Takeda Advances TAK-861 Into Phase 3 for Narcolepsy With Cataplexy, Setting Up a New CNS Catalyst

Takeda Pharmaceutical Company (TAK) announced an update on their ongoing clinical study.

Study Overview

Takeda is launching a late-stage trial to test TAK-861 in people with narcolepsy type 1, also known as narcolepsy with cataplexy. The official title is “A Double-blind, Placebo-Controlled, Randomized Withdrawal Trial to Evaluate the Efficacy and Safety of TAK-861 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1).” The main goal is to see how well the drug controls symptoms and whether that benefit holds over time, which is important for judging its potential as a long-term treatment in a chronic sleep disorder market with meaningful unmet need.

Intervention/Treatment

The study tests TAK-861, an oral tablet developed by Takeda, against a matching placebo. TAK-861 is designed to reduce daytime sleep attacks and cataplexy episodes in narcolepsy type 1. Participants first receive TAK-861 for several months, and then some continue on the drug while others switch to placebo to see if symptoms return.

Study Design

This is a phase 3 interventional study. Participants are randomly assigned to either stay on TAK-861 or move to placebo, similar to flipping a coin. The model is parallel, meaning each group stays on its assigned treatment. The trial is double blind, so neither patients nor study doctors know who is receiving the active drug. The main purpose is treatment, aiming to show that TAK-861 keeps working and is safe over time compared with placebo.

Study Timeline

The trial was first submitted on 7 January 2026, signaling Takeda’s move into a pivotal stage for this asset. The primary completion date, when main results should be collected, has not yet been reported but will be a key future catalyst once disclosed. The estimated overall completion date is also not yet listed, but investors should expect data readouts to follow the primary completion milestone. The most recent update to the record was submitted on 22 January 2026, and the current recruitment status is “not yet recruiting,” which confirms the program is active and moving toward patient enrollment.

Market Implications

For Takeda (TAK), this phase 3 narcolepsy program adds to its late-stage pipeline and could support a new revenue stream in a specialized central nervous system segment. Positive outcomes could lift sentiment around Takeda’s growth profile beyond its core franchises and may help offset patent and pricing pressures in other areas. The narcolepsy market already includes established therapies from players such as Jazz Pharmaceuticals and others focused on sleep disorders, so a successful launch could intensify competition but also expand the overall market by offering an oral, potentially more convenient option. In the near term, the update mainly signals ongoing R&D investment and future data catalysts; share price impact is likely to hinge on later efficacy and safety readouts rather than this early status change.

The study is ongoing and has been recently updated, with further details available on the ClinicalTrials portal.

To learn more about TAK’s potential, visit the Takeda Pharmaceutical Company drug pipeline page.