Psychedelic · CYB004
CYB004 (deuterated DMT)
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
- 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.
| Target | Action | Affinity |
|---|---|---|
| 5-HT2AprimaryHTR2A | Agonist | —ⓘ |
Formulations
| Formulation | Route | Regimen | Pharmacokinetics |
|---|---|---|---|
| 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 | Intravenous | Single dose | t½ 0.65 h |
Development timeline
- 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)
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).
Identifiers
Sources
- CYB004 — Wikipedia
- CYB004-002 (NCT06051721) — ClinicalTrials.gov
- Cybin Announces Positive Topline Data from Phase 1 Studies of Deuterated DMT Molecules CYB004 and SPL028 — Cybin Inc. (IR)
- Cybin Announces Positive Topline Data from Phase 1 Studies of Proprietary Deuterated DMT Molecules CYB004 and SPL028 — Cybin / Business Wire
- Cybin Initiates Phase 2 in GAD — Cybin / Business Wire
- HLP004 Phase 2 GAD results — Psychiatric Times