- Drug profiles in the detailed report…..
- Mid Stage Products (Phase II/III)
- MN-166: MediciNova
- Drug profiles in the detailed report…..
- Early Stage Products (Phase I)
- QRL-201: QurAlis Corporation
- Drug profiles in the detailed report…..
- Preclinical and Discovery Stage Products
- Drug name: Company name
- Drug profiles in the detailed report…..
- Inactive Products
- Amyotrophic Lateral Sclerosis Key Companies
- Amyotrophic Lateral Sclerosis Key Products
- Amyotrophic Lateral Sclerosis- Unmet Needs
- Amyotrophic Lateral Sclerosis- Market Drivers and Barriers
- Amyotrophic Lateral Sclerosis- Future Perspectives and Conclusion
- Amyotrophic Lateral Sclerosis Analyst Views
- Amyotrophic Lateral Sclerosis Key Companies
- Appendix
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