Delving into the Latest Updates on Oveporexton with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

TAK 861, TAK-861

Target

OX2R

Mechanism

OX2R agonists(Orexin receptor type 2 agonists)

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication

Disorders of Excessive SomnolenceNarcolepsyPrimary Hypersomnia

Inactive Indication-

Originator Organization

Takeda Pharmaceutical Co., Ltd.

Active Organization

Takeda Pharmaceutical Co., Ltd.Takeda Development Center Americas, Inc.

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

Login to view timeline

Structure/Sequence

Molecular FormulaC23H25F5N2O4S

InChIKeyKVMGAIOTUIGROS-AZUAARDMSA-N

CAS Registry2460722-04-5

The main aim of this study is to learn how effective TAK-861 is in improving excessive sleepiness during the day (called excessive daytime sleepiness or EDS) after 3 months of treatment. Other aims are to learn how effective TAK-861 is in lowering the number of sudden, unexpected attacks of muscle weakness while staying conscious (cataplexy) in a week; to learn the effect TAK-861 has on participants' ability to maintain attention, participant's overall quality of life, the spectrum of narcolepsy symptoms and daily life functions; and to learn about the safety of TAK-861.

Start Date07 Nov 2024

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

NCT06470828

/ RecruitingPhase 3

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)

The main aim of this study is to learn how effective TAK-861 is in improving excessive sleepiness during the day (called excessive daytime sleepiness or EDS) after 3 months of treatment. Other aims are to learn how effective TAK-861 is in lowering the number of sudden, unexpected attacks of muscle weakness while staying conscious (cataplexy) in a week; to learn the effect TAK-861 has on participants' ability to maintain attention, participant's overall quality of life, the spectrum of narcolepsy symptoms, and daily life functions; and to learn about the safety of TAK-861.

Start Date02 Jul 2024

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

100 Clinical Results associated with Oveporexton

Login to view more data

100 Translational Medicine associated with Oveporexton

Login to view more data

100 Patents (Medical) associated with Oveporexton

Login to view more data

100 Deals associated with Oveporexton

Login to view more data

R&D Status

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Disorders of Excessive Somnolence	Phase 3	US	Takeda Development Center Americas, Inc.	04 Nov 2024
Disorders of Excessive Somnolence	Phase 3	CN	Takeda Development Center Americas, Inc.	04 Nov 2024
Disorders of Excessive Somnolence	Phase 3	JP	Takeda Development Center Americas, Inc.	04 Nov 2024
Disorders of Excessive Somnolence	Phase 3	AU	Takeda Development Center Americas, Inc.	04 Nov 2024
Disorders of Excessive Somnolence	Phase 3	BE	Takeda Development Center Americas, Inc.	04 Nov 2024
Disorders of Excessive Somnolence	Phase 3	CA	Takeda Development Center Americas, Inc.	04 Nov 2024
Disorders of Excessive Somnolence	Phase 3	FR	Takeda Development Center Americas, Inc.	04 Nov 2024
Disorders of Excessive Somnolence	Phase 3	DE	Takeda Development Center Americas, Inc.	04 Nov 2024
Disorders of Excessive Somnolence	Phase 3	IT	Takeda Development Center Americas, Inc.	04 Nov 2024
Disorders of Excessive Somnolence	Phase 3	NL	Takeda Development Center Americas, Inc.	04 Nov 2024

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05687903 (TAK-861-2001, CTgov)	Phase 2	Narcolepsy	112	Placebo (Placebo)	ifytexzndo(svhguyajfm) = vudretxluw xzkfboylsh (syaxyhcqyf, upnjfttmzp - ydhdutleqj) View more	-	09 Jan 2025
				TAK-861 (TAK-861 0.5 mg BID)	ifytexzndo(svhguyajfm) = wdbslekrnz xzkfboylsh (syaxyhcqyf, tgyrlwlbeb - bxufcqzpon) View more
NCT05687916 (CTgov)	Phase 2	Narcolepsy	71	Placebo (Placebo)	ymmrgtqyey(ysypvrugme) = jakgvyvgyc umagukrbep (trfsofahan, zfjegijhkf - udirldsxlb) View more	-	09 Jan 2025
				TAK-861 2 mg and 5 mg (TAK-861 2 mg and 5 mg)	ymmrgtqyey(ysypvrugme) = rtxtmdfisx umagukrbep (trfsofahan, mdhjfkuzjy - ogsyjnybhq) View more
NCT05687903 (TAK-861-2001, NEWS) Manual	Phase 2	Narcolepsy	112	TAK-861	ufwifnnzwz(eeqwdasalx) = The primary endpoint demonstrated statistically significant and clinically meaningful increased sleep latency on the Maintenance of Wakefulness Test (MWT) versus placebo across all doses (LS mean difference versus placebo all p ≤0.001). Improvements were sustained over 8 weeks. Mean sleep latency ranged from 16.5 minutes for the lowest 0.5mg/0.5mg dose up to 30.7 minutes for the 2mg/5mg dose, compared to just 7 minutes for placebo. lgthfrpwfp (vctugwwrmi ) View more	Positive	03 Jun 2024
				placebo
WSC2023	Not Applicable	Narcolepsy \| Disorders of Excessive Somnolence	-	TAK-861	qmcmrzycbz(bwkjonptqb) = tjitupkfbv sdhzxaeujz (dymongoufo )	-	24 Oct 2023
				TAK-994	qmcmrzycbz(bwkjonptqb) = yyfhhlmruy sdhzxaeujz (dymongoufo ) View more
WSC2023	Not Applicable	Sleep Disorders, Circadian Rhythm	-	TAK-861 high-dose (HD)	qbzhraqvpy(feeerrvcqg) = reported by 3 (27.3%) subjects on TAK‑861 HD pnvbckkuwg (jusokicahu )	-	23 Oct 2023
				TAK-861 low-dose (LD)