CYB004 · program

CYB004 (deuterated DMT) for Generalized anxiety disorder

Phase 2CompletedHelus Pharma (HELP)

CYB004 (now HLP004) for generalized anxiety disorder. Phase 2a signal-detection study (CYB004-002 / NCT06051721): two IM doses 3 weeks apart, HAM-A primary endpoint. Positive topline reported Q1 2026 (~10-point HAM-A reduction at 6 weeks; ~70% responders, ~40% remission at 6 months).

Data current as of

Development timeline

Phase 2Mar 2024 – Mar 2026
  1. Positive Phase 2 topline (Q1 2026): ~10-point HAM-A reduction at 6 weeks; ~70% responders, ~40% remission at 6 months. Date approximate.↗
  2. Initiated Phase 2 proof-of-concept study in GAD (NCT06051721).↗
Phase 1Jan 2024
  1. Positive Phase 1 topline for deuterated DMT CYB004; FDA cleared the IND.↗

Clinical trials in Generalized anxiety disorder

NCT06051721CYB004-002Phase 2Completedn=36

A Study of a DMT Analog (CYB004) in Participants With Generalized Anxiety Disorder (GAD)

Started May 2024· Primary completion Oct 2025· 📍 6 sites across 1 country (United States)

metprimaryHAM-A change at 6 weeks — ~10-point reduction

Both active doses showed a statistically significant ~10-point HAM-A reduction at 6 weeks (press-release level; no registry results posting).

Formulations

FormulationRouteRegimenPharmacokinetics
CYB004 inhalation
Inhaled presentation under evaluation to extend the therapeutic window (preclinically ~300% longer duration of effect vs. IV DMT); route selection between IV and inhalation ongoing
Inhaled——
CYB004 intravenous
IV bolus ± infusion; doses studied in the 2–30 mg range (Phase 1); rapid onset (robust psychedelic effects within ~2 min, peak ~13 min) and duration of action ~40 min
IntravenousSingle doset½ 0.65 h

Mechanism of action (compound-wide)

A deuterated DMT isotopologue acting as a potent 5-HT2A agonist; deuteration slows metabolism without changing the primary pharmacodynamic profile. No compound-specific affinities disclosed.

TargetActionAffinity
5-HT2AprimaryHTR2AAgonist—ⓘ

← Full CYB004 compound page (identity, identifiers, all indications)

Sources

  1. CYB004 — Wikipedia
  2. CYB004-002 (NCT06051721) — ClinicalTrials.gov
  3. Cybin Announces Positive Topline Data from Phase 1 Studies of Deuterated DMT Molecules CYB004 and SPL028 — Cybin Inc. (IR)
  4. Cybin Announces Positive Topline Data from Phase 1 Studies of Proprietary Deuterated DMT Molecules CYB004 and SPL028 — Cybin / Business Wire
  5. Cybin Initiates Phase 2 in GAD — Cybin / Business Wire
  6. HLP004 Phase 2 GAD results — Psychiatric Times