Nizatidine
| Evidence Level: L5 | Predicted Indications: 3 |
Table of Contents
Nizatidine: Duodenal obstruction
One-Sentence Summary
Nizatidine is an H2-receptor antagonist originally used to treat gastric ulcer, duodenal ulcer, gastroesophageal reflux disease and related acid-related conditions. Support comes from 0 registered clinical trials and 19 publications, mostly older clinical studies and reviews on duodenal ulcer.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Duodenal obstruction |
| TxGNN Prediction Score | 0.9986 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (1 of 1) – CDSCO approval status is not included in this data |
| Number of Listed Products | 1 (valid: 1) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Based on known information, nizatidine belongs to the H2-receptor antagonist class. It suppresses basal, nocturnal and stimulated gastric acid secretion, as described in the literature (for example the 1988 review in Drugs).
Active peptic ulcer disease is closely related to nizatidine’s original indications (gastric and duodenal ulcer). Acid suppression is the mechanism behind both, so the prediction is mechanistically reasonable. It is better read as confirmation of an existing use than as a new therapeutic direction.
Other predicted indications are weaker:
- Gastrojejunal ulcer and gastroduodenitis: acid-related and plausible, but supported only by indirect literature (duodenal ulcer, NSAID-induced injury).
- Peptic ulcer perforation, duodenal obstruction, and multiple endocrine neoplasia: prediction only, with no trials or literature. These are surgical complications or conditions where PPIs are the standard acid-suppression therapy.
- Duodenogastric reflux: the link to H2-receptor blockade is weak, because the pathology is driven by bile and pancreatic secretions rather than mainly by acid.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
The literature below is for active peptic ulcer disease (primarily duodenal ulcer).
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 2570656 | 1989 | Randomized, double-blind, placebo-controlled trial | Clin Pharmacol Ther | Two-phase multicentre trial of nizatidine 150 mg twice daily vs placebo for duodenal ulcer healing and recurrence |
| 7960687 | 1994 | Randomized, double-blind, placebo-controlled trial | Isr J Med Sci | Nizatidine 300 mg nightly vs placebo for 4 weeks in 55 patients with active duodenal ulcer; healing and mucosal mediators assessed |
| 2892259 | 1987 | Randomized, double-blind trial | Scand J Gastroenterol Suppl | In 513 patients with healed duodenal ulcer, 12-month recurrence was 34% on nizatidine vs 64% on placebo |
| 7863254 | 1994 | Open clinical study | Scand J Gastroenterol Suppl | Maintenance therapy in healed duodenal ulcer; efficacy and quality of life over 12 months |
| 15683433 | 2005 | Randomized controlled trial | J Gastroenterol Hepatol | Nizatidine vs famotidine for maintenance therapy of erosive esophagitis (related condition) |
| 2905640 | 1988 | Review | Drugs | Pharmacology and therapeutic use of nizatidine in peptic ulcer disease; potent inhibitor of gastric acid secretion |
| 2184124 | 1990 | Review | Gastroenterol Clin North Am | Overview of medical therapy; nizatidine and roxatidine described as safe and effective |
| 2892253 | 1987 | Safety analysis | Scand J Gastroenterol Suppl | Safety assessed in 3,800 nizatidine-treated patients in US and European trials |
| 26883979 | 2016 | Preclinical (rat) | Life Sci | Gastroprotective effects of several H2RAs on ibuprofen-induced gastric ulcer |
| 2567267 | 1989 | Preclinical (rat) | Nihon Yakurigaku Zasshi | Nizatidine inhibited gastric acid secretion and protected against lesions; 2 to 8 times more potent than cimetidine |
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 3891 | Axid Capsule (Apex Laboratories Pvt Ltd) | Strip of 10 capsules | Not stated in the available data |
Safety Considerations
- Contraindications (from the knowledge graph, not label text): liver disease, gallbladder disease, impaired renal function, and gastric cancer or neoplasm (including gastric carcinoma, diffuse gastric adenocarcinoma and linitis plastica).
- Drug Interactions: 263 interactions are recorded in total. Examples include:
- Major: atazanavir, dasatinib
- Moderate: acalabrutinib, bosutinib, brigatinib, cefditoren, cefpodoxime, cefuroxime, ceritinib, chlorpropamide, dabrafenib, dacomitinib
- Minor: ketorolac, ibuprofen, alendronic acid, axitinib, cyanocobalamin, diclofenac, magnesium oxide, oxaprozin
Several of these (atazanavir, dasatinib and the other kinase inhibitors) are consistent with reduced absorption when gastric acid is suppressed.
Package insert warnings and contraindications for the India product were not available. Please refer to the package insert for complete safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The evidence level is L4: there are no registered trials, and the literature consists mainly of older duodenal ulcer studies and reviews, with study designs not fully verifiable from the available titles. Because this is essentially an existing use, it adds little repurposing value. The other predicted indications rely on indirect or no evidence.
To proceed, the following is needed:
- India package insert warnings and contraindications (a blocking gap for safety screening)
- Detailed mechanism of action data
- Verification of the design and phase of the key duodenal ulcer studies
- Approved indication text for the India license, to confirm whether peptic ulcer disease is already covered
- Evaluation of the interaction burden with drugs that depend on gastric acidity for absorption
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.