Autism Spectrum Disorder - Pipeline Insight, 2025

DelveInsight's, "Autism Spectrum Disorder - Pipeline Insight, 2025" report provides comprehensive insights about 18+ companies and 20+ pipeline drugs in Autism Spectrum Disorder 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.

Geography Covered:

• Global coverage

Autism Spectrum Disorder: Understanding

Autism Spectrum Disorder: Overview

Autism spectrum disorder (ASD) is a developmental disability caused by differences in the brain. Some people with ASD have a known difference, such as a genetic condition. Other causes are not yet known. Scientists believe there are multiple causes of ASD that act together to change the most common ways people develop. People with ASD may behave, communicate, interact, and learn in ways that are different from most other people. There is often nothing about how they look that sets them apart from other people. The abilities of people with ASD can vary significantly. Autism Spectrum Disorder (ASD) is considered the broad term for autism, but three separate sub-types fit within the ASD category. The 3 types of autism are: Autistic Disorder, Asperger's Syndrome and Pervasive Development Disorder.

Signs and symptoms of Autism Spectrum Disorder (ASD) include challenges with social communication, such as avoiding or not maintaining eye contact, not responding to one's name by 9 months of age, and lacking typical facial expressions like happiness, sadness, or surprise. Individuals may also engage in repetitive behaviors like echolalia, where they repeat words or phrases. Additionally, they may experience gastrointestinal issues like constipation, display unusual mood or emotional reactions, and may have distinct ways of learning, moving, or paying attention. Its pathology involves genetic, neurobiological, and environmental factors, with neuroimaging showing structural anomalies in brain regions like the frontal and temporal lobes. Symptoms, such as delayed language and rigid routines, typically emerge in early childhood. The spectrum nature of ASD reflects its wide variability in symptom presentation, from low to high functioning.

Diagnosing ASD can be difficult since there is no medical test, like a blood test, to diagnose the disorder. Doctors look at the child's behavior and development to make a diagnosis. ASD can sometimes be detected at 18 months of age or younger. By age 2, a diagnosis by an experienced professional can be considered reliable. However, many children do not receive a final diagnosis until they are much older. Some people are not diagnosed until they are adolescents or adults. This delay means that people with ASD might not get the early help they need. Current treatments for autism spectrum disorder (ASD) seek to reduce symptoms that interfere with daily functioning and quality of life. ASD affects each person differently, meaning that people with ASD have unique strengths and challenges and different treatment needs. Therefore, treatment plans usually involve multiple professionals and are catered toward the individual. Treatments can be given in education, health, community, or home settings, or a combination of settings.

"Autism Spectrum Disorder- Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Autism Spectrum Disorder pipeline landscape is provided which includes the disease overview and Autism Spectrum Disorder treatment guidelines. The assessment part of the report embraces, in depth Autism Spectrum Disorder commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Autism Spectrum Disorder collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights:

• The companies and academics are working to assess challenges and seek opportunities that could influence Autism Spectrum Disorder R&D. The therapies under development are focused on novel approaches to treat/improve Autism Spectrum Disorder.

Autism Spectrum Disorder Emerging Drugs Chapters

This segment of the Autism Spectrum Disorder report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, II, I, Preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Autism Spectrum Disorder Emerging Drugs

• AST-001: Astrogen

AST-001 is a small-molecule drug developed by Astrogen to treat Autism Spectrum Disorder (ASD). AST-001 functions as an L-isomer of serine, which plays a critical role in various neurological processes. It has been shown to improve social deficits and restore dopamine neuron activity in preclinical models of ASD. The drug enhances dopamine neuron firing through the normalization of specific ion channel activities, suggesting its potential as a therapeutic agent for improving social interaction and cognitive function in patients with ASD. It targets neurological mechanisms to improve core symptoms in ASD patients and has advanced to Phase III clinical trials following regulatory approval in South Korea.

• ML004: MapLight Therapeutics

ML-004 is MapLight's lead clinical compound. Its selective pharmacological properties of make it a highly specific therapy with limited side effects. The company is developing ML-004 for multiple indications, including sociability and irritability in ASD and agitation and aggression in Alzheimer's disease. Currently, the drug is in Phase II stage of its clinical trial for the treatment of Autism Spectrum Disorder.

• AJA001: Ajna BioSciences

AJA001 is a full-spectrum cannabinoid formulation derived from Cannabis sativa, designed specifically for Autism Spectrum Disorder (ASD). Created through DEFLORIA LLC-a joint venture between Ajna, Charlotte's Web, and BAT-it aims to be the first FDA-approved botanical hemp extract for ASD. Leveraging Charlotte's Web's patented genetics, AJA001 optimizes bioavailability, showing promising symptom relief and quality-of-life improvements in early clinical trials.

Autism Spectrum Disorder: Therapeutic Assessment

This segment of the report provides insights about the different Autism Spectrum Disorder drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Autism Spectrum Disorder
• There are approx. 18+ key companies which are developing the therapies for Autism Spectrum Disorder. The companies which have their Autism Spectrum Disorder drug candidates in the most advanced stage, i.e. Phase III include, Astrogen.
• Phases

DelveInsight's 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) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Autism Spectrum 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
• Molecule Type

Products have been categorized under various Molecule types such as

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

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Autism Spectrum Disorder: Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Autism Spectrum Disorder therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Autism Spectrum Disorder drugs.

Autism Spectrum Disorder Report Insights

• Autism Spectrum Disorder Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Autism Spectrum Disorder Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions:

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Autism Spectrum Disorder drugs?
• How many Autism Spectrum Disorder drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Autism Spectrum Disorder?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Autism Spectrum Disorder therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Autism Spectrum Disorder and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Astrogen
• MapLight Therapeutics
• Axial Therapeutics
• Aardvark Therapeutics
• Ajna BioSciences
• Intra-Cellular Therapies
• Finch Therapeutics Group
• PharmAla Biotech

Key Products

• AST-001
• ML004
• AB-2004
• ARD-501
• AJA001
• Lumateperone
• FIN211
• ALA-002