Psychedelic · CYB004

CYB004 (deuterated DMT)

Phase 2Helus Pharma (HELP)

A proprietary deuterated N,N-dimethyltryptamine (dDMT) given intramuscularly; deuteration extends half-life for a short (~90 min) scalable psychedelic experience. Renamed HLP004 after the developer's Jan 2026 rebrand (Cybin → Helus Pharma). Lead indication is generalized anxiety disorder. (MDD is pursued via the separate compound CYB003/HLP003 — not this asset.)

Also known as: CYB004, HLP004, deuterated DMT

Data current as of

Key facts

Modality
Psychedelic
Chemical class
tryptamine
DEA schedule
Schedule I
Chemistry
Achiral · Deuterated
Mechanism
5-HT2A agonist
Highest phase
Phase 2
Lead indication
Generalized anxiety disorder
Developer
Helus Pharma (HELP)
Trials
1 tracked · 6 sites

Mechanism of action#

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—ⓘ

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

Development timeline#

Jan 24Jul 24Jan 25Jul 25Jan 26Jul 26TodayPhase 231 Mar 2026 — phase change — Positive Phase 2 topline (Q1 2026): ~10-point HAM-A reduction at 6 weeks; ~70% responders, ~40% remission at 6 months. Date approximate.15 Mar 2024 — phase change — Initiated Phase 2 proof-of-concept study in GAD (NCT06051721).23 Oct 2023 — Acquisition — Cybin completes acquisition of Small Pharma, consolidating the deuterated DMT (dDMT) programPhase 18 Jan 2024 — phase change — Positive Phase 1 topline for deuterated DMT CYB004; FDA cleared the IND.
Phase change Readout Event UpcomingHover a marker for details.
Phase 2Oct 2023 – 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).↗
  3. AcquisitionCybin completes acquisition of Small Pharma, consolidating the deuterated DMT (dDMT) program↗
Phase 1Jan 2024
  1. Positive Phase 1 topline for deuterated DMT CYB004; FDA cleared the IND.↗

CYB004 (deuterated DMT) for Generalized anxiety disorder#

Phase 2CompletedGeneralized anxiety disorder indication →

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).

Clinical trials#

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).

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 Completes Acquisition of Small Pharma Inc. to Create International Clinical-stage Leader in Novel Psychedelic Therapeutics — BioSpace / Business Wire
  6. Cybin Initiates Phase 2 in GAD — Cybin / Business Wire
  7. HLP004 Phase 2 GAD results — Psychiatric Times