Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Oveporexton
TAK-861 · 6 trials · 4 indications
The ESS provides individuals with 8 different situations of daily life and asks them how likely they are to fall asleep in those situations (scored 0 to 3) and to try to imagine their likelihood of dozing even if they have not actually been in the identical situation; the scores are summed to give an overall score of 0 to 24. Higher scores indicate stronger subjective daytime sleepiness, and scores below 10 are considered to be within normal range.
The MWT evaluates a person's ability to remain awake under soporific conditions for a defined period of time. Because there is no biological measure of wakefulness, wakefulness is measured indirectly by the inability or delayed tendency to fall asleep. This tendency to fall asleep is measured via electroencephalography-derived sleep latency in the MWT. The MWT consists of four 40-minute sessions (trials) done 2 hours apart. Sleep latency in each session was recorded. Participants were required to stay awake in between the four sessions. A positive change from baseline indicates an improvement. The linear MMRM was used for analysis.
The ESS provides individuals with 8 different situations of daily life and asks them how likely they are to fall asleep in those situations (scored 0 to 3) and to try to imagine their likelihood of dozing even if they have not actually been in the identical situation; the scores are summed to give an overall score of 0 to 24. Higher scores indicate stronger subjective daytime sleepiness. A negative change from baseline indicates an improvement. The linear mixed effects model for repeated measures (MMRM) was used for analysis.
The MWT evaluates a person's ability to remain awake under soporific conditions for a defined period of time. Because there is no biological measure of wakefulness, wakefulness is measured indirectly by the inability or delayed tendency to fall asleep. This tendency to fall asleep is measured via electroencephalography-derived sleep latency in the MWT. The MWT consists of four 40-minute sessions (trials) done 2 hours apart. Sleep latency in each session was recorded. Participants were required to stay awake in between the four sessions. A positive change from baseline indicates an improvement. The linear mixed effects model for repeated measures (MMRM) was used for analysis.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving trial intervention.
The MWT is a validated, objective measure that evaluates a participant's ability to remain awake under soporific conditions for a defined period. During each MWT session (1 session = 40 minutes), participants were instructed to sit quietly and remain awake for as long as possible. Sleep latency in each session was recorded on EEG. If no sleep was observed according to these rules, then the latency was defined as 40 minutes. The linear mixed effects model for repeated measures (MMRM) was used for analysis.
| Arm | Type | Description |
|---|---|---|
| Double-blind RW Period: TAK-861 | EXPERIMENTAL | Participants on stable TAK 861 dose will receive the same dose of TAK-861 they were taking at the end of the OL treatment period, for up to 4 weeks in the double-blind RW period. |
| Double-blind RW Period: Placebo | PLACEBO_COMPARATOR | Participants will receive TAK-861 matching-placebo, for up to 4 weeks in the double-blind RW period. |
| Placebo | PLACEBO_COMPARATOR | Participants received oveporexton matching placebo tablets, orally, twice daily (BID) for 12 weeks. |
| TAK-861 | EXPERIMENTAL | Participants received oveporexton tablets, 2 milligrams (mg), orally, BID for 12 weeks. |
| OVE 1 mg BID | EXPERIMENTAL | Participants received OVE tablets, 1 milligram (mg), orally, for 12 weeks. |
| OVE 2 mg BID | EXPERIMENTAL | Participants received OVE tablets, 2 mg, orally, for 12 weeks. |
| TAK-861 0.5 mg BID | EXPERIMENTAL | Participants received TAK-861 0.5 milligrams (mg), orally, BID, from Days 1 to 56. |
| TAK-861 2 mg BID | EXPERIMENTAL | Participants received TAK-861 2 mg, orally, BID, from Days 1 to 56. |
| TAK-861 2 mg and 5 mg | EXPERIMENTAL | Participants received TAK-861 2 mg followed by 5 mg dose, orally, BID, from Days 1 to 56. |
| TAK-861 7 mg QD | EXPERIMENTAL | Participants received TAK-861 7 mg, orally, once daily (QD), from Day 1 to 56. Placebo was given as the second dose. |
| TAK-861 2 milligrams (mg) BID | EXPERIMENTAL | Participants received TAK-861 2 mg, orally, BID, from Days 1 to 56. |
| Name | Type | Description |
|---|---|---|
| TAK-861 | DRUG | TAK-861 tablets |
| Placebo | DRUG | TAK-861-matching placebo tablets |
| Oveporexton | DRUG | Oral tablet. |
| TAK-861 2 mg | DRUG | TAK-861 2 mg tablets. |
| TAK-861 2 mg and 5 mg | DRUG | TAK-861 2 mg and 5 mg tablets. |
Inclusion Criteria: 1. The participant has a body mass index (BMI) within the range 18 to 40 kilograms per square meter (kg/m\^2). 2. The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or International Classification of Sleep Disorders, Third Edition, Tex...
TAK-861 is an investigational oral therapy being developed for narcolepsy type 1 and narcolepsy type 2, which are central disorders of hypersomnolence. It is also being studied in selected central hypersomnia conditions. It is not approved for any indication and remains in clinical development.
TAK-861 targets OX2R, the orexin 2 receptor. It is a small molecule designed to act on this receptor, which is part of the orexin signaling system involved in regulating wakefulness. Loss of orexin-producing neurons is a hallmark of narcolepsy type 1.
TAK-861 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is running the clinical program across multiple countries, including the United States, Japan, and several European nations.
TAK-861 is in Phase 3 development. Two Phase 3 trials have been conducted or are ongoing, alongside two Phase 2 studies. The program has enrolled 815 participants in total across randomized, double-blind, placebo-controlled trials.
TAK-861 trials include NCT07363720, an active Phase 3 trial in narcolepsy with cataplexy; NCT06505031, a completed Phase 3 study in narcolepsy type 1; NCT05816382, a recruiting Phase 2 study in central hypersomnia conditions; and NCT05687916, a completed Phase 2 study in narcolepsy type 2.