Overview
A histamine congener, it competitively inhibits histamine binding to histamine H2 receptors. Cimetidine has a range of pharmacological actions. It inhibits gastric acid secretion, as well as pepsin and gastrins output. It also blocks the activity of cytochrome P-450 which might explain proposals for use in neoadjuvant therapy.
Background
A histamine congener, it competitively inhibits histamine binding to histamine H2 receptors. Cimetidine has a range of pharmacological actions. It inhibits gastric acid secretion, as well as pepsin and gastrins output. It also blocks the activity of cytochrome P-450 which might explain proposals for use in neoadjuvant therapy.
Indication
Cimetidine is indicated to reduce gastric acid secretion and to treat the following disease states: duodenal ulcers, non-malignant gastric ulcers, gastroesophageal reflux disease, and pathological hypersecretion associated with Zollinger-Ellison Syndrome, systemic mastocytosis, and multiple endocrine adenomas. It is indicated for prophylaxis of recurrent gastric or duodenal ulcers, as adjunctive therapy in the management of cystic fibrosis in children, and to treat NSAID induced lesions and gastrointestinal symptoms.
Associated Conditions
- Cystic Fibrosis (CF)
- Gastric hypersecretion
- Gastro-esophageal Reflux Disease (GERD)
- Gastrointestinal Symptoms
- Heartburn
- Active Duodenal ulcer
- Benign gastric ulcers
- Develop NSAID-induced gastric ulcers
- Recurrent Ulcers, Duodenal and Gastric
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/09/28 | Phase 4 | Recruiting | |||
2023/05/31 | Phase 1 | Completed | Haisco Pharmaceutical Group Co., Ltd. | ||
2022/05/09 | Early Phase 1 | Completed | |||
2021/08/25 | Phase 2 | Completed | Amy K. Dickey, M.D. | ||
2021/04/28 | Phase 2 | Completed | |||
2020/07/30 | Phase 1 | Completed | |||
2019/07/12 | Phase 3 | UNKNOWN | |||
2018/08/07 | Phase 1 | Completed | |||
2017/12/21 | Phase 1 | Completed | |||
2017/10/11 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Mylan Pharmaceuticals Inc. | 0378-0317 | ORAL | 300 mg in 1 1 | 7/11/2019 | |
| Physicians Total Care, Inc. | 54868-3316 | ORAL | 800 mg in 1 1 | 10/4/2011 | |
| Carilion Materials Management | 68151-1497 | ORAL | 200 mg in 1 1 | 1/21/2013 | |
| Carilion Materials Management | 68151-1742 | ORAL | 300 mg in 1 1 | 4/2/2016 | |
| Dispensing Solutions, Inc. | 66336-945 | ORAL | 400 mg in 1 1 | 10/4/2011 | |
| Chartwell RX, LLC | 62135-631 | ORAL | 300 mg in 1 1 | 8/18/2023 | |
| Sincerus Florida, LLC | 72934-1047 | TOPICAL | 5 g in 100 g | 5/17/2019 | |
| Teva Pharmaceuticals USA, Inc. | 0093-8192 | ORAL | 300 mg in 1 1 | 11/30/2022 | |
| Aidarex Pharmaceuticals LLC | 33261-024 | ORAL | 400 mg in 1 1 | 12/17/2013 | |
| Akorn Operating Company LLC | 50383-050 | ORAL | 300 mg in 5 mL | 10/17/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| CIMETIDINE TABLETS 200 mg | SIN07788P | TABLET, FILM COATED | 200 mg | 7/15/1994 | |
| CIMETIDINE TABLET 200 mg | SIN09571P | TABLET | 200 mg | 12/5/1997 | |
| XEPAMET TABLETS 400 mg | SIN08030P | TABLET, FILM COATED | 400 mg | 2/23/1995 | |
| SHINTAMET FILM COATED TABLET 400 mg | SIN08468P | TABLET, FILM COATED | 400 mg | 12/9/1995 | |
| CIMETIDINE 400 FILM-COATED TABLET 400 mg | SIN08908P | TABLET, FILM COATED | 400.00 mg | 9/4/1996 | |
| SHINTAMET INJECTION 150 mg/ml | SIN07894P | INJECTION | 150 mg/ml | 10/31/1994 | |
| CIMETIDINE TABLETS 200 mg | SIN07835P | TABLET, FILM COATED | 200 mg | 9/1/1994 | |
| XEPAMET TABLETS 200 mg | SIN08029P | TABLET, FILM COATED | 200 mg | 2/23/1995 | |
| CIMETIDINE-400 TABLET 400 mg | SIN09860P | TABLET, FILM COATED | 400 mg | 7/2/1998 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Emulsio Cimetidini | 国药准字H10940151 | 化学药品 | 乳剂 | 5/9/2020 | |
| Cimetidine Sustained-release Tablets | 国药准字H10940061 | 化学药品 | 片剂 | 10/12/2020 | |
| Cimetidine Chewable Tablets | 国药准字H10950120 | 化学药品 | 片剂(咀嚼) | 6/29/2021 | |
| Cimetidine Chewable Tablets | 国药准字H10950119 | 化学药品 | 片剂(咀嚼) | 6/29/2021 | |
| Cimetidine Tablets | 国药准字H34021224 | 化学药品 | 片剂 | 6/8/2020 | |
| Cimetidine Tablets | 国药准字H14023134 | 化学药品 | 片剂 | 8/18/2020 | |
| Cimetidine Tablets | 国药准字H21020746 | 化学药品 | 片剂 | 3/23/2023 | |
| Cimetidine Tablets | 国药准字H42020435 | 化学药品 | 片剂 | 7/13/2020 | |
| Cimetidine Tablets | 国药准字H34020121 | 化学药品 | 片剂 | 5/8/2020 | |
| Cimetidine Tablets | 国药准字H44020624 | 化学药品 | 片剂 | 7/18/2019 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| BELLASED 400 TAB 400MG | N/A | N/A | N/A | 1/11/2002 | |
| DUOCER TABLETS 400MG | N/A | N/A | N/A | 2/24/2025 | |
| ULTIPUS TABLETS 200MG | N/A | N/A | N/A | 11/14/2012 | |
| SYNGAMET TABLET 400MG | N/A | N/A | N/A | 12/4/2014 | |
| SYNTRODINE TABLETS 200MG | N/A | N/A | N/A | 3/28/2024 | |
| STOGAMET TAB 200MG | N/A | N/A | N/A | 8/1/1994 | |
| MARTINDALE TAB 400MG | N/A | N/A | N/A | 1/11/2002 | |
| HEALING-U TAB 400MG | N/A | N/A | N/A | 1/11/2002 | |
| TROWAY CIMETIDINE TABLETS 200MG | N/A | N/A | N/A | 5/26/2025 | |
| CIMETIDINE FU YUAN TABLETS 200MG | N/A | N/A | N/A | 5/26/2025 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||