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Last Updated: January 14, 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
Chronic Low Back Pain 2
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
Arthritis 2
Osteoarthritis 2
Nociceptive Pain 2
Low 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 9
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Trials by US State

Trials by US State for Famotidine; Ibuprofen
Location Trials
Texas 2
Pennsylvania 2
Massachusetts 1
Louisiana 1
Illinois 1
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Clinical Trial Progress for Famotidine; Ibuprofen

Clinical Trial Phase

Clinical Trial Phase for Famotidine; Ibuprofen
Clinical Trial Phase Trials
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
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
Pediatric Rheumatology Collaborative Study Group 1
Duke University 1
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Sponsor Type

Sponsor Type for Famotidine; Ibuprofen
Sponsor Trials
Industry 5
Other 2
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Famotidine and Ibuprofen: Clinical Trials, Market Analysis, and Projections

Introduction to Famotidine and Ibuprofen

Famotidine and ibuprofen are two widely used medications, each with distinct therapeutic applications. Famotidine, commonly known by the brand name Pepcid, is a histamine H2-receptor antagonist used primarily to treat acid reflux and peptic ulcers. Ibuprofen, on the other hand, is a nonsteroidal anti-inflammatory drug (NSAID) used for pain relief, reducing inflammation, and lowering fever. This article will delve into recent clinical trials, market analysis, and projections for these drugs.

Clinical Trials: Famotidine

COVID-19 Treatment

Recent clinical trials have explored the potential of famotidine in treating COVID-19. A phase two clinical trial published in the journal Molecular Medicine revealed that famotidine can alleviate COVID-19 symptoms by activating the vagus nerve, which in turn reduces cytokine storms. This mechanism involves the release of anti-inflammatory molecules that help mitigate life-threatening inflammation[1].

Combination Therapies

Another clinical trial is testing the combination of famotidine and celecoxib for treating COVID-19 patients. This study aims to determine if this combination can reduce inflammation and help fight the virus. Participants receive 80 mg of famotidine four times a day and 400 mg of celecoxib as an initial dose, followed by 200 mg twice a day for five days, with famotidine treatment continuing for an additional nine days[5].

Safety and Efficacy

Clinical trials conducted by Northwell Health and Cold Spring Harbor Laboratory have shown that famotidine leads to earlier resolution of inflammation in patients and alleviates symptoms such as breathing difficulties, chest congestion, cough, and the return of taste and smell. These findings suggest that famotidine is safe and effective in treating COVID-19, although further studies are needed to replicate these results in human subjects[1].

Clinical Trials: Ibuprofen

Combination with Famotidine

Ibuprofen and famotidine are also used in combination for treating rheumatoid arthritis and osteoarthritis. This combination, known as ibuprofen-famotidine tablets, is indicated to relieve signs and symptoms of these conditions while reducing the risk of developing upper gastrointestinal ulcers associated with ibuprofen use. Clinical trials have primarily enrolled patients under 65 years old without a prior history of gastrointestinal ulcers, and the trials did not extend beyond six months[4].

Adverse Effects

Common adverse reactions to ibuprofen-famotidine tablets include nausea, diarrhea, constipation, upper abdominal pain, and headache. Serious side effects such as blurred vision, scotomata, and changes in color vision have also been reported, necessitating ophthalmologic examination if such symptoms occur[4].

Market Analysis: Famotidine

Current Market and Forecast

The global famotidine market is expected to grow significantly, driven by its potential in treating COVID-19 and other inflammatory diseases. The market analysis includes historical data from 2019 to 2023 and forecasted data from 2025 to 2031. The base year for calculations is 2023, and the report provides detailed insights into market size, revenue, volume share, CAGR, competitor analysis, and regional analysis[2].

Key Factors Affecting the Market

The market for famotidine is influenced by several factors, including the increasing prevalence of gastrointestinal disorders, the affordability and generic availability of the drug, and its potential in new therapeutic areas such as COVID-19 treatment. The tablet form of famotidine has a significant impact on the market due to its ease of administration and patient compliance[2].

Market Analysis: Ibuprofen

Ibuprofen API Market

The ibuprofen API market is projected to grow at a CAGR of more than 2.1% from 2025 to 2037, driven by the increasing prevalence of influenza and other inflammatory conditions. The market size is estimated to be over USD 715 million in 2024 and is expected to cross USD 936 million by the end of 2037. The use of ibuprofen in combination with acetaminophen to relieve symptoms such as headaches and muscle aches is a key driver of this market[3].

Combination Products

The launch of generic versions of combination products like ibuprofen-famotidine tablets also impacts the market. For instance, Endo launched a generic version of Duexis, which combines ibuprofen and famotidine, with sales of approximately $49 million for the 12 months ended December 31, 2023[4].

Regional Analysis and Market Dominance

Famotidine Market

The global famotidine market is expected to be dominated by regions with high prevalence rates of gastrointestinal disorders and those with a strong healthcare infrastructure. The market report provides a detailed regional analysis, including country-specific data, to help understand the market dynamics and potential growth areas[2].

Ibuprofen Market

The ibuprofen API market is also influenced by regional factors, with areas experiencing high rates of influenza and other inflammatory conditions driving demand. The market is expected to be dominated by regions with significant healthcare spending and a high demand for over-the-counter and prescription pain relief medications[3].

Technological Trends and Innovations

Bioelectronic Medicine

The use of famotidine in activating the vagus nerve to reduce inflammation represents a significant advancement in bioelectronic medicine. This area of research opens up new avenues for treating inflammatory diseases beyond COVID-19, potentially revolutionizing how we approach inflammation management[1].

Combination Therapies

The development of combination therapies like ibuprofen-famotidine tablets highlights the trend towards creating more effective and safer treatment options. These combinations aim to mitigate the adverse effects associated with individual drugs while enhancing therapeutic efficacy[4].

Consumer Behavior and ESG Analysis

Consumer Preferences

Consumer behavior plays a crucial role in the market dynamics of both famotidine and ibuprofen. Patients increasingly prefer medications that are affordable, effective, and have minimal side effects. The generic availability of these drugs and their inclusion in combination products cater to these preferences[2][4].

ESG Analysis

Environmental, Social, and Governance (ESG) factors are becoming increasingly important in the pharmaceutical industry. Companies that prioritize ESG considerations, such as sustainable manufacturing practices and ethical business operations, are likely to gain a competitive edge in the market[2].

Key Takeaways

  • Famotidine's Role in COVID-19: Clinical trials have shown that famotidine can alleviate COVID-19 symptoms by activating the vagus nerve and reducing cytokine storms.
  • Combination Therapies: Famotidine and ibuprofen are being used in combination therapies to treat various conditions, including COVID-19 and arthritis.
  • Market Growth: The global famotidine and ibuprofen markets are expected to grow significantly, driven by increasing demand and new therapeutic applications.
  • Regional Dominance: The markets for these drugs will be dominated by regions with high healthcare spending and significant prevalence of relevant diseases.
  • Technological Advancements: Bioelectronic medicine and combination therapies are key trends driving innovation in the treatment of inflammatory diseases.

FAQs

What is the mechanism of action of famotidine in treating COVID-19?

Famotidine activates the vagus nerve, which signals the release of anti-inflammatory molecules to reduce cytokine storms and inflammation in the body[1].

What are the common adverse reactions to ibuprofen-famotidine tablets?

Common adverse reactions include nausea, diarrhea, constipation, upper abdominal pain, and headache. Serious side effects such as blurred vision and changes in color vision can also occur[4].

How is the global famotidine market expected to grow?

The global famotidine market is expected to grow significantly from 2025 to 2031, driven by its potential in treating COVID-19 and other inflammatory diseases[2].

What drives the growth of the ibuprofen API market?

The growth of the ibuprofen API market is driven by the increasing prevalence of influenza and other inflammatory conditions, as well as the use of ibuprofen in combination with other medications[3].

Are there any ongoing clinical trials for famotidine and celecoxib in treating COVID-19?

Yes, there are ongoing clinical trials testing the combination of famotidine and celecoxib to help hospitalized COVID-19 patients and newly infected individuals[5].

Sources

  1. Biospace: "Famotidine (Pepcid) Activates the Vagus Nerve to Reduce Cytokine Storm in COVID-19: New Study Shows" - https://www.biospace.com/famotidine-pepcid-activates-the-vagus-nerve-to-reduce-cytokine-storm-in-covid-19-new-study-shows
  2. Cognitive Market Research: "Famotidine Market Report 2024 (Global Edition)" - https://www.cognitivemarketresearch.com/famotidine-market-report
  3. Research Nester: "Ibuprofen API Market Size" - https://www.researchnester.com/reports/ibuprofen-api-market/5471/market-size
  4. PR Newswire: "Endo Launches Ibuprofen-Famotidine Tablets, Generic Version of Duexis" - https://www.prnewswire.com/news-releases/endo-launches-ibuprofen-famotidine-tablets-generic-version-of-duexis-302098827.html
  5. Withpower: "Celecoxib + Famotidine for COVID-19 - Clinical Trials" - https://www.withpower.com/trial/phase-3-communicable-diseases-9-2021-bdd26

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