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NCT06051721 (HLP004 in Generalized Anxiety Disorder): BVCT ex-ante prediction vs. reported outcome

On 21 Apr 2025, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 5 Mar 2026 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

NCTID
NCT06051721
Drug Name
HLP004(CYB004)
Drug MoA
deuterated DMT
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Mental Disorders
Indication
Generalized Anxiety Disorder
Human Patients
36
Sponsor
Cybin Inc.
Phase
Phase 2

Prediction of , index 1989

Prospective Prediction
Prediction Index
1989
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit to SoC in HAM-A scale slightly superior to deuterated lumateperone + SoC yet moderately inferior to GH001 + SoC)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit to SoC in HAM-A scale compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
318 days in advance
Readout Data Interpretation
HLP004 20mg + SoC achieved 10.4-point placebo-adjusted HAM-A reduction at Week 6 (p<0.0001); generally well tolerated
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 2a, Randomized, Double-Blind, Active-Controlled Study to Assess the Preliminary Clinical Efficacy, Safety, Tolerability, and Pharmacokinetics, of CYB004 in Participants With Generalized Anxiety Disorder (GAD)
Phase
Phase 2
Status
Completed
Enrollment
36
Lead sponsor
Cybin IRL Limited
Conditions
Generalized Anxiety Disorder
Interventions
DRUG: CYB004; BEHAVIORAL: Psychotherapy
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2024-05-10
Primary completion
2025-10-14
Completion
2026-08-05
Primary outcomes
  • Hamilton Anxiety Rating Scale (HAM-A) (Screening (Day-63 and Day-1), Day 2, Day 8, Day 21, Day 23, Day 29, Day 43, Day 64, Day 85, Day 169, Day 266, and End of Treatment (Day 364))

NCT06051721 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials