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-411Tactogen's next-generation entactogens, engineered to retain MDMA's therapeutic benefit while reducing cardiovascular load and serotonergic toxicity.
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 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.
Building entactogens engineered for the FDA path post-Lykos.
Phase 1 sets the endpoint baseline. Four observation choices made now define what you can prove at Phase 2.
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.
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.
Endpoints chosen at Phase 1 lock in the evidence package for everything that follows. Multimodal behavioral capture from FIH onward keeps options open.
Whether the comparison is in TACT's favor depends on whether the data is available to support it. Architecture starts now.
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.
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.
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.
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.
AI-powered tardive dyskinesia screening built on the AIMS standard. AUC 0.89 vs. trained raters, peer-reviewed in J Clin Psychiatry.
Conversational AI + video screener for postpartum depression. Used in real homes, on real devices, validated against clinical frameworks.
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.
Your trial design strategy from FIH forward, mapped to Videra capabilities in production.
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.
We'd welcome a 30-minute session to walk Tactogen through a tailored, protocol-by-protocol proposal for the next-gen entactogen platform.