Autistic Disorder Pipeline 2025: FDA Approvals and Clinical Trials Landscape with MOA and ROA Highlights by DelveInsight

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

The Autistic 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.

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

Some of the key takeaways from the Autistic Disorder Pipeline Report: https://www.delveinsight.com/sample-request/autistic-disorder-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr
• Companies across the globe are diligently working toward developing novel Autistic Disorder treatment therapies with a considerable amount of success over the years.
• Autistic Disorder companies working in the treatment market are Scioto Biosciences, Hoffmann-La Roche, Yamo Pharmaceutical, Jazz Pharmaceuticals, Axial Therapeutics, Eli Lilly and Company, AbbVie, and others, are developing therapies for the Autistic Disorder treatment
• Emerging Autistic Disorder therapies in the different phases of clinical trials are- SB-121, RO6953958, L1-79, JZP541, AB-2004, Tasimelteon, Cariprazine, and others are expected to have a significant impact on the Autistic 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 Cannabis 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.

Autistic Disorder Overview
Autistic Disorder, commonly referred to as autism, is a neurodevelopmental disorder characterized by significant challenges in social interaction, communication, and restricted, repetitive behaviors and interests. Autism Spectrum Disorder (ASD) encompasses a range of conditions, including Autistic Disorder, Asperger's Syndrome, and Pervasive Developmental Disorder-Not Otherwise Specified (PDD-NOS). Here, the focus is on Autistic Disorder specifically.

Get a Free Sample PDF Report to know more about Autistic Disorder Pipeline Therapeutic Assessment-
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Emerging Autistic Disorder Drugs Under Different Phases of Clinical Development Include:
• SB-121: Scioto Biosciences
• RO6953958: Hoffmann-La Roche
• L1-79: Yamo Pharmaceutical
• JZP541: Jazz Pharmaceuticals
• AB-2004: Axial Therapeutics
• Tasimelteon: Eli Lilly and Company
• Cariprazine: AbbVie

Autistic Disorder Route of Administration
Autistic Disorder pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Autistic Disorder Molecule Type
Autistic Disorder Products have been categorized under various Molecule types, such as
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

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

DelveInsight's Autistic 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 Autistic Disorder product details are provided in the report. Download the Autistic Disorder pipeline report to learn more about the emerging Autistic Disorder therapies
https://www.delveinsight.com/sample-request/autistic-disorder-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

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

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

Autistic Disorder Pipeline Market Drivers
• Increasing Prevalence of Autistic Disorder, government initiatives to increase the awareness for the disease are some of the important factors that are fueling the Autistic Disorder Market.

Autistic Disorder Pipeline Market Barriers
• However, side-effects associated with the treatment of Autistic Disorder, a lack of knowledge about the types of treatment available and other factors are creating obstacles in the Autistic Disorder Market growth.

Scope of Autistic Disorder Pipeline Drug Insight
• Coverage: Global
• Key Autistic Disorder Companies: Scioto Biosciences, Hoffmann-La Roche, Yamo Pharmaceutical, Jazz Pharmaceuticals, Axial Therapeutics, Eli Lilly and Company, AbbVie, and others
• Key Autistic Disorder Therapies: SB-121, RO6953958, L1-79, JZP541, AB-2004, Tasimelteon, Cariprazine, and others
• Autistic Disorder Therapeutic Assessment: Autistic Disorder current marketed and Autistic Disorder emerging therapies
• Autistic Disorder Market Dynamics: Autistic Disorder market drivers and Autistic Disorder market barriers

Contact Us:
Gaurav Bora
gbora@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

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.

This release was published on openPR.