glycerin

Small moleculeapproved

Approved

May 6, 1982

Glycerin (glycerol) is 3-carbon alcohol naturally occurring in the human body. It is the structural backbone triacylglycerol molecules, and can also be converted to a glycolytic substrate for subsequent metabolism. Glycerin is a colorless, odorless, viscous, sweet-tasting liquid. The FDA classifies glycerol as "generally recognized as safe". Glycerin is used in the pharmaceutical industry as a sweetener in syrups, lozenges, and as an excipient in eyewash solutions. As an individual prescription product, glycerin has uses as a hyperosmotic, osmotic diuretic, and ophthalmic agent. It may be used as an eye drop in the treatment of glaucoma to reduce intraocular pressure, as a solution or suppository for short-term treatment of constipation, to evacuate the bowel prior to a colonoscopy, and in some ocular surgeries. It may be given intravenously to reduce pressure inside the brain and used externally on the skin as a moisturizer. Glycerin has many other uses in the agricultural, food and pharmaceutical industry. — NCATS

Clinical trial activity

69 trials · 89 clinical orgs · 1 marketing orgs

Phase 1
2
Phase 2
16
Phase 3
10
Phase 4
19

Earliest trial started Oct 1, 1999 (NCT00005889)

Timeline

1980s

  1. May 6, 1982

    B. Braun — Earliest FDA Approval

  2. May 6, 1982

    Evidence of US Marketing

  3. May 6, 1982

    B. Braun — NDA Secondary Org

  4. May 6, 1982

    B. Braun — NDA Organization

2000s

  1. Jan 1, 2005

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2008

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Jan 1, 2016

    Earliest Phase 1 Sponsor(trial)

Indications

Mechanism of action

Combination products

Approval history

  • approvedMay 6, 1982
  • approvedMay 6, 1982

Chemistry & pharmacology

Loading structure…

SMILES

OCC(O)CO
Mol. weight
92.0938 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Discontinued

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • 1,2,3-propanetriol
  • 1,2,3-propanetriol
  • 1,2,3-triglycerol
  • 1,2,3-trihydroxypropane
  • 1,2,3-trihydroxypropane
  • 2-chloro-n-(4-chlorobiphenyl-2-yl)nicotinamide
  • boscalid
  • boscalid
  • boscalid
  • e422
  • e422
  • endura
  • endura
  • endura
  • glycerin
  • glycerin
  • glycerin
  • glycerin
  • glycerin
  • glycerin
  • glycerin
  • glycerin,anhydrous
  • glycerin,anhydrous
  • glycerin, anhydrous
  • glycerin, anhydrous
  • glycerine
  • glycerine
  • glycerine
  • glycérine
  • glycérine
  • glycerinum
  • glycerinum
  • glycerol
  • glycerol
  • glycerol
  • glycerol
  • glycerol
  • glycerol
  • glycerol
  • glycerol
  • glycérol
  • glycérol
  • glycogelatin
  • glycyl alcohol
  • glyzerin
  • glyzerin
  • keybells
  • lubriderm
  • monoctanoin component d
  • monoctanoin component d
  • monoctanoin component d
  • nirolex
  • ölsüß
  • ölsüß
  • ophthalgan
  • ophthalgan
  • optim
  • optim
  • osmoglyn
  • osmoglyn
  • propane-1,2,3-triol
  • propanetriol
  • propanetriol
  • senokot direct relief
  • taponoto
  • tixylix baby
  • tixylix toddler
  • trihydroxypropane
  • trihydroxypropane
  • waterhouse

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07226739Phase 4Jan 31, 2026Emory University, National Institutes of Health (NIH)
NCT07284381Phase 3Dec 15, 2025AbbVie
NCT06048614N/ASep 30, 2023Duke University, KK Women's and Children's Hospital, National University of Singapore, Singapore General Hospital, SingHealth Investigational Medicine Unit
NCT05660447Phase 2/Phase 3 (Phase 3)Dec 19, 2022Thomas Jefferson University
NCT05660681N/ADec 12, 2022Andover Research Eye Institute, Calm Water Therapeutics LLC
NCT05217160Phase 4May 11, 2021The Metis Foundation
NCT04493333Phase 2Dec 31, 2020AMAG Pharmaceuticals, Inc., University of Arkansas
NCT05057351N/ASep 1, 2020Complife Italia Srl, Greenpharma S.A.S.
NCT04409873Phase 2Jul 1, 2020University of California, San Francisco
NCT03978338N/AJul 31, 2019Chinese Academy of Medical Sciences, Zhitong Biopharma CO.,LTD
NCT04855279N/AJan 7, 2019Istanbul Medipol University
NCT02942082N/ANov 1, 2017Cairo University
NCT03197922Phase 3Oct 25, 2017Department of Defense, Emory University
NCT03355326Phase 4Oct 1, 2017Indiana University
NCT04253704Phase 1/Phase 2 (Phase 2)Feb 13, 2017Cantor Research Laboratory, Sytheon Ltd.
NCT02936830Phase 4Oct 1, 2016Riyadh Colleges of Dentistry and Pharmacy
NCT02797067Phase 4Sep 1, 2016Changhai Hospital
NCT02811289N/AAug 5, 2016Centre de Recherche Clinique du CHUS, University of Sherbrooke
NCT03657407Phase 4Jun 1, 2016Mercy Medical Center, University of Maryland
NCT02624661Phase 1/Phase 2 (Phase 2)May 1, 2016Norwegian University of Science and Technology
Showing 20 of 69 trials
Page 1 / 4

Organizations

Research & Development (89)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AllerganFor profit13942004
Emory UniversityAcademic/Hospital3332015
Thomas Jefferson UniversityAcademic/Hospital3332004
Baylor UniversityAcademic/Hospital2111999
FerringFor profit2222010
Innovative Medical Research of South Florida, IncFor profit2212007
The University of Texas, DallasAcademic/Hospital2122014
University of RochesterAcademic/Hospital2112008
AbbVieFor profit1112025
AMAG Pharmaceuticals, Inc.For profit1012020
Andover Research Eye InstituteAcademic/Hospital1012022
Arbor PharmaceuticalsFor profit1112013
Arrayan HospitalAcademic/Hospital1012014
BayerFor profit1012008
Bp Consulting, IncFor profit1112008
Cairo UniversityAcademic/Hospital1112017
Calm Water Therapeutics LLCFor profit1112022
Cantor Research LaboratoryFor profit1012017
Centre de Recherche Clinique du CHUSAcademic/Hospital1012016
Changhai HospitalAcademic/Hospital1112016
89 organizations
Page 1 / 5

Marketing (2)

OrganizationOrg typeRelationshipDate
B. BraunFor profitNDA2May 6, 1982
B. BraunFor profitNDAMay 6, 1982