FindTrial
Sign In

TAK-861

DRUG9 trials

Sponsors

Takeda Development Center Americas Inc., Takeda

Conditions

NarcolepsyNarcolepsy Type 1Narcolepsy Type 1 (NT1)Narcolepsy With CataplexyNarcolepsy with Cataplexy (Narcolepsy Type 1)

Phase 1

Open-label single dose trial to evaluate pharmacokinetics, safety, and acceptability/palatability of oveporexton in children from 6 years to less than 18 years of age with narcolepsy type 1 (NT1)
RecruitingCTIS2025-522034-31-00
Takeda Development Center Americas Inc.Narcolepsy with Cataplexy (Narcolepsy Type 1)
Start: 2026-01-07Target: 16Updated: 2025-11-27

Phase 2

A Study of TAK-861 in Participants With Narcolepsy Type 1
CompletedNCT05687903
TakedaNarcolepsy Type 1
Start: 2023-01-09End: 2023-12-14Updated: 2025-01-09
A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions
RecruitingNCT05816382
TakedaNarcolepsy Type 1
Start: 2023-04-05End: 2028-02-28Target: 500Updated: 2026-03-05
A Long-term Extension Study to Evaluate the Safety and Tolerability of TAK-861 in Participants With Selected Central Hypersomnia Conditions.
Active, not recruitingCTIS2023-508462-15-00
Takeda Development Center Americas Inc.Narcolepsy with Cataplexy (Narcolepsy Type 1)
Start: 2023-04-27Target: 304Updated: 2025-09-09

Phase 3

A Study of TAK-861 in People With Narcolepsy Type 1
CompletedNCT06505031
TakedaNarcolepsy Type 1
Start: 2024-10-08End: 2025-06-04Updated: 2026-07-16
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-861 for the Treatment of Narcolepsy with Cataplexy (Narcolepsy Type 1)
CompletedCTIS2023-508465-32-00
Takeda Development Center Americas Inc.Narcolepsy with Cataplexy (Narcolepsy Type 1)
Start: 2024-09-03End: 2025-06-03Target: 85Updated: 2025-04-02
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-861 for the Treatment of Narcolepsy with Cataplexy (Narcolepsy Type 1)
CompletedCTIS2024-511998-30-00
Takeda Development Center Americas Inc.Narcolepsy with Cataplexy (Narcolepsy Type 1)
Start: 2024-10-18End: 2025-05-30Target: 80Updated: 2025-04-07
A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy
Active, not recruitingNCT07363720
TakedaNarcolepsy Type 1 (NT1), Narcolepsy With Cataplexy
Start: 2026-01-29End: 2026-10-02Updated: 2026-09-01
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)
Not yet recruitingCTIS2024-519466-44-00
Takeda Development Center Americas Inc.Narcolepsy
Target: 12Updated: 2026-02-11

Related Papers

Oveporexton for Narcolepsy Type 1 - Results from Two Phase 3 Trials.
2026-09-09
An actigraphy-based algorithm to assess daytime napping in people with narcolepsy type 1.
PubMed2026-08-18
Nocturnal Features and Daytime Characteristics in Narcolepsy: Reliability and Diagnostic Relevance for NT1 vs NT2
SLEEP2026-07-07
Mechanisms biomarkers and therapeutic strategies of human endogenous retroviruses in cancer
Discover Oncology2026-04-16
Methods for Wearable-Derived Pulse Rate Measures and Their Application to Modeling the Relationship Between Pulse Rate and Motor Activity in Narcolepsy Type 1
Digital Biomarkers2026-03-24
Effects of Oveporexton, an Orexin Receptor 2-Selective Agonist, on Cognition in Narcolepsy Type 1: A Secondary Analysis of a Randomized Clinical Trial.
2025-12-08
Oveporexton, an Oral Orexin Receptor 2–Selective Agonist, in Narcolepsy Type 1
New England Journal of Medicine2025-05-1422 citations
0847 Treatment with an Orexin Agonist Reduces Microsleeps and Improves Wakefulness During MWT in People with NT1
SLEEP2025-05-01
0846 Actigraphy-Based Assessment of the Impact of TAK-861 on Daytime Napping in People with Narcolepsy Type 1
SLEEP2025-05-01