Gaboxadol

Overview

Gaboxadol also known as 4,5,6,7-tetrahydroisoxazolo(5,4-c)pyridin-3-ol (THIP) is an experimental sleep aid drug developed by Lundbeck and Merck, who reported increased deep sleep without the reinforcing effects of benzodiazepines. Development of Gaboxadol was stopped in March 2007 after concerns regarding safety and efficacy. It acts on the GABA system, but in a seemingly different way from benzodiazepines and other sedatives.

Background

Indication

Investigated for use/treatment in sleep disorders and insomnia.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Placebo-Controlled, Single-Dose Challenge Study of Gaboxadol in Adult Males With Fragile X Syndrome (FXS)	2024/03/28	NCT06334419	Phase 2	Recruiting	Craig Erickson
Investigation of Sulindac (HLX-0201) and Gaboxadol (HLX-0206) in Male Fragile X Syndrome Patients Aged 13-40	2021/03/30	NCT04823052	Phase 2	Withdrawn	Healx Limited
A Study of OV101 in Individuals With Angelman Syndrome (AS)	2019/09/27	NCT04106557	Phase 3	Completed	Ovid Therapeutics Inc.
An Open-Label Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of OV101 in Individuals With Angelman Syndrome	2019/03/20	NCT03882918	Phase 3	Terminated	Ovid Therapeutics Inc.
Single Dose Pharmacokinetic (PK) Study	2017/04/12	NCT03109756	Phase 1	Completed	Ovid Therapeutics Inc.
Short-term Study of Combination Treatment of Escitalopram and Gaboxadol in Major Depressive Disorder	2008/12/11	NCT00807248	Phase 2	Completed	H. Lundbeck A/S
MK0928 Study in Adult Patients With Primary Insomnia (0928-040)(COMPLETED)	2005/12/16	NCT00266344	Phase 2	Completed	H. Lundbeck A/S
A Study of Gaboxadol in Primary Insomnia	2005/09/21	NCT00209924	Phase 3	Completed	H. Lundbeck A/S
A Study of Gaboxadol in Primary Insomnia	2005/09/21	NCT00209963	Phase 3	Completed	H. Lundbeck A/S
A Study of Gaboxadol in Primary Insomnia	2005/09/21	NCT00209846	Phase 3	Completed	H. Lundbeck A/S

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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