Drugs / Rapastinel
last change Nov 2021 re-read 9 days ago

Rapastinel

also known as GLYX-13 · Rapastinelum · Tppt-amide

Other / unclassified

Developed for
major depressive disorder · psychiatric disorder
Investigated by
Naurex, Inc · New York State Psychiatric Institute · Northwestern University

Trials 19

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT03814733 Nov 2018 → Mar 2019 — Naurex, Inc Completed No outcome recorded
Phase 1 NCT03799900 Nov 2018 → Mar 2019 substance abuse Naurex, Inc Completed No outcome recorded
Phase 1 NCT01014650 Nov 2009 → Oct 2015 — Naurex, Inc Completed No outcome recorded
Phase 26 trials · 1 missed
Phase 2 NCT03352453 Dec 2017 → Jun 2019 major depressive disorder Naurex, Inc Terminated No outcome recorded Stop: Business
Phase 2 NCT02267629 Oct 2014 → Feb 2016 obsessive-compulsive disorder New York State Psychiatric Institute Completed No outcome recorded
Phase 2 NCT02192099 Sep 2014 → Nov 2018 major depressive disorder Naurex, Inc Terminated No outcome recorded
Phase 2 NCT01844726 May 2013 → Jan 2016 psychiatric disorder Northwestern University Terminated Missed primary
Phase 2 NCT01684163 Nov 2012 → Apr 2014 major depressive disorder Naurex, Inc Completed No outcome recorded
Phase 2 NCT01234558 May 2011 → Jun 2012 major depressive disorder Naurex, Inc Completed No outcome recorded
Phase 310 trials · 4 missed
Phase 3 NCT03855865 Jul 2019 → Dec 2020 major depressive disorder Naurex, Inc Withdrawn No outcome recorded Stop: Business
Phase 3 NCT03675776 Oct 2018 → Jul 2019 major depressive disorder Naurex, Inc Terminated No outcome recorded Stop: Business
Phase 3 NCT03668600 Aug 2018 → Jul 2019 major depressive disorder Naurex, Inc Terminated No outcome recorded Stop: Business
Phase 3 NCT03614156 Aug 2018 → Jul 2019 major depressive disorder Naurex, Inc Terminated No outcome recorded Stop: Business
Phase 3 NCT03560518 Jun 2018 → Jul 2019 major depressive disorder Naurex, Inc Terminated No outcome recorded Stop: Business
Phase 3 NCT03002077 Feb 2017 → Dec 2018 major depressive disorder Naurex, Inc Completed No outcome recorded
Phase 3 NCT02951988 Nov 2016 → Feb 2019 major depressive disorder Naurex, Inc Completed Missed primary
Phase 3 NCT02943577 Nov 2016 → Oct 2018 major depressive disorder Naurex, Inc Completed Missed primary
Phase 3 NCT02943564 Nov 2016 → Dec 2018 major depressive disorder Naurex, Inc Completed Missed primary
Phase 3 NCT02932943 Oct 2016 → Sep 2018 major depressive disorder Naurex, Inc Completed Missed primary

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2019-03-06 AbbVie Results Allergan Announces Phase 3 Results for Rapastinel as an Adjunctive Treatment of Major Depressive Disorder (MDD) abbvie.com ↗
In three acute studies (RAP-MD-01,-02,-03), the rapastinel treatment arms did not differentiate from placebo on the primary and key secondary endpoints.
2019-01-03 AbbVie Results New Data Published in the International Journal of Neuropsychopharmacology Support that Rapastinel May Produce Rapid and Sustained Antidepressant Effects Through a Potentially Novel Mechanism of Action abbvie.com ↗
Preclinical research demonstrated rapastinel positively modulates the NMDA receptor

Evidence & citations 8 cited values

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

FieldValueCited text
Known as Rapastinel ClinicalTrials.gov intervention name — accepted as the source's own label NCT03799900 ↗
14

NCT03668600 ↗

NCT03814733 ↗

NCT02943577 ↗

NCT03855865 ↗

NCT03675776 ↗

NCT03560518 ↗

NCT02943564 ↗

NCT02267629 ↗

NCT02932943 ↗

NCT03002077 ↗

Show 4 more sources

Known as GLYX-13 “10 mg/kg IV Rapastinel (formerly GLYX-13)” NCT02267629 ↗
4

NCT01684163 ↗

NCT01014650 ↗

NCT01844726 ↗

NCT01234558 ↗

Known as Rapastinelum ChEMBL registry synonym — accepted as the source's own label CHEMBL3544917 ↗
Known as Tppt-amide ChEMBL registry synonym — accepted as the source's own label CHEMBL3544917 ↗
Action Activate “NMDA receptor glycine site functional partial agonist” NCT01014650 ↗
Modality Other / unclassified “N-methyl-D-aspartate ionotropic glutamatergic receptor (NMDAR) modulators, including rapastinel and ketamine” PMID 34423904 ↗ Nov 2021
Route Intravenous “single IV or SC dose” NCT01014650 ↗
Route Subcutaneous “single IV or SC dose” NCT01014650 ↗