Bretisilocin's short psychoactive window is a clinical breakthrough and an eCOA challenge. Videra Health is the AI measurement platform built to capture rapid-onset behavioral data at the speed your trials, sites, and reviewers demand.
See how we'd partner on bretisilocinA novel, short-acting serotonin 5-HT2A receptor agonist and 5-HT releaser. This next-generation tryptamine delivers the durable antidepressant effect of a psychedelic without the multi-hour session that has historically gated adoption.
Bretisilocin (5-fluoro-N-methyl-N-ethyltryptamine) is a substituted tryptamine from Gilgamesh: a potent, well-balanced 5-HT2A / 5-HT2C agonist with serotonin-releasing activity. Peak effects hit 10 to 20 minutes after IV administration. The experience resolves within 60 to 90 minutes.
That short duration is the asset's commercial superpower. It also makes traditional clinical endpoints, designed for hour-long sessions or weekly questionnaires, mismatched to the molecule's mechanism.
In a 40-patient Phase 2a MDD study, a single 10 mg IV dose drove a −21.6 point change in MADRS at Day 14 versus −12.1 for the low-dose comparator (p = 0.003). A repeated-dose 10 mg + 15 mg arm reached 94% remission at Day 29, with durability through Day 74. Effect size: ~1.0, roughly 3× conventional antidepressants.
Well tolerated. No serious adverse events. First psychedelic ever admitted to EMA's PRIME scheme (March 2026).
From the ASCP topline to the AbbVie acquisition to the EMA PRIME designation.
The compressed, in-and-out psychoactive experience that makes bretisilocin commercially viable creates four measurement gaps standard ePRO tooling cannot close.
Peak effects hit at 10 to 20 minutes. By the time a clinician administers a MADRS or HAM-D, the most informative behavioral signal (vocal, facial, linguistic) is already fading. You need continuous capture during the session, not after.
Phase 3 will run across dozens of sites with different facilitators, rooms, and "psychological support" styles. Without a verified, observable record, signal-vs-noise becomes a regulatory exposure and a payer talking point post-launch.
Whether bretisilocin earns adoption against Spravato, and whether payers fund it, will hinge on durable functional outcomes between visits. Videra's behavioral health network already captures that data at scale.
The story versus longer-duration psychedelics is the commercial wedge. Vocal, facial, and movement biomarkers can timestamp onset, peak, and resolution in a way self-report cannot.
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 bretisilocin.
A clinical-grade camera and directional audio rig that drops into any AbbVie trial site in minutes. It captures every researcher and participant interaction in the dosing room with the same framing, angles, and fidelity. Videra's AI watches in real time, flagging protocol deviations as they happen.
Our ASSESS platform analyzes voice, video, and language during and after each dosing session. It surfaces the rapid behavioral shifts bretisilocin produces in the first 90 minutes, then tracks durability over the weeks that follow. Built for digital endpoints, ePRO+, and real-world evidence.
We don't stop at data collection. We build condition-specific algorithms on real patient data, with peer-reviewed results. For bretisilocin, that means a proprietary "response signature" model that identifies responders earlier, predicts relapse risk, and underwrites both regulatory submissions and payer evidence.
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 trained on Phase 2/3 data, combining vocal, facial, and linguistic biomarkers to timestamp psychoactive onset and offset and predict durability of antidepressant effect.
Your priorities, mapped to capabilities Videra already has in production.
Videra's network isn't our customer base. It's the living dataset that powers every algorithm we build. For AbbVie, that means real clinical depth and peer-reviewed validation.
We'd welcome a 30-minute session to walk AbbVie's Neuroscience team through a tailored, protocol-by-protocol proposal for bretisilocin and the broader psychiatry pipeline.