Autistic Disorder Pipeline: A New Era of Innovation Driven by 18+ Trailblazing Companies | DelveInsight

The autistic disorder market is accelerating with cutting-edge therapies from over 18 innovators, including Auzone Biological Technology, Vanda Pharmaceuticals, Paxmedica, Stalicla SA, and ACADIA Pharmaceuticals. These trailblazers are revolutionizing treatment approaches and bringing new hope to patients worldwide.

DelveInsight's "Autistic Disorder Pipeline Insight, 2025" comprehensively analyzes the current clinical landscape and growth prospects in the Autistic Disorder market. The report covers disease insights, treatment guidelines, and a detailed pipeline assessment from preclinical to marketed stages. It includes drug mechanisms, clinical studies, regulatory progress, and key developments such as collaborations, mergers, funding, and designations.

For emerging Autistic Disorder drugs, the Autistic Disorder pipeline analysis report provides a 360° view of the therapeutics landscape by development point, product type, route of administration, molecule type, and MOA. The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.

Key Takeaways from the Autistic Disorder Pipeline Report
• DelveInsight's autistic disorder pipeline analysis depicts a robust space with 18+ active players working to develop 20+ pipeline drugs for autistic disorder treatment.
• The leading autistic disorder companies include Astrogen, Inc., Yamo Pharmaceuticals LLC, Axial Therapeutics, Inc., NeuroNOS, Shanghai Auzone Biological Technology Co., Ltd., Vanda Pharmaceuticals, Paxmedica, Stalicla SA, ACADIA Pharmaceuticals Inc., MapLight Therapeutics, Intra-Cellular Therapies, Inc., Aardvark Therapeutics, Inc., Astrogen, Inc., IAMA Therapeutics S.r.l., GEXVal, and others are evaluating their lead assets to improve the Autistic Disorder treatment landscape.
• Key autistic disorder pipeline therapies in various stages of development include AST-001, L1-79, AB-2004, BA102, TTYP01, Tasimelteon, Suramin Sodium, Pimavanserin, ML-004, Lumateperone, ARD-501, Cannabidivarin, AST-001, AB-2004, GXV 001, and others.
• In March 2025, GRIN Therapeutics, Inc. announced that the FDA granted Orphan Drug designation for its investigational drug, radiprodil, for the treatment of GRIN-related neurodevelopmental disorder (NDD).
• In Feb 2025, DeFloria, Inc. announced that the FDA completed its review of the Investigational New Drug (IND) application for AJA001, an orally delivered, multi-cannabin0id botanical drug for treating symptoms of autism spectrum disorder (ASD). The company plans to proceed with its Phase 2 clinical trial, set to begin by mid-2025.
• In January 2025, the FDA granted Orphan Drug Designation (ODD) to Capsida Biotherapeutics for CAP-002, a first-in-class gene therapy for STXBP1 disorder, developed in collaboration with Dr. Mingshan Xue at Texas Children's Duncan Neurological Research Institute.

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Autistic Disorder Overview
Autism Spectrum Disorder (ASD) is a group of neurodevelopmental conditions marked by repetitive behaviors, restricted interests, and social communication challenges. Symptoms usually appear in early childhood and can significantly affect daily life. Children with ASD may struggle with changes in routine and often have co-occurring issues like language delays, intellectual disabilities, and epilepsy.

Childhood Disintegrative Disorder (CDD), or Heller syndrome, is a rare and severe subtype of ASD. It involves a sudden and dramatic loss of previously acquired language, social, and motor skills after normal development, typically after age three. The cause of CDD is unknown, though it's sometimes linked to conditions such as subacute sclerosing panencephalitis, tuberous sclerosis, leukodystrophies, and lipid storage diseases.

The pathophysiology of ASD and CDD is not fully understood. In CDD, the abrupt regression has led to comparisons with childhood dementia, with unconfirmed theories suggesting a possible link to amyloid buildup in the brain.

Treatment focuses on intensive behavioral interventions to help children regain skills, supported by speech, occupational, and sensory therapies. Family counseling plays a key role in reinforcing care at home. Medications may be used to manage symptoms like aggression, repetitive behaviors, and seizures, though there's no cure. CDD, in particular, often requires lifelong support due to the extent of developmental regression.

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Autistic Disorder Treatment Analysis: Drug Profile
AST-001: Astrogen, Inc.
AST-001 is a novel therapeutic candidate from Astrogen, Inc., developed to treat core symptoms of Autism Spectrum Disorder (ASD). It is based on L-serine, a naturally occurring amino acid essential for neurotransmitter synthesis and brain metabolism. By boosting L-serine levels in the brain, AST-001 aims to enhance cognitive function and social skills in children with ASD. Its mechanism targets dopaminergic pathways, which are often disrupted in autism-related behavioral symptoms. AST-001 is currently in Phase III clinical trials for Autistic Disorder.

L1-79: Yamo Pharmaceuticals LLC
L1-79 is an experimental therapy from Yamo Pharmaceuticals designed to improve social interaction deficits in individuals with ASD. It has demonstrated a strong safety profile and is well-tolerated in healthy individuals and ASD patients. The drug modulates catecholamine pathways, which affect mood, attention, motor control, and social behavior. It also addresses central nervous system hyperactivity and gut-brain interactions often linked to autism. By regulating catecholaminergic signaling, L1-79 holds promise for enhancing social communication. The therapy is currently in Phase II clinical trials for Autistic Disorder.

Key Autistic Disorder Therapies and Companies
• AST-001: Astrogen, Inc.
• L1-79: Yamo Pharmaceuticals LLC
• AB-2004: Axial Therapeutics, Inc.
• ML-004: MapLight Therapeutics
• RG7816 (alogabat/RO7017773): Hoffmann-La Roche
• AB-2004: Axial Therapeutics

Learn more about the novel and emerging autistic disorder pipeline therapies @ https://www.delveinsight.com/report-store/autistic-disorder-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Autistic Disorder Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• 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

By Route of Administration
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

By Molecule Type
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Scope of the Autistic Disorder Pipeline Report
• Coverage: Global
• Key Autistic Disorder Companies: Astrogen, Inc., Yamo Pharmaceuticals LLC, Axial Therapeutics, Inc., NeuroNOS, Shanghai Auzone Biological Technology Co., Ltd., Vanda Pharmaceuticals, Paxmedica, Stalicla SA, ACADIA Pharmaceuticals Inc., MapLight Therapeutics, Intra-Cellular Therapies, Inc., Aardvark Therapeutics, Inc., Astrogen, Inc., IAMA Therapeutics S.r.l., GEXVal, and others.
• Key Autistic Disorder Pipeline Therapies: AST-001, L1-79, AB-2004, BA102, TTYP01, Tasimelteon, Suramin Sodium, Pimavanserin, ML-004, Lumateperone, ARD-501, Cannabidivarin, AST-001, AB-2004, GXV 001, and others.

Dive deep into rich insights for drugs used for the treatment of autistic disorder; visit @ https://www.delveinsight.com/report-store/autistic-disorder-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

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

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This release was published on openPR.