Developer · HELP · Canada
Helus Pharma
Cybin Inc. (operating under the brand Helus Pharma) is a clinical-stage neuropsychiatry company incorporated in Ontario, Canada, developing deuterated serotonergic compounds for psychiatric disorders. Its lead program, CYB003 (now branded HLP003; INN deupsilocin, a deuterated psilocin analog), is in Phase 3 development for the adjunctive treatment of major depressive disorder and holds FDA Breakthrough Therapy designation.
Pipeline (2)
- Major depressive disorderPhase 3Active
- Generalized anxiety disorderPhase 2Completed
Deals & partnerships
- CYB004 (deuterated DMT)Licensor Small Pharma Inc.
- Oct 23, 2023AcquisitionCybin completes acquisition of Small Pharma, consolidating the deuterated DMT (dDMT) programAll-share acquisition (plan of arrangement under the BCBCA; announced August 28, 2023; each Small Pharma share exchanged for 0.2409 Cybin common shares) in which Cybin Inc. (now Helus Pharma) acquired Small Pharma Inc., combining the two companies' deuterated DMT programs. CYB004 was Cybin's own pre-existing proprietary dDMT molecule for generalized anxiety disorder; the deal added Small Pharma's complementary SPL028 dDMT candidate, creating what the company described as the most advanced systematic dataset on short-duration DMT/dDMT molecules.
Catalysts · 1 upcoming · 2 reported
- Q4 2026Anticipated
CYB003 (deupsilocin)forMajor depressive disorderTopline data
Phase 3 APPROACH topline data expected in Q4 2026.
Recently reported
- 2024-11-18met
CYB003 (deupsilocin)forMajor depressive disorderFull results
Phase 2 12-month durability: 100% response, 71% remission, ~23-pt MADRS reduction after two 16 mg doses.
- 2023-11-30met
CYB003 (deupsilocin)forMajor depressive disorderTopline data
Phase 2 met primary: -14 MADRS vs placebo at 3 wk (single 12 mg dose; p<0.0005); 79% remission at 6 wk after two 12 mg doses.
Recent activity
- Jun 24, 2026Phase changeCYB003 (deupsilocin)·Major depressive disorderPhase 3Helus Pharma reaffirmed that Phase 3 APPROACH data for HLP003 (CYB003) in MDD is expected in Q4 2026 (disclosed in a US$50M financing announcement). APPROACH topline not yet reported as of 2026-06-25.source ↗
- Mar 31, 2026Phase changeCYB004 (deuterated DMT)·Generalized anxiety disorderPhase 2Positive Phase 2 topline (Q1 2026): ~10-point HAM-A reduction at 6 weeks; ~70% responders, ~40% remission at 6 months. Date approximate.source ↗
- Jan 5, 2026Phase changeCYB003 (deupsilocin)·Major depressive disorderPhase 3Corporate rebrand: Cybin Inc. began doing business as Helus Pharma and commenced trading on Nasdaq (ticker HELP; formerly CYBN on NYSE American); CYB003 referred to as HLP003. No change to development status: HLP003 remains in Phase 3 for MDD with Breakthrough Therapy Designation.source ↗
- Nov 18, 2024ReadoutCYB003 (deupsilocin)·Major depressive disordermetPhase 2 12-month durability: 100% response, 71% remission, ~23-pt MADRS reduction after two 16 mg doses.source ↗
- Nov 13, 2024Phase changeCYB003 (deupsilocin)·Major depressive disorderPhase 3Cybin initiated the Phase 3 PARADIGM pivotal program (APPROACH initiated; EMBRACE and EXTEND to follow); APPROACH to enroll 220 patients at 36 sites across the U.S. and Europe, topline expected in 2026.source ↗
- Mar 15, 2024Phase changeCYB004 (deuterated DMT)·Generalized anxiety disorderPhase 2Initiated Phase 2 proof-of-concept study in GAD (NCT06051721).source ↗
- Mar 13, 2024Phase changeCYB003 (deupsilocin)·Major depressive disorderPhase 2FDA granted Breakthrough Therapy Designation for CYB003 in MDD (first known BTD for an adjunctive psychedelic-based therapy for MDD); Cybin also reported positive four-month durability data (75% remission after two 16 mg doses; mean 22-point MADRS reduction).source ↗
- Jan 8, 2024Phase changeCYB004 (deuterated DMT)·Generalized anxiety disorderPhase 1Positive Phase 1 topline for deuterated DMT CYB004; FDA cleared the IND.source ↗
- Nov 30, 2023ReadoutCYB003 (deupsilocin)·Major depressive disordermetPhase 2 met primary: -14 MADRS vs placebo at 3 wk (single 12 mg dose; p<0.0005); 79% remission at 6 wk after two 12 mg doses.source ↗
- Oct 16, 2023Phase changeCYB003 (deupsilocin)·Major depressive disorderPhase 1/2Phase 1/2a study (NCT05385783, n=57, healthy participants and MDD) primary completion. The MDD efficacy cohort met the primary endpoint: mean -14 point MADRS difference vs placebo at 3 weeks after a single 12 mg dose (p<0.0005, Cohen's d 2.151); 79% remission at 6 weeks after two 12 mg doses.source ↗
Trials recruiting · 3 recruiting of 5 sponsored
- Phase 3CYB003 (deupsilocin)
EMBRACE: An Efficacy and Safety, Phase III, Multi-center, Double-Blind, Randomized Controlled Study Comparing 2 Active Doses of CYB003 and Placebo in Eligible Participants With Major Depressive Disorder
- Phase 3CYB003 (deupsilocin)
EXTEND: A Phase III Long-Term Extension Trial With Optional Additional Doses of CYB003 to Assess the Safety and Long-term Efficacy in Participants With Major Depressive Disorder
- Phase 3CYB003 (deupsilocin)
APPROACH: A Phase III, Placebo-Controlled, Randomized, Double-Blind Trial of Oral Doses of CYB003 to Assess Combined Safety and Efficacy in Humans With Major Depressive Disorder
Competitive landscape
Other companies developing against Helus Pharma's targets or indications.
- Definium Therapeutics, Inc.1 compound5-HT2AMajor depressive disorderGeneralized anxiety disorder
- Intra-Cellular Therapies, Inc.2 compounds5-HT2AMajor depressive disorderGeneralized anxiety disorder
- Beckley Psytech Limited1 compound5-HT2AMajor depressive disorder
- COMPASS Pathways plc1 compound5-HT2AMajor depressive disorder
- Delix Therapeutics, Inc.1 compound5-HT2AMajor depressive disorder
- Gilgamesh Pharmaceuticals, Inc.2 compounds5-HT2AMajor depressive disorder
- Mindset Pharma Inc.1 compound5-HT2AMajor depressive disorder
- Otsuka Pharmaceutical Co., Ltd.2 compoundsMajor depressive disorderGeneralized anxiety disorder
- Reunion Neuroscience Inc.1 compound5-HT2AGeneralized anxiety disorder
- Vanda Pharmaceuticals Inc.2 compounds5-HT2AMajor depressive disorder
- ACADIA Pharmaceuticals Inc.1 compound5-HT2A
- Alto Neuroscience, Inc.2 compoundsMajor depressive disorder
