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Disease

Autism Spectrum Disorder

Late-stage therapeutic developmentActively researchedSteady momentum
88
Publications
22
Clinical trials
12
Related conditions
7
Related proteins
2025
Latest publication
Current focus
Membrane biologyNerve tissue biologyTherapeutic developmentGenetics & risk factorsInflammation & immunityMetabolic & lifestyle factors
Latest activity
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Recent clinical, regulatory, research and industry developments relating to this disease.

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Clinical Milestones10View all 10
+2 more in the activity timeline below
Industry & Market1View
Activity timeline11

Therapeutic landscape

Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.

Approved & established therapies
Melatoninapproved

Approval — Slenyto is indicated for: treatment of insomnia in children and adolescents aged 2-18 ye… (2018)

Clinical trials

15 sponsors · 2 new · 3 completed in the last 12 months (net +1)

The current development programme across all trial phases.

Clinical programme
22
All trials
6
Active
18
Late-stage
6
Completed
Late-stage studies
Recruiting
Recently completed

Regulatory timeline

Drug regulatory events matched to this condition by indication — EMA.

First approvals
2018emaApprovalMelatonin· Slenyto is indicated for: treatment of insomnia in children and adolescents aged 2-18 years with Autism Spectrum Disorder (ASD), and / or neurogenetic disorders with aberrant diurnal melatonin secretion and /or nocturnal awakenings, where sleep hygiene measures have been insufficient. treatment of insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient. source ↗

European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.

Research activity

88 papers

Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.

Publications over time
20162025
Most influential
Recent publications
Major themes8
  • Autism Spectrum Disorder65
  • Attention Deficit Disorder with Hyperactivity11
  • Gastrointestinal Microbiome11
  • Mental Disorders11
  • Autistic Disorder10
  • Major Depressive Disorder7
  • Bipolar Disorder6
  • Neurodevelopmental Disorders6
Leading journals6
  • Molecular psychiatry9
  • International journal of molecular sciences8
  • Morbidity and mortality weekly report. Surveillance summaries (Washington, D.C. : 2002)6
  • Translational psychiatry6
  • Molecular autism5
  • BMC medicine3
Leading researchers8
  • Durkin MS7
  • Fitzgerald RT6
  • Pettygrove S6
  • Zahorodny W6
  • Hall-Lande J5
  • Lopez M5
  • Maenner MJ5
  • Shenouda J5
Affiliations (unnormalised)6
  • School of Medicine5
  • Donders Institute for Brain4
  • Imaging Genetics Center4
  • Institute of Psychiatry4
  • Karolinska Institutet4
  • National Institute of Mental Health4

Disease biology

7 matches

Key proteins & gene products studied in this disease. Number shows shared papers.

Related conditions

12 matches

Diseases frequently studied alongside this one. Number shows shared papers.

Disease profile

A grounded synthesis of the condition — overview, causes, mechanism, risk factors and current standard of care.

Overview

Autism spectrum disorder is a wide continuum of cognitive and neurobehavioral conditions defined by core impairments in socialization, verbal and nonverbal communication, and restricted, repetitive patterns of behavior. The literature grounding also treats it as a neurodevelopmental disorder with substantial genetic and biological heterogeneity.

Causes

The supplied grounding supports a genetic contribution, including associations from genome-wide studies and single-nucleotide polymorphism analyses. It also supports investigation of microbiome-related and brain-gut axis factors, but does not establish a single cause.

Pathophysiology

The literature grounding points to altered neuronal plasticity, signal transduction, transcriptome and gene regulatory network changes, and involvement of proteins such as trkB, cytokines, tumor necrosis factor-alpha, interleukin-4, and membrane proteins. It also supports a role for gut microbiota and microbiota-derived metabolites in bidirectional brain-gut communication, with immunological, neuronal, and endocrine pathways implicated.

Risk factors

The supplied grounding supports biological sex, sociodemographic status, ethnicity/race, and nativity as factors examined in relation to prevalence variation, but not as established causal risk factors. It also includes genetic variation and microbiome-related factors as areas of study, without defining them as confirmed risks.

Current standard of care

The grounding supports therapy and drug therapy as literature topics, but it does not provide specific treatment standards or modalities for autism spectrum disorder. No supported standard-of-care treatment category can be stated from the supplied material alone.

AI-generated summary grounded in MeSH and 6 peer-reviewed sources. Informational only — not medical advice. Generated 2026-07-07.

Reference

Authoritative identity, definition & identifiers.

Defined in MeSH

Wide continuum of associated cognitive and neurobehavioral disorders, including, but not limited to, three core-defining features: impairments in socialization, impairments in verbal and nonverbal communication, and restricted and repetitive patterns of behaviors. (from DSM-V)

References & data sources
  • Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
  • Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
  • Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
  • Related entities are derived from literature co-mention (studied together) — associative, not causal.