drugset
Drugs / Gaboxadol
last change Jun 2025 re-read 9 days ago

Gaboxadol

also known as MK0928 · OV101 · HLX-0206
Developed for
insomnia · Angelman syndrome · fragile X syndrome · major depressive disorder
Investigated by
H. Lundbeck A/S · Healx AI · Craig Erickson · Healx Limited

Trials 19

today NCT06334419 · Ph 2 NCT04106557 · Ph 3 NCT02996305 · Ph 2 NCT00807248 · Ph 2 NCT00420810 · Ph 3 NCT00266357 · Ph 2 NCT00266344 · Ph 2 NCT00102167 · Ph 3 NCT00103818 · Ph 3 NCT00102154 · Ph 3 NCT00094666 · Ph 3 NCT00094627 · Ph 3 NCT00095069 · Ph 3 NCT00095043 · Ph 3 NCT00209950 · Ph 3 NCT00209846 · Ph 3 NCT00209924 · Ph 3 NCT00209963 · Ph 3 NCT00209937 · Ph 3
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 25 trials · 1 missed
Phase 2 NCT06334419 Jan 2024 → May 2025 fragile X syndrome Craig Erickson Completed No outcome recorded
Phase 2 NCT02996305 Jan 2016 → Jun 2018 Angelman syndrome Healx AI Completed No outcome recorded
Phase 2 NCT00807248 Nov 2008 → Dec 2009 major depressive disorder H. Lundbeck A/S Completed Missed primary
Phase 2 NCT00266357 Nov 2005 → Mar 2007 insomnia H. Lundbeck A/S Terminated No outcome recorded
Phase 2 NCT00266344 Nov 2005 → Oct 2006 insomnia H. Lundbeck A/S Completed No outcome recorded
Phase 314 trials · 2 missed
Phase 3 NCT04106557 Sep 2019 → Nov 2020 Angelman syndrome Healx AI Completed Missed primary
Phase 3 NCT00420810 Sep 2006 → Mar 2007 insomnia H. Lundbeck A/S Terminated No outcome recorded
Phase 3 NCT00102167 Feb → Dec 2005 insomnia H. Lundbeck A/S Completed No outcome recorded
Phase 3 NCT00103818 Feb 2005 → Oct 2006 insomnia H. Lundbeck A/S Completed No outcome recorded
Phase 3 NCT00102154 Jan 2005 → ? insomnia H. Lundbeck A/S Withdrawn No outcome recorded
Phase 3 NCT00094666 Nov 2004 → Mar 2007 insomnia H. Lundbeck A/S Terminated No outcome recorded
Phase 3 NCT00094627 Nov 2004 → Apr 2006 insomnia H. Lundbeck A/S Completed No outcome recorded
Phase 3 NCT00095069 Oct 2004 → Feb 2007 insomnia H. Lundbeck A/S Completed Missed primary
Phase 3 NCT00095043 Oct 2004 → Jun 2006 insomnia H. Lundbeck A/S Completed No outcome recorded
Phase 3 NCT00209950 Jul 2004 → Sep 2005 insomnia H. Lundbeck A/S Completed No outcome recorded
Comparator or background therapy1 trial
Phase 2 NCT04823052 Comparator May → Oct 2022 fragile X syndrome Healx Limited Withdrawn No outcome recorded Stop: Enrollment

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2022-07-18 Healx AI Results Healx presents data on AI-predicted therapies for fragile X syndrome at the National Fragile X Foundation (NFXF) International Conference 2022 healx.ai ↗

All press releases naming this drug 1 release

DateIssuerRelease

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 21 sources stand behind the page.

FieldValueCited text
Known as gaboxadol “OBJECTIVE: To evaluate safety and tolerability and exploratory efficacy end points for gaboxadol (OV101) compared with placebo in individuals with Angelman syndrome (AS).” PMID 33443117 ↗ Dec 2020
18

“MK0928, gaboxadol / Duration of Treatment: 6 days for treatment periods (2 days/dose)” NCT00266357 ↗

“MK0928, gaboxadol / Duration of Treatment: 10 months” NCT00102154 ↗

“MK0928, gaboxadol / Duration of Treatment - 6 weeks” NCT00094666 ↗

“MK0928, gaboxadol / Duration of Treatment 3 Weeks” NCT00266344 ↗

NCT00095069 ↗

NCT00102167 ↗

NCT00209846 ↗

NCT04106557 ↗

NCT00095043 ↗

NCT00094627 ↗

Show 8 more sources
Known as HLX-0206 “Gaboxadol (HLX-0206) Capsule” NCT04823052 ↗
Known as MK0928 “A study to evaluate the efficacy, safety and tolerability of MK-0928 in Primary Insomnia.” NCT00266357 ↗
7

“MK0928, gaboxadol / Duration of Treatment - 1 year” NCT00095069 ↗

“MK0928, gaboxadol” NCT00095043 ↗

NCT00102154 ↗

NCT00420810 ↗

NCT00094666 ↗

NCT00266344 ↗

NCT00266357 ↗
Known as OV101 “OBJECTIVE: To evaluate safety and tolerability and exploratory efficacy end points for gaboxadol (OV101) compared with placebo in individuals with Angelman syndrome (AS).” PMID 33443117 ↗ Dec 2020
1

“OV101 (gaboxadol), oral, provided once daily at bedtime for 12 week duration” NCT04106557 ↗
Action Activate “Gaboxadol is a highly selective orthosteric agonist that activates δ-subunit-containing extrasynaptic γ-aminobutyric acid type A (GABAA) receptors.” PMID 33443117 ↗ Dec 2020
Route Oral “The purpose of the study is to assess the safety and tolerability of oral OV101 (gaboxadol) in adult and adolescent subjects with Angelman syndrome.” NCT02996305 ↗