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# Takeda Moving Narcolepsy Drug to Phase 3
- URL: https://www.fdaweb.com/takeda-moving-narcolepsy-drug-to-phase-3/
- Published: 2024-06-03T12:00:00.000Z
- Updated: 2026-09-14T14:32:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157102

Takeda says it is beginning a Phase 3 trial by 6/30 of its narcolepsy Type 1 (NT1) drug TAK-861 after reporting positive results from a Phase 2b trial. Based on the data, the investigational oral orexin receptor 2 (OX2R) agonist has the potential to “provide transformative efficacy in addressing the overall disease burden in people with NT1,” it says.

The double-blind, placebo-controlled Phase 2b trial, involved 112 patients with NT1 and demonstrated statistically significant and clinically meaningful improvements across primary and secondary endpoints, with efficacy sustained over eight weeks of treatment, Takeda says.

NT1 is described as a chronic, rare neurological central disorder of hypersomnolence caused by a large loss of orexin neurons, which leads to low levels of orexin neuropeptides in the brain and cerebrospinal fluid. “People with NT1 suffer from excessive daytime sleepiness (EDS), cataplexy (sudden loss of muscle tone), disrupted nighttime sleep, hypnagogic and hypnopompic hallucinations and sleep paralysis,” Takeda says.

The company highlights the following from the Phase 2b trial:

- The primary endpoint demonstrated statistically significant and clinically meaningful increased sleep latency on the Maintenance of Wakefulness Test (MWT) versus placebo across all doses.
- Consistent results were achieved in the key secondary endpoints including the Epworth Sleepiness Scale (ESS) and Weekly Cataplexy Rate (WCR), demonstrating significantly improved subjective measures of sleepiness and cataplexy frequency versus placebo.
- The majority of NT1 patients in the trial were found to be within normative ranges for MWT and ESS by the end of the 8-week treatment period.
- Data showed that TAK-861 was generally safe and well tolerated during the study, with no treatment-related serious treatment-emergent adverse events (TEAEs) or discontinuations due to TEAEs.
- No cases of hepatotoxicity or visual disturbances were reported. The most common TEAEs were insomnia, urinary urgency and frequency, and salivary hypersecretion.