Depression Drug Trial Enrollment Finished

Researchers have completed enrollment for a late-stage trial of HLP003, a potential treatment for major depressive disorder.

Updated on Sept. 28, 2026 in Mental Health

Isometric editorial illustration showing a row of glass vials on a shelf, representing the clinical drug trial process. — Helus Pharma has finalized enrollment for its phase 3 trial of HLP003, a drug candidate aimed at treating major depressive disorder in patients resistant to initial therapy. AI Illustration. Upload story photo >

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Helus Pharma finished enrollment for the APPROACH phase 3 clinical trial in July 2026, marking a step in testing the efficacy of HLP003 for major depressive disorder. The research aims to support treatment options for the roughly 50% of patients who do not respond adequately to first-line therapies.

Why it matters

Because approximately half of patients with major depressive disorder do not achieve sufficient relief from initial treatments, new adjunctive options are a significant clinical priority. This research assesses whether the drug, which has earned FDA Breakthrough Therapy Designation, can provide a more effective alternative for these individuals.

The APPROACH phase 3 randomized trial evaluated 16 mg of HLP003 against a placebo in 223 participants aged 18 to 85. These findings follow earlier Phase 1/2a results indicating a 12.99-point improvement on the MADRS scale at day 21 compared to placebo.

The players

Helus Pharma

A pharmaceutical company developing novel therapies for complex mental health conditions including major depressive disorder.

The details

The drug HLP003 is being studied as an adjunctive therapy for major depressive disorder through the PARADIGM program. Participants receive two doses, on day 1 and day 22, with researchers monitoring the change in total scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) through day 42. The program currently evaluates both 8 mg and 16 mg doses across multiple trials to determine effectiveness.

July 2026: Helus Pharma finished enrollment for the APPROACH trial.
September 15-19, 2026: Trial design was presented at Psych Congress in New Orleans.
Q4 2026: Topline data from the APPROACH trial is expected.
2027: The EMBRACE study is estimated to reach completion.
2028: The EXTEND study is expected to finish, followed by a potential New Drug Application.

Health Landscape

The study of HLP003 represents a critical milestone for the PARADIGM clinical program, which is evaluating new pharmacological strategies for treatment-resistant depression. This development aligns with a shift toward adjunctive therapies for patients who struggle with standard first-line treatments.

This research is in the trial phase and is not yet available for clinical use. If you are struggling with current treatment for depression, it is worth discussing with your doctor whether you are a candidate for clinical trials or what other evidence-based adjunctive options may exist.

The takeaway

HLP003 is currently being tested to see if it can improve outcomes for adults with depression who have not seen success with primary treatments. Patients seeking relief from persistent symptoms should maintain an ongoing dialogue with their physician regarding evolving treatment standards.