Amyotrophic Lateral Sclerosis Pipeline Outlook 2025: Clinical Trial Studies, EMA, PDMA, FDA Approvals, MOA, ROA, NDA, IND, and Companies

DelveInsight's, "Amyotrophic Lateral Sclerosis Pipeline Insight 2025" report provides comprehensive insights about 75+ companies and 80+ 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 20 August 2025, Amydis Inc . announced a study is to assess safety and tolerability of a single intravenous (given through a vein) dose of the investigational retinal tracer AMDX-2011P in patients with neurodegenerative diseases (Parkinson's disease and ALS).
* On 19 August 2025, AL-S Pharma conducted a phase 2a Study to Evaluate Safety, Tolerability, Pharmacodynamic Markers, and Pharmacokinetics of AP-101 in Patients With Familial Amyotrophic Lateral Sclerosis (fALS) and Sporadic Amyotrophic Lateral Sclerosis (sALS).
* On 13 August 2025, Amylyx Pharmaceuticals Inc. announced a study for patients with ALS who participated in the CENTAUR study (Study AMX3500). During the OLE, all participants received active treatment (AMX0035), and the investigators, evaluators, and participants remained blinded to the randomized treatment assigned at the beginning of the double-blind main study. The study was designed to assess the longer term safety and therapeutic potential of AMX0035.
* On 12 August 2025, Ionis Pharmaceuticals Inc. a study is to evaluate the efficacy of ION363 on clinical function and survival in carriers of fused in sarcoma mutations with amyotrophic lateral sclerosis (FUS-ALS).
* DelveInsight's Amyotrophic Lateral Sclerosis pipeline report depicts a robust space with 75+ active players working to develop 80+ 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 Emerging Drugs Profile

* MN-166: MediciNova

MN-166 is a first-in-class, orally bioavailable, small molecule glial attenuator that suppresses pro-inflammatory cytokines IL-1Ss, TNF-a, and IL-6, and may upregulate the anti-inflammatory cytokine IL-10. It has additionally been shown to be a toll-like receptor 4 (TLR4) functional antagonist that may contribute to its attenuation of neuroinflammation. The drug is currently being evaluated under Phase II/III clinical trial for the treatment of ALS.

* RNS60: Revalesio

RNS60 is being developed to provide disease modifying and potentially restorative treatments for neurological diseases. The drug activates intracellular signaling pathways to increase mitochondrial biogenesis and function and reduce inflammation. RNS60 safely protects neurons and oligodendrocytes and modulates the activity of immune cells to restore homeostasis. RNS60 has been granted Orphan Drug and Fast Track designations for ALS from the US Food and Drug Administration. The drug is currently being evaluated under Phase II clinical trial for the treatment of ALS.

* VM202: Helixmith

VM202 is an innovative gene therapy drug that provides fundamental treatment through tissue regeneration. The drug is injected along the peripheral nerves and their branches, the internal production of HGF may protect nerves and promote the growth of neurons while also ameliorating atrophic conditions. The US FDA granted orphan drug and fast track designation to VM202. The drug is currently being evaluated under Phase II clinical trial for the treatment of ALS.

* QRL-201: QurAlis Corporation

QRL-201 is a first-in-class therapeutic product candidate aiming to restore STMN2 expression in ALS patients. STMN2 is a well-validated protein important for neural repair and axonal stability, the expression of which is significantly decreased in nearly all ALS patients. QRL-201 rescues STMN2 loss of function in QurAlis ALS patient-derived motor neuron disease models in the presence of TDP-43 pathology. The drug is currently being evaluated under Phase I clinical trial for the treatment of ALS.

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

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 [https://www.delveinsight.com/sample-request/amyotrophic-lateral-sclerosis-als-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

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

About Us

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