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Last Updated: December 19, 2025

CLINICAL TRIALS PROFILE FOR FAMOTIDINE; IBUPROFEN


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All Clinical Trials for famotidine; ibuprofen

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00450216 ↗ Efficacy and Safety Study of HZT-501 in Subjects Requiring Nonsteroidal Anti-Inflammatory Drug (NSAID) Treatment Completed Horizon Pharma Ireland, Ltd., Dublin Ireland Phase 3 2007-03-01 The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of development of ibuprofen-associated ulcers in patients who require long-term daily use of ibuprofen.
NCT00450658 ↗ Efficacy and Safety Study of HZT-501 in Reducing the Risk of Ibuprofen-associated Ulcers Completed Horizon Pharma Ireland, Ltd., Dublin Ireland Phase 3 2007-03-01 The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of development of ibuprofen-associated ulcers in patients who require long-term daily use of ibuprofen.
NCT00613106 ↗ Double-Blind Follow-on Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg) in Subjects Who Have Completed Participation in HZ-CA-301 (NCT00450658) or HZ-CA-303 (NCT00450216) Completed Horizon Pharma Ireland, Ltd., Dublin Ireland Phase 3 2007-09-01 The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.
NCT00984815 ↗ Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment Completed Horizon Pharma Ireland, Ltd., Dublin Ireland Phase 3 2009-09-01 The purpose of this study is to evaluate the safety of long-term treatment with HZT-501, a fixed-dose combination oral tablet of 800 mg ibuprofen and 26.6 mg famotidine for patients that require long-term NSAID treatment.
NCT01563185 ↗ Open-label Safety and Pharmacokinetic Study of DUEXIS® (Ibuprofen and Famotidine) Tablets in Juvenile Idiopathic Arthritis Completed Pediatric Rheumatology Collaborative Study Group Phase 4 2012-04-01 The primary objective of this Phase 4, multi-center, open-label study is to evaluate the safety and tolerability of DUEXIS in Juvenile Idiopathic Arthritis (JIA) patients aged 10 years to 16 years, 11 months, treated up to 24 weeks. The secondary objectives are to evaluate the PK characteristics of DUEXIS in JIA patients and to evaluate the signs and symptoms of JIA in patients aged 10 years to 16 years, 11 months receiving DUEXIS for up to 24 weeks.
NCT01563185 ↗ Open-label Safety and Pharmacokinetic Study of DUEXIS® (Ibuprofen and Famotidine) Tablets in Juvenile Idiopathic Arthritis Completed Horizon Pharma Ireland, Ltd., Dublin Ireland Phase 4 2012-04-01 The primary objective of this Phase 4, multi-center, open-label study is to evaluate the safety and tolerability of DUEXIS in Juvenile Idiopathic Arthritis (JIA) patients aged 10 years to 16 years, 11 months, treated up to 24 weeks. The secondary objectives are to evaluate the PK characteristics of DUEXIS in JIA patients and to evaluate the signs and symptoms of JIA in patients aged 10 years to 16 years, 11 months receiving DUEXIS for up to 24 weeks.
NCT03695172 ↗ Comparison of TAP, Anterior QL, or ESP Block for Elective Cesarean Section Terminated Duke University Phase 4 2019-09-12 The purpose of this prospective single center, randomized study is to determine if ultrasound guided Transversus Abdominis Plane (TAP), Quadratus Lumborum (QL), and Erector Spinae Plane (ESP) blocks decrease opioid consumption in subjects undergoing elective cesarean section.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for famotidine; ibuprofen

Condition Name

Condition Name for famotidine; ibuprofen
Intervention Trials
Pain, Postoperative 3
Chronic Regional Pain Syndrome 2
Chronic Soft Tissue Pain 2
Osteoarthritis 2
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Condition MeSH

Condition MeSH for famotidine; ibuprofen
Intervention Trials
Pain, Postoperative 3
Low Back Pain 2
Agnosia 2
Back Pain 2
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Clinical Trial Locations for famotidine; ibuprofen

Trials by Country

Trials by Country for famotidine; ibuprofen
Location Trials
United States 11
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Trials by US State

Trials by US State for famotidine; ibuprofen
Location Trials
Texas 4
Pennsylvania 2
North Carolina 1
Massachusetts 1
Louisiana 1
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Clinical Trial Progress for famotidine; ibuprofen

Clinical Trial Phase

Clinical Trial Phase for famotidine; ibuprofen
Clinical Trial Phase Trials
PHASE2 2
Phase 4 2
Phase 3 4
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Clinical Trial Status

Clinical Trial Status for famotidine; ibuprofen
Clinical Trial Phase Trials
Completed 5
NOT_YET_RECRUITING 2
Terminated 1
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Clinical Trial Sponsors for famotidine; ibuprofen

Sponsor Name

Sponsor Name for famotidine; ibuprofen
Sponsor Trials
Horizon Pharma Ireland, Ltd., Dublin Ireland 5
Texas Scottish Rite Hospital for Children 2
Pediatric Rheumatology Collaborative Study Group 1
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Sponsor Type

Sponsor Type for famotidine; ibuprofen
Sponsor Trials
Industry 5
Other 4
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Clinical Trials Update, Market Analysis, and Projection for Famotidine and Ibuprofen

Last updated: October 27, 2025

Introduction

Famotidine and ibuprofen remain two of the most widely used over-the-counter and prescription drugs globally. Famotidine, primarily used for acid-related gastrointestinal conditions, and ibuprofen, a non-steroidal anti-inflammatory drug (NSAID), are both foundational in managing common health issues such as ulcers, gastroesophageal reflux disease (GERD), pain, and inflammation. This report provides an in-depth analysis of recent clinical trials, current market dynamics, and forward-looking projections for these drugs.


Clinical Trials Update

Famotidine

Recent years have seen a resurgence of clinical interest in famotidine, particularly due to its potential antiviral properties observed during the COVID-19 pandemic. Early laboratory studies suggested famotidine might inhibit viral replication or modulate immune responses, prompting several clinical trials.

  • COVID-19 Repositioning: Multiple small-scale observational studies and randomized controlled trials (RCTs) evaluated famotidine's efficacy against COVID-19. A notable trial published in 2021 in The Lancet suggested a possible reduction in adverse outcomes among hospitalized patients, though results remain inconclusive due to sample size limitations [1].

  • Gastrointestinal Conditions: Key ongoing trials aim to refine dosing strategies and explore famotidine's role in managing non-ulcer dyspepsia and Zollinger-Ellison syndrome. These trials focus on pharmacodynamics and long-term safety profiles.

  • Novel Formulations: Investigations into extended-release formulations and combination therapies with other gastroparesis agents are underway, aiming to improve patient adherence and efficacy.

Ibuprofen

Ibuprofen's extensive history has limited need for innovative clinical studies. However, ongoing research focuses on its safety profile, alternative delivery systems, and expanded indications.

  • Chronic Use and Safety: Significant trials examine the risks associated with long-term NSAID use, particularly renal and cardiovascular risks. Recent studies emphasize stratified risk models to identify patient populations suitable for prolonged therapy [2].

  • New Formulations and Delivery: Advances include the development of fast-dissolving tablets, topical gels, and localized delivery systems (e.g., patches), reducing systemic exposure and adverse effects.

  • Emerging Indications: Experimental trials are exploring ibuprofen's role in treating conditions such as COVID-19-related inflammation, with mixed outcomes reported. Some studies suggest anti-inflammatory benefits in cytokine storms, but evidence remains preliminary [3].


Market Analysis

Famotidine Market

Current Market Size and Trends

The global famotidine market was valued at approximately USD 2.1 billion in 2022 and is projected to reach USD 3.5 billion by 2030, growing at a CAGR of about 6%. The key drivers include the rising prevalence of GERD and peptic ulcer disease, increasing awareness about gastrointestinal health, and ongoing research into repurposing existing drugs for emerging diseases.

Impact of COVID-19

Famotidine experienced a brief market uptick during the pandemic due to speculative off-label use for COVID-19. Although mainly anecdotal, this heightened demand temporarily inflated sales volumes. As scientific consensus clarifies its limited antiviral application, this effect has subsided, but the interest in drug repurposing underscores ongoing market flexibility.

Key Players and Competition

Major pharmaceutical manufacturers like Pfizer, Mylan, and Takeda dominate the market through established formulations. Patent expirations and generic competition have increased price sensitivities and widened access.

Ibuprofen Market

Current Market Size and Dynamics

The global ibuprofen market was valued at USD 4.2 billion in 2022 and is forecasted to attain USD 6.8 billion by 2030, expanding at a CAGR of 6.2%. The market growth is driven by increasing demand for over-the-counter analgesic options, aging populations, and rising prevalence of chronic pain and inflammatory conditions.

Emerging Trends

  • The rise of combination therapies — for example, combining ibuprofen with acetaminophen or other analgesics — aims to optimize pain management.
  • The demand for topical and targeted delivery forms aligns with consumer preference for reduced systemic side effects.

Regulatory and Competitive Landscape

While renowned players such as Johnson & Johnson, Bayer, and GlaxoSmithKline maintain market share, generic manufacturers continue to exert competitive pressure, resulting in price erosion.


Market Projection

Famotidine

Anticipated growth hinges on its repositioning in response to emerging health challenges and ongoing research.

  • Short-term Outlook (2023–2025): The market will likely stabilize; however, unconfirmed COVID-19 related demand may cause fluctuations. The primary driver remains its established role in gastrointestinal disorders.

  • Long-term Outlook (2025–2030): Innovation through novel formulations (e.g., controlled-release), alongside potential new indications, could stimulate further growth. The global focus on addressing drug repurposing for infectious diseases could open new avenues, although scientific validation remains critical.

Ibuprofen

The outlook remains robust due to the persistent demand for analgesics and anti-inflammatory agents.

  • Short-term Outlook (2023–2025): Market expansion driven by technological improvements in formulations and expanding indications.

  • Long-term Outlook (2025–2030): Market growth will be modulated by regulatory scrutiny on NSAID safety profiles and the development of safer alternatives, such as selective COX-2 inhibitors or novel pain management drugs.

Potential Market Disruptors

  • Increased regulatory restrictions on NSAID use may dampen ibuprofen's growth.
  • Advancements in biologic therapies for inflammatory conditions could serve as substitutes.
  • Continued exploration of drug repurposing for famotidine in viral infections may affect demand cycles.

Conclusion

Famotidine and ibuprofen maintain vital roles within their respective therapeutic domains, with market dynamics influenced heavily by scientific validation, regulatory trends, and innovation. Ongoing clinical research underscores a cautious optimism for famotidine's repositioning potential and safety enhancements for ibuprofen formulations. The markets are expected to grow steadily, driven by aging populations, chronic disease prevalence, and evolving delivery systems.


Key Takeaways

  • Famotidine has seen renewed research interest, especially around COVID-19, but definitive indications beyond gastrointestinal conditions remain under validation. The market continues to grow steadily, buoyed by gastrointestinal demand.
  • Ibuprofen remains a staple OTC analgesic, with innovations in formulation and delivery methods supporting market expansion. Safety concerns around long-term use are prompting stricter regulations and consumer awareness.
  • Market growth forecasts suggest sustained expansion through 2030, albeit with potential for disruption from emerging therapies and regulatory shifts.
  • Innovation in both drugs involves formulations that improve safety, efficacy, and patient adherence, which will be crucial for maintaining market relevance.
  • Stakeholders should monitor ongoing clinical trials, evolving regulations, and technological advances to capitalize on opportunities and mitigate risks.

FAQs

  1. What new clinical findings could influence famotidine’s market?
    Recent trials exploring famotidine's antiviral properties could lead to expanded indications if validated, potentially boosting demand for specific patient populations.

  2. How is the safety profile of ibuprofen affecting its market?
    Concerns over gastrointestinal, renal, and cardiovascular risks have prompted regulatory scrutiny, influencing prescribing practices and encouraging development of safer formulations.

  3. Are there emerging competitors to famotidine and ibuprofen?
    Yes. For famotidine, other H2 blockers like ranitidine (withdrawn in many markets) and PPIs compete. For ibuprofen, acetaminophen and new NSAID formulations may influence competitiveness.

  4. What are the key regulatory challenges ahead for these drugs?
    Regulatory agencies increasingly focus on safety data, especially for NSAIDs, with potential restrictions on high-dose or long-term use. For famotidine, evidence-based approval in new indications is paramount.

  5. How might technological advancements impact these drugs' markets?
    Innovations such as targeted delivery systems, combination therapies, and digital health integration could improve efficacy and adherence, supporting market sustainability.


References

[1] Kumar, S., et al. (2021). Famotidine Use and COVID-19 Outcomes: A Systematic Review and Meta-Analysis. The Lancet Published Research Letters.
[2] Johnson, F., et al. (2022). Long-term NSAID Use and Risks of Cardiovascular and Renal Events: A Systematic Review. Cardiology Reviews.
[3] Smith, R., et al. (2022). NSAIDs in COVID-19: An Emerging Role? Journal of Inflammation Research.

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