Autism Spectrum Disorder Pipeline 2025: Therapies Under Investigation, Clinical Trials Milestones, and FDA Approvals by DelveInsight | Mindmed, Finch Therapeutics Group, Axial Therapeutics, Hoffmann-La Roche, STALICLA

(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Autism Spectrum Disorder pipeline constitutes 18+ key companies continuously working towards developing 20+ Autism Spectrum Disorder treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

"Autism Spectrum Disorder Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Autism Spectrum Disorder Market.

The Autism Spectrum Disorder 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 Autism Spectrum Disorder Pipeline Report: https://www.delveinsight.com/sample-request/autism-spectrum-disorder-asd-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr
• Companies across the globe are diligently working toward developing novel Autism Spectrum Disorder treatment therapies with a considerable amount of success over the years.
• Autism Spectrum Disorder companies working in the treatment market are Mindmed, Finch Therapeutics Group, Axial Therapeutics, Hoffmann-La Roche, STALICLA, Axial Therapeutics, GW Pharmaceuticals, MapLight Therapeutics, Vanda Pharmaceuticals, AbbVie, and others, are developing therapies for the Autism Spectrum Disorder treatment
• Emerging Autism Spectrum Disorder therapies in the different phases of clinical trials are- MM-402, FIN 211, AB-2004 PTR, RO6953958, STP 1, AB-2004, ML 004, Tasimelteon, Cariprazine, and others are expected to have a significant impact on the Autism Spectrum Disorder market in the coming years.
• In May 2025, Yamo Pharmaceuticals, a clinical-stage biopharma company focused on addressing the core symptoms of autism spectrum disorder (ASD), announced encouraging Phase II results for its candidate L1-79. The findings were shared at the 2025 Annual Meeting of the International Society for Autism Research (INSAR). In a 12-week, randomized, double-blind, placebo-controlled crossover study involving 58 participants aged 12 to 21, L1-79 demonstrated statistically significant and clinically meaningful improvements in the Vineland-3 Socialization Standard Score (VSSS) and multiple secondary outcomes during the first treatment period, all while maintaining a favorable safety profile.
• In February 2025, Charlotte's Web Holdings, Inc. announced that the U.S. Food and Drug Administration (FDA) has completed its review of the Phase I data and Investigational New Drug (IND) application submitted by DeFloria, Inc. Following the review, the FDA has authorized DeFloria to move forward with its planned Phase II clinical trial of AJA001 Oral Solution, a botanical drug candidate intended to treat symptoms associated with autism spectrum disorder (ASD).
• In January 2025, The Israeli Medical Cannabs Agency (IMCA) under the Ministry of Health renewed SciSparc's clinical trial of SCI-210 for treating pediatric patients with autism spectrum disorder (ASD). This renewal is essential to ensure the study's continuation while complying with IMCA's regulatory standards.
• In July 2024, Jaguar Gene Therapy, a clinical-stage biotechnology company advancing gene therapy for severe genetic diseases affecting large patient populations, announced it has received U.S. Food and Drug Administration (FDA) feedback from a Type C meeting. The discussion focused on the Phase I clinical trial for JAG201, a gene replacement therapy targeting a genetic form of autism spectrum disorder (ASD) associated with SHANK3 mutations or deletions, as well as Phelan-McDermid syndrome.

Autism Spectrum Disorder Overview
Autism Spectrum Disorder is a neurodevelopmental condition characterized by challenges with social interaction, communication, and repetitive behaviors. The term "spectrum" reflects the wide range of symptoms and severity across individuals. People with Autism Spectrum Disorder may have difficulty understanding social cues, forming relationships, or adapting to changes in routine. Some may also have unique strengths, such as attention to detail or exceptional memory. Autism Spectrum Disorder typically appears in early childhood and affects individuals throughout their lives. While there is no cure, early diagnosis and intervention-such as behavioral, speech, and occupational therapies-can significantly improve outcomes.

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Emerging Autism Spectrum Disorder Drugs Under Different Phases of Clinical Development Include:
• MM-402: Mindmed
• FIN 211: Finch Therapeutics Group
• AB-2004 PTR: Axial Therapeutics
• RO6953958: Hoffmann-La Roche
• STP 1: STALICLA
• AB-2004: Axial Therapeutics
• ML 004: MapLight Therapeutics
• Tasimelteon: Vanda Pharmaceuticals
• Cariprazine: AbbVie

Autism Spectrum Disorder Pipeline Therapeutics Assessment
• Autism Spectrum Disorder Assessment by Product Type
• Autism Spectrum Disorder By Stage and Product Type
• Autism Spectrum Disorder Assessment by Route of Administration
• Autism Spectrum Disorder By Stage and Route of Administration
• Autism Spectrum Disorder Assessment by Molecule Type
• Autism Spectrum Disorder by Stage and Molecule Type

DelveInsight's Autism Spectrum Disorder Report covers around 20+ 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 Autism Spectrum Disorder product details are provided in the report. Download the Autism Spectrum Disorder pipeline report to learn more about the emerging Autism Spectrum Disorder therapies
https://www.delveinsight.com/sample-request/autism-spectrum-disorder-asd-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

Some of the key companies in the Autism Spectrum Disorder Therapeutics Market include:
Key companies developing therapies for Autism Spectrum Disorder are - Q BioMed Inc., PaxMedica, Yamo Pharmaceuticals, Otsuka Pharmaceutical Co., Ltd., F. Hoffmann-La Roche Ltd, Curemark, LLC, Zynerba Pharmaceuticals, Inc, Axial Therapeutics, Novartis AG, STALICLA, and others.

Autism Spectrum Disorder Pipeline Analysis:
The Autism Spectrum Disorder pipeline report provides insights into
• The report provides detailed insights about companies that are developing therapies for the treatment of Autism Spectrum Disorder 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 Autism Spectrum Disorder Treatment.
• Autism Spectrum Disorder key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• Autism Spectrum Disorder 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 Autism Spectrum Disorder 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 Autism Spectrum Disorder drugs and therapies
https://www.delveinsight.com/sample-request/autism-spectrum-disorder-asd-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

Autism Spectrum Disorder Pipeline Market Drivers
• Increase in prevalence of Autism Spectrum Disorder (ASD), rise in demand for early diagnosis are some of the important factors that are fueling the Autism Spectrum Disorder Market.

Autism Spectrum Disorder Pipeline Market Barriers
• However, lack of Approved Drugs, high cost of treatment & diagnosis and other factors are creating obstacles in the Autism Spectrum Disorder Market growth.

Scope of Autism Spectrum Disorder Pipeline Drug Insight
• Coverage: Global
• Key Autism Spectrum Disorder Companies: Mindmed, Finch Therapeutics Group, Axial Therapeutics, Hoffmann-La Roche, STALICLA, Axial Therapeutics, GW Pharmaceuticals, MapLight Therapeutics, Vanda Pharmaceuticals, AbbVie, and others
• Key Autism Spectrum Disorder Therapies: MM-402, FIN 211, AB-2004 PTR, RO6953958, STP 1, AB-2004, ML 004, Tasimelteon, Cariprazine, and others
• Autism Spectrum Disorder Therapeutic Assessment: Autism Spectrum Disorder current marketed and Autism Spectrum Disorder emerging therapies
• Autism Spectrum Disorder Market Dynamics: Autism Spectrum Disorder market drivers and Autism Spectrum Disorder market barriers

Request for Sample PDF Report for Autism Spectrum Disorder Pipeline Assessment and clinical trials
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Table of Contents
1. Autism Spectrum Disorder Report Introduction
2. Autism Spectrum Disorder Executive Summary
3. Autism Spectrum Disorder Overview
4. Autism Spectrum Disorder- Analytical Perspective In-depth Commercial Assessment
5. Autism Spectrum Disorder Pipeline Therapeutics
6. Autism Spectrum Disorder Late Stage Products (Phase II/III)
7. Autism Spectrum Disorder Mid Stage Products (Phase II)
8. Autism Spectrum Disorder Early Stage Products (Phase I)
9. Autism Spectrum Disorder Preclinical Stage Products
10. Autism Spectrum Disorder Therapeutics Assessment
11. Autism Spectrum Disorder Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Autism Spectrum Disorder Key Companies
14. Autism Spectrum Disorder Key Products
15. Autism Spectrum Disorder Unmet Needs
16 . Autism Spectrum Disorder Market Drivers and Barriers
17. Autism Spectrum Disorder Future Perspectives and Conclusion
18. Autism Spectrum Disorder Analyst Views
19. Appendix
20. About DelveInsight

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