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Autistic Disorder Clinical Trial Pipeline Expands as 25+ Companies Driving Innovation in the Therapeutics | DelveInsight

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Autistic Disorder Clinical Trial Pipeline Expands as 25+ Companies Driving Innovation in the Therapeutics | DelveInsight

January 22
20:50 2026
Autistic Disorder Clinical Trial Pipeline Expands as 25+ Companies Driving Innovation in the Therapeutics | DelveInsight

DelveInsight’s “Autistic Disorder Pipeline Insight 2025” report provides comprehensive insights about 25+ companies and 25+ pipeline drugs in the Autistic Disorder pipeline landscape. It covers the Autistic Disorder pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Autistic Disorder pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Discover the latest drugs and treatment options in the Autistic Disorder Pipeline. Dive into DelveInsight’s comprehensive report today! @ https://www.delveinsight.com/sample-request/autistic-disorder-pipeline-insight

Key Takeaways from the Autistic Disorder Pipeline Report

  • On January 15, 2026- Universidad San Francisco de Quito announced a clinical trial is to determine the effects of Saccharomyces boulardii (Sb) consumption on Ecuadorian children with a diagnosis of autism spectrum disorder (ASD) and digestive symptoms. Saccharomyces boulardii is a probiotic, in other words, a beneficial microorganism. The main question it aims to answer is: Does Sb improve intestinal health, defenses against infections, nutrition and behavior of the participants. Researchers will compare children when they are taking and not taking Saccharomyces boulardii to know if there are changes in digestive symptoms, immune system function, nutritional status and behavior. Participants will take Saccharomyces boulardii for 4 months and will be 4 months without taking Sb. All participants must provide stool, urine and blood samples. A medical, nutritional and psychological team will follow the participants at least 5 times during the study.
  • On January 07, 2026- Children’s Hospital of Orange County initiated a study to evaluate the preliminary proof of concept, safety, and PK of suramin sodium (KZ101) with repeat dosing by IV infusion in males 5-14 years of age who have been diagnosed with ASD. The study will be conducted at approximately 3 sites contributing approximately 15 subjects per site. Total enrollment of approximately 45 subjects is planned to achieve approximately 36 participants completing the study.
  • DelveInsight’s Autistic Disorder pipeline report depicts a robust space with 25+ active players working to develop 25+ pipeline therapies for Autistic Disorder treatment.
  • The leading Autistic Disorder Companies such as AbbVie, Yamo Pharmaceuticals, Stalicla SA, Vanda Pharmaceuticals, Paxmedica, SciSparc, Scioto Biosciences, Inc., Hoffmann-La Roche, ACADIA Pharmaceuticals Inc., Neurotech International, Neuren Pharmaceuticals, MapLight Therapeutics, Jazz Pharmaceuticals, Axial Therapeutics Inc. and others.
  • Promising Autistic Disorder Pipeline Therapies such as Aripiprazole, Sapropterin, Kuvan®, Fluoxetine, Atomoxetine, Terpenes-Enriched CBD-Predominant Oil, L1-79, Midomafetamine HCl, Cannabidivarin and others.

Stay ahead with the most recent pipeline outlook for Autistic Disorder. Get insights into clinical trials, emerging therapies, and leading companies with DelveInsight @ Autistic Disorder Treatment Drugs

The Autistic Disorder Pipeline Report provides a disease overview, pipeline scenario, and therapeutic assessment of the key pipeline therapies in this domain. The Autistic Disorder Pipeline Report also highlights the unmet needs with respect to Autistic Disorder.

Autistic Disorder Overview

Autistic Disorder is a neurodevelopmental condition that falls under Autism Spectrum Disorder (ASD). It is characterized by challenges in social interaction, communication, and behavior, which typically appear in early childhood and persist throughout life. Individuals with autistic disorder often have difficulty understanding social cues, maintaining eye contact, and engaging in typical back-and-forth conversations. Language development may be delayed, and some individuals may have limited or no verbal communication, while others may speak fluently but struggle with social use of language.

Autistic Disorder Emerging Drugs Profile

  • Cariprazine: AbbVie

Cariprazine is an atypical antipsychotic. It is thought to be effective due to its partial agonist activity at the dopamine D2 receptor and serotonin 5HT1A receptor and its antagonism at the serotonin 5HT2A receptor. Additionally, Cariprazine has a high affinity for dopamine D3 receptors, acting as a partial agonist at D3 receptors. Cariprazine is primarily metabolized by CYP3A4 into Desmethyl Cariprazine (DCAR), and DCAR is then further metabolized by CYP3A4 into Didesmethyl Cariprazine (DDCAR). DCAR and DDCAR both display similar pharmacological potencies as Cariprazine. Currently, the drug is in the Phase III stage of its development for the treatment of Autistic Disorder.

  • L1-79: Yamo Pharmaceuticals

L1-79 is a novel therapy that targets the core symptoms of autism. Previous experience with open-label administration of L1-79 in patients with autism demonstrated that L1-79 is a well-tolerated oral treatment that has the potential to improve the core symptoms of autism. In a recently completed Phase II study, multiple independent efficacy measures assessed using commonly accepted and validated psychometric tests demonstrated positive trends supporting improvements in the target core symptom domains affected by autism, especially social domains, despite a short treatment period and small number of patients. This data supported the granting of a Fast Track Designation by the Food and Drug Administration (FDA) in May of 2018. Currently, the drug is in the Phase II stage of its development for the treatment of Autistic Disorder.

  • STP1: Stalicla SA

STP1 is a fixed dose combination of PDE4/3 inhibitor (ibudilast) and NKCC1 antagonist (bumetanide) shown to be a top drug match for a subgroup of patients with autism spectrum disorder (ASD) called phenotype 1. STP1 has completed phase 1b trials showing strong safety and tolerability, improvements in brain function for executive function and memory and improved autism severity scores. Currently, the drug is in Phase II stage of its development for the treatment of autistic disorder.

Explore groundbreaking therapies and clinical trials in the Autistic Disorder Pipeline. Access DelveInsight’s detailed report now! @ New Autistic Disorder Drugs

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 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

Autistic Disorder Companies

AbbVie, Yamo Pharmaceuticals, Stalicla SA, Vanda Pharmaceuticals, Paxmedica, SciSparc, Scioto Biosciences, Inc., Hoffmann-La Roche, ACADIA Pharmaceuticals Inc., Neurotech International, Neuren Pharmaceuticals, MapLight Therapeutics, Jazz Pharmaceuticals, Axial Therapeutics Inc. and others.

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 Products have been categorized under various Molecule types such as

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

Unveil the future of Autistic Disorder Treatment. Learn about new drugs, pipeline developments, and key companies with DelveInsight’s expert analysis @ Autistic Disorder Market Drivers and Barriers

Scope of the Autistic Disorder Pipeline Report

  • Coverage- Global
  • Autistic Disorder Companies- AbbVie, Yamo Pharmaceuticals, Stalicla SA, Vanda Pharmaceuticals, Paxmedica, SciSparc, Scioto Biosciences, Inc., Hoffmann-La Roche, ACADIA Pharmaceuticals Inc., Neurotech International, Neuren Pharmaceuticals, MapLight Therapeutics, Jazz Pharmaceuticals, Axial Therapeutics Inc. and others.
  • Autistic Disorder Pipeline Therapies- Aripiprazole, Sapropterin, Kuvan®, Fluoxetine, Atomoxetine, Terpenes-Enriched CBD-Predominant Oil, L1-79, Midomafetamine HCl, Cannabidivarin and others.
  • Autistic Disorder Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
  • Autistic Disorder Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Get the latest on Autistic Disorder Therapies and clinical trials. Download DelveInsight’s in-depth pipeline report today! @ Autistic Disorder Companies, Key Products, and Unmet Needs

Table of Contents

  1. Introduction
  2. Executive Summary
  3. Autistic Disorder: Overview
  4. Pipeline Therapeutics
  5. Therapeutics Assessment
  6. Autistic Disorder– DelveInsight’s Analytical Perspective
  7. Late Stage Products (Phase III)
  8. Cariprazine: AbbVie
  9. Mid Stage Products (Phase II)
  10. L1-79: Yamo Pharmaceuticals
  11. Early Stage Products (Phase I)
  12. STP1: Stalicla SA
  13. Preclinical and Discovery Stage Products
  14. Inactive Products
  15. Autistic Disorder Key Companies
  16. Autistic Disorder Key Products
  17. Autistic Disorder- Unmet Needs
  18. Autistic Disorder- Market Drivers and Barriers
  19. Autistic Disorder- Future Perspectives and Conclusion
  20. Autistic Disorder Analyst Views
  21. Autistic Disorder Key Companies
  22. Appendix

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