Numerous clinical trials, ranging from early-phase to Phase 4, evaluate the pharmacological effects and clinical utility of cimetidine across conditions such as gastroesophageal reflux disease, amyotrophic lateral sclerosis, myelodysplastic syndrome, kidney transplantation, atopic dermatitis, and lactation. Supported by academic institutions, government agencies including the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and biopharmaceutical sponsors such as Knopp Biosciences and Poxel SA, these active and completed studies assess critical outcomes including pharmacokinetic interactions and mammary drug transport.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06056583 | RECRUITING | Postpartum; Lactation; Drugs in Breast Milk; Mammary Drug Transporters; BCRP; OCT1 |
University of Washington |
2023-12-04 | PHASE4 |
| NCT05020184 | COMPLETED | Erythropoietic Protoporphyria; X-linked Protoporphyria |
Amy K. Dickey, M.D. |
2022-06-14 | PHASE2 |
| 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 |
| NCT06056583 | Recruiting | Lactation |
University of Washington|Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
2023-12-04 | Phase 4 |
| NCT05365451 | COMPLETED | Interaction; Endogenous Biomarkers |
Washington State University |
2022-04-11 | EARLY_PHASE1 |
| NCT05881811 | COMPLETED | PHN - Post-Herpetic Neuritis |
Haisco Pharmaceutical Group Co., Ltd. |
2023-03-20 | PHASE1 |
| NCT04493931 | COMPLETED | Infections, Bacterial |
GlaxoSmithKline |
2020-08-14 | PHASE1 |
| NCT04018131 | UNKNOWN | Atopic Dermatitis; Immunoglobulin E Concentration, Serum |
Fakultas Kedokteran Universitas Indonesia |
2018-03-26 | PHASE3 |
| NCT03618316 | COMPLETED | Healthy |
Poxel SA |
2018-06-19 | PHASE1 |
| NCT03307252 | COMPLETED | Healthy |
Boehringer Ingelheim |
2017-10-25 | PHASE1 |
| NCT03380455 | COMPLETED | Healthy Subjects |
Idorsia Pharmaceuticals Ltd. |
2018-01-09 | PHASE1 |
| NCT02157376 | COMPLETED | Stress Ulcer Prophylaxis |
AstraZeneca |
2014-07 | PHASE3 |
| NCT01757275 | COMPLETED | Bleeding Peptic Ulcer |
AstraZeneca |
2013-02 | PHASE3 |
| NCT02202512 | COMPLETED | Healthy |
Boehringer Ingelheim |
2014-09 | PHASE1 |
| NCT02287272 | COMPLETED | COPD |
Chiesi Farmaceutici S.p.A. |
2014-05 | PHASE1 |
| NCT01256879 | COMPLETED | Healthy |
University of Maryland, Baltimore |
2011-03 | PHASE4 |
| NCT00515073 | COMPLETED | Endometrial Cancer |
M.D. Anderson Cancer Center |
2001-04 | PHASE2 |
| NCT01010698 | COMPLETED | Healthy |
University of Maryland, Baltimore |
2009-06 | PHASE1 |
| NCT01536249 | COMPLETED | Amyotrophic Lateral Sclerosis |
Knopp Biosciences |
2012-03 | PHASE1 |
| NCT01169012 | COMPLETED | Myelodysplastic Syndrome; Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Chronic Myelomonocytic Leukemia |
UNC Lineberger Comprehensive Cancer Center |
2010-09 | PHASE1 |
| NCT01536249 | Completed | Amyotrophic Lateral Sclerosis |
Knopp Biosciences |
2012-03 | Phase 1 |
| NCT01169012 | Completed | Myelodysplastic Syndrome|Acute Myeloid Leukemia|Acute Lymphoblastic Leukemia|Chronic Myelomonocytic Leukemia |
UNC Lineberger Comprehensive Cancer Center|Genzyme a Sanofi Company |
2010-09 | Phase 1 |
| NCT00800280 | TERMINATED | Generalized Anxiety Disorder |
Pfizer |
2009-01 | PHASE1 |
| NCT00475059 | COMPLETED | Kidney Transplantation |
Centre Hospitalier Universitaire de Saint Etienne |
2007-03 | |
| NCT00475059 | Completed | Kidney Transplantation |
Centre Hospitalier Universitaire de Saint Etienne |
2007-03 | Not Applicable |
| NCT01366378 | COMPLETED | Healthy Adult Subjects |
Bausch Health Americas, Inc. |
2007-01 | PHASE1 |
| NCT02172417 | COMPLETED | Healthy |
Boehringer Ingelheim |
2000-07 | PHASE1 |
| NCT00002733 | COMPLETED | Kidney Cancer; Melanoma (Skin); Unspecified Adult Solid Tumor, Protocol Specific |
Hoag Memorial Hospital Presbyterian |
1996-01 | PHASE2 |
| NCT00045799 | COMPLETED | Upper Gastrointestinal Bleeding |
Bausch Health Americas, Inc. |
2002-05 | PHASE3 |
| NCT00002092 | COMPLETED | HIV Infections |
Community Research Initiative of New England |
(data from https://clinicaltrials.gov, updated on 2024-08-06)
Check the
Cimetidine
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
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>).
Note: Technical data last updated: Sep 1, 2026.