Drugs / Famotidine
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Famotidine

also known as Pepcid · FAM · Pepcid AC · Pepcid AC Acid reducer · RLD2101

Other / unclassified targets SELP via inhibition

Developed for
COVID-19 · peptic ulcer disease · complex regional pain syndrome · gastroesophageal reflux disease · osteoarthritis · rheumatoid arthritis · schizophrenia · aspiration pneumonia
+21 more · calcific tendinitis · dyskinesia of esophagus · dyspepsia · eosinophilic esophagitis · functional gastric disease · heart failure · hyperpigmentation of the skin · juvenile idiopathic arthritis · lung disorder · pulmonary arterial hypertension · sickle cell disease · ulcer disease · acute coronary syndrome · acute kidney injury · acute myocardial infarction · esophagitis · gastric ulcer · gastritis · laryngeal disorder · lymphoma · movement disorder
Investigated by
Amgen · Bristol-Myers Squibb · Emory University · Leidos Life Sciences · United States Department of Defense · Incyte Corporation
+74 more · Jesper Ekelund · Mayo Clinic · Pfizer · Ranbaxy Laboratories Limited · Research Foundation Flanders · University Ghent · Ahokas foundation, Finland · Assistance Publique - Hôpitaux de Paris · Astellas Pharma Inc · AstraZeneca · Bayer · Boston Children's Hospital · CURE Drug Repurposing Collaboratory (CDRC) · California Baptist University · Calithera Biosciences, Inc · Celgene Corporation · Chattogram General Hospital · City of Helsinki · Clemson University · DHR Health Institute for Research and Development · Dong-A ST Co., Ltd. · Dr. Reddy's Laboratories Limited · Eisai Inc. · Exelixis · Finland: Lilly saatio foundation · First Affiliated Hospital Xi'an Jiaotong University · Georgetown University · Gilead Sciences · INSERM U 1163 - Laboratory of molecular mechanisms of hematologic disorders and therapeutic implications, Paris · Idorsia Pharmaceuticals Ltd. · Janssen Research & Development, LLC · Kaohsiung Veterans General Hospital. · Karolinska Institutet · King Saud University · Lexicon Pharmaceuticals · Long Beach Memorial Medical Center · M Abdur Rahim Medical College and Hospital · M.D. Anderson Cancer Center · Main Line Health · Merck Sharp & Dohme LLC · Mirati Therapeutics Inc. · National Heart, Lung, and Blood Institute (NHLBI) · Novotech (Australia) Pty Limited · PMV Pharmaceuticals, Inc · Parexel · Pediatric Rheumatology Collaborative Study Group · Prisma Health-Upstate · Purdue Pharma LP · QuantumLeap Healthcare Collaborative · R-Pharm · Region Stockholm · Second Affiliated Hospital of Xi'an Jiaotong University · Stanley Medical Research Institute · Tel Aviv Medical Center · Tel-Aviv Sourasky Medical Center · The University of Texas Medical Branch, Galveston · URC-CIC Paris Descartes Necker Cochin · University Hospital Dubrava · University Hospitals Cleveland Medical Center · University of Alabama at Birmingham · University of California, Davis · University of California, Irvine · University of California, San Francisco · University of Colorado, Denver · University of Copenhagen · University of Miami · University of Michigan · University of Southern California · University of Texas · University of Washington · Wake Forest University Health Sciences · West Virginia University · Yale University · drpykessupplements.com

Regulatory milestones approvals, filings & regulatory actions · 7 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (3) US (FDA) PEPCID AC 1998-11-09 – 2007-12-17 fda.gov
Label expansions (3) US (FDA) PEPCID 1988-10-17 – 2002-06-06 fda.gov
Approved US (FDA) PEPCID 1986-10-15 fda.gov

Trials 60 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 125 trials
Phase 1 NCT07018635 Jul → Sep 2025 Incyte Corporation Completed No outcome recorded
Phase 1 NCT06170723 Mar → May 2024 Celgene Corporation Completed No outcome recorded
Phase 1 NCT06213818 Mar 2024 → Aug 2025 Incyte Corporation Completed No outcome recorded
Phase 1 NCT06054464 Sep → Nov 2023 PMV Pharmaceuticals, Inc Completed No outcome recorded
Phase 1 NCT05866627 Jul → Sep 2023 Bristol-Myers Squibb Completed No outcome recorded
Phase 1 NCT04935112 Jul → Aug 2021 Mirati Therapeutics Inc. Completed No outcome recorded
Phase 1 NCT04941755 Jun → Sep 2021 Bristol-Myers Squibb Completed No outcome recorded
Phase 1 NCT04903093 Jun → Oct 2021 Pfizer Completed No outcome recorded
Phase 1 NCT04545008 Oct 2020 → Jun 2021 COVID-19 Prisma Health-Upstate Terminated No outcome recorded
Phase 1 NCT04540965 Sep → Dec 2020 Calithera Biosciences, Inc Completed No outcome recorded
Phase 26 trials
Phase 2 NCT05085574 Feb 2023 COVID-19 Leidos Life Sciences Withdrawn No outcome recorded
Phase 2 NCT05077332 Dec 2021 → Nov 2025 COVID-19 Leidos Life Sciences Completed No outcome recorded
Phase 2 NCT05077969 Dec 2021 → Jun 2022 COVID-19 Leidos Life Sciences Terminated No outcome recorded
Phase 2 NCT04488081 Jul 2020 → Jul 2028 expected COVID-19 QuantumLeap Healthcare Collaborative Active not recruiting No outcome recorded
Phase 2 NCT04248712 Jul 2020 → Dec 2021 eosinophilic esophagitis Mayo Clinic Terminated No outcome recorded
Phase 2 NCT03554291 May 2019 → Jul 2023 heart failure, pulmonary arterial hypertension University of Washington Completed No outcome recorded
Phase 2/33 trials
Phase 2/3 NCT05084521 Jan → Dec 2022 sickle cell disease Assistance Publique - Hôpitaux de Paris Completed No outcome recorded
Phase 2/3 NCT01946295 Mar 2014 → Aug 2016 schizophrenia Jesper Ekelund Unknown No outcome recorded
Phase 2/3 NCT00141960 Sep 2005 → ? gastroesophageal reflux disease Astellas Pharma Inc Completed No outcome recorded
Phase 37 trials
Phase 3 NCT06801626 Mar 2025 → Dec 2026 expected The University of Texas Medical Branch, Galveston Recruiting No outcome recorded
Phase 3 NCT05946551 Mar → Jun 2024 COVID-19 Emory University Terminated No outcome recorded
Phase 3 NCT04504240 Aug 2020 → Apr 2021 COVID-19 Chattogram General Hospital Completed No outcome recorded
Phase 3 NCT00984815 Sep 2009 → Jul 2011 complex regional pain syndrome, osteoarthritis, rheumatoid arthritis Amgen Completed No outcome recorded
Phase 3 NCT00613106 Sep 2007 → Oct 2008 complex regional pain syndrome, osteoarthritis, rheumatoid arthritis Amgen Completed No outcome recorded
Phase 3 NCT00450216 Mar 2007 → Aug 2008 ulcer disease Amgen Completed No outcome recorded
Phase 3 NCT00450658 Mar 2007 → Sep 2008 peptic ulcer disease Amgen Completed No outcome recorded
Phase 410 trials
Phase 4 NCT05455359 Feb 2025 → May 2027 expected aspiration pneumonia, dyskinesia of esophagus, functional gastric disease, gastroesophageal reflux disease Boston Children's Hospital Recruiting No outcome recorded
Phase 4 NCT04836806 Aug 2021 → Jul 2022 COVID-19 Emory University Withdrawn No outcome recorded
Phase 4 NCT04565392 May → Nov 2021 COVID-19 drpykessupplements.com Withdrawn No outcome recorded
Phase 4 NCT01563185 Apr 2012 → Mar 2015 juvenile idiopathic arthritis Amgen Completed No outcome recorded
Phase 4 NCT02703896 Jan 2012 lung disorder King Saud University Completed No outcome recorded
Phase 4 NCT01232127 Feb → Jun 2011 HIV infectious disease Bristol-Myers Squibb Completed No outcome recorded
Phase 4 NCT00950339 Aug 2009 → Jun 2011 coronary artery disorder Tel-Aviv Sourasky Medical Center Completed No outcome recorded
Phase 4 NCT00565175 Jan 2008 → Dec 2011 schizophrenia Jesper Ekelund Completed No outcome recorded
Phase 4 NCT00384904 Dec 2006 → Dec 2007 HIV infectious disease Bristol-Myers Squibb Completed No outcome recorded
Phase 4 NCT01928888 May 2003 → Feb 2004 dyspepsia Bayer Completed No outcome recorded
Phase not applicable9 trials
NCT07539961 Sep 2026 → Dec 2027 expected calcific tendinitis University Hospital Dubrava Not yet recruiting No outcome recorded
NCT06629337 Apr → Aug 2024 hypertensive disorder California Baptist University Completed No outcome recorded
NCT06313307 Apr → Nov 2023 hyperpigmentation of the skin Second Affiliated Hospital of Xi'an Jiaotong University Completed No outcome recorded
NCT05131555 Aug → Dec 2021 University Ghent Completed No outcome recorded
NCT04123899 Oct → Nov 2019 peptic ulcer disease Dong-A ST Co., Ltd. Unknown No outcome recorded
NCT04450134 Oct → Dec 2019 University Ghent Completed No outcome recorded
NCT02551744 Jul 2012 → Jul 2018 peptic ulcer disease Kaohsiung Veterans General Hospital. Completed No outcome recorded
NCT01079052 Nov 2007 Ranbaxy Laboratories Limited Completed No outcome recorded
NCT01079065 Nov 2007 Ranbaxy Laboratories Limited Completed No outcome recorded
Also used as a comparator or background therapy in 65 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 119 trials
Phase 1 NCT07629999 Background Jun 2026 → Jun 2027 expected Bristol-Myers Squibb Not yet recruiting No outcome recorded
Phase 1 NCT07171619 Comparator Aug → Nov 2025 SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany Completed No outcome recorded
Phase 1 NCT06789172 Background Jan 2025 → Jul 2028 expected colorectal cancer, dedifferentiated liposarcoma, gastric adenocarcinoma, gastroesophageal adenocarcinoma +6 Epkin Recruiting No outcome recorded
Phase 1 NCT06332638 Comparator Mar → Jul 2024 HK inno.N Corporation Unknown No outcome recorded
Phase 1 NCT06144697 Background Jan → Oct 2024 Bristol-Myers Squibb Terminated No outcome recorded
Phase 1/25 trials
Phase 1/2 NCT06481306 Background Jul 2024 → Apr 2028 expected sickle cell disease Bristol-Myers Squibb Recruiting No outcome recorded
Phase 1/2 NCT06265077 Comparator Feb → Oct 2024 breast cancer Noha Mansour Completed No outcome recorded
Phase 1/2 NCT06207305 Background Jan 2024 → Jan 2028 expected appendix adenocarcinoma M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 1/2 NCT04990388 Background Oct 2021 → Mar 2023 glycogen storage disease III Ultragenyx Pharmaceutical Inc Terminated No outcome recorded
Phase 1/2 NCT04614974 Comparator Nov 2020 → May 2024 gastroesophageal reflux disease, laryngeal disorder Reema Padia Terminated No outcome recorded
Phase 211 trials
Phase 2 NCT06819670 Comparator May 2025 → Feb 2028 expected infantile spasms University of California, Los Angeles Recruiting No outcome recorded
Phase 2 NCT06706258 Comparator Jan 2025 → Dec 2026 expected acute kidney injury The University of Texas Health Science Center, Houston Recruiting No outcome recorded
Phase 2 NCT06154226 Comparator Jan → Sep 2024 acute kidney injury The University of Texas Health Science Center, Houston Completed No outcome recorded
Phase 2 NCT05977998 Background Sep 2023 → Oct 2028 expected gastric adenocarcinoma, metastatic carcinoma M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 2 NCT04918147 Background Oct 2021 → Jan 2024 immunoglobulin G4-related sclerosing disease National Institute of Allergy and Infectious Diseases (NIAID) Terminated No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT04862585 Comparator Oct 2021 → Jun 2024 breast carcinoma in situ, female breast carcinoma Ohio State University Comprehensive Cancer Center Completed No outcome recorded
Phase 2/3 NCT05043350 Background Sep 2021 → Jul 2022 COVID-19 Ain Shams University Completed No outcome recorded
Phase 38 trials
Phase 3 NCT05965492 Background Jun 2024 → Jun 2025 spinal cord disorder University of Miami Withdrawn No outcome recorded
Phase 3 NCT05024721 Comparator Aug 2021 → Mar 2022 gastritis Hanmi Pharmaceutical Company Limited Completed No outcome recorded
Phase 3 NCT04340297 Background Jun 2020 → Dec 2021 gastroesophageal reflux disease Xiyuan Hospital of China Academy of Chinese Medical Sciences Unknown No outcome recorded
Phase 3 NCT04370262 Comparator Apr → Sep 2020 COVID-19 Northwell Health Completed No outcome recorded
Phase 3 NCT03647072 Comparator Aug 2018 → Oct 2027 expected lymphoma Tanta University Recruiting No outcome recorded
Phase 414 trials
Phase 4 NCT07101445 Background Sep 2025 → Dec 2026 expected plasma cell myeloma Emory University Recruiting No outcome recorded
Phase 4 NCT06743243 Comparator Jul 2025 → Oct 2026 expected Seok Kyeong Oh Enrolling by invitation No outcome recorded
Phase 4 NCT06241183 Comparator Nov 2023 → Dec 2027 expected dyspepsia, gastroesophageal reflux disease Stony Brook University Recruiting No outcome recorded
Phase 4 NCT04990804 Background Aug 2021 → Feb 2022 spinal cord disorder, substance-related disorder Vanderbilt University Medical Center Terminated No outcome recorded
Phase 4 NCT04766996 Background May → Dec 2021 substance-related disorder Emory University Terminated No outcome recorded
Phase not applicable6 trials
NCT06211088 Comparator Aug → Dec 2024 Aswan University Hospital Completed No outcome recorded
NCT04463420 Background Aug → Nov 2020 COVID-19 Baqiyatallah Medical Sciences University Unknown No outcome recorded
NCT02473042 Background Mar 2016 → Nov 2024 breast cancer M.D. Anderson Cancer Center Completed No outcome recorded
NCT02700087 Comparator Feb 2016 → Feb 2017 gastroesophageal reflux disease, laryngeal disorder Stanford University Withdrawn No outcome recorded
NCT02410460 Background Sep 2013 → Jun 2014 Mercy Facial Plastic Surgery Center Completed No outcome recorded

Press releases naming this drug 2 releases

DateIssuerRelease
2001-05-31 Teva Branded Pharmaceutical Products R&D, Inc. Teva Announces Final Approval of Famotidine Tablets,10mg tevapharm.com
2001-04-17 Teva Branded Pharmaceutical Products R&D, Inc. Teva Announces Final Approval of Famotidine 20 & 40mg tevapharm.com

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 126 sources stand behind the page.

FieldValueCited text
Known as Famotidine “HZT-501, a fixed-dose combination of ibuprofen, a pain and inflammation relieving non-steroidal anti-inflammatory drug (NSAID), and famotidine, a histamine type 2 receptor...” NCT00984815
122

“The subject should maintain a minimum of 10 hours of empty stomach before administration, and swallow an oral dose of 1 tablets (Famotidine 20 mg) after moistening mouth with...” NCT04123899

“Topical H2RA (2% famotidine solution solved in double-distilled water (containing poloxamer 407, glycerol, lauryl alcohol polyether-4, polyethylene glycol-8, and propylene...” NCT06313307

“The patients will be randomly assigned to receive either (1) famotidine (40 mg qd) plus thienopyridine used previously or (2) placebo plus thienopyridine treatment alone for 6 months.” NCT02418312

“Subjects ingested fexofenadine (540 mg, tablet) at least 50 minutes before and famotidine (40 mg, tablet) 1 hour 50 minutes before the onset of each protocol” NCT06629337

“Therefore, this study compared the efficacy and safety of HIP2101 and 20-mg famotidine (RLD2101) in patients with gastric erosions.” PMID 39949051 Feb 2025

“in the 3-4 weeks, acid inhibitor was changed from PPI to famotidine tablets, 20mg each time, before going to bed” NCT04340297

Famotidine 20mg/10ml+saline 10ml IV + Tegoprazan OD tab. 50 mg placebo PO, one hour before general anesthesia.” NCT06743243

Famotidine (20mg BID) or Omeprazole (20mg daily) will be prescribed along with NSAIDS for GI prophylaxis” NCT04990804

“HZT-501 is a combination product including ibuprofen and the acid reducing agent famotidine.” NCT00450658

Famotidine 20 mg IV (as a slow push over 2 minutes) administered 3 hours prior to OKN4395” NCT06789172

“Ibuprofen 800mg/famotidine 26.6 mg administered orally 3 times daily for 2 weeks” NCT00613106

“* H2 receptor blockers: famotidine 4 mg, ranitidine 7.5 mg” NCT01734759

“1600 mg GS-9973 (Formulation 1) plus 40 mg famotidineNCT01841489

“40 mg famotidine every 12 hours for 5 days” NCT04463420

famotidine tab 40 mg qd for 6 months.” NCT02551744

“Group F (famotidine 20 mg)” NCT02703896

“40 mg FamotidineNCT05131555

famotidineNCT04990388

NCT00557349

NCT04470778

NCT00839488

NCT04941755

NCT04935112

NCT06213818

NCT04390334

NCT01232127

NCT06170723

NCT04918147

NCT04175925

NCT06054464

NCT01928888

NCT05085574

NCT04724720

NCT04550195

NCT04308837

NCT06241183

NCT06801626

NCT04540965

NCT03330028

NCT00451880

NCT06481306

NCT06265077

NCT02097329

NCT05043350

NCT06154226

NCT04179071

NCT05977998

NCT04536961

NCT04065932

NCT05077332

NCT05035407

NCT04949269

NCT00843063

NCT00422097

NCT03107182

NCT07101445

NCT03805932

NCT00978159

NCT01180179

NCT05866627

NCT01563185

NCT06819670

NCT04453189

NCT05599828

NCT07018635

NCT02142712

NCT07629999

NCT00384904

NCT05084521

NCT00633035

NCT04565392

NCT06211088

NCT04504240

NCT02700087

NCT06144697

NCT06207305

NCT01062516

NCT05965492

NCT07539961

NCT04614974

NCT05946551

NCT04209699

NCT06332638

NCT04248712

NCT04862585

NCT01511731

NCT03647072

NCT05077969

NCT01499368

NCT01937078

NCT02410460

NCT02684799

NCT03667703

NCT04488081

NCT01079065

NCT04450134

NCT07171619

NCT00450216

NCT04903093

NCT01079052

NCT01946295

NCT04836806

NCT02534636

NCT00565175

NCT01408186

NCT04621149

NCT04840615

NCT00141960

NCT00365339

NCT00950339

NCT04545008

NCT00229424

NCT05455359

NCT03142165

NCT01000818

NCT03302845

NCT03451110

NCT02763969

NCT03554291

NCT00683111

NCT04370262

NCT06706258

Known as FAM “group three received famotidine (FAM) 40 mg p.o. once daily one week before cycle” PMID 33394214 Jan 2021
1

Famotidine (FAM)” NCT01232127

Known as Pepcid “Famotidine (Pepcid), a histamine H2 antagonist widely available over-the-counter” NCT04370262
6

“Famotidine (Pepcid) will be given at 6 different timepoints:” NCT06706258

“20mg of oral famotidine (pill) daily Other names: PepcidNCT03554291

“oral famotidine (Pepcid)” NCT06801626

Pepcid 40 mg Tablets” NCT01511731

NCT04766996

NCT02473042

Known as Pepcid AC “This research is to determine which medication, Zegerid (Omeprazole/Sodium Bicarbonate) or Pepcid AC (Famotidine), works best at reducing the chance that a patient will get an...” NCT00557349
1

“Pepcid® AC Acid reducer famotidine tablets 20 mg (containing famotidine 20 mg)” NCT01079065

Known as Pepcid AC Acid reducer “Pepcid® AC Acid reducer famotidine tablets 20 mg (containing famotidine 20 mg) distributed by Johnson \& Johnson. Merck Consumer Pharmaceutical Co. Fort Washington, PA 19034...” NCT01079052
Known as RLD2101 “Therefore, this study compared the efficacy and safety of HIP2101 and 20-mg famotidine (RLD2101) in patients with gastric erosions.” PMID 39949051 Feb 2025
Action Inhibit “blockade of the histamine H2 receptors in the brain” NCT00565175
Modality Other / unclassified “a histamine 2 receptor antagonist (famotidine)” NCT01180179
Route Oral Oral administration of famotidine by 40mg/day along with lafutidine placebo” NCT00229424
Target SELP “famotidine may prevent vaso-occlusion by decreasing P-selectin expression by endothelial cells.” NCT05084521