Cimetidine
| Evidence Level: L5 | Predicted Indications: 9 |
Table of Contents
- Cimetidine
- Cimetidine: From Acid-Related Gastrointestinal Disease to Smouldering Systemic Mastocytosis
Cimetidine: From Acid-Related Gastrointestinal Disease to Smouldering Systemic Mastocytosis
One-Sentence Summary
Cimetidine is a histamine H2-receptor blocker, marketed in the US for stomach-acid conditions such as peptic ulcer. The TxGNN model predicts it may be useful for Smouldering systemic mastocytosis, but there are currently 0 clinical trials and 0 publications for this prediction, so it rests on the model score alone.
Quick Overview
| Item | Content |
|---|---|
| Predicted New Indication | Smouldering systemic mastocytosis |
| TxGNN Prediction Score | 99.80% |
| Evidence Level | L5 (model prediction only) |
| US Market Status | ✓ Marketed |
| Number of NDAs | 20 (total US licenses, mostly generic ANDAs plus the brand NDA020238, TAGAMET) |
| Recommended Decision | Hold |
The evidence pack has no approved-indication text, so the original indication is not listed in the table. The title uses the general acid-related use of the drug class, not label wording.
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Cimetidine is an H2 antagonist that reduces gastric acid secretion. Its efficacy in acid-related disease is well established, and mechanistically it may be applicable to mast cell disease through histamine blockade.
Mast cells release large amounts of histamine, which drives gastric acid hypersecretion and related symptoms in mastocytosis. Blocking H2 receptors could plausibly relieve these symptoms.
This would be symptom control only. Cimetidine would not change the underlying clonal mast cell disease. The link is inferred, and nothing in this package supports it with trial or literature data.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
US Market Information
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| ANDA074329 | Cimetidine | Tablet, film coated | Chartwell RX, LLC |
| ANDA074251 | Cimetidine hydrochloride | Solution | Chartwell RX, LLC |
| ANDA074151 | Cimetidine | Tablet, film coated | Teva Pharmaceuticals USA, Inc. |
| NDA020238 | TAGAMET | Tablet | Prestige Brands Holdings, Inc. |
| ANDA218220 | Cimetidine | Tablet, film coated | Bionpharma Inc. |
Approved-indication text was not provided for any of these licenses.
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction has a very high model score, but no trials or literature support it. The only rationale is symptomatic histamine blockade, which would not treat the underlying mast cell disease.
Among the other predictions in the pack, “active peptic ulcer disease” (L1) is most likely an existing labeled use rather than true repurposing. Confirm it against the current label before treating it as a candidate.
To proceed, the following is needed:
- The current FDA package insert, to confirm the approved indications and to obtain warnings and contraindications
- Mechanism of action data from DrugBank
- A targeted search for cimetidine or H2-blocker studies in systemic mastocytosis
- A clinical case for the value of symptom control in smouldering disease, including comparison with standard antihistamine and mast-cell-directed therapy
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.