CAMBRIDGE, Mass.– Takeda Pharmaceutical Company announced Monday that its investigational oral drug oveporexton (TAK-861) achieved statistically significant results across all primary and secondary endpoints in two pivotal Phase 3 clinical trials for narcolepsy type 1 (NT1). The findings mark a major advancement in targeting the root cause of the sleep disorder by restoring orexin signaling in the brain.
The two global studies—FirstLight (TAK-861-3001) and RadiantLight (TAK-861-3002)—evaluated oveporexton as a first-in-class oral orexin receptor 2 (OX2R)-selective agonist. Both trials were randomized, double-blind, and placebo-controlled, involving participants in 19 countries. The trials demonstrated statistically significant improvements (p<0.001) in key symptoms such as excessive daytime sleepiness, cataplexy, attention span, wakefulness, and quality of life, with results observed across all tested doses by the 12-week mark.
“These results validate for the first time in Phase 3 that targeting orexin deficiency can deliver clinically meaningful improvements for patients with narcolepsy type 1,” said Christophe Weber, president and CEO of Takeda. “Oveporexton represents our deep commitment to developing innovative treatments for patients with limited options, and it underscores the strength of our orexin-focused research.”
Oveporexton was also shown to be generally well-tolerated, with a safety profile consistent with earlier trial phases. No serious treatment-related adverse events were reported, and the most common side effects included insomnia and increased urinary urgency and frequency. More than 95% of trial participants have chosen to continue treatment in a long-term extension study.
Dr. Andy Plump, Takeda’s president of R&D, emphasized the speed and scale of the trial program. “We are grateful to the patients, families, and clinical teams who made these results possible. The speed at which we reached this milestone reflects our urgency to address an unmet medical need,” he said. “These results build on the transformative outcomes of our earlier Phase 2b study and strengthen our late-stage pipeline.”
Takeda plans to submit a New Drug Application to the U.S. Food and Drug Administration, along with filings to other global regulators, in fiscal year 2025. The company also plans to present the full data at upcoming medical conferences.
The trial results are not expected to materially impact Takeda’s financial forecast for the fiscal year ending March 31, 2026.
