Posted: 17 March 2026
Dimerix Limited has announced that the ACTION3 Phase 3 clinical trial of DMX-200 has achieved a key milestone, with the final adult patient having been dosed and total enrolment exceeding the original target. A total of 333 adult patients have been randomised and dosed in the study, surpassing the initial recruitment target of 286 participants.
CEO and Managing Director Dr Nina Webster states: “I am delighted with the achievement of such a significant milestone in the Company’s clinical development of DMX-200 in FSGS patients… This will ultimately support the statistical powering of the study endpoints.”
The over-recruitment has occurred as patients already in the screening process at the time the 286-patient threshold was reached were permitted to proceed to randomisation and dosing, in line with standard clinical trial practice. Recruitment of adult patients has now been closed, while enrolment of paediatric patients has continued as a separate cohort, as agreed with regulators.
The ACTION3 study has been described as a pivotal, multi-centre, randomised, double-blind, placebo-controlled Phase 3 trial evaluating the efficacy and safety of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS). The therapy has been administered alongside a stable dose of an angiotensin II receptor blocker over a two-year treatment period.
The trial has been conducted across 219 sites in 21 countries, including Australia, the United States, Europe, and Asia-Pacific regions. It has successfully passed seven Independent Data Monitoring Committee reviews, with no protocol changes required and no safety concerns identified.
Completion of the full two-year study period has been anticipated in March 2028. The company has indicated it remains focused on advancing the trial and pursuing licensing opportunities in unpartnered territories.
