Amyotrophic Lateral Sclerosis (ALS) Pipeline Analysis Report 2026

Report Coverage

The Amyotrophic Lateral Sclerosis (ALS) Pipeline Analysis Report by Expert Market Research gives comprehensive insights into amyotrophic lateral sclerosis (ALS) therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for amyotrophic lateral sclerosis (ALS). The amyotrophic lateral sclerosis (ALS) report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The amyotrophic lateral sclerosis (ALS) pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with amyotrophic lateral sclerosis (ALS) treatment guidelines to ensure optimal care practices.

The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to amyotrophic lateral sclerosis (ALS).

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Amyotrophic Lateral Sclerosis (ALS) Pipeline Outlook

The amyotrophic lateral sclerosis (ALS) pipeline outlook reflects growing innovation beyond traditional symptomatic management.

ALS treatment currently relies mainly on riluzole and edaravone, which modestly slow disease progression without altering long-term outcomes. However, the development of pipeline increasingly targets genetic and molecular drivers of ALS. A major milestone occurred in April 2023, when the US FDA granted accelerated approval to Qalsody (tofersen) for SOD1-associated ALS, marking the first therapy directed at a defined genetic cause. This approval has strengthened momentum for precision medicine approaches and late-stage pipeline activity in ALS.

Amyotrophic Lateral Sclerosis (ALS) Epidemiology

Amyotrophic lateral sclerosis (ALS) is a rare, progressive neurodegenerative disorder with well-defined epidemiological characteristics. Approximately 90-95% of ALS cases are sporadic, showing a clear male predominance of 2:1, while familial ALS accounts for the remaining cases with an equal male-to-female ratio. The lifetime risk is estimated at 1:350 for men and 1:400 for women, with a mean age at onset of 64 years and peak risk around 75 years. Globally, ALS incidence ranges from 1-2.6 per 100,000, with prevalence estimated at 4-5 per 100,000, demonstrating marked geographic variation.

Amyotrophic Lateral Sclerosis (ALS) – Pipeline Therapeutic Assessment

Amyotrophic Lateral Sclerosis (ALS) Pipeline Assessment Segmentation, By Phases

The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase II covers a major share of the total amyotrophic lateral sclerosis (ALS) clinical trials. Phase II dominates with 41%, followed by phase I (35%), phase III (14%), and early phase I (9%). This distribution highlights the strong focus on mid-stage clinical development, reflecting growing efforts to advance promising ALS therapies toward late-stage evaluation and potential commercialization.

Amyotrophic Lateral Sclerosis (ALS) Pipeline Assessment Segmentation, By Drug Classes

The drug molecule categories covered under amyotrophic lateral sclerosis (ALS) pipeline analysis include monoclonal antibodies, small molecules, and peptides. The amyotrophic lateral sclerosis (ALS) report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for amyotrophic lateral sclerosis (ALS). In August 2025, Coya Therapeutics announced that the U.S. FDA accepted its Investigational New Drug (IND) application for COYA 302, an immunomodulatory biologic for amyotrophic lateral sclerosis (ALS). This acceptance enables initiation of a phase II multicenter, double-blind, placebo-controlled clinical trial to evaluate safety and efficacy in ALS patients. This milestone also triggers a USD 4.2 million payment from partner Dr Reddy’s Laboratories, marking a significant advancement in Coya’s ALS drug development program.

Amyotrophic Lateral Sclerosis (ALS) Clinical Trials – Key Players

The EMR report for the amyotrophic lateral sclerosis (ALS) pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed amyotrophic lateral sclerosis (ALS) therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in amyotrophic lateral sclerosis (ALS) clinical trials:

• Ionis Pharmaceuticals, Inc.
• MediciNova
• Rapa Therapeutics LLC
• Shanghai Zhimeng Biopharma, Inc.
• Insmed Gene Therapy LLC
• Cellenkos, Inc.
• Ractigen Therapeutics.
• RJK Biopharma Ltd
• Eli Lilly and Company
• Everfront Biotech Co., Ltd.
• Xalud Therapeutics, Inc.

Amyotrophic Lateral Sclerosis (ALS) – Emerging Drugs Profile

Key Questions Answered in the Amyotrophic Lateral Sclerosis (ALS) Pipeline Insight Report

• Which companies/institutions are leading the amyotrophic lateral sclerosis (ALS) drug development?
• Which company is leading the amyotrophic lateral sclerosis (ALS) pipeline development activities?
• What is the current amyotrophic lateral sclerosis (ALS) commercial assessment?
• What are the opportunities and challenges present in the amyotrophic lateral sclerosis (ALS) pipeline landscape?
• What is the efficacy and safety profile of amyotrophic lateral sclerosis (ALS) pipeline drugs?
• Which company is conducting major trials for amyotrophic lateral sclerosis (ALS) drugs?
• Which companies/institutions are involved in amyotrophic lateral sclerosis (ALS) collaborations aimed at providing enhanced therapeutic alternatives for patients?
• What are the geographies covered for clinical trials in amyotrophic lateral sclerosis (ALS)?

Reasons To Buy This Report

The Amyotrophic Lateral Sclerosis (ALS) Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for amyotrophic lateral sclerosis (ALS). It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into amyotrophic lateral sclerosis (ALS) collaborations, regulatory environments, and potential growth opportunities.

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