glycine

Small moleculeapproved

Approved

May 25, 1976

Glycine (Cly) is a natural amino acid neurotransmitter that acts as a co-agonist at Glutamate [NMDA] receptors in the brain and is an activator of glycine receptors, GLRA1-3, GLRB. The abnormal Gly levels have been implicated in neuropsychiatric disorders. Alterations in Gly levels are implicated in several diseases of the central nervous system. Glycine was studied in phase II of clinical trials in patients with schizophrenia. The results have shown that using of glycine was associated with reduced symptoms with promising effect sizes and a possibility of improvement in cognitive function. Besides, glycine was also studied in clinical trials phase II in children with cystic fibrosis. The clinical, spirometric and inflammatory status of subjects with cystic fibrosis improved after just 8 weeks of glycine intake, suggesting that this amino acid might constitute a novel therapeutic tool for these patients. In addition, Gly was proposed as a biomarker for brain tumor malignancy. Glycine is a component of a nutrients mixture for peripheral administration to well-nourished mildly catabolic adult patients who require only short-term parenteral nutrition. — NCATS

Clinical trial activity

43 trials · 42 clinical orgs · 5 marketing orgs

Phase 1
10
Phase 2
16
Phase 3
10
Phase 4
1

Earliest trial started Oct 1, 1997 (NCT00635102)

Timeline

1970s

  1. May 25, 1976

    Hospira — Earliest FDA Approval

  2. May 25, 1976

    Evidence of US Marketing

  3. May 25, 1976

    Hospira — NDA Secondary Org

  4. May 25, 1976

    Hospira — NDA Organization

  5. Feb 6, 1978

    B. Braun — NDA Secondary Org

1980s

  1. Feb 22, 1980

    ICU Medical Inc — NDA Secondary Org

  2. May 30, 1980

    Baxalta — NDA Secondary Org

  3. May 30, 1980

    Baxter — NDA Secondary Org

1990s

  1. Jan 1, 1998

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Jan 1, 2000

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2007

    Earliest Phase 1 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approvedMay 25, 1976
  • approvedMay 25, 1976

Chemistry & pharmacology

Loading structure…

SMILES

NCC(O)=O
Mol. weight
75.0666 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • 2-aminoacetic acid
  • aminoacetic acid
  • aminoacetic acid
  • aminoacetic acid
  • aminoacetic acid
  • aminoacetic acid
  • aminoessigsäure
  • aminoessigsäure
  • aminoethanoic acid
  • aminoethanoic acid
  • gly
  • gly
  • glycin
  • glycin
  • glycine
  • glycine
  • glycine
  • glycine
  • glycine
  • glycine
  • glycine
  • glycine
  • glycine
  • glycine
  • glycine
  • glycocoll
  • glycocoll
  • glycocoll
  • glycolixir
  • glycolixir
  • glykokoll
  • glykokoll
  • glyzin
  • glyzin
  • leimzucker
  • leimzucker

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07285135N/ADec 31, 2025Singapore General Hospital
NCT06959251N/AOct 2, 2025Instituto Nacional de Enfermedades Respiratorias
NCT06083480Phase 4Mar 31, 2024National Institute on Aging (NIA), Vanderbilt University
NCT06726902N/AMar 3, 2024Alexandria University
NCT05799521Phase 2Jun 27, 2023Indiana University
NCT06998160N/AJul 5, 2022Changsha Stomatological Hospital
NCT04740580Early Phase 1 (Phase 1)Jul 1, 2021Baylor University, The University of Texas, Dallas
NCT04703036Early Phase 1 (Phase 1)Jan 11, 2021Baylor University
NCT04658134N/ADec 15, 2020Baylor University, National University of Singapore, Singapore General Hospital
NCT04738422Phase 2Sep 11, 2020Indiana University
NCT04443673N/AAug 20, 2020Instituto Nacional de Enfermedades Respiratorias
NCT03850314Phase 2/Phase 3 (Phase 3)Mar 31, 2019Technion University
NCT03617718Phase 1/Phase 2 (Phase 2)Sep 30, 2018Case Western Reserve University, National Institutes of Health (NIH)
NCT03493178Early Phase 1 (Phase 1)Apr 14, 2018Baylor University, The University of Texas, Dallas
NCT03353441N/ANov 15, 2017Daacro, MNPK BIOTIKI
NCT03166228Phase 2Jul 5, 2017Assiut University
NCT03154840Phase 1May 29, 2017LG
NCT04381026N/AApr 19, 2017Clínica Barem, Nektium Pharma SL
NCT02348762Phase 1Nov 1, 2014Baylor University
NCT02348775Phase 1Nov 1, 2014Baylor University
Showing 20 of 43 trials
Page 1 / 3

Organizations

Research & Development (42)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Baylor UniversityAcademic/Hospital8722010
National Institute of Allergy and Infectious Diseases (NIAID)Government4122004
Yale UniversityAcademic/Hospital4431997
Brain & Behavior Research FoundationAcademic/Hospital3032006
Instituto Nacional de Enfermedades RespiratoriasAcademic/Hospital3322012
Mclean HospitalAcademic/Hospital3232007
National Institute of Mental Health (NIMH)Government3122000
National Institutes of Health (NIH)Government3022008
University of VirginiaAcademic/Hospital3312004
Harvard UniversityAcademic/Hospital2121998
Indiana UniversityAcademic/Hospital2212020
LGFor profit2222014
National Institute on Aging (NIA)Government2022013
New York UniversityAcademic/Hospital2122000
Singapore General HospitalAcademic/Hospital2212020
Stanley Medical Research InstituteAcademic/Hospital2012002
The University of Texas, DallasAcademic/Hospital2012018
Alexandria UniversityAcademic/Hospital1112024
Assiut UniversityAcademic/Hospital1112017
Canadian Institutes of Health Research (CIHR)Academic/Hospital1012014
42 organizations
Page 1 / 3

Marketing (6)

OrganizationOrg typeRelationshipDate
B. BraunFor profitNDA2Feb 6, 1978
BaxaltaFor profitNDA2May 30, 1980
BaxterFor profitNDA2May 30, 1980
HospiraFor profitNDA2May 25, 1976
HospiraFor profitNDAMay 25, 1976
ICU Medical IncFor profitNDA2Feb 22, 1980