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famotidine

Trade name: pepcid

Small moleculeapproved

Approved

Oct 15, 1986

Famotidine, a competitive histamine H2-receptor antagonist, is used to treat gastrointestinal disorders such as gastric or duodenal ulcer, gastroesophageal reflux disease, and pathological hypersecretory conditions. Famotidine inhibits many of the isoenzymes of the hepatic CYP450 enzyme system. Other actions of Famotidine include an increase in gastric bacterial flora such as nitrate-reducing organisms. Famotidine binds competitively to H2-receptors located on the basolateral membrane of the parietal cell, blocking histamine affects. This competitive inhibition results in reduced 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. — NCATS

Clinical trial activity

115 trials · 113 clinical orgs · 53 marketing orgs

Phase 1
48
Phase 2
30
Phase 3
18
Phase 4
23

Earliest trial started Oct 1, 1998 (NCT01511731)

Timeline

1980s

  1. Oct 15, 1986

    Bausch Health Companies — Earliest FDA Approval

  2. Oct 15, 1986

    Bausch Health Companies — NDA Secondary Org

  3. Oct 15, 1986

    Bausch Health Companies — NDA Organization

  4. Oct 15, 1986

    Bausch Health Companies — Marketing Organization

  5. Nov 4, 1986

    Merck — Marketing Organization

  6. Nov 4, 1986

    Merck — NDA Secondary Org

  7. Feb 2, 1987

    Salix — NDA Secondary Org

1990s

  1. Apr 28, 1995

    Johnson and Johnson — NDA Secondary Org

  2. Jan 1, 1998

    Dr. Reddy's Laboratories — Earliest Phase 1 Sponsor(trial)

  3. Nov 20, 1998

    Marsam Pharmaceuticals — Marketing Organization

  4. Nov 20, 1998

    Henry Schein, Inc — Marketing Organization

2000s

  1. Feb 7, 2001

    Apothecon — Marketing Organization

  2. Apr 16, 2001

    Athenex, Inc. — Marketing Organization

  3. Apr 16, 2001

    Ionis Pharmaceuticals, Inc. — Marketing Organization

  4. Apr 16, 2001

    Dr. Reddy's Laboratories — Marketing Organization

  5. Apr 16, 2001

    Fresenius — Marketing Organization

  6. Apr 16, 2001

    Hospira — Marketing Organization

  7. Apr 16, 2001

    Mylan — Marketing Organization

  8. Apr 16, 2001

    PL Developments — Marketing Organization

  9. Apr 16, 2001

    Sandoz — Marketing Organization

  10. Apr 16, 2001

    Watson Pharmaceuticals — Marketing Organization

  11. Apr 16, 2001

    West-Ward Pharmaceutical — Marketing Organization

  12. Apr 16, 2001

    Celltrion — Marketing Organization

  13. Apr 16, 2001

    Hikma — Marketing Organization

  14. Apr 16, 2001

    Mankind Pharma — Marketing Organization

  15. Apr 16, 2001

    Rising Pharmaceuticals — Marketing Organization

  16. Apr 16, 2001

    Novartis — Marketing Organization

  17. May 10, 2001

    Baxalta — Marketing Organization

  18. May 10, 2001

    Baxter — Marketing Organization

  19. Jul 23, 2001

    Apotex — Marketing Organization

  20. Jul 26, 2001

    P&L Development — Marketing Organization

  21. Sep 14, 2001

    Actavis — Marketing Organization

  22. Dec 17, 2001

    AbbVie — Marketing Organization

  23. Aug 22, 2003

    Perrigo — Marketing Organization

  24. Sep 24, 2004

    UCB — NDA Secondary Org

  25. Jan 1, 2005

    Earliest Phase 2 Sponsor(trial)

  26. Jan 1, 2005

    Earliest Phase 3 Sponsor(trial)

  27. Mar 7, 2005

    Glenmark Pharmaceuticals — Marketing Organization

  28. Mar 7, 2005

    Wockhardt — Marketing Organization

  29. May 22, 2009

    Alembic — Marketing Organization

  30. Nov 17, 2009

    Sun Pharmaceuticals — Marketing Organization

2010s

  1. May 27, 2010

    Navinta — Marketing Organization

  2. Jun 29, 2010

    Lupin — Marketing Organization

  3. Apr 23, 2011

    Horizon Pharma — Marketing Organization

  4. Apr 23, 2011

    Horizon Pharma — NDA Secondary Org

  5. Dec 17, 2012

    Novel Anti-Infective Technologies, LLC — Marketing Organization

  6. May 30, 2014

    Hi Tech Pharmaceuticals — Marketing Organization

  7. May 30, 2014

    Akorn, Inc. — Marketing Organization

  8. Dec 22, 2015

    Aurobindo Pharma — Marketing Organization

  9. Dec 23, 2019

    Alkem Labs Ltd — Marketing Organization

2020s

  1. Apr 20, 2021

    Novitium Pharma — Marketing Organization

  2. Apr 20, 2021

    Ani Pharmaceuticals — Marketing Organization

  3. Oct 15, 2021

    Ascent Pharmahealth — Marketing Organization

  4. Oct 29, 2021

    Teva — Marketing Organization

  5. Nov 4, 2021

    Annora Pharma — Marketing Organization

  6. Jan 7, 2022

    VKT Pharma — Marketing Organization

  7. Jun 3, 2022

    Zydus Discovery DMCC — Marketing Organization

  8. Aug 4, 2022

    Amneal Pharmaceuticals — Marketing Organization

  9. Mar 8, 2023

    Marksans Pharma — Marketing Organization

  10. Jun 16, 2023

    Appco Pharma — Marketing Organization

  11. Jul 7, 2023

    CARNEGIE — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedOct 15, 1986

Chemistry & pharmacology

Loading structure…

SMILES

NC(=N)NC1=NC(CSCCC(=N)NS(N)(=O)=O)=CS1
Mol. weight
337.445 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-amino-3-(((2-((diaminomethylene)amino)-4-thiazolyl)methyl)thio)propylidene)sulfamide
  • (1-amino-3-(((2-((diaminomethylene)amino)-4-thiazolyl)methyl)thio)propylidene)sulfamide
  • 3-(((2-((aminoiminomethyl)amino)-4-thiazolyl)methyl)thio)-n-(aminosulfonyl)propanimidamide
  • 3-(((2-((aminoiminomethyl)amino)-4-thiazolyl)methyl)thio)-n-(aminosulfonyl)propanimidamide
  • 3-(((2-((diaminomethylene)amino)-4-thiazolyl)methyl)thio)-n(sup 2)-sulfamoylpropionamidine
  • 3-(((2-((diaminomethylene)amino)-4-thiazolyl)methyl)thio)-n(sup 2)-sulfamoylpropionamidine
  • agufam
  • amfamox
  • antodine
  • apogastine
  • bestidine
  • brolin
  • cepal
  • digervin
  • dispromil
  • famotidina
  • famotidina
  • famotidine
  • famotidine
  • famotidine
  • famotidine
  • famotidine
  • famotidine
  • famotidine
  • famotidine
  • famotidine
  • famotidine
  • famotidine
  • famotidinum
  • famotidinum
  • fluxid
  • fluxid
  • mk-2048
  • mk-2048
  • mk-208
  • mk-208
  • n-sulfamoyl-3-((2-guanidinothiazol-4-yl)methylthio)propionamide
  • n-sulfamoyl-3-((2-guanidinothiazol-4-yl)methylthio)propionamide
  • pepcid
  • pepcid
  • pepcid
  • pepcid
  • pepcid ac
  • pepcid ac
  • pepcid rpd
  • pepcid rpd
  • t502
  • t502

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07101445Phase 4Sep 24, 2025Emory University, Gamida Cell, National Cancer Institute (NCI)
NCT07171619Phase 1Sep 9, 2025Medpace, Inc., SpringWorks Therapeutics, Inc.
NCT07018635Phase 1Jul 16, 2025Incyte
NCT06743243Phase 4Mar 31, 2025Chung-Ang University, Inno.N, Korea University, University of Ulsan
NCT06507904Phase 1Mar 31, 2025Pfizer
NCT06819670Phase 2Mar 1, 2025Pediatric Epilepsy Research Foundation, University of California, Los Angeles
NCT06851871Phase 1Jan 23, 2025Bristol-Myers Squibb
NCT06332638Phase 1Mar 19, 2024Inno.N
NCT06265077Phase 1/Phase 2 (Phase 2)Feb 29, 2024Mansoura University
NCT05965492Phase 3Feb 1, 2024University of Miami
NCT05946551Phase 3Jan 31, 2024Emory University
NCT06207305Phase 1/Phase 2 (Phase 2)Jan 30, 2024University of Texas at Houston
NCT06144697Phase 1Jan 17, 2024Bristol-Myers Squibb
NCT06170723Phase 1Jan 12, 2024Bristol-Myers Squibb, Celgene
NCT06154226Phase 4Dec 1, 2023Society of Cardiovascular Anesthesiologists, University of Texas at Houston
NCT06241183Phase 4Nov 9, 2023Stony Brook University
NCT06054464Phase 1Sep 19, 2023PMV Pharmaceuticals, Inc
NCT05977998Phase 2Sep 8, 2023University of Texas at Houston
NCT05866627Phase 1Jul 4, 2023Bristol-Myers Squibb
NCT06211088N/AJan 1, 2023Aswan University
Showing 20 of 115 trials
Page 1 / 6

Organizations

Research & Development (113)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Bristol-Myers SquibbFor profit201632006
University of Texas at HoustonAcademic/Hospital6642015
Horizon PharmaFor profit5522007
Emory UniversityAcademic/Hospital4422021
The University of Hong KongAcademic/Hospital4412004
Department of DefenseGovernment3012021
Harvard UniversityAcademic/Hospital3232018
LeidosFor profit3312021
MerckFor profit3212006
PfizerFor profit3312014
Chinese University of Hong KongAcademic/Hospital2222010
Far Eastern Memorial HospitalAcademic/Hospital2212007
Inno.NFor profit2122024
Korea UniversityAcademic/Hospital2122011
National Institute of Allergy and Infectious Diseases (NIAID)Government2222015
Northwell HealthAcademic/Hospital2222020
PerrigoFor profit2212004
RanbaxyFor profit2212007
Taichung Veterans General HospitalAcademic/Hospital2212012
University of HelsinkiAcademic/Hospital2222008
113 organizations
Page 1 / 6

Marketing (69)

OrganizationOrg typeRelationshipDate
AbbVieFor profitMKTGDec 17, 2001
ActavisFor profitMKTGSep 14, 2001
Akorn, Inc.For profitMKTGMay 30, 2014
AlembicFor profitMKTGMay 22, 2009
Alkem Labs LtdFor profitMKTGDec 23, 2019
Amneal PharmaceuticalsFor profitMKTGAug 4, 2022
Ani PharmaceuticalsFor profitMKTGApr 20, 2021
Annora PharmaFor profitMKTGNov 4, 2021
ApotexFor profitMKTGJul 23, 2001
ApotexFor profitSYNAug 2, 2002
ApotheconFor profitMKTGFeb 7, 2001
Appco PharmaFor profitMKTGJun 16, 2023
Ascent PharmahealthFor profitMKTGOct 15, 2021
Athenex, Inc.For profitMKTGApr 16, 2001
Aurobindo PharmaFor profitMKTGDec 22, 2015
Aurobindo PharmaFor profitSYNApr 26, 2016
Bausch Health CompaniesFor profitNDA2Oct 15, 1986
Bausch Health CompaniesFor profitNDAOct 15, 1986
Bausch Health CompaniesFor profitMKTGOct 15, 1986
BaxaltaFor profitMKTGMay 10, 2001
BaxterFor profitMKTGMay 10, 2001
CARNEGIEFor profitMKTGJul 7, 2023
CelltrionFor profitMKTGApr 16, 2001
Dr. Reddy's LaboratoriesFor profitMKTGApr 16, 2001
FreseniusFor profitMKTGApr 16, 2001
Glenmark PharmaceuticalsFor profitMKTGMar 7, 2005
Henry Schein, IncFor profitMKTGNov 20, 1998
Hi Tech PharmaceuticalsFor profitMKTGMay 30, 2014
HikmaFor profitMKTGApr 16, 2001
HikmaFor profitMKTGApr 16, 2001
Horizon PharmaFor profitMKTGApr 23, 2011
Horizon PharmaFor profitNDA2Apr 23, 2011
HospiraFor profitMKTGApr 16, 2001
Ionis Pharmaceuticals, Inc.For profitMKTGApr 16, 2001
Johnson and JohnsonFor profitNDA2Apr 28, 1995
LupinFor profitMKTGJun 29, 2010
Mankind PharmaFor profitMKTGApr 16, 2001
Marksans PharmaFor profitMKTGMar 8, 2023
Marsam PharmaceuticalsFor profitMKTGNov 20, 1998
MerckFor profitSYNFeb 18, 1994
MerckFor profitMKTGNov 4, 1986
MerckFor profitNDA2Nov 4, 1986
MylanFor profitMKTGApr 16, 2001
MylanFor profitSYNJun 25, 2008
MylanFor profitSYNApr 18, 2001
NavintaFor profitMKTGMay 27, 2010
NovartisFor profitMKTGApr 16, 2001
Novel Anti-Infective Technologies, LLCFor profitMKTGDec 17, 2012
Novitium PharmaFor profitMKTGApr 20, 2021
P&L DevelopmentFor profitMKTGJul 26, 2001
PL DevelopmentsFor profitMKTGApr 16, 2001
PerrigoFor profitMKTGAug 22, 2003
PerrigoFor profitSYNJul 27, 2005
Rising PharmaceuticalsFor profitSYNApr 16, 2001
Rising PharmaceuticalsFor profitMKTGApr 16, 2001
SalixFor profitNDA2Feb 2, 1987
SandozFor profitMKTGApr 16, 2001
Sun PharmaceuticalsFor profitMKTGNov 17, 2009
Sun PharmaceuticalsFor profitSYNDec 12, 2001
TevaFor profitSYNApr 16, 2001
TevaFor profitMKTGApr 16, 2001
TevaFor profitMKTGOct 29, 2021
UCBFor profitNDA2Sep 24, 2004
VKT PharmaFor profitMKTGJan 7, 2022
Watson PharmaceuticalsFor profitMKTGApr 16, 2001
West-Ward PharmaceuticalFor profitMKTGApr 16, 2001
WockhardtFor profitMKTGMar 7, 2005
WockhardtFor profitSYNApr 16, 2001
Zydus Discovery DMCCFor profitMKTGJun 3, 2022