Otsuka Pharmaceutical
Phase III2 active candidates
shared compound: Psilocybinsame indication: Major Depressive Disorder (MDD)Phase III peer2 overlapping stages
Back to StakeholdersProgramme tracker View landscape
Lead program: Phase III
Categories
1 domain / 2 areas / 1 specialization
Helus PharmaNYSE: HELP
Also known as: Cybin, Cybin Inc.
Data updated
Toronto, ON, CanadaNew York, NY, United StatesLondon, United Kingdom
2 Drug Candidates
Helus Pharma is the commercial operating name of Cybin Inc., a clinical-stage biopharmaceutical company developing proprietary Novel Serotonergic Agonists (NSAs) — synthetic deuterated molecules designed to activate serotonin pathways and promote neuroplasticity. Operating across Canada, the US, UK, and Ireland, Helus holds over 100 granted patents and 250+ pending applications across its NSA portfolio.
Its lead asset, HLP003 (formerly CYB003, a deuterated psilocin analogue), has received FDA Breakthrough Therapy Designation for the adjunctive treatment of major depressive disorder and is in two concurrent Phase 3 trials: APPROACH™ (topline data Q4 2026) and EMBRACE™. A key differentiator is its adjunctive design — allowing patients to continue background antidepressant medications without washout.
HLP004 (a deuterated DMT analogue for intramuscular use) posted encouraging Phase 2 topline results in GAD in March 2026: 10.4-point HAM-A reduction at 6 weeks, 67% responders at 6 months, and an ~90-minute in-clinic session window. US composition-of-matter patent coverage through at least 2041.
Pipeline Intelligence
Developer Momentum
- Active candidates
- 2
- Active programmes
- 2
- Lead stage
- Phase III
- Forecast coverage
- 2 of 2
All tracked candidates active
All tracked programmes active
Multiple active stages
2 active programmes with forecast fields
Latest sourced update
NCT06793397 — APPROACH Phase 3 Study (HLP003 MDD)
Jun 26, 2026 - trial-registry - ClinicalTrials.gov - HLP003 (CYB003)
Next known catalyst
Phase III topline
Q4 2026 - HLP003 (CYB003) / PARADIGM — HLP003 Phase 3 (APPROACH + EMBRACE) - Confidence: 70%
11 sources0 pipeline-linked trials0 pipeline-linked papers1 Phase III1 Phase II
Development Programmes
2HLP003 (CYB003)
PsilocybinPhase III
Deuterated psilocin analogue (novel serotonergic agonist / NSA) for adjunctive treatment of MDD. Oral administration. Designed for a compressed 4–6 hour session vs standard psilocybin. Phase 2 (EMBARK, NCT05385783): −14.08-point placebo-adjusted MADRS at Week 3; 71% remission at 12 months after two 16 mg doses. FDA Breakthrough Therapy Designation (March 2024). Phase 3 PARADIGM programme: APPROACH (NCT06793397) and EMBRACE studies ongoing. Cybin rebranded to Helus Pharma, Nasdaq: HELP, January 2026.
Programme Tracker
Major Depressive Disorder (MDD)
Primary: US (FDA)
Phase IIIActive
Forecast
Phase III topline - Likely: Q4 2026 - Approval eventual: 55%
APPROACH Phase 3 enrollment has surpassed 86%, with dosing ongoing and topline results still expected in Q4 2026. EMBRACE and EXTEND remain part of the broader PARADIGM HLP003 registrational programme.
Milestones
Phase II completed
CompletedActual: Oct 3, 2023
EMBARK Phase 2 (NCT05385783) dosing complete; all 60+ patients dosed
Why it matters: Enabled subsequent BTD application and Phase 3 programme design
Watch next: Topline data and Breakthrough Therapy Designation
Phase III started
CompletedActual: Nov 13, 2024
PARADIGM Phase 3 programme initiated: APPROACH (NCT06793397) and EMBRACE pivotal studies launched across US, Europe, UK, and Australia
Why it matters: Pivotal programme that, if successful, will form the basis of an NDA for HLP003 in MDD — a multi-billion dollar indication
Watch next: Enrollment milestones, regulatory approvals per country, topline Q4 2026
Phase III topline
PlannedLikely: Q4 2026
APPROACH topline data expected Q4 2026 per company guidance
Why it matters: First pivotal data readout for HLP003; if positive, triggers NDA preparation
Watch next: EMBRACE topline to follow APPROACH
Regulatory review accepted
CompletedActual: Mar 13, 2024
FDA granted Breakthrough Therapy Designation to CYB003/HLP003 for adjunctive treatment of MDD — first BTD for an adjunctive psychedelic therapy for MDD
Why it matters: BTD provides more frequent FDA guidance, rolling review, and expedited development; strongly de-risks the regulatory pathway
Watch next: End-of-Phase 2 meeting with FDA and Phase 3 launch
Company milestone
CompletedActual: Jan 5, 2026
Cybin rebrands to Helus Pharma and commences trading on Nasdaq (ticker: HELP)
Why it matters: Corporate rebrand signals transition from clinical-stage to near-commercial; also reflects expanded pipeline focus
Watch next: Phase 3 topline results (APPROACH) expected Q4 2026
Recorded Events
Jan 5, 2026: Company milestone
Nov 13, 2024: Phase III started
Mar 13, 2024: Regulatory review accepted
Oct 3, 2023: Phase II completed
Evidence Links
NCT05385783 — EMBARK Phase 2 Study (CYB003 MDD)
trial-registry - ClinicalTrials.gov - Mar 25, 2024 - Verified
NCT06793397 — APPROACH Phase 3 Study (HLP003 MDD)
trial-registry - ClinicalTrials.gov - Jun 26, 2026 - Verified
Helus Pharma Development Pipeline
company-website - Helus Pharma - Aug 27, 2021 - Verified
HLP004 (CYB004)
DMTPhase II
HLP004 (CYB004) is an intramuscular deuterated DMT analogue / novel serotonergic agonist for generalized anxiety disorder as adjunctive treatment for patients who remain symptomatic despite standard-of-care therapy. Helus announced positive Phase 2 signal-detection topline results on 2026-03-05, including a 10.4-point HAM-A reduction at six weeks for the 20 mg arm and pooled six-month response/remission rates of 67%/39%.
Programme Tracker
Anxiety Disorders
Primary: US (FDA)
Phase IIActive
Forecast
Phase III planned - Likely: Q1 2027 - Approval eventual: 20%
Helus announced positive Phase 2 signal-detection topline results for HLP004 in GAD on 2026-03-05. The 20 mg adjunctive arm showed a 10.4-point mean HAM-A reduction at six weeks, with pooled six-month response/remission rates of 67%/39%. Next watch items are durability follow-up, a peer-reviewed publication, or Phase 3 guidance.
Milestones
Phase II started
CompletedActual: Mar 15, 2024
Phase 2 GAD study (NCT06051721) initiated; first patient dosed
Why it matters: First clinical trial of a deuterated DMT analogue in an anxiety indication
Watch next: Enrollment completion and topline data
Phase II topline
CompletedActual: Mar 5, 2026 - Likely: Q1 2026
Topline data expected Q1 2026 per company guidance
Why it matters: Proof-of-concept readout for deuterated DMT in GAD — could open a new indication pathway
Watch next: Press release with HAM-A score results at 6 weeks
Enrollment complete
CompletedActual: Sep 8, 2025
All 36 participants enrolled in Phase 2 GAD study
Why it matters: Enrollment completion unlocks topline data timeline of Q1 2026
Watch next: Topline data announcement
Recorded Events
Mar 5, 2026: Phase II topline
Sep 8, 2025: Enrollment complete
Mar 15, 2024: Phase II started
Evidence Links
NCT06051721 — CYB004/HLP004 Phase 2 GAD Study
Registry update - ClinicalTrials.gov - Oct 27, 2025 - Verified
ClinicalTrials.gov registry for CYB004/HLP004 GAD Phase 2; last update posted 2025-10-27, active not recruiting with estimated study completion in September 2026.
Similar Developers
Reference points selected from shared pipeline stage, indications, compounds, regulatory pathways, and evidence footprint.
Definium Therapeutics
Phase III3 active candidates9 trials4 papers
2 shared indicationsPhase III peer2 overlapping stagessame regulator: US FDA
Reunion Neuroscience
Phase III4 active candidates
shared compound: Psilocybinsame indication: Anxiety DisordersPhase III peer2 overlapping stages
Usona Institute
Phase III2 active candidates23 trials
shared compound: Psilocybinsame indication: Major Depressive Disorder (MDD)Phase III peersame regulator: US FDA
Quick Facts
- Type
- Public Biotech
- Founded
- 2019
- Ticker
- NYSE: HELP
- Lead Stage
- Phase III
- HQ
- Toronto, ON, Canada
- Website
- Visit