Clinical Trials

Ranitidine has been evaluated across numerous clinical trials spanning Phase 1 through Phase 4, primarily investigating gastrointestinal disorders—such as dyspepsia, gastroesophageal reflux disease, and stress ulcer prophylaxis—alongside pharmacokinetic assessments in healthy volunteers and oncology cohorts. Sponsored by academic institutions, government agencies, and commercial pharmaceutical companies, these studies encompass both early-phase safety assessments and late-stage efficacy evaluations. Although the majority of these trials are completed, select protocols are actively recruiting, terminated, or withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02966665 RECRUITING
Chronic Obstructive Pulmonary Disease; Pulmonary Artery Hypertension; Heart Failure; Hypertension
Russell Richardson
 2008-09 PHASE1
NCT05298683 UNKNOWN
Multiple Myeloma; Renal Impairment; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases
Hellenic Society of Hematology
 2022-05 PHASE2
NCT04681105 COMPLETED
Recurrent Acute Leukemia; Recurrent B Acute Lymphoblastic Leukemia; Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm; Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Recurrent Hairy Cell Leukemia; Recurrent Hematologic Malignancy; Recurrent Hodgkin Lymphoma; Recurrent T Acute Lymphoblastic Leukemia; Refractory Acute Leukemia; Refractory B Acute Lymphoblastic Leukemia; Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm; Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Refractory Hairy Cell Leukemia; Refractory Hematologic Malignancy; Refractory Hodgkin Lymphoma; Refractory T Acute Lymphoblastic Leukemia; Systemic Mastocytosis
City of Hope Medical Center
 2020-11-18 PHASE1
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
NCT04294459 TERMINATED
Immune System Disorder
Sanofi
 2020-06-18 PHASE1; PHASE2
NCT03368664 TERMINATED
Multiple Sclerosis
Genzyme, a Sanofi Company
 2017-10-23 PHASE3
NCT04397445 COMPLETED
Ranitidine Adverse Reaction; Pharmacokinetics; Food-drug Interaction
Food and Drug Administration (FDA)
 2020-06-08 PHASE1
NCT05338502 COMPLETED
Healthy
Eli Lilly and Company
 2019-07-08 PHASE1
NCT03583567 COMPLETED
Protamine Adverse Reaction
Mahidol University
 2018-09-05 PHASE4
NCT02441673 UNKNOWN
Post Anaesthetic Shivering
Lagos State Health Service Commission
 2018-10-12 PHASE2
NCT03145012 COMPLETED
Cancer
Nova Scotia Health Authority
 2018-05-01 PHASE4
NCT03468777 TERMINATED
Healthy
Janssen Research & Development, LLC
 2018-03-06 PHASE1
NCT02999633 TERMINATED
T-cell Type Acute Leukemia-Precursor; T-lymphoblastic Lymphoma/Leukaemia
Sanofi
 2017-03-08 PHASE2
NCT03140033 UNKNOWN
Hemorrhage Postpartum
Ain Shams Maternity Hospital
 2016-07 PHASE2
NCT01332630 COMPLETED
Breast Cancer
M.D. Anderson Cancer Center
 2011-08-16 PHASE2
NCT03011463 COMPLETED
Pharmacokinetics; Inhibition Enzyme; Drug Interaction Potentiation
Dr. R. Pfleger Chemische Fabrik GmbH
 2016-11 PHASE1
NCT02700087 WITHDRAWN
Laryngomalacia; Acid Reflux; Stridor
Stanford University
 2016-02
NCT00223691 COMPLETED
Autonomic Failure; Orthostatic Hypotension
Vanderbilt University
 2002-03 PHASE1
NCT02953210 UNKNOWN
Pain, Postoperative; Anesthesia Complication; Nausea; Vomiting; Ileus Paralytic; Hemodynamic Instability
Federal University of São Paulo
 2016-11 PHASE4
NCT02205489 COMPLETED
Relapsing-remitting Multiple Sclerosis
Genzyme, a Sanofi Company
 2014-10 PHASE4
NCT02441894 COMPLETED
Prostate Cancer
Sanofi
 2015-04 PHASE4
NCT05399927 Completed
Music Therapy|Cardiovascular Diseases|Critical Care|Emergencies
Universidad Miguel Hernandez de Elche
 2015-07 Not Applicable
NCT02733640 COMPLETED
Antiplatelet Effect
Seoul National University Bundang Hospital
 2012-10
NCT02123498 WITHDRAWN
Eustachian Tube Dysfunction; Laryngopharyngeal Reflux
Loma Linda University
 PHASE4
NCT02197143 COMPLETED
Dyspepsia
Pamukkale University
 2013-03 PHASE4
NCT01908257 COMPLETED
Healthy
Ardea Biosciences, Inc.
 2013-07 PHASE1
NCT01896557 COMPLETED
Coronary Artery Disease; Drug Interaction Potentiation
University of Sao Paulo General Hospital
 2011-10 PHASE4
NCT01737840 COMPLETED
Dyspepsia
Akdeniz University
 2012-10 PHASE4
NCT01682408 COMPLETED
Pharmacokinetics
AstraZeneca
 2012-09 PHASE1
NCT01539655 COMPLETED
Medullary Thyroid Cancer
Sanofi
 2012-02 PHASE1
NCT01539655 Completed
Medullary Thyroid Cancer
Sanofi
 2012-02 Phase 1
NCT00930670 COMPLETED
Coronary Artery Disease
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
 2009-06 PHASE4
NCT01392755 COMPLETED
Healthy Volunteer
Hoffmann-La Roche
 2011-07 PHASE1
NCT01209455 COMPLETED
Poisoning
University of Edinburgh
 2011-01-03
NCT00527878 TERMINATED
JOB's Syndrome; Hyper-IgE Recurrent Infection Syndrome; Immune Deficiency
National Institute of Allergy and Infectious Diseases (NIAID)
 2007-09 PHASE2
NCT01287520 COMPLETED
Advanced Cancer
Eli Lilly and Company
 2007-11 PHASE1
NCT01017198 Completed
Advanced Solid Tumors
Biogen
 2009-11 Phase 1
NCT00668317 TERMINATED
Cough
Hull University Teaching Hospitals NHS Trust
 2006-09 PHASE3
NCT00839306 COMPLETED
Gastroesophageal Reflux Disease (GERD)
Eisai Inc.
 2008-08 PHASE3
NCT00838526 COMPLETED
Gastroesophageal Reflux Disease (GERD)
Eisai Inc.
 2008-08-31 PHASE3
NCT02195804 COMPLETED
Healthy
Boehringer Ingelheim
 2009-05 PHASE1
NCT00030992 COMPLETED
Renal Cell Carcinoma
National Cancer Institute (NCI)
 2002-02 PHASE2
NCT00131248 COMPLETED
Gastroesophageal Reflux
The University of Texas Health Science Center, Houston
 2004-04 PHASE3
NCT00585351 COMPLETED
Stroke
University of Iowa
 2007-01
NCT00247130 WITHDRAWN
Peptic Ulcers
Keio University
 2005-10 PHASE4
NCT00405119 COMPLETED
Gastroesophageal Reflux Disease; Reflux, Gastroesophageal
GlaxoSmithKline
 2006-05 PHASE2
NCT00161200 TERMINATED
Esophageal Metaplasia
University of Medicine and Dentistry of New Jersey
 2002-12 PHASE3
NCT00590928 COMPLETED
Critically Ill Patients; Indication for Stress Ulcer Prophylaxis
Medical University of Vienna
 2004-07 PHASE4
NCT00702871 COMPLETED
Ventilator Associated Pneumonia; Etiological Organisms; Antimicrobial Drug Susceptibility Pattern; Stress Ulcer Prophylaxis
Maulana Azad Medical College
 2005-03 PHASE4
NCT00633672 COMPLETED
NSAID Associated Gastric Ulcers
AstraZeneca
 2001-02 PHASE3
NCT01131702 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2003-01 PHASE1
NCT02170792 COMPLETED
Healthy
Boehringer Ingelheim
 2001-02 PHASE1
NCT02172417 COMPLETED
Healthy
Boehringer Ingelheim
 2000-07 PHASE1
NCT01538797 COMPLETED
Reflux Oesophagitis
Trio Medicines Ltd.
 1996-07 PHASE1
NCT00000964 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00247715 COMPLETED
Dyspepsia; Gastrointestinal Diseases
Radboud University Medical Center
 2003-10
NCT00220909 TERMINATED
Patients Undergoing Elective Coronary Artery Bypass Graft
Temple University
 2005-09 PHASE4
NCT00633412 COMPLETED
NSAID Associated Gastric Ulcers
AstraZeneca
 2001-02 PHASE3
NCT00002106 COMPLETED
HIV Infections
Glaxo Wellcome
 PHASE2
NCT00401752 COMPLETED
Gastric Ulcer
AstraZeneca
 2006-03 PHASE3

(data from https://clinicaltrials.gov, updated on 2025-09-26)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ranitidine selectively binds to and competitively inhibits the histamine H2 receptor on gastric parietal cells, thereby blocking histamine-stimulated activation of adenylate cyclase and downstream cyclic AMP production. This cellular inhibition suppresses basal and stimulated gastric acid secretion, providing therapeutic efficacy in clinical conditions such as dyspepsia, gastroesophageal reflux disease, and stress-related gastric ulceration.

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.