Autism (ASD) Unified — Pipeline

The premise

The mechanism we're betting on.

Unified ASD + Seizure + Tourette protocol. Four convergent mechanisms: E/I imbalance, neuroinflammation, CSTC/basal-ganglia circuit, gut-brain / 5-HT. Blend TRI-01 lead candidate. Phase IIa N=30, 16-week protocol. The full mechanism map — including compound list, dose escalation, pre-specified biomarker thresholds, and the cross-walk modifiers used when re-fitting blends from related indications — is part of the gated methodology pack.Gated

RWE — real-world public landscape

What the rest of the world is doing.

Numbers below are surfaced by Atlas Bio's ClinicalTrials.gov and PubMed RWE pipelines, run against the Autism (ASD) Unified indication. Counts are industry-wide trials registered on ClinicalTrials.gov, not Atlas Bio studies. Methodology →

RWE refreshed 2026-05-12

Phase I (B1/B2)

114

trials

Phase II (B3)

200

trials

Phase III (B4)

trials

Phase IV (B5)

trials

Top public trials by enrollment

NCT03333629 · Promoting Positive Outcomes for Individuals With ASD: Linking Early Detection, Treatment, and Long-term Outcomes · Drexel University · n=2,087 · PHASE4 · COMPLETED

NCT01592786 · An Open-Label Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Othe · Forest Laboratories · n=906 · PHASE2 · COMPLETED

NCT01592773 · Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified · Forest Laboratories · n=747 · PHASE2 · TERMINATED

Recent published clinical evidence

Study protocol: a randomized controlled trial study on the effect of a game-based exercise training program on promoting physical fitness and mental health in c · PMID 29486750 · BMC psychiatry · 2018
Comprehensive Nutritional and Dietary Intervention for Autism Spectrum Disorder-A Randomized, Controlled 12-Month Trial. · PMID 29562612 · Nutrients · 2018
Efficacy of Motor Interventions on Functional Performance Among Preschool Children With Autism Spectrum Disorder: A Pilot Randomized Controlled Trial. · PMID 37992052 · The American journal of occupational therapy : official publ · 2023

Pre-registered predictions

Locked before readout.

Predictions for this study are SHA-256 locked before any readout. Pre-registration covers target engagement, primary endpoint, secondary endpoints, and the falsification criterion. The hash, prediction wording, and timestamp are available to verified clinicians and indication researchers on request.Gated

Methodology pillars used

Same stack, every indication.

M2 · Pre-Registration — SHA-256 locking before readout.
M1 · IBC Reasoning — 19-agent audit (11 core + 8 reasoning nodes).
M3 · Cross-Trial Validation — mechanism-anchored bridging across indications.
M4 · RWE Pipelines — ClinicalTrials.gov, PubMed, FDA, EDGAR feeds (the source of the numbers above).

Want the full Autism (ASD) Unified protocol?

The abstract above is open. Compound lists, dose escalations, SHA-256-locked prediction documents, agent-network reasoning chains, and trial design specifics are available to verified clinicians, indication researchers, and sponsors under MNDA. Contact management to begin the access request.

Contact management →