Methylone's compressed entactogenic window is exactly where the therapeutic signal lives, and exactly where standard PRO tools are blindest. Videra Health is the AI observation platform that captures vocal, facial, linguistic, and somatic signal across the session and the weeks that follow.
See how we'd observe TSND-201IV methylone, a next-generation entactogen with a compressed session profile. The only Phase 3 entactogen besides MDMA in PTSD, with a distinct regulatory path post-Lykos.
TSND-201 is IV methylone, an entactogen pharmacologically related to MDMA but with a shorter, more compressed session profile. Peak effects hit within minutes of IV administration and the subjective experience resolves in approximately two hours, versus 6 to 8 hours for oral MDMA.
That compressed window is the commercial wedge: less therapist time, smaller scheduling burden, faster patient throughput. It is also where the therapeutic signal lives, and where standard PROs miss the most.
Phase 2 established efficacy and tolerability. Phase 3 is the proof point for a market that just watched Lykos receive a Complete Response Letter on MDMA-AT. The FDA wanted endpoint data Lykos did not have. Building observation into trial design is how that data gets generated.
Compressed session, controllable experience, distinct regulatory path. The evidence package is the differentiator.
From Phase 2 efficacy to Phase 3 initiation in the post-Lykos PTSD landscape.
The compressed methylone session creates four observation gaps that standard PROs cannot close.
Affect trajectory, somatic response, therapeutic alliance, vocal and linguistic patterns — all peak inside the session. CAPS-5 at Day 28 cannot reach back inside that window. Continuous multimodal observation can.
Functional unblinding evidence, therapist fidelity records, objective behavioral endpoints — these are exactly what Lykos did not deliver. TSND-201 has the advantage of designing for that bar from the start.
Durable label claims hinge on between-session functional data: PTSD symptom trajectories, sleep, daily functioning. Videra's behavioral health network captures that at scale.
As Phase 3 scales to more sites, facilitator variability becomes the largest hidden risk. Observable session records make that variance measurable.
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.
We bring the hardware, software, and AI to your site. Behavioral signal collected the same way at every visit, every site, every time.
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.
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.
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 TSND-201.
A clinical-grade camera and directional audio rig that drops into any TSND-201 site in minutes. Every clinician-participant interaction during the 2-hour entactogenic session captured with the same framing, angles, and fidelity. Videra's AI watches in real time, flagging protocol or therapist deviations.
Broad, continuous observation of the full room and the patient during the TSND-201 session. Videra algorithms run on captured video, voice, and movement signal — triggering alerts on abnormalities, acute findings, and protocol-defined events.
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.
Stream Videra carts from one or many rooms to a single central observation point, scaling oversight across TSND-201 sites — in clinic and at commercial launch.
Our ASSESS platform analyzes voice, video, and language continuously through the methylone session and the weeks that follow. It surfaces the affect shifts, somatic responses, and linguistic patterns PROs cannot capture, then tracks PTSD symptom durability between visits.
For TSND-201, that means a proprietary entactogen response signature — identifying likely responders early, predicting relapse risk, and underwriting both the FDA dossier and payer evidence post-launch.
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.
Consumer-friendly video assessment for perinatal & postpartum depression. Surfaces postpartum risk earlier than standard EPDS administration, and routes to care with rich signal.
Multimodal AI model trained on Phase 3 data, combining vocal, facial, and linguistic biomarkers within the session to predict PTSD symptom durability at 6, 12, and 26 weeks.
Co-developed with your team, the same way we built TDScreen and Check on Mom for our existing pharma partners.
Your priorities for TSND-201 and the post-Lykos PTSD landscape, 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 Transcend Therapeutics, that means real clinical depth and peer-reviewed validation.
We'd welcome a 30-minute session to walk Transcend's clinical team through a tailored, protocol-by-protocol proposal for TSND-201's Phase 3 program.