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. The drug has a reported duration of acute subjective effects of approximately 4–6 hours, with onset within 15 minutes of dosing. HLP003 has been granted
Breakthrough Therapy Designation by the
U.S. Food and Drug Administration for the adjunctive treatment of
major depressive disorder (MDD). 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. 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.
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. 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. == Leadership ==