Clinical Trials

Famotidine has a well-documented clinical history supported by 127 trials recorded across multiple clinical phases ranging from Phase 1 to Phase 4. Research efforts evaluate the compound across diverse medical conditions, including gastroesophageal reflux disease, COVID-19, laryngomalacia, and solid tumors such as non-small-cell lung cancer and colorectal cancer, as well as pharmacokinetic assessments in healthy volunteers. These trials encompass a wide range of recruitment statuses, including completed, active not recruiting, recruiting, terminated, and withdrawn. Clinical studies are backed by various sponsors spanning pharmaceutical developers like Bristol-Myers Squibb, Astellas Pharma, and Exelixis to public institutions such as the National Institute of Allergy and Infectious Diseases.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05977998 RECRUITING
Gastric Adenocarcinoma; Carcinomatosis
M.D. Anderson Cancer Center
 2023-09-08 PHASE2
NCT04488081 ACTIVE_NOT_RECRUITING
COVID-19
QuantumLeap Healthcare Collaborative
 2020-07-31 PHASE2
NCT06819670 RECRUITING
Infantile Spasms; Infantile Epileptic Spasms Syndrome; West Syndrome
University of California, Los Angeles
 2025-05-05 PHASE2
NCT06207305 RECRUITING
Metastatic Appendiceal Adenocarcinoma; Intraperitoneal Paclitaxel
M.D. Anderson Cancer Center
 2024-01-30 PHASE1; PHASE2
NCT06241183 RECRUITING
Dyspepsia; GERD; Acid Reflux
Stony Brook University
 2023-11-09 PHASE4
NCT07539961 NOT_YET_RECRUITING
Calcific Tendinitis
University Hospital Dubrava
 2026-09-01
NCT03647072 RECRUITING
Lymphoma
Sherief Abd-Elsalam
 2018-08-01 PHASE3
NCT07629999 RECRUITING
Healthy Volunteers
Bristol-Myers Squibb
 2026-07-13 PHASE1
NCT05455359 RECRUITING
Esophageal Motility Disorders; Gastric Motor Dysfunction; Aspiration Pneumonia; Gastro Esophageal Reflux
Boston Children's Hospital
 2025-02-13 PHASE4
NCT06507904 NOT_YET_RECRUITING
Healthy
Pfizer
 2026-09-15 PHASE1
NCT07742384 NOT_YET_RECRUITING
Healthy Adult Participants
Nuvation Bio Inc.
 2026-08-01 PHASE1
NCT06481306 RECRUITING
Anemia, Sickle Cell; Healthy Volunteers
Bristol-Myers Squibb
 2024-07-17 PHASE1; PHASE2
NCT07101445 RECRUITING
Multiple Myeloma
Emory University
 2025-09-24 PHASE4
NCT06801626 RECRUITING
Burn Scar; Itch Scarring; Wound
The University of Texas Medical Branch, Galveston
 2025-03-01 PHASE3
NCT06706258 RECRUITING
Acute Kidney Injury
The University of Texas Health Science Center, Houston
 2025-01-24 PHASE2
NCT06743243 ENROLLING_BY_INVITATION
General Anesthesia
Seok Kyeong Oh
 2025-07-23 PHASE4
NCT06717269 COMPLETED
Healthy Volunteer
Nurix Therapeutics, Inc.
 2024-11-30 PHASE1
NCT07171619 COMPLETED
Healthy
SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
 2025-08-21 PHASE1
NCT05077332 COMPLETED
2019 Novel Coronavirus Disease; 2019 Novel Coronavirus Infection; 2019-nCoV Disease; 2019-nCoV Infection; COVID-19 Pandemic; COVID-19 Virus Disease; COVID-19 Virus Infection; Covid19; Coronavirus Disease 2019; SARS-CoV-2 Infection; SARS-CoV-2 Acute Respiratory Disease; COVID-19
Leidos Life Sciences
 2021-12-29 PHASE2
NCT07018635 COMPLETED
Healthy Participants
Incyte Corporation
 2025-07-16 PHASE1
NCT06213818 COMPLETED
Healthy Participants
Incyte Corporation
 2024-03-14 PHASE1
NCT04308837 UNKNOWN
Gastric Cancer; Stomach Cancer
Icahn School of Medicine at Mount Sinai
 2018-12-03 PHASE2
NCT05035407 TERMINATED
Kita-kyushu Lung Cancer Antigen 1, Human
National Cancer Institute (NCI)
 2022-03-08 PHASE1
NCT05965492 WITHDRAWN
Spinal Disorder
University of Miami
 2024-06-01 PHASE3
NCT06851871 COMPLETED
Healthy Participants
Bristol-Myers Squibb
 2025-01-23 PHASE1
NCT06211088 COMPLETED
Postoperative Nausea and Vomiting
Aswan University Hospital
 2024-08-01
NCT06265077 COMPLETED
Breast Cancer; Filgrastim Adverse Reaction
Noha Mansour
 2024-02-01 PHASE1; PHASE2
NCT06144697 TERMINATED
Healthy Participants
Bristol-Myers Squibb
 2024-01-29 PHASE1
NCT06154226 COMPLETED
Acute Kidney Injury
The University of Texas Health Science Center, Houston
 2024-01-10 PHASE2
NCT03107182 COMPLETED
HPV-Related Squamous Cell Carcinoma; HNSCC
University of Chicago
 2017-06-27 PHASE2
NCT06332638 UNKNOWN
Healthy
HK inno.N Corporation
 2024-03-19 PHASE1
NCT05946551 TERMINATED
COVID-19
Emory University
 2024-03-08 PHASE3
NCT04862585 COMPLETED
Anatomic Stage 0 Breast Cancer AJCC v8; Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Anatomic Stage IB Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIIB Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Breast Carcinoma; Prognostic Stage 0 Breast Cancer AJCC v8; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage IA Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Prognostic Stage IIB Breast Cancer AJCC v8; Prognostic Stage III Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IIIB Breast Cancer AJCC v8; Prognostic Stage IIIC Breast Cancer AJCC v8; Prognostic Stage IV Breast Cancer AJCC v8
Ohio State University Comprehensive Cancer Center
 2021-10-07 PHASE2; PHASE3
NCT06170723 COMPLETED
Healthy Participants
Celgene
 2024-03-18 PHASE1
NCT04614974 TERMINATED
Laryngomalacia; Gastro Esophageal Reflux
Reema Padia
 2020-11-18 PHASE1; PHASE2
NCT04918147 TERMINATED
IgG4 Related Disease; IgG4-RD
National Institute of Allergy and Infectious Diseases (NIAID)
 2021-10-13 PHASE2
NCT06054464 COMPLETED
Healthy Volunteers
PMV Pharmaceuticals, Inc
 2023-09-19 PHASE1
NCT05866627 COMPLETED
Healthy Volunteers
Bristol-Myers Squibb
 2023-07-04 PHASE1
NCT06054464 Active not recruiting
Healthy Volunteers
PMV Pharmaceuticals Inc
 2023-09-19 Phase 1
NCT03554291 COMPLETED
Pulmonary Arterial Hypertension; Right Heart Failure
University of Washington
 2019-05-01 PHASE2
NCT03805932 ACTIVE_NOT_RECRUITING
Hairy Cell Leukemia
National Cancer Institute (NCI)
 2019-10-03 PHASE1
NCT03330028 COMPLETED
Diseases of Oesophagus Stomach and Duodenum
M.D. Anderson Cancer Center
 2017-10-27 PHASE1
NCT05085574 WITHDRAWN
2019 Novel Coronavirus Disease; 2019 Novel Coronavirus Infection; 2019-nCoV Disease; 2019-nCoV Infection; COVID-19 Pandemic; COVID-19 Virus Disease; COVID-19 Virus Infection; Covid19; Coronavirus Disease 2019; SARS-CoV-2 Infection; SARS-CoV-2 Acute Respiratory Disease; COVID-19
Leidos Life Sciences
 2023-02-07 PHASE2
NCT05084521 COMPLETED
Sickle Cell Disease
Assistance Publique - Hôpitaux de Paris
 2022-01-12 PHASE2; PHASE3
NCT05043350 COMPLETED
Covid19
Ain Shams University
 2021-09-13 PHASE2; PHASE3
NCT04836806 WITHDRAWN
Covid19
Emory University
 2021-08 PHASE4
NCT03667703 COMPLETED
Congenital Heart Disease; Upper Gastrointestinal Bleeding; Stress Ulcer; Infection
Boston Children's Hospital
 2019-03-10 PHASE4
NCT05077969 TERMINATED
2019 Novel Coronavirus Disease; 2019 Novel Coronavirus Infection; 2019-nCoV Disease; 2019-nCoV Infection; COVID-19; COVID-19 Pandemic; COVID-19 Virus Disease; COVID-19 Virus Infection; Covid19; Coronavirus Disease 2019; SARS-CoV2 Infection; SARS-CoV-2 Acute Respiratory Disease
Leidos Life Sciences
 2021-12-29 PHASE2
NCT04621149 TERMINATED
COVID-19
Profact, Inc.
 2020-11-15 PHASE2
NCT04949269 COMPLETED
Healthy Participants
Bristol-Myers Squibb
 2021-07-20 PHASE1
NCT04248712 TERMINATED
Eosinophilic Esophagitis
Mayo Clinic
 2020-07-10 PHASE2
NCT04840615 TERMINATED
Mesothelioma
National Cancer Institute (NCI)
 2021-06-11 PHASE1
NCT04565392 WITHDRAWN
Covid19
drpykessupplements.com
 2021-05-01 PHASE4
NCT04903093 COMPLETED
Healthy Volunteers
Pfizer
 2021-06-04 PHASE1
NCT04941755 COMPLETED
Healthy Participants
Bristol-Myers Squibb
 2021-06-25 PHASE1
NCT04935112 COMPLETED
Healthy Adults
Mirati Therapeutics Inc.
 2021-07-07 PHASE1
NCT04175925 COMPLETED
Healthy Participants
Bristol-Myers Squibb
 2019-11-15 PHASE1
NCT04545008 TERMINATED
Covid19
Prisma Health-Upstate
 2020-10-20 PHASE1
NCT04941755 Completed
Healthy Participants
Bristol-Myers Squibb
 2021-06-25 Phase 1
NCT04724720 COMPLETED
Covid-19
Northwell Health
 2021-01-19 PHASE2
NCT04504240 COMPLETED
Covid19
Chattogram General Hospital
 2020-08-01 PHASE3
NCT04470778 COMPLETED
Healthy Participants
Bristol-Myers Squibb
 2020-07-20 PHASE1
NCT04550195 COMPLETED
Healthy Volunteers
Bristol-Myers Squibb
 2020-09-17 PHASE1
NCT04536961 COMPLETED
Healthy Volunteers
Bristol-Myers Squibb
 2020-09-10 PHASE1
NCT04540965 COMPLETED
Drug Interaction
Calithera Biosciences, Inc
 2020-09-22 PHASE1
NCT04614974 Active not recruiting
Laryngomalacia|Gastro Esophageal Reflux
Reema Padia|University of Pittsburgh
 2020-11-18 Phase 1|Phase 2
NCT04453189 COMPLETED
Healthy Participants
Janssen Research & Development, LLC
 2020-07-20 PHASE1
NCT05599828 COMPLETED
Healthy Participants
Amgen
 2020-07-17 PHASE1
NCT04370262 COMPLETED
COVID-19
Northwell Health
 2020-04-07 PHASE3
NCT04390334 COMPLETED
Healthy
Idorsia Pharmaceuticals Ltd.
 2020-05-13 PHASE1
NCT04179071 COMPLETED
Solid Tumours
AstraZeneca
 2019-12-13 PHASE1
NCT04209699 COMPLETED
Healthy Participants
Bristol-Myers Squibb
 2019-12-27 PHASE1
NCT04450134 COMPLETED
Exercise Training; Physical Activity
University Ghent
 2019-10-02
NCT04065932 COMPLETED
Lupus
Bristol-Myers Squibb
 2019-08-22 PHASE1
NCT04123899 UNKNOWN
Gastroduodenal Ulcer
Dong-A ST Co., Ltd.
 2019-10-11
NCT01180179 COMPLETED
Peptic Ulcer
Chinese University of Hong Kong
 2010-06 PHASE4
NCT02551744 COMPLETED
Peptic Ulcer
Kaohsiung Veterans General Hospital.
 2012-07
NCT03451110 COMPLETED
Healthy Subjects
Eisai Inc.
 2018-02-05 PHASE1
NCT03142165 COMPLETED
Fibrosis
Bristol-Myers Squibb
 2017-05-11 PHASE1
NCT03302845 COMPLETED
Drug-drug Interaction
Lexicon Pharmaceuticals
 2017-09-21 PHASE1
NCT02922933 COMPLETED
Volunteers; Healthy Volunteers; Human Volunteers; Normal Volunteers
Syndax Pharmaceuticals
 2016-10-25 PHASE1
NCT02700087 WITHDRAWN
Laryngomalacia; Acid Reflux; Stridor
Stanford University
 2016-02
NCT00153673 COMPLETED
Arthritis; Gastric Ulcer
Chinese University of Hong Kong
 2001-02 PHASE3
NCT02763969 COMPLETED
Psoriasis
Bristol-Myers Squibb
 2016-05-18 PHASE1
NCT02534636 COMPLETED
Healthy Subjects
Bristol-Myers Squibb
 2015-10 PHASE1
NCT01289678 TERMINATED
Acute Myelogenous Leukemia
Leo W. Jenkins Cancer Center
 2006-07 PHASE2
NCT01946295 UNKNOWN
Schizophrenia
Jesper Ekelund
 2014-03 PHASE2; PHASE3
NCT02684799 COMPLETED
Healthy
Tobira Therapeutics, Inc.
 2016-01-31 PHASE1
NCT01408186 COMPLETED
Upper Gastrointestinal Bleeding
Chinese University of Hong Kong
 2011-01 PHASE3
NCT01563185 COMPLETED
Juvenile Idiopathic Arthritis
Amgen
 2012-04 PHASE4
NCT02142712 COMPLETED
Acute Cerebrovascular Accident; Cerebral Edema
University of Florida
 2014-12 PHASE2
NCT02410460 COMPLETED
Rhytidoplasty
Mercy Facial Plastic Surgery Center
 2013-09
NCT02097329 COMPLETED
Healthy
Pfizer
 2014-04 PHASE1
NCT01937078 COMPLETED
Dyskinesia
University Health Network, Toronto
 2011-04 PHASE2
NCT00978159 UNKNOWN
Aspirin; Dyspepsia
Ruttonjee Hospital
 2009-09 PHASE4
NCT01910090 COMPLETED
Healthy
Pharmaceutical Research Unit, Jordan
 2012-12 PHASE1
NCT01499368 COMPLETED
Erosive Esophagitis
Boryung Pharmaceutical Co., Ltd
 2011-11 PHASE3
NCT00683111 COMPLETED
Acute Coronary Syndrome; Acute Myocardial Infarction
Ruttonjee Hospital
 2008-07 PHASE4
NCT00565175 COMPLETED
Schizophrenia
Jesper Ekelund
 2008-01 PHASE4
NCT00451880 COMPLETED
Cancer; Non-small-cell Lung Cancer; Colorectal Cancer; Papillary Thyroid Cancer; Melanoma
Exelixis
 2007-02 PHASE1
NCT00950339 COMPLETED
Coronary Heart Disease; GI Bleeding
Tel-Aviv Sourasky Medical Center
 2009-08 PHASE4
NCT01232127 COMPLETED
HIV
Bristol-Myers Squibb
 2011-02 PHASE4
NCT01062516 COMPLETED
Acute Coronary Syndrome; Acute Myocardial Infarction
Ruttonjee Hospital
 2010-01 PHASE4
NCT00633035 COMPLETED
Ulcer
Far Eastern Memorial Hospital
 2007-09 PHASE4
NCT00422097 COMPLETED
Cancer
R-Pharm
 2007-01 PHASE1
NCT00839488 TERMINATED
Stomach Ulcer
Far Eastern Memorial Hospital
 2008-04 PHASE4
NCT01000818 COMPLETED
HIV-1 Infection; HIV Infections
Merck Sharp & Dohme LLC
 2008-06 PHASE1
NCT00843063 COMPLETED
Peptic Ulcer/Erosions
Ruttonjee Hospital
 2004-08 PHASE4
NCT00613106 COMPLETED
Osteoarthritis; Rheumatoid Arthritis; Chronic Low Back Pain; Chronic Regional Pain Syndrome; Chronic Soft Tissue Pain
Amgen
 2007-09 PHASE3
NCT00450216 COMPLETED
Ulcer
Amgen
 2007-03 PHASE3
NCT00944671 COMPLETED
Heartburn
Johnson & Johnson Consumer and Personal Products Worldwide
 2008-02 PHASE1
NCT00384904 COMPLETED
HIV Infections
Bristol-Myers Squibb
 2006-12 PHASE4
NCT01079052 COMPLETED
Healthy
Ranbaxy Laboratories Limited
 2007-11
NCT00557349 COMPLETED
Marginal Ulcers
University of Missouri-Columbia
 2006-11 PHASE4
NCT01079065 COMPLETED
Healthy
Ranbaxy Laboratories Limited
 2007-11
NCT00229424 COMPLETED
Gastroesophageal Reflux
Taiho Pharmaceutical Co., Ltd.
 2005-04 PHASE3
NCT00945750 COMPLETED
Heartburn
Merck Sharp & Dohme LLC
 2006-08 PHASE1
NCT00365339 COMPLETED
HIV Infections
Bristol-Myers Squibb
 2006-04 PHASE1
NCT00803192 COMPLETED
Bioavailability
Perrigo Company
 2004-06 PHASE1
NCT00802828 COMPLETED
Bioavailability
Perrigo Company
 2004-06 PHASE1
NCT01928888 COMPLETED
Heartburn
Bayer
 2003-05 PHASE4
NCT01511731 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 1998-10 PHASE1
NCT00141960 COMPLETED
Gastroesophageal Reflux
Astellas Pharma Inc
 2005-09 PHASE2; PHASE3

(data from https://clinicaltrials.gov, updated on 2026-05-22)

Check the Famotidine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Famotidine functions as a selective histamine H2-receptor antagonist that competitively binds H2 receptors on gastric parietal cells, thereby blocking downstream cyclic AMP activation and suppressing histamine-stimulated gastric acid secretion. This inhibition of gastric acid production directly accounts for its clinical utility in treating gastroesophageal reflux disease and managing acid-dependent drug absorption during clinical trials.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.