CDEK
← All drugs Report issue

cimetidine

Trade name: tagamet

Small moleculeapproved

Approved

Aug 16, 1977

Cimetidine is a histamine H2-receptor antagonist. It reduces basal and nocturnal gastric acid secretion and a reduction in gastric volume, acidity, and amount of gastric acid released in response to stimuli including food, caffeine, insulin, betazole, or pentagastrin. It is used to treat gastrointestinal disorders such as gastric or duodenal ulcer, gastroesophageal reflux disease, and pathological hypersecretory conditions. Cimetidine inhibits many of the isoenzymes of the hepatic CYP450 enzyme system. Other actions of Cimetidine include an increase in gastric bacterial flora such as nitrate-reducing organisms. Cimetidine binds to an H2-receptor located on the basolateral membrane of the gastric parietal cell, blocking histamine effects. This competitive inhibition results in reduced gastric acid secretion and a reduction in gastric volume and acidity. — NCATS

Clinical trial activity

30 trials · 33 clinical orgs · 30 marketing orgs

Phase 1
13
Phase 2
11
Phase 3
5
Phase 4
2

Earliest trial started Jan 1, 1996 (NCT00002733)

Timeline

1970s

  1. Aug 16, 1977

    GlaxoSmithKline — Earliest FDA Approval

  2. Aug 16, 1977

    GlaxoSmithKline — NDA Secondary Org

  3. Aug 16, 1977

    GlaxoSmithKline — NDA Organization

1990s

  1. May 17, 1994

    Chartwell Pharmaceuticals — Marketing Organization

  2. May 17, 1994

    Mylan — Marketing Organization

  3. Jun 1, 1994

    G & W Laboratories Inc. — Marketing Organization

  4. Aug 31, 1994

    Vintage — Marketing Organization

  5. Dec 20, 1994

    Lutipold — Marketing Organization

  6. Dec 20, 1994

    Sankyo — Marketing Organization

  7. Dec 22, 1994

    Lannett Company, Inc. — Marketing Organization

  8. Dec 23, 1994

    Cycle Pharmaceuticals Ltd. — Marketing Organization

  9. Dec 27, 1994

    Hospira — Marketing Organization

  10. Jan 31, 1995

    Fosun — Marketing Organization

  11. May 30, 1995

    Teva — Marketing Organization

  12. Jun 19, 1995

    Medtech Products — NDA Secondary Org

  13. Jun 23, 1995

    DAVA Pharmaceuticals — Marketing Organization

  14. Jun 23, 1995

    Novitium Pharma — Marketing Organization

  15. Jun 29, 1995

    Sandoz — Marketing Organization

  16. Jan 1, 1996

    Earliest Phase 2 Sponsor(trial)

  17. Jan 24, 1996

    Upsher-Smith Laboratories — Marketing Organization

  18. Feb 28, 1996

    Watson Pharmaceuticals — Marketing Organization

  19. Sep 26, 1996

    Ani Pharmaceuticals — Marketing Organization

  20. Jan 27, 1997

    Pharmaceutical Associates — Marketing Organization

  21. Feb 27, 1997

    Pliva — Marketing Organization

  22. Oct 17, 1997

    Wockhardt — Marketing Organization

  23. Oct 17, 1997

    Xttrium Laboratories — Marketing Organization

  24. Oct 28, 1997

    Hi Tech Pharmaceuticals — Marketing Organization

  25. Oct 28, 1997

    Akorn, Inc. — Marketing Organization

  26. Jun 19, 1998

    Apotex — Marketing Organization

  27. Jun 19, 1998

    Contract Pharmacal — Marketing Organization

  28. Jun 19, 1998

    Novartis — Marketing Organization

  29. Oct 29, 1998

    Perrigo — Marketing Organization

  30. Dec 18, 1998

    Hikma — Marketing Organization

2000s

  1. Jan 1, 2000

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2002

    Earliest Phase 3 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAug 16, 1977

Chemistry & pharmacology

Loading structure…

SMILES

CN/C(=N\CCSCc1nc[nH]c1C)NC#N
Mol. weight
252.35 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Over the Counter

Oral

Yes

Parenteral

Yes

Topical

No

Sources

Also known as

  • 1-cyano-2-methyl-3-(2-(((5-methyl-4-imidazolyl)methyl)thio)ethyl)guanidine
  • 1-cyano-2-methyl-3-(2-(((5-methyl-4-imidazolyl)methyl)thio)ethyl)guanidine
  • 2-cyano-1-methyl-3-(2-(((5-methylimidazol-4-yl)methyl)thio)ethyl)guanidine
  • 2-cyano-1-methyl-3-(2-(((5-methylimidazol-4-yl)methyl)thio)ethyl)guanidine
  • acid-eze
  • acitak 200
  • acitak 400
  • acitak 800
  • brumetadina
  • brumetadina
  • cimetag
  • cimetag
  • cimetidin
  • cimetidin
  • cimetidina
  • cimetidina
  • cimetidine
  • cimetidine
  • cimetidine
  • cimetidine
  • cimetidine
  • cimetidine
  • cimetidine
  • cimetidine
  • cimetidine
  • cimetidine
  • cimetidine
  • cimétidine
  • cimétidine
  • cimetidine hcl
  • cimetidine hcl
  • cimetidine hcl
  • cimetidine hydrochloride
  • cimetidine hydrochloride
  • cimetidine hydrochloride
  • cimetidine hydrochloride
  • cimetidinum
  • cimetidinum
  • dyspamet
  • dyspamet
  • galenamet
  • galenamet
  • kentamet
  • n-cyano-n'-methyl-n''-(2-([(5-methyl-1h-imidazol-4-yl)methyl]sulfanyl)ethyl)guanidine
  • n-cyano-n'-methyl-n''-(2-([(5-methyl-1h-imidazol-4-yl)methyl]sulfanyl)ethyl)guanidine
  • n''-cyano-n-methyl-n'-(2-{[(5-methyl-1h-imidazol-4-yl)methyl]thio}ethyl)guanidine
  • n''-cyano-n-methyl-n'-(2-{[(5-methyl-1h-imidazol-4-yl)methyl]thio}ethyl)guanidine
  • peptimax 200
  • peptimax 400
  • peptimax 800
  • tagadine
  • tagamet
  • tagamet
  • tagamet
  • tagamet
  • tagamet 100
  • tagamet hb
  • tagamet hb
  • tagamet hb 200
  • tagamet hb 200
  • tagamet hb 200
  • tametin
  • ulcedin
  • ulcedine
  • ulcerex
  • ulcerfen
  • ulcerfen
  • ulcerfen
  • ultec
  • valmagen
  • valmagen
  • zita
  • zita

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06010342Phase 2Jan 31, 2024Suzhou Teligene Ltd.
NCT06056583Phase 4Jan 15, 2024National Institutes of Health (NIH), University of Washington
NCT05881811Phase 1Mar 20, 2023Haisco Pharmaceutical
NCT05365451Early Phase 1 (Phase 1)Apr 11, 2022National Institutes of Health (NIH), Washington State University
NCT05020184Phase 2Dec 31, 2021Harvard University, University of Texas, Galveston, Wake Forest University
NCT04862585Phase 2/Phase 3 (Phase 3)Oct 7, 2021Ohio State University
NCT04493931Phase 1Aug 14, 2020GlaxoSmithKline
NCT03618316Phase 1Jun 19, 2018Poxel SA
NCT04018131Phase 3Mar 26, 2018University of Indonesia
NCT03380455Phase 1Jan 9, 2018Idorsia Pharmaceuticals Ltd.
NCT03307252Phase 1Oct 25, 2017Boehringer Ingelheim
NCT02202512Phase 1Sep 1, 2014Boehringer Ingelheim
NCT02157376Phase 3Jul 1, 2014AstraZeneca, Fudan University
NCT02287272Phase 1May 1, 2014Chiesi, SGS Life Sciences
NCT01659502Phase 2Dec 1, 2013Tiltan Pharma
NCT01757275Phase 3Feb 1, 2013AstraZeneca
NCT01536249Phase 1Mar 1, 2012Knopp Biosciences
NCT01509911Phase 2Jan 1, 2012Novatrials, Technostat, Tiltan Pharma
NCT02703896Phase 4Jan 1, 2012King Saud University
NCT01256879Phase 1Mar 1, 2011Food and Drug Administration, University of Maryland
Showing 20 of 30 trials
Page 1 / 2

Organizations

Research & Development (33)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Boehringer IngelheimFor profit3312000
Tiltan PharmaFor profit3312009
AstraZenecaFor profit2212013
Food and Drug AdministrationGovernment2012009
National Institutes of Health (NIH)Government2022022
University of MarylandAcademic/Hospital2212009
Bausch Health CompaniesFor profit1112002
Cancer Biotherapy Research GroupAcademic/Hospital1011996
ChiesiFor profit1112014
Community Research Initiative of New EnglandAcademic/Hospital1111999
Fudan UniversityAcademic/Hospital1012014
GlaxoSmithKlineFor profit1112020
Haisco PharmaceuticalFor profit1112023
Harvard UniversityAcademic/Hospital1112021
Hoag Memorial Hospital PresbyterianAcademic/Hospital1111996
Idorsia Pharmaceuticals Ltd.For profit1112018
King Saud UniversityAcademic/Hospital1112012
Knopp BiosciencesFor profit1112012
NovatrialsFor profit1012012
Ohio State UniversityAcademic/Hospital1112021
33 organizations
Page 1 / 2

Marketing (41)

OrganizationOrg typeRelationshipDate
Akorn, Inc.For profitMKTGOct 28, 1997
Ani PharmaceuticalsFor profitMKTGSep 26, 1996
Ani PharmaceuticalsFor profitSYNSep 26, 1996
ApotexFor profitMKTGJun 19, 1998
ApotexFor profitSYNMar 15, 2000
Chartwell PharmaceuticalsFor profitMKTGMay 17, 1994
Chartwell PharmaceuticalsFor profitSYNDec 22, 1994
Chartwell PharmaceuticalsFor profitSYNJan 31, 1995
Contract PharmacalFor profitMKTGJun 19, 1998
Cycle Pharmaceuticals Ltd.For profitMKTGDec 23, 1994
Cycle Pharmaceuticals Ltd.For profitSYNDec 23, 1994
DAVA PharmaceuticalsFor profitMKTGJun 23, 1995
FosunFor profitMKTGJan 31, 1995
G & W Laboratories Inc.For profitMKTGJun 1, 1994
GlaxoSmithKlineFor profitNDA2Aug 16, 1977
GlaxoSmithKlineFor profitNDAAug 16, 1977
Hi Tech PharmaceuticalsFor profitMKTGOct 28, 1997
HikmaFor profitMKTGDec 18, 1998
HospiraFor profitMKTGDec 27, 1994
Lannett Company, Inc.For profitMKTGDec 22, 1994
LutipoldFor profitMKTGDec 20, 1994
Medtech ProductsFor profitNDA2Jun 19, 1995
MylanFor profitMKTGMay 17, 1994
NovartisFor profitMKTGJun 19, 1998
Novitium PharmaFor profitMKTGJun 23, 1995
PerrigoFor profitMKTGOct 29, 1998
PerrigoFor profitSYNJun 19, 1998
Pharmaceutical AssociatesFor profitMKTGJan 27, 1997
PlivaFor profitMKTGFeb 27, 1997
SandozFor profitMKTGJun 29, 1995
SandozFor profitSYNJun 29, 1995
SankyoFor profitMKTGDec 20, 1994
TevaFor profitMKTGMay 30, 1995
TevaFor profitSYNMay 17, 1994
TevaFor profitSYNNov 26, 1997
TevaFor profitSYNJul 29, 1999
Upsher-Smith LaboratoriesFor profitMKTGJan 24, 1996
VintageFor profitMKTGAug 31, 1994
Watson PharmaceuticalsFor profitMKTGFeb 28, 1996
WockhardtFor profitMKTGOct 17, 1997
Xttrium LaboratoriesFor profitMKTGOct 17, 1997