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Helus Pharma, also known formerly as Cybin IRL, is a Canadian pharmaceutical company that was led by CEO Doug Drysdale from 2020-2025, developing psychedelic drugs as medicines.[1][2][3]

The company’s drug candidates include psilocybin (HLP001; CYB001),[4] HLP002 (CYB002; discontinued),[5] HLP003 (CYB003; deuterated psilocin),[6][7][8][9] HLP004 (CYB004; deuterated dimethyltryptamine (DMT)),[10] HLP005 (CYB005; deuterated phenethylamine derivative),[11][12][13] and HLP006 (CYB006).[14][15] Another drug that the company has developed is CYB210010 (2C-T-TFM).[16][17][18]

As of January 2025, HLP003 is in phase 3 clinical trials.[6][7] The drug is one of the only other psychedelics besides Compass Pathways‘s COMP360 (psilocybin) to have reached this late stage of clinical development.[19][20]

In 2020, Helus Pharma acquired psychedelic pharmaceutical company Adelia Therapeutics.[21] In late 2023, it acquired Small Pharma, the developer of SPL026 (DMT) and SPL028 (D2-DMT).[22] Helus Pharma was originally known as Cybin but changed its name in December 2025.[23]

Clinical programs

HLP003

Main article: HLP003

HLP003 is a deuterated oral formulation of psilocin, the active metabolite of psilocybin. Unlike psilocybin, HLP003 bypasses the first metabolic step (dephosphorylation), which the company reports results in higher drug delivery efficiency, with studies showing approximately 2x higher Cmax and 3.5x greater AUC compared to equivalent doses of psilocybin.[24] The drug has a reported duration of acute subjective effects of approximately 4–6 hours, with onset within 15 minutes of dosing.[24]

HLP003 has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration for the adjunctive treatment of major depressive disorder (MDD).[24] As of early 2026, it is in Phase 3 clinical trials as part of the PARADIGM program, which comprises three studies: APPROACH (a two-arm study of two 16 mg doses vs. placebo, n=220), EMBRACE (a three-arm study comparing two dose levels and placebo, n=330), and EXTEND (a long-term extension study to assess durability and redosing). The multinational program includes more than 100 sites across the United States, Europe and Australia. Topline efficacy data from the APPROACH study is anticipated in Q4 2026.[24]

In Phase 2 trials, two doses of HLP003 16 mg resulted in 100% of patients being classified as responders and 71% achieving remission at 12 months, with a mean approximately 23-point reduction in Montgomery–Åsberg Depression Rating Scale (MADRS) scores from baseline. All reported adverse events were mild to moderate, with no adverse events of suicidality and no serious adverse events reported during the 12-month follow-up.[24]

HLP004

Main article: HLP004

HLP004 is a deuterated dimethyltryptamine (DMT) formulation administered intramuscularly, being developed for the treatment of generalized anxiety disorder (GAD). Deuteration extends the duration of DMT’s effects relative to intravenous DMT, while intramuscular administration allows for patient discharge readiness within approximately 3 hours.[24]

In Q1 2026, Helus reported positive Phase 2 topline data from a signal-detection study of HLP004 as an adjunctive treatment for moderate-to-severe GAD. Both active dose levels (2 mg and 20 mg) demonstrated a statistically significant approximately 10-point reduction in Hamilton Anxiety Rating Scale (HAM-A) scores from baseline at 6 weeks (p<0.0001), with effects seen as early as Day 2 and sustained through at least 6 months. Approximately 70% of patients were responders and approximately 40% achieved remission at 6 months following a single treatment cycle of two doses. All adverse events were mild to moderate, and no drug-related serious adverse events or suicidality signals were recorded.[24]

Leadership

Executive team

As of early 2026, Helus Pharma is led by Chief Executive Officer Michael Cola and Executive Chairman and Co-Founder Eric So. Other members of the senior leadership team include Chief Medical Officer Amir Inamdar (MBBS, DNB(Psych), FFPM), Chief Scientific Officer Alex Nivorozhkin (Ph.D.), Chief Operating Officer Aaron Bartlone, Chief Business Officer George Tziras, and Co-Founder and Chief Growth Officer Paul Glavine.[24] The company was previously led by CEO Doug Drysdale from 2020 to 2025.

Scientific advisory board

The company’s scientific advisory board includes Robert Langer, Institute Professor at the Massachusetts Institute of Technology and co-founder of Moderna; Maurizio Fava, Chair of the Department of Psychiatry at Mass General Brigham and Massachusetts General Hospital; Thomas Laughren, former Director of the FDA‘s Division of Psychiatry Products; Freda Lewis-Hall, former Chief Medical Officer and Chief Patient Officer of Pfizer; Steve Brannan, former Chief Medical Officer of Karuna Therapeutics; and Andrew J. Cutler, a psychiatrist and principal investigator with experience across more than 400 clinical trials.[24]

See also

References

  1. ^ Lowe H, Toyang N, Steele B, Valentine H, Grant J, Ali A, et al. (May 2021). “The Therapeutic Potential of Psilocybin”. Molecules. 26 (10): 2948. doi:10.3390/molecules26102948. PMC 8156539. PMID 34063505.
  2. ^ Aday JS, Barnett BS, Grossman D, Murnane KS, Nichols CD, Hendricks PS (September 2023). “Psychedelic Commercialization: A Wide-Spanning Overview of the Emerging Psychedelic Industry”. Psychedelic Medicine. 1 (3): 150–165. doi:10.1089/psymed.2023.0013. PMC 11661494. PMID 40046566. Cybin is currently launching a pilot study of a psilocybin analogue that may produce psychoactive effects for only 4 hours.
  3. ^ Rhee TG, Davoudian PA, Sanacora G, Wilkinson ST (December 2023). “Psychedelic renaissance: Revitalized potential therapies for psychiatric disorders”. Drug Discovery Today. 28 (12) 103818. doi:10.1016/j.drudis.2023.103818. PMID 37925136.
  4. ^ “Psilocybin – Cybin – AdisInsight”. adisinsight.springer.com.
  5. ^ “Delving into the Latest Updates on CYB-002 with Synapse”. Synapse. 23 January 2025. Retrieved 31 January 2025.
  6. ^ a b “CYB 003 – AdisInsight”. adisinsight.springer.com.
  7. ^ a b “Delving into the Latest Updates on CYB-003 with Synapse”. synapse.patsnap.com.
  8. ^ Palfreyman M, Krakowsky J, Morgan M, Canal C, Pathare P, Avery K, et al. (December 2022). “ACNP 61st Annual Meeting: Poster Abstracts P271-P540”. Neuropsychopharmacology. 47 (Suppl 1): 220–370. doi:10.1038/s41386-022-01485-0. PMC 9714399. PMID 36456694.
  9. ^ Inamdar A, Morgan M, Krakowsky J, Reichelt A, Canal C, Mueller T, et al. (December 2022). “ACNP 61st Annual Meeting: Poster Abstracts P271-P540”. Neuropsychopharmacology. 47 (Suppl 1): 220–370. doi:10.1038/s41386-022-01485-0. PMC 9714399. PMID 36456694.
  10. ^ “CYB 004 – AdisInsight”. adisinsight.springer.com.
  11. ^ “CYB 005 – AdisInsight”. adisinsight.springer.com.
  12. ^ “Delving into the Latest Updates on CYB-005 with Synapse”. synapse.patsnap.com.
  13. ^ “| BioWorld”. www.bioworld.com.
  14. ^ Alpha P (29 June 2021). “Cybin Announces Positive Pre-Clinical Results With Multiple Proprietary Psychedelic Molecules and Adelia Milestone Achievement”. Psychedelic Alpha. Retrieved 31 January 2025.
  15. ^ “Development Pipeline”. Cybin.
  16. ^ Varty GB, Canal CE, Mueller TA, Hartsel JA, Tyagi R, Avery K, et al. (April 2024). “Synthesis and Structure-Activity Relationships of 2,5-Dimethoxy-4-Substituted Phenethylamines and the Discovery of CYB210010: A Potent, Orally Bioavailable and Long-Acting Serotonin 5-HT2 Receptor Agonist”. Journal of Medicinal Chemistry. 67 (8): 6144–6188. doi:10.1021/acs.jmedchem.3c01961. PMID 38593423.
  17. ^ Palfreyman M, Varty G, Canal C, Hartsel J, Tyagi R, Avery K, et al. (December 2023). “ACNP 62nd Annual Meeting: Poster Abstracts P251 – P500: P405. Discovery and Preclinical Characterization of the Phenylalkylamine, CYB210010, a Potent and Long-Acting Serotonin 5-HT2A Receptor Agonist”. Neuropsychopharmacology. 48 (Suppl 1): 211–354 (299–299. doi:10.1038/s41386-023-01756-4. PMC 10729596. PMID 38040810.
  18. ^ WO 2023156450, Nivorozhkin A, JA Hartsel, Canal CE, Salituro FG, Mueller TA, Greene BJ, Belser A, Avery KL, Reichelt AC, Varty GB, Palfreyman M, ”Therapeutic phenethylamine compositions and methods of use”, published 24 August 2023, assigned to Cybin Irl Limited 
  19. ^ Peplow M (June 2024). “Next-generation psychedelics: should new agents skip the trip?”. Nature Biotechnology. 42 (6): 827–830. doi:10.1038/s41587-024-02285-1. PMID 38831049.
  20. ^ Haichin M (2024). “Psychedelics Drug Development Tracker”. Psychedelic Alpha. Retrieved 29 January 2025.
  21. ^ Cybin Inc. (14 December 2020). “CYBIN Closes Acquisition of Adelia Therapeutics; Bolsters Scientific Team and Grows IP Portfolio to 7 Patent Filings”. GlobeNewswire News Room (Press release). Retrieved 6 February 2025.
  22. ^ Singh P (29 August 2023). “Cybin Enters Definitive Agreement To Acquire Small Pharma”. International Business Times. Retrieved 14 April 2026.
  23. ^ Taylor NP (19 December 2025). “Cybin alters state to become Helus Pharma for Nasdaq trip”. Fierce Pharma. Retrieved 20 February 2026.
  24. ^ a b c d e f g h i https://s28.q4cdn.com/259445127/files/doc_presentations/2026/Mar/18/Helus-Corporate-Deck-March-18-2026-Final.pdf