TACTOGEN in partnership with
A trial observation brief for Tactogen

Next-gen entactogens need observation built into FIH, not bolted on at Phase 2.

Preclinical to Phase 1 is where trial design choices compound. Videra Health is the AI observation platform that lets you build the differentiation story from FIH onward — the multimodal signal that defines what TACT-411 looks like alongside MDMA.

See how we'd observe TACT-411

The Asset

TACT-411 / TACT-833

Tactogen's next-generation entactogens, engineered to retain MDMA's therapeutic benefit while reducing cardiovascular load and serotonergic toxicity.

IndicationPTSD, depression, and related
PhasePreclinical / Phase 1
ClassEngineered entactogens
DifferentiatorReduced CV + serotonergic load vs MDMA
SettingDesigned for in-clinic protocol
Stage advantageEndpoint stack architected from FIH
Why we're paying attention

Preclinical-to-Phase-1 is where endpoint choices compound.

Engineering past MDMA

Tactogen's next-generation entactogens are engineered to retain MDMA's therapeutic benefit while reducing the cardiovascular and serotonergic toxicity that have constrained the parent compound's clinical use.

Whether that translates to a better drug, a better trial, and a better label depends on what you can measure — and when you start measuring it.

The FIH-onward advantage

The endpoint stack architected at FIH defines what you can claim at Phase 2, what TACT-411 looks like alongside MDMA, and what evidence becomes available for the differentiation story. Continuous multimodal behavioral capture, built into FIH and dose-finding, gives you a head start on the comparison every entactogen will face.

The comparison case lives in the data. The data lives in the protocol.

FIH
Stage where endpoint architecture compounds most
vs MDMA
Differentiation case built into observation
2 assets
TACT-411 + TACT-833 in parallel development
In the News

We've tracked Tactogen since the company's founding.

Building entactogens engineered for the FDA path post-Lykos.

The observation problem

Build the comparison data, or retrofit it later.

Phase 1 sets the endpoint baseline. Four observation choices made now define what you can prove at Phase 2.

Gap 1: Differentiation Baseline

You can only claim what you measured.

Without multimodal observation in FIH, the "reduced cardiovascular load" and "reduced serotonergic toxicity" claims become assertions, not findings. Behavioral baseline data taken from FIH onward makes the differentiation story measurable.

Gap 2: Therapeutic Window Mapping

Where MDMA ends and TACT begins is a session-level question.

Vocal, facial, and somatic signal across the session can map dose-response, peak effects, and integration in a way that PRO scales designed for chronic depression cannot.

Gap 3: Endpoint Lock-In

Phase 2 builds on what Phase 1 measured.

Endpoints chosen at Phase 1 lock in the evidence package for everything that follows. Multimodal behavioral capture from FIH onward keeps options open.

Gap 4: Comparison Architecture

Every next-gen entactogen will be compared to MDMA.

Whether the comparison is in TACT's favor depends on whether the data is available to support it. Architecture starts now.

How we partner

Capture, Analyze, Co-Develop — pick the entry point.

Bring us a question and we'll capture the data. Bring us your data and we'll run it through our models. Or start from a hypothesis and we'll co-develop a novel endpoint with you, end-to-end.

Capture

Trial or study data capture

We bring the hardware, software, and AI to your site. Behavioral signal collected the same way at every visit, every site, every time.

Analyze

Behavioral insight & analytics

Bring us your existing video, voice, or trial data. Our multimodal models surface vocal, facial, and linguistic biomarkers you couldn't see in PRO data alone.

Co-Develop

Digital models & endpoints

Start from a clinical hypothesis. We build the digital endpoint, the screener, or the response model end-to-end — from study design through peer review.

Three ways Videra observes TACT-411

Purpose-built for FIH-onward entactogen development.

Our platform pairs in-clinic AI hardware with multimodal behavioral analytics and a custom algorithm engine, already proven in TDScreen and Check on Mom. Here's how each maps to TACT-411.

01 · Ambient Monitoring

An AI-powered video cart that captures FIH sessions consistently.

A clinical-grade camera and directional audio rig that drops into any TACT trial site from FIH onward. Every healthy-volunteer or patient session captured at the same fidelity. The behavioral baseline that lets Phase 2 build a differentiation story.

  • Verifies dosing protocol adherence and consistent administration across sites
  • Standardizes facilitator language and post-dose check-ins
  • Generates a defensible session record for regulators, monitors, and post-hoc review
  • HIPAA-compliant, end-to-end encrypted; data never leaves the secure pipeline
See it in action. Videra Monitoring Stand reference →
PRODUCT 01 ROOMVIEW

Ambient room & patient observation

Broad, continuous observation of the full room and the patient during the TACT-411 session. Videra algorithms run on captured video, voice, and movement signal — triggering alerts on abnormalities, acute findings, and protocol-defined events.

  • Cart built for full-room and patient capture
  • AI analysis on the captured signal
  • Real-time alerts on acute findings
PRODUCT 02 FIDELITYVIEW

High-fidelity encounter monitoring

Multi-view cameras and high-fidelity audio focused on close-contact patient–provider interactions. Purpose-built to monitor protocol adherence remotely and protect the fidelity of the trial.

  • Cart built for close-contact capture
  • Multi-view cameras + hi-fi audio
  • Remote protocol-adherence monitoring
PRODUCT 03 LIVEVIEW

Centralized live oversight

Stream Videra carts from one or many rooms to a single central observation point, scaling oversight across TACT-411 sites — in clinic and at commercial launch.

VoiceVitals · Live capture● Recording
00:00T+18 min00:60
Vocal affect tone↑ 32% vs. baseline
Speech rate variabilityNormalized at T+45
Facial expressivity (FACS)Peak T+22 min
Linguistic sentiment+1.8σ shift sustained
02 · Multimodal AI Endpoints

ASSESS turns FIH and dose-finding sessions into longitudinal data.

Multimodal analysis of voice, video, and language from FIH onward. The behavioral characterization that defines what TACT-411 and TACT-833 look like in humans, in the data, not just in the deck.

  • Objectively capture onset, peak, and resolution of the psychoactive window
  • Augment MADRS and HAM-D with continuous, between-visit behavioral data
  • Built on 1M+ patient interactions across 300+ behavioral health facilities
  • Designed for 21 CFR Part 11, HIPAA, and SOC 2 Type II environments
Proof point: Check on Mom. Live AI video screener for postpartum depression →
03 · Custom Algorithms

Custom biomarkers for entactogen differentiation.

For TACT, that means a proprietary entactogen comparison framework — measuring TACT-411 and TACT-833 against MDMA across vocal, facial, and somatic signal in directly comparable conditions.

  • Establish behavioral baselines for TACT-411 and TACT-833 from FIH onward
  • Stratify likely responders vs. non-responders earlier in treatment
  • Feed regulatory submissions, label expansion, and payer dossiers
  • Live algorithms today: TDScreen (AUC 0.89, J Clin Psychiatry) and Check on Mom
Proof point: TDScreen. AI that outperforms trained clinician raters, in production →
LIVE · IN MARKET

TDScreen

AI-powered tardive dyskinesia screening built on the AIMS standard. A short, video-based assessment that quantifies involuntary movements, reducing reliance on subjective rating. AUC 0.89 vs. trained raters, peer-reviewed in J Clin Psychiatry.

  • Early & objective detection
  • Scalable, remote, device-agnostic
  • Geographic, demographic, prevalence RWE
  • Supports post-market & HEOR strategies

tdscreen.ai →

LIVE · IN MARKET

Check on Mom

Consumer-friendly video assessment for perinatal & postpartum depression. Surfaces postpartum risk earlier than standard EPDS administration, and routes to care with rich signal.

  • Multi-touch perinatal monitoring
  • Routes to provider with rich signal
  • Built for advocacy + commercial channels
  • Pharma-sponsored deployment model

checkonmom.ai →

PROPOSED · TACT-411

A "TACT Entactogen Comparison Framework"

Multimodal AI model built from FIH onward, capturing the behavioral baselines that define TACT-411 and TACT-833 against MDMA and informing trial design from Phase 2 forward.

Co-developed with your team, the same way we built TDScreen and Check on Mom for our existing pharma partners.

Strategic Alignment

Where Tactogen is headed, and how Videra fits.

Your trial design strategy from FIH forward, mapped to Videra capabilities in production.

Tactogen's Priority
How Videra Accelerates
Architect endpoint stack from FIH onward
ePRO+ with VoiceVitals provides multimodal behavioral baseline from FIH onward
Capture session-level differentiation vs MDMA
ASSESS multimodal analysis maps dose-response and session phases
Build evidence for "reduced CV load" claims
Behavioral biomarkers capture physiological proxies during the session
Set up Phase 2 with locked-in endpoints
Continuous capture from FIH onward provides the longitudinal data Phase 2 needs
Position TACT for the post-Lykos regulatory bar
EngageEntry for eventual screening, SignalSort for response monitoring, InsightTranscribe for KOL prep
Built on real-world data

Not a pitch. A platform.

Videra's network isn't our customer base. It's the living dataset that powers every algorithm we build. For Tactogen, that means real clinical depth and peer-reviewed validation.

300+
Behavioral health facilities
1M+
Patient interactions analyzed
0.89
AUC for TDScreen (J Clin Psychiatry, 2025)
94%
Patient program completion rate
HIPAA Compliant SOC 2 Type II 21 CFR Part 11 ready End-to-End Encrypted

Let's explore what this could look like for TACT-411 and TACT-833.

We'd welcome a 30-minute session to walk Tactogen through a tailored, protocol-by-protocol proposal for the next-gen entactogen platform.

Your Videra contact
Ryan Roberts
Videra Health
ryan@viderahealth.com viderahealth.com →