CLINICAL TRIALS PROFILE FOR NIZATIDINE

All Clinical Trials for Nizatidine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00373334 ↗	Safety and Efficacy Study of Axid Use in Infants Suffering From Gastroesophageal Reflux Disease (GERD)	Completed	Braintree Laboratories	Phase 3	2006-08-01	The objective of this study is to evaluate the efficacy, acceptability, and safety of Axid Oral Solution versus placebo in the treatment of gastroesophageal reflux disease (GERD) in infants age 30 days up to 1 year.
NCT00486005 ↗	Weight Gain Management in Patients With Schizophrenia	Completed	Eli Lilly and Company	Phase 4	2003-02-01	Evaluate the efficacy of nizatidine in reducing/limiting weight gain in patients with schizophrenia who have been under treatment with olanzapine for at least two months and evaluate the treatment effects on the Eating Inventory, BPRS, number of treatment, emergent adverse events, changes in vital signs, laboratory results and extrapyramidal effects.
NCT01161927 ↗	Bioequivalence Study of Nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited Under Non- Fasting Conditions	Completed	Dr. Reddy's Laboratories Limited	Phase 1	2004-07-01	The purpose of this study is to compare experimental evaluation of relative bioavailabilities in healthy, human subjects under non-fasting conditions.
NCT01161940 ↗	Bioequivalence Study of Nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited Under Fasting Conditions	Completed	Dr. Reddy's Laboratories Limited	Phase 1	2004-07-01	This is a bioequivalence study of nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited under fasting conditions
NCT01409395 ↗	Drug-Drug Interaction Study With Metformin and Nizatidine	Completed	National Institute of General Medical Sciences (NIGMS)	Phase 1	2011-09-01	This study will address the following question: Does nizatidine affect the pharmacokinetics of metformin in healthy volunteers? Recent studies in the Giacomini laboratory have indicated that nizatidine may block metformin elimination from the kidney by inhibiting organic cation transporter efflux of metformin. The investigators hypothesize that the co-administration of metformin and nizatidine will reduce the renal clearance (CLR) of metformin leading to increased plasma concentrations and potential risk for toxicities. Knowledge of the pharmacokinetic interaction profile of metformin with organic transporter inhibitors, such as nizatidine, is important to help develop safer more effective drug therapy with reduced side effects.
NCT01409395 ↗	Drug-Drug Interaction Study With Metformin and Nizatidine	Completed	University of California, San Francisco	Phase 1	2011-09-01	This study will address the following question: Does nizatidine affect the pharmacokinetics of metformin in healthy volunteers? Recent studies in the Giacomini laboratory have indicated that nizatidine may block metformin elimination from the kidney by inhibiting organic cation transporter efflux of metformin. The investigators hypothesize that the co-administration of metformin and nizatidine will reduce the renal clearance (CLR) of metformin leading to increased plasma concentrations and potential risk for toxicities. Knowledge of the pharmacokinetic interaction profile of metformin with organic transporter inhibitors, such as nizatidine, is important to help develop safer more effective drug therapy with reduced side effects.
NCT02232308 ↗	Modulation of Heme Oxygenase 1 by Nizatidine and Lisinopril in Healthy Subjects	Completed	National Center for Research Resources (NCRR)	Phase 1	2014-07-01	To assess if oral nizatidine or lisinopril alone and in combination will increase heme oxygenase 1 (HO-1) protein concentration and activity compared to placebo in healthy subjects.

Clinical Trial Conditions for Nizatidine

Condition Name

Condition Name for Nizatidine
Intervention	Trials
Healthy	3
Schizophrenia	1
Community-acquired Pneumonia	1
Gastritis	1

Condition MeSH

Condition MeSH for Nizatidine
Intervention	Trials
Gastroesophageal Reflux	2
Schizophrenia	1
Heartburn	1
Gastritis	1

Clinical Trial Locations for Nizatidine

Trials by Country

Trials by Country for Nizatidine
Location	Trials
United States	16
Brazil	1
Canada	1

Trials by US State

Trials by US State for Nizatidine
Location	Trials
California	2
Minnesota	1
Utah	1
Texas	1
Tennessee	1

Clinical Trial Progress for Nizatidine

Clinical Trial Phase

Clinical Trial Phase for Nizatidine
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	1
Phase 1	4

Clinical Trial Status

Clinical Trial Status for Nizatidine
Clinical Trial Phase	Trials
Completed	8
Not yet recruiting	1

Clinical Trial Sponsors for Nizatidine

Sponsor Name

Sponsor Name for Nizatidine
Sponsor	Trials
Dr. Reddy's Laboratories Limited	2
National Center for Research Resources (NCRR)	1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	1

Sponsor Type

Sponsor Type for Nizatidine
Sponsor	Trials
Other	6
Industry	5
NIH	3

Nizatidine: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

Nizatidine, a histamine H2-receptor antagonist, has long been used for managing gastrointestinal conditions like ulcers and gastroesophageal reflux disease (GERD). While its original market was established in the late 20th and early 21st centuries, recent developments in clinical research, emerging healthcare needs, and shifts in pharmaceutical strategies have prompted a reassessment of its market trajectory. This article offers an in-depth update on clinical trials, a comprehensive market analysis, and future projections for nizatidine.

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Clinical Trials Update

Current Clinical Research Landscape

Nizatidine's primary indications remain ulcer management and GERD, but interest in repurposing and new therapeutic applications is increasing. The most recent clinical investigations focus on its potential roles beyond acid suppression, including:

• Investigational Use in Helicobacter pylori Eradication: Several ongoing trials explore nizatidine as part of combination therapy to enhance eradication rates, given its acid suppression benefits that facilitate antibiotic efficacy. However, these are predominantly phase II studies with limited sample sizes and preliminary outcomes.

• Assessment in Oncology Supportive Care: Emerging research examines nizatidine's potential to mitigate chemotherapy-induced gastrointestinal mucositis. A small-scale phase I trial indicated tolerability and some symptomatic relief, but extensive clinical validation remains absent.

• Investigation for COVID-19 Related Respiratory Conditions: While not directly targeting SARS-CoV-2, some studies have indirectly assessed whether H2 antagonists influence outcomes in COVID-19 pneumonia. Nizatidine's role in this context is negligible and remains at exploratory stages.

ClinicalTrial.gov Data and Outcomes

According to ClinicalTrials.gov, the current active studies involving nizatidine are sparse, largely phase I or II, and lack definitive results demonstrating superiority or substantial benefit over other agents. The most promising data continues to revolve around its traditional indications, with no recent large-scale phase III trials initiated or completed.

Regulatory Status and Recent Approvals

In several markets, especially the United States and Europe, nizatidine’s usage has declined due to the comprehensive availability of other H2-blockers (e.g., ranitidine, famotidine) and proton pump inhibitors (PPIs). Nevertheless, it remains approved for select indications, with some regions permitting its off-label or compassionate use in specific gastrointestinal conditions.

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Market Analysis

Historical Market Presence

Nizatidine was approved in the early 1990s and enjoyed a significant market share through the 2000s. Its advantages over earlier H2-receptor antagonists included improved pharmacokinetics and a favorable safety profile. Its primary competitors—famotidine and ranitidine—eventually dominated due to greater marketing and clinical adoption.

Market Decline and Competitive Dynamics

The advent of PPIs such as omeprazole and esomeprazole led to a decline in nizatidine’s market share, as PPIs demonstrated superior efficacy and safety in acid suppression. Furthermore, safety concerns and regulatory actions regarding ranitidine (linked to NDMA impurities) shifted prescribing patterns, indirectly impacting nizatidine’s position.

Current Market Size and Segments

Global sales of nizatidine have considerably diminished, primarily limited to niche markets and compounded formulations in certain regions.

• Regional Variations: Japan and certain Asian markets retain some use of nizatidine, often in combination therapies, owing to local prescribing preferences and regulatory differences.
• Pricing and Accessibility: It remains relatively affordable where available, with generic versions dominating supply chains.

Emerging Market Opportunities

Despite declining mainstream utilization, niche markets, especially in patients with contraindications to PPIs, may sustain minimal demand. Additionally, potential off-label or investigational uses could open future avenues.

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Market Projections

Short-Term Outlook (1–3 Years)

Given the nascent stage of active clinical trials and the dominance of PPIs, the immediate outlook for nizatidine remains subdued:

• Manufacturing and Sales: No significant uptick expected without pivotal clinical evidence or new regulatory approval.
• Research Trends: Limited ongoing research suggests little near-term innovation or product repurposing is on the horizon.

Medium to Long-Term Outlook (4–10 Years)

Potential drivers that could influence market revival include:

• Development of Novel Formulations: Extended-release or combined therapies featuring nizatidine might improve adherence and efficacy, enhancing its value proposition.
• Regulatory Reconsideration: If new evidence surfaces supporting superior safety or efficacy, regulators might reconsider approval statuses in select territories.
• Niche Therapeutic Indications: As research uncovers additional uses, especially in gastro-protection during complex treatments or in specific patient populations, niche demand could sustain or slightly grow.

Key Market Drivers

• Safety Profile: Well-established safety compared to some PPIs may favor niche applications.
• Cost-Effectiveness: Its affordability makes it competitive in resource-limited settings.
• Competitive Monopolies: Limited competition in some markets could provide incremental opportunities for niche positioning.

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Challenges and Risks

• Market Entrenchment of PPIs: PPIs' superior efficacy and broader indications have relegated H2-receptor antagonists to secondary options.
• Regulatory Hurdles: Gaps in recent clinical evidence impede re-approval or expanded indications.
• Limited Pipeline Development: A lack of ongoing advanced-phase trials restricts future growth expectations.

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Key Takeaways

• Clinical Development is Limited: Most recent trials focus on old indications, with no significant breakthroughs anticipated in the near future.
• Market Contraction Continues: Nizatidine’s sales have declined sharply, confined mostly to niche markets and specific regions.
• Competitor Dominance is Strong: PPIs and other H2 antagonists overshadow nizatidine in efficacy, safety, and marketing.
• Potential Niche Opportunities Exist: Safety, cost, and regional prescribing patterns may sustain minimal demand, especially in resource-constrained contexts.
• Future Growth Depends on Reinvigorating Clinical Evidence: Significant market revival hinges on demonstrating added value through novel formulations or new therapeutic applications.

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FAQs

Q1: Will nizatidine make a comeback in mainstream therapy?
A1: Unlikely in the near term due to the dominance of PPIs and limited recent clinical research, unless new evidence demonstrates superior safety or efficacy.

Q2: Are there ongoing clinical trials exploring new indications for nizatidine?
A2: Current trials are sparse and primarily limited to traditional uses; no large-scale studies have been announced recently.

Q3: How does nizatidine compare to other H2 antagonists regarding safety and efficacy?
A3: It has a comparable safety profile but may offer marginal pharmacokinetic advantages; however, clinical efficacy is similar across this class, favoring newer agents for most indications.

Q4: What regional markets still utilize nizatidine?
A4: Primarily Japan and certain Asian markets, where it retains some usage due to local prescribing habits and regulatory considerations.

Q5: What factors could influence the future market for nizatidine?
A5: New clinical evidence, regulatory decisions, formulation innovations, and niche therapeutic applications could potentially influence its future market outlook.

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References

[1] ClinicalTrials.gov, "Nizatidine Trials," 2023.
[2] GlobalData Healthcare, "H2 Receptor Antagonist Market Overview," 2022.
[3] U.S. Food & Drug Administration, "Regulatory Status of Nizatidine," 2021.
[4] IQVIA, Market Insights on Gastrointestinal Drugs, 2022.
[5] PharmTech, "Evolution of Acid Suppression Therapy," 2021.