Multiple System Atrophy Clinical Trials Analysis, 2025 MSA Companies Include Theravance Biopharma, H. Lundbeck A/S, Yoda Pharmaceuticals, Alterity Therapeutics, CORESTEM, Inc., Promis Neurosciences

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"Multiple System Atrophy Clinical Trials Analysis"DelveInsight's,“Multiple System Atrophy- Pipeline Insight, 2025” report provides comprehensive insights about 20+ companies and 22+ pipeline drugs in Multiple System Atrophy pipeline landscape. It covers the 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.

DelveInsight's Multiple System Atrophy Clinical Trials Analysis Report provides deep insights to support strategic decision-making for MSA pipeline expansion, competitive positioning, and partnership identification in the rare neurodegenerative disease space.

DelveInsight reports that more than 12 key companies are actively engaged in developing over 12 therapeutic candidates for Multiple System Atrophy. Key therapies showing promising results include Ampreloxetine, YA-101, ATH434, and others.

Multiple system atrophy Overview:

Multiple System Atrophy (MSA) is a rare and progressive neurodegenerative condition that affects an estimated 15,000 to 50,000 people in the United States, across all racial groups. The underlying cause remains unknown, and most cases appear sporadically.

The disorder involves both the central nervous system, which governs movement, and the autonomic nervous system, which manages involuntary functions such as blood pressure regulation and digestion.

MSA is classified into two primary subtypes based on predominant symptoms:

• MSA-P (Parkinsonian type): Characterized by Parkinson's disease–like features, including slowness of movement, rigidity, tremors, and balance problems, often accompanied by autonomic issues such as bladder or digestive dysfunction.

• MSA-C (Cerebellar type): Marked by impaired coordination and balance (ataxia), difficulties with speech and swallowing, and abnormal eye movements.

Both forms underscore the complex and debilitating nature of the disease.

"Multiple system atrophy Pipeline Insight 2025" report by DelveInsight provides a comprehensive analysis of the ongoing clinical development activities and growth prospects across the Multiple system atrophy Therapeutics Market.

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Key Takeaways from the Multiple system atrophy Pipeline Report

• In March 2025, the FDA granted Orphan Drug Designation to exidavnemab, a monoclonal antibody developed by BioArctic, for the treatment of Multiple System Atrophy (MSA). This designation offers incentives to advance therapies for rare diseases.

• Earlier, in February 2025, the FDA awarded Fast Track status to amlenetug, a monoclonal antibody designed to target extracellular α-synuclein, aiming to block its aggregation and support immune-mediated clearance. Previously, in April 2024, amlenetug had also received Orphan Drug Designation, highlighting its potential in addressing a rare condition with high unmet medical need.

• According to DelveInsight, the MSA pipeline is dynamic, with 12+ companies actively pursuing over 12 investigational therapies. Key players include Theravance Biopharma, H. Lundbeck A/S, Yoda Pharmaceuticals, Alterity Therapeutics, CORESTEM, Inc., ProMIS Neurosciences, among others, all working to advance treatment options.

• Notable emerging therapies in development for MSA include Ampreloxetine, YA-101, ATH434, and more, reflecting a promising shift toward improving the treatment landscape.

Multiple system atrophy Pipeline Analysis

The report provides insights into:

• The report offers comprehensive insights into the key companies developing therapies for the Multiple System Atrophy (MSA) market. It assesses therapeutic candidates across early-, mid-, and late-stage development for MSA treatment. The analysis covers companies engaged in targeted therapeutics, including both active and inactive (dormant or discontinued) projects.

• The report also examines emerging drugs based on factors such as development stage, route of administration, target receptor, monotherapy versus combination therapy, mechanism of action, and molecular type. Additionally, it provides a detailed overview of collaborations (company-to-company and company-to-academia), licensing agreements, and financing activities driving the future growth of the MSA market.

Major trends shaping the clinical trial and competitive landscape for Multiple System Atrophy (MSA)

• Focus on Disease-Modifying Therapies: Shift from purely symptomatic treatments to targeting α-synuclein aggregation, neuroinflammation, and neuroprotection.

• Emerging Modalities: Increased development of gene therapies and monoclonal antibodies.

• Expanding Clinical Trial Activity: Growth in early- and mid-stage trials, often in multinational settings; adaptive trial designs to accelerate timelines.

• Strategic Collaborations: Partnerships between biotech, pharma, and academia for shared expertise, patient recruitment, and biomarker development.

• Biomarkers and Diagnostics: Use of biomarkers for early diagnosis, patient stratification, and improved trial endpoints.

• Regulatory Incentives: Orphan Drug and Fast Track designations encourage investment and shorten time-to-market.

• Differentiation by Mechanism and Delivery: Focus on route of administration, molecular type, combination therapies, and long-acting formulations.

• Patient-Centric Approaches: Incorporation of patient-reported outcomes and quality-of-life metrics in clinical trials.

• Real-World Evidence: Leveraging real-world data to support regulatory approval and reimbursement strategies.

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Multiple System Atrophy Emerging Drugs and Companies

• Ampreloxetine: Theravance Biopharma

Ampreloxetine is an investigational, long-acting norepinephrine reuptake inhibitor administered once daily, currently in development for managing symptomatic neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA). Results from Study 0170 in MSA patients demonstrated encouraging findings, including elevated norepinephrine levels, better blood pressure control, durable symptom relief, and no evidence of supine hypertension (high blood pressure when lying flat).

• YA-101: Yoda Pharmaceuticals

YA-101, developed by Yoda Pharmaceuticals, is a novel chemical entity (NCE) aimed at treating neurodegenerative diseases by lowering neuroinflammation and enhancing neural plasticity. It acts as a dual modulator, targeting both the GluN1 subunit of the NMDA receptor and the NLRP3 inflammasome, with potential applications in conditions such as Multiple System Atrophy (MSA), Alzheimer's disease, and schizophrenia. The therapy is currently being assessed in a Phase II clinical trial for MSA patients.

• ATH434: Alterity Therapeutics

Alterity's lead candidate, ATH434, is an oral therapy designed to prevent the accumulation of toxic proteins associated with neurodegenerative diseases. Preclinical research indicates that ATH434 can lessen α-synuclein pathology and preserve neuronal function by regulating brain iron levels. As an iron chaperone, it shows strong promise for treating Parkinson's disease and related conditions such as Multiple System Atrophy (MSA). The drug is currently under evaluation in a Phase II clinical trial for MSA patients.

Multiple system atrophy Companies

More than 12 key companies are engaged in developing therapies for Multiple System Atrophy (MSA). Among these, Theravance Biopharma leads the field, with its drug candidate progressing to a Phase III clinical trial, the most advanced stage of development so far.

Explore which key multiple system atrophy companies are working to develop novel therapies which will drive the market in the upcoming years

DelveInsight's report covers around 12+ products under different phases of clinical development like

• Late stage products (Phase III)

• Mid-stage products (Phase II)

• Early-stage product (Phase I) along with the details of

• Pre-clinical and Discovery stage candidates

• Discontinued & Inactive candidates

Multiple system atrophy 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

Multiple system atrophy Products have been categorized under various Molecule types such as

• Monoclonal antibody

• Small molecule

• Peptide

Download Sample Pages to Get an in-depth Assessment of the Emerging Multiple system atrophy Therapies and Key Companies: Multiple system atrophy Clinical Trials and advancements

Multiple system atrophy Pipeline Therapeutic Assessment

. Multiple system atrophy Assessment by Product Type

. Multiple system atrophy By Stage

. Multiple system atrophy Assessment by Route of Administration

. Multiple system atrophy Assessment by Molecule Type

Multiple system atrophy Report Section Includes:

• Multiple system atrophy competitive landscape clinical trials

• Multiple system atrophy emerging drugs analysis

• Multiple system atrophy investigational drugs report

• Multiple system atrophy clinical trial trends analysis

• Multiple system atrophy pipeline benchmarking report

• Multiple system atrophy drug pipeline competitive intelligence

• Multiple System Atrophy competitive landscape

Download Multiple system atrophy Sample report to know in detail about the Multiple system atrophy treatment market

Table of Content

1. Report Introduction

2. Executive Summary

3. Multiple system atrophy Current Treatment Patterns

4. Multiple system atrophy - DelveInsight's Analytical Perspective

5. Therapeutic Assessment

6. Multiple system atrophy Late-Stage Products (Phase-III)

7. Multiple system atrophy Mid-Stage Products (Phase-II)

8. Early Stage Products (Phase-I)

9. Pre-clinical Products and Discovery Stage Products

10. Inactive Products

11. Dormant Products

12. Multiple system atrophy Discontinued Products

13. Multiple system atrophy Product Profiles

14. Multiple system atrophy Key Companies

15. Multiple system atrophy Key Products

16. Dormant and Discontinued Products

17. Multiple system atrophy Unmet Needs

18. Multiple system atrophy Future Perspectives

19. Multiple system atrophy Analyst Review

20. Appendix

21. Report Methodology

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.

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