Amyotrophic Lateral Sclerosis Pipeline 2025: FDA Approvals and Clinical Trials Landscape with MOA and ROA Highlights by DelveInsight | COSCIENS Biopharma, BenevolentAI, Verge Genomics, ProJenX

(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Amyotrophic Lateral Sclerosis pipeline constitutes 70+ key companies continuously working towards developing 80+ Amyotrophic Lateral Sclerosis treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

"Amyotrophic Lateral Sclerosis Pipeline Insight, 2025 [https://www.delveinsight.com/sample-request/amyotrophic-lateral-sclerosis-als-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Amyotrophic Lateral Sclerosis Market.

The Amyotrophic Lateral Sclerosis Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

Some of the key takeaways from the Amyotrophic Lateral Sclerosis Pipeline Report:

*
Companies across the globe are diligently working toward developing novel Amyotrophic Lateral Sclerosis treatment therapies with a considerable amount of success over the years.

*
Amyotrophic Lateral Sclerosis companies working in the treatment market are COSCIENS Biopharma Inc., BenevolentAI, Verge Genomics, ProJenX, QurAlis Corporation, Woolsey Pharmaceuticals, Revalesio Corporation, Ionis Pharmaceuticals, CYTOKINETICS, Ionis Pharmaceuticals, and others, are developing therapies for the Amyotrophic Lateral Sclerosis treatment

*
Emerging Amyotrophic Lateral Sclerosis therapies in the different phases of clinical trials are- AEZS-130, BEN-34712, VRG50635, Prosetin, QRL 201, WP-0512, RNS60, Ulefnersen, Reldesemtiv, ION363, and others are expected to have a significant impact on the Amyotrophic Lateral Sclerosis market in the coming years.

*
In June 2025, PharmaTher Holdings Ltd. announced that the U.S. Patent and Trademark Office (USPTO) has granted U.S. Patent No. 12,128,012, valid until May 14, 2041, covering the use of ketamine for the treatment of Amyotrophic Lateral Sclerosis (ALS).

*
In May 2025, Zydus Lifesciences announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Usnoflast (ZYIL1), a first-in-class oral NLRP3 inhibitor, for the treatment of Amyotrophic Lateral Sclerosis (ALS).

*
In May 2025, The U.S. Food and Drug Administration (FDA) has authorized BrainStorm Cell Therapeutics to initiate a Phase IIIb clinical trial of its NurOwn therapy for the treatment of amyotrophic lateral sclerosis (ALS).

*
In January 2025, The US Food and Drug Administration (FDA) has authorized Zydus Lifesciences to initiate a randomized Phase IIb clinical trial of Usnoflast, its oral NLRP3 inflammasome inhibitor, for the treatment of amyotrophic lateral sclerosis (ALS). This multi-center, double-blind, placebo-controlled study will evaluate the drug's safety, pharmacodynamics, efficacy, and pharmacokinetics in adult ALS patients.

*
In January 2025, The US Food and Drug Administration (FDA) has removed the clinical hold on Amylyx Pharmaceuticals' Phase I trial of AMX0114 for amyotrophic lateral sclerosis (ALS). With the hold lifted, Amylyx can now initiate screening, enrollment, and dosing at US sites for the Phase I LUMINA study (NCT06665165). This multi-center, multiple ascending dose trial will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AMX0114 in 48 ALS patients. Participants will be randomized in a 3:1 ratio to receive either AMX0114 or a placebo via intrathecal injection every four weeks, for up to four doses.

*
In December 2024, Ractigen Therapeutics has administered the first dose in its randomized Phase I clinical trial of RAG-17, a small interfering RNA (siRNA) therapy designed to treat amyotrophic lateral sclerosis (ALS) linked to mutations in the superoxide dismutase 1 (SOD1) gene. The initial dosing took place at the Second Affiliated Hospital of Zhejiang University School of Medicine. This placebo-controlled, double-blind study aims to evaluate the therapy's pharmacokinetics, preliminary efficacy, pharmacodynamics, and overall safety and tolerability in individuals with SOD1-related ALS.

*
In September 2024, QurAlis Corporation, a clinical-stage biotechnology company focused on developing precision medicines with the potential to transform the treatment of amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD), and other neurodegenerative diseases, announced today that it has completed dosing for the first participant cohort in its Phase 1 multiple-ascending dose (MAD) clinical trial of QRL-101 (QRL-101-03; NCT06532396). QRL-101 is a first-in-class selective Kv7.2/7.3 ion channel opener designed to address hyperexcitability-induced disease progression in ALS. Kv7.2 is a mis-spliced protein found in sporadic ALS patients.

*
In June 2024, Woolsey Pharmaceuticals has reported promising results from its Phase IIa study of BRAVYL, showing a significant reduction in neurofilament light chain (NfL) levels and potential clinical benefits for ALS patients. The open-label, single-arm trial, named Rho Kinase Inhibition in Amyotrophic Lateral Sclerosis (REAL), assessed the initial tolerability, safety, and effects of BRAVYL on clinical outcomes and neurodegeneration biomarkers in ALS patients.

*
In February 2024, Biogen Inc. (Nasdaq: BIIB) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the marketing authorization of QALSODY Registered (tofersen) under exceptional circumstances for the treatment of adults with amyotrophic lateral sclerosis (ALS) linked to a mutation in the superoxide dismutase 1 (SOD1) gene. If approved by the European Commission (EC), QALSODY will become the first treatment in the European Union targeting a genetic cause of ALS, also known as motor neuron disease (MND).

Amyotrophic Lateral Sclerosis Overview

Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's disease, is a progressive neurodegenerative disorder that affects motor neurons in the brain and spinal cord. These neurons are responsible for controlling voluntary muscle movements, and as they deteriorate, muscles weaken and atrophy. ALS leads to symptoms such as muscle weakness, difficulty speaking and swallowing, and eventually respiratory failure. The exact cause is often unknown, though genetic and environmental factors may contribute. There is no cure, but treatments focus on managing symptoms, improving quality of life, and extending survival.

Get a Free Sample PDF Report to know more about Amyotrophic Lateral Sclerosis Pipeline Therapeutic Assessment-

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

Emerging Amyotrophic Lateral Sclerosis Drugs Under Different Phases of Clinical Development Include:

*
AEZS-130: COSCIENS Biopharma Inc.

*
BEN-34712: BenevolentAI

*
VRG50635: Verge Genomics

*
Prosetin: ProJenX

*
QRL 201: QurAlis Corporation

*
WP-0512: Woolsey Pharmaceuticals

*
RNS60: Revalesio Corporation

*
Ulefnersen: Ionis Pharmaceuticals

*
Reldesemtiv: CYTOKINETICS

*
ION363: Ionis Pharmaceuticals

Amyotrophic Lateral Sclerosis Route of Administration

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

*
Intra-articular

*
Intraocular

*
Intrathecal

*
Intravenous

*
Ophthalmic

*
Oral

*
Parenteral

*
Subcutaneous

*
Topical

*
Transdermal

Amyotrophic Lateral Sclerosis Molecule Type

Amyotrophic Lateral Sclerosis Products have been categorized under various Molecule types, such as

*
Oligonucleotide

*
Peptide

*
Small molecule

Amyotrophic Lateral Sclerosis Pipeline Therapeutics Assessment

*
Amyotrophic Lateral Sclerosis Assessment by Product Type

*
Amyotrophic Lateral Sclerosis By Stage and Product Type

*
Amyotrophic Lateral Sclerosis Assessment by Route of Administration

*
Amyotrophic Lateral Sclerosis By Stage and Route of Administration

*
Amyotrophic Lateral Sclerosis Assessment by Molecule Type

*
Amyotrophic Lateral Sclerosis by Stage and Molecule Type

DelveInsight's Amyotrophic Lateral Sclerosis Report covers around 80+ products under different phases of clinical development like

*
Late-stage products (Phase III)

*
Mid-stage products (Phase II)

*
Early-stage product (Phase I)

*
Pre-clinical and Discovery stage candidates

*
Discontinued & Inactive candidates

*
Route of Administration

Further Amyotrophic Lateral Sclerosis product details are provided in the report. Download the Amyotrophic Lateral Sclerosis pipeline report to learn more about the emerging Amyotrophic Lateral Sclerosis therapies [https://www.delveinsight.com/sample-request/amyotrophic-lateral-sclerosis-als-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Some of the key companies in the Amyotrophic Lateral Sclerosis Therapeutics Market include:

Key companies developing therapies for Amyotrophic Lateral Sclerosis are - Helixmith, Sanofi, Denali Therapeutics, Transposon Therapeutics, Alector, GSK, NeuroSense Therapeutics, Biogen, Ionis Pharmaceuticals, Brainstorm Cell Therapeutics, Cytokinetics, Astellas Pharma, Apellis Pharmaceuticals, Clene Nanomedicine Biosciences, AL-S Pharma, MediciNova, Seelos Theraputics, Prilenia Therapeutics, AB Science, Eledon Pharmaceuticals, Revalesio Corporation, Biohaven Pharmaceuticals, UCB Pharma, Ra Pharmaceuticals, AI Therapeutics, and others.

Amyotrophic Lateral Sclerosis Pipeline Analysis:

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 key 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.

The report is built using data and information traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

Download Sample PDF Report to know more about Amyotrophic Lateral Sclerosis drugs and therapies [https://www.delveinsight.com/sample-request/amyotrophic-lateral-sclerosis-als-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Amyotrophic Lateral Sclerosis Pipeline Market Drivers

*
Need for disease-specific treatment options, rising geriatric population, increasing research and developmental activities are some of the important factors that are fueling the Amyotrophic Lateral Sclerosis Market.

Amyotrophic Lateral Sclerosis Pipeline Market Barriers

*
However, No standard cure for ALS, unknown cause of the disease and other factors are creating obstacles in the Amyotrophic Lateral Sclerosis Market growth.

Scope of Amyotrophic Lateral Sclerosis Pipeline Drug Insight

*
Coverage: Global

*
Key Amyotrophic Lateral Sclerosis Companies: COSCIENS Biopharma Inc., BenevolentAI, Verge Genomics, ProJenX, QurAlis Corporation, Woolsey Pharmaceuticals, Revalesio Corporation, Ionis Pharmaceuticals, CYTOKINETICS, Ionis Pharmaceuticals, and others

*
Key Amyotrophic Lateral Sclerosis Therapies: AEZS-130, BEN-34712, VRG50635, Prosetin, QRL 201, WP-0512, RNS60, Ulefnersen, Reldesemtiv, ION363, and others

*
Amyotrophic Lateral Sclerosis Therapeutic Assessment: Amyotrophic Lateral Sclerosis current marketed and Amyotrophic Lateral Sclerosis emerging therapies

*
Amyotrophic Lateral Sclerosis Market Dynamics: Amyotrophic Lateral Sclerosis market drivers and Amyotrophic Lateral Sclerosis market barriers

Request for Sample PDF Report for Amyotrophic Lateral Sclerosis Pipeline Assessment and clinical trials [https://www.delveinsight.com/sample-request/amyotrophic-lateral-sclerosis-als-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Table of Contents

1. Amyotrophic Lateral Sclerosis Report Introduction

2. Amyotrophic Lateral Sclerosis Executive Summary

3. Amyotrophic Lateral Sclerosis Overview

4. Amyotrophic Lateral Sclerosis- Analytical Perspective In-depth Commercial Assessment

5. Amyotrophic Lateral Sclerosis Pipeline Therapeutics

6. Amyotrophic Lateral Sclerosis Late Stage Products (Phase II/III)

7. Amyotrophic Lateral Sclerosis Mid Stage Products (Phase II)

8. Amyotrophic Lateral Sclerosis Early Stage Products (Phase I)

9. Amyotrophic Lateral Sclerosis Preclinical Stage Products

10. Amyotrophic Lateral Sclerosis Therapeutics Assessment

11. Amyotrophic Lateral Sclerosis Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Amyotrophic Lateral Sclerosis Key Companies

14. Amyotrophic Lateral Sclerosis Key Products

15. Amyotrophic Lateral Sclerosis Unmet Needs

16 . Amyotrophic Lateral Sclerosis Market Drivers and Barriers

17. Amyotrophic Lateral Sclerosis Future Perspectives and Conclusion

18. Amyotrophic Lateral Sclerosis Analyst Views

19. Appendix

20. About DelveInsight

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

Media Contact
Company Name: DelveInsight
Contact Person: Gaurav Bora
Email:Send Email [https://www.abnewswire.com/email_contact_us.php?pr=amyotrophic-lateral-sclerosis-pipeline-2025-fda-approvals-and-clinical-trials-landscape-with-moa-and-roa-highlights-by-delveinsight-cosciens-biopharma-benevolentai-verge-genomics-projenx]
Phone: +14699457679
Address:304 S. Jones Blvd #2432
City: Las Vegas
State: NV
Country: United States
Website: https://www.delveinsight.com/

Legal Disclaimer: Information contained on this page is provided by an independent third-party content provider. ABNewswire makes no warranties or responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you are affiliated with this article or have any complaints or copyright issues related to this article and would like it to be removed, please contact retract@swscontact.com



This release was published on openPR.