Takeda Advances Two Neuroscience Clinical Trials: Narcolepsy and Teen Depression

Takeda Pharmaceutical Company has advanced two late-stage clinical trials in its neuroscience pipeline, advancing a Phase 2 narcolepsy study and a Phase 3 teen depression study. The company announced updates on the ongoing clinical studies, reinforcing its strategic focus on central nervous system disorders.

For its narcolepsy program, Takeda is moving ahead with a Phase 2 trial of TAK-360 for adults with narcolepsy type 1, also known as narcolepsy with cataplexy. The interventional study is testing oral tablets of TAK-360 against matching placebo tablets. The goal is to see if TAK-360 can reduce daytime sleep attacks and cataplexy episodes while staying safe for long-term use. The trial is randomized and triple-blind, meaning patients, investigators, and outcome assessors do not know who receives the drug. The study was first submitted on June 2, 2026, and is currently recruiting, with the latest update filed on June 8, 2026. Primary and final completion dates have not yet been reported.

In another update, Takeda is running a Phase 3 study of vortioxetine in Japanese teens with major depressive disorder. The trial, titled "A Randomized, Double-blind, Placebo-Controlled Phase 3 Study," is testing oral vortioxetine tablets, also sold as Trintellix, given once a day for 14 weeks. The goal is to evaluate how well the drug treats depression symptoms versus placebo, while tracking safety and drug levels. The study is interventional, randomized, and triple-blind. Each participant stays in the study for about 20 weeks, including screening, treatment, and safety follow-up, with teens visiting the clinic 13 times. The trial is recruiting and has not yet reported results. The study was first submitted on September 30, 2025, with the latest update on February 12, 2026. Primary and final completion dates are not yet posted. Further details are available on ClinicalTrials.gov under identifier NCT07204314.

Both studies are currently active and recruiting. The updates signal Takeda's continued investment in expanding its central nervous system pipeline, which includes both new compounds and new indications for existing drugs.