Samsung Pharmaceutical has submitted a domestic Phase 3 clinical trial plan (IND) for 'GV1001,' a treatment candidate for progressive supranuclear palsy (PSP), to the Ministry of Food and Drug Safety (MFDS).

According to a regulatory filing, Samsung Pharmaceutical officially submitted the Phase 3 clinical trial plan for GV1001 to the MFDS on June 30, 2026. Once MFDS approval is completed, full-scale clinical trials will begin.

■ Clinical Design and Target This clinical trial is designed to confirm the efficacy and safety of 0.56mg subcutaneous injections of GV1001 in patients with progressive supranuclear palsy Richardson's syndrome (PSP-RS). It will be conducted as a multi-center, randomized, double-blind, placebo-controlled, parallel-group Phase 3 clinical trial.

The trial will be conducted at seven to nine institutions in South Korea, including Seoul Boramae Hospital, with a total of 204 patients participating. Some of the trial subjects will be recruited from Japan.

■ Schedule and Evaluation Endpoints The clinical trial period is expected to last approximately 33 months following approval from regulatory authorities and each institution's Institutional Review Board (IRB), and may be extended depending on patient recruitment speed.

The primary efficacy endpoint is the change in the total PSPRS (Progressive Supranuclear Palsy Rating Scale) score at 48 weeks compared to baseline. Samsung Pharmaceutical plans to comprehensively evaluate the effect on improving disease severity, as well as the effects on cognitive function, detailed function-specific symptoms on clinical scales, activities of daily living, overall clinical symptom progression, and safety through this trial.

■ Future Plans and Investment Caution Samsung Pharmaceutical plans to apply for product approval for the progressive supranuclear palsy indication based on the results after completing the Phase 3 clinical trial. Upon obtaining approval, the company intends to pursue market launch and supply of the treatment.

However, the company noted in its investment cautionary statement that the probability of a clinical trial drug ultimately receiving product approval is known to be statistically around 10%. It added that if results during the clinical trial and approval process fall short of expectations, commercialization plans may be changed or discontinued.