CNS · v1: Treatment-Resistant Depression

The Brain's
Digital Twin.

Simulate CNS drug trials before a single patient is enrolled.
We start with the hardest problem in psychiatry.

API-first  ·  Explainable  ·  Benchmarked against published clinical data

Running structured discovery calls with early members — not just collecting emails.

$2.6B Average cost to bring a CNS drug to market
90% Clinical trials fail before Phase III
12 yrs Average CNS drug development timeline
30% Depression patients are treatment-resistant

From hypothesis to simulation in hours

Nyurolink compresses months of trial design into days by modeling the brain at a systems level.

01

Define Your Trial

Specify compound, cohort parameters, dosage, and endpoints. v1 covers SSRI/SNRI compounds against TRD cohorts — the most data-rich CNS starting point.

02

Run the Simulation

Our AI engine models pharmacokinetics, blood-brain barrier dynamics, and neuroplasticity across synthetic patient populations. Results in 4–12 minutes via async job.

03

Review Outcomes

Get efficacy distributions, adverse event rates, and attribution maps showing which brain regions drove each prediction — traceable, not just a number.

API-first platform
POST /v1/simulations GET /v1/results/{id} Python & R SDKs FHIR R4 native OpenAPI 3.1 docs

A complete simulation report — not a black box score

Every run returns a structured result set your team can act on, document, and reproduce.

escitalopram · 20mg · 12 weeks TRD cohort · n=500 · synthetic
Complete
Remission rate
41.2% CI [37.8, 44.6]
Response rate
58.4% CI [54.9, 61.8]
Nausea (adverse event)
12.1% CI [9.8, 14.4]
Top predictor Prefrontal cortex — 38% attribution
Sensitivity ±20% dose → ±6.2 pp Δ remission
Model version nyl-cns-v1.4.2 · immutable · reproducible
v1 Simulation Scope
Compounds
Escitalopram Sertraline Venlafaxine Duloxetine Fluoxetine Paroxetine
Condition
Treatment-Resistant Depression (TRD)
Endpoints
HDRS-17 MADRS Remission rate Response rate Adverse events
Cohort size 50 – 2,000 (synthetic)
Age range 18 – 75
Duration 4 – 24 weeks
Turnaround 4 – 12 min (async)
Custom compounds & conditions available in v2 — contact us for roadmap access.
Supports decisions at
Pre-IND go / no-go
Dose optimisation
Cohort stratification

Trust built on verifiable science

Pharma won't submit an IND based on a black box. Every Nyurolink output is traceable, benchmarked, and honest about what it doesn't know.

Open Data Foundations

Built on the Human Connectome Project and Allen Brain Atlas — publicly auditable, not proprietary. Any neuroscientist can inspect our starting point.

v1 PK/PD outputs benchmarked against published SSRI clinical trials. We show where the model fits and where it diverges — before you trust it with your compound.

Explainability-First

Every result includes brain-region attribution, sensitivity analysis at ±20% dosage, and confidence intervals on every outcome. No number without a traceable reason.

Regulatory teams can follow every prediction back through the model — designed with pre-IND documentation workflows in mind.

HIPAA + FHIR Compliant

Synthetic cohorts only — no real patient data, ever. FHIR R4 native. FDA 21 CFR Part 11 audit trail. Immutable model versioning for regulatory reproducibility.

Real data may inform model training offline under explicit HIPAA BAA — but your API calls are clean by design.

Regulatory consultant engaged (FDA SaMD framework)
Scientific Advisory Board — neuroscience + clinical pharmacology
Immutable model versioning — every simulation reproducible years later
FDA 21 CFR Part 11 audit trail on all trial records
Pharmaceutical & Biotech

De-risk before Phase I

90-day structured pilots — one compound, one cohort, one measurable outcome. No long procurement cycles. You'll know if it works before committing to an annual license.

Pilot from $15K  ·  Annual license custom  ·  HIPAA BAA included
Express Interest
Researchers & Clinical Teams

Validate computationally

Free sandbox access — 10 simulations per month, full API access, no credit card required. Institutional plans for hospitals and academic research groups.

Free sandbox  ·  Institutional plans available  ·  HIPAA BAA included
Join the Waitlist
Early Access Waitlist

Join the first cohort

We're onboarding early users in small groups and running discovery calls — not just collecting emails. Tell us what you're working on.