Drugs / Glycine

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Maapliv 2025-07-28 europa.eu
Approved US (FDA) GLYCINE 1.5% IN PLASTIC CONTAINER 1976-05-25 fda.gov

Trials 13 · a red edge is where a trial was stopped

19751976197719781979198019811982198319841985198619871988198919901991199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027202820292030
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 26 trials
Phase 2 NCT05799521 Jun 2023 → Mar 2027 expected COVID-19 Indiana University Active not recruiting No outcome recorded
Phase 2 NCT04738422 Sep 2020 → Jul 2028 expected lower respiratory tract disorder Indiana University Enrolling by invitation No outcome recorded
Phase 2 NCT00913692 Jun 2009 → Dec 2011 herpes labialis National Institute of Allergy and Infectious Diseases (NIAID) Terminated No outcome recorded
Phase 2 NCT00338598 Jun 2003 → Dec 2015 alcohol dependence, schizophrenia Yale University Completed No outcome recorded
Phase 2 NCT00268749 Jul 2002 → Nov 2004 schizophrenia Yale University Completed No outcome recorded
Phase 2 NCT00005658 May 2000 → Jan 2002 schizoaffective disorder, schizophrenia National Institute of Mental Health (NIMH) Completed No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT00291226 Mar 2006 → Jul 2009 schizophrenia Yale University Completed No outcome recorded
Phase 2/3 NCT00222235 Jan 2000 → Jun 2004 schizoaffective disorder, schizophrenia University of Maryland, Baltimore Completed No outcome recorded
Phase 33 trials
Phase 3 NCT00338221 Aug 2004 → Apr 2005 University of Virginia Withdrawn No outcome recorded
Phase 3 NCT00133562 Aug 2004 → May 2006 nutritional disorder University of Virginia Withdrawn No outcome recorded
Phase 3 NCT00000372 Mar 1998 → Nov 2005 schizophrenia Massachusetts General Hospital Withdrawn No outcome recorded
Phase 41 trial
Phase 4 NCT06083480 Dec 2024 → Sep 2028 expected chronic pain syndrome, osteoarthritis, knee Vanderbilt University Medical Center Recruiting No outcome recorded
Phase not applicable1 trial
NCT00405535 Jun 2004 → Dec 2006 obsessive-compulsive disorder Nathan Kline Institute for Psychiatric Research Completed No outcome recorded
Also used as a comparator or background therapy in 4 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 22 trials
Phase 2 NCT03166228 Comparator Jan 2018 → Jun 2022 hypertensive disorder Assiut University Completed No outcome recorded
Phase 2 NCT01720316 Comparator Dec 2012 → May 2017 bipolar disorder, schizoaffective disorder Mclean Hospital Completed No outcome recorded
Phase 41 trial
Phase 4 NCT07575984 Comparator Nov 2025 → Apr 2027 expected ischemic stroke Pharmasoft Recruiting No outcome recorded
Phase not applicable1 trial
NCT00635102 Comparator Oct 1997 → Feb 2008 alcohol dependence Yale University Completed No outcome recorded

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 18 sources stand behind the page.

FieldValueCited text
Known as glycine ClinicalTrials.gov intervention name — accepted as the source's own label NCT00268749
14

NCT00291226

NCT00913692

NCT00338221

NCT07575984

NCT00005658

NCT00635102

NCT03166228

NCT00133562

NCT01720316

NCT00338598

NCT00405535

NCT00222235

NCT00000372

NCT06083480

Known as Alkaline glycine ClinicalTrials.gov intervention name — accepted as the source's own label NCT04738422
Known as FEMA NO. 3287 ChEMBL registry synonym — accepted as the source's own label CHEMBL773
Known as Glicina ChEMBL registry synonym — accepted as the source's own label CHEMBL773
Known as Glycolixir ChEMBL registry synonym — accepted as the source's own label CHEMBL773
Known as NSC-25936 ChEMBL registry synonym — accepted as the source's own label CHEMBL773
Known as Optate ClinicalTrials.gov intervention name — accepted as the source's own label NCT05799521
Action Activate “the full agonist, glycine, would not be expected to worsen negative symptoms in the presence of clozapine.” NCT00000372
Modality Other / unclassified “the amino acid glycine” NCT00005658
Route Oral “The amino acid glycine, if given orally in adequate dosages” NCT00405535