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Infantile autism — Treatment Landscape & Competitive Intelligence

Infantile autism (disease) competitive landscape: 4 marketed treatments tracked, 0 Phase 3 candidates, 0 Phase 2 candidates. Recent regulatory actions and upcoming PDUFA dates across the entire treatment set.

4 marketed 0 Phase 3 0 Phase 2 Live · 30-min refresh

Marketed treatment landscape

Approved drugs treating Infantile autism, deduplicated by molecule. See the full disease page for line-of-therapy detail.

DrugGenericSponsorClassTargetLine of therapyFirst approval
Abilify aripiprazole Generic (originally Otsuka/BMS) Third-generation antipsychotic (D2 partial agonist) 5-hydroxytryptamine receptor 1E, 5-hydroxytryptamine receptor 5A, 5-hydroxytryptamine receptor 6 2002-11-15
Risperdal risperidone Johnson & Johnson (Janssen) Atypical Antipsychotic [EPC] 5-hydroxytryptamine receptor 1E, 5-hydroxytryptamine receptor 5A, 5-hydroxytryptamine receptor 6 1993-12-29
Abilify Abilify Johnson & Johnson Pharmaceutical Research & Development, L.L.C. 5-hydroxytryptamine receptor 1E, 5-hydroxytryptamine receptor 5A, 5-hydroxytryptamine receptor 6
Risperdal Risperdal Ohio State University 5-hydroxytryptamine receptor 1E, 5-hydroxytryptamine receptor 5A, 5-hydroxytryptamine receptor 6

Phase 3 pipeline

No Phase 3 pipeline candidates tracked.

Phase 2 pipeline

No Phase 2 pipeline candidates tracked.

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this treatment set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this treatment set.

Sponsor landscape

  1. Generic (originally Otsuka/BMS) · 1 drug in Infantile autism
  2. Johnson & Johnson (Janssen) · 1 drug in Infantile autism
  3. Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · 1 drug in Infantile autism
  4. Ohio State University · 1 drug in Infantile autism

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Every new regulatory action, PDUFA date, or trial completion in Infantile autism:

Cite this brief

Drug Landscape (2026). Infantile autism — Treatment Landscape & Competitive Intelligence Brief. https://druglandscape.com/ci/disease/infantile-autism. Accessed 2026-06-10.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing