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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR IBUPROFEN


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505(b)(2) Clinical Trials for Ibuprofen

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT00011063 ↗ Effect of Ginkgo Biloba on Phenytoin Elimination Completed National Institutes of Health Clinical Center (CC) Phase 1 2001-02-01 This study will examine how the herbal remedy ginkgo biloba may affect the body's elimination of other medicines. Many people take ginkgo biloba to improve memory, mental alertness and overall feeling of well being. Since this product is considered a food supplement and not a drug, it is not subject to the rigorous pre-market testing required for prescription and over-the-counter (OTC) drugs. As a result, information has not been collected on possible interactions between ginkgo biloba and other medications. This study will look at how ginkgo biloba affects the elimination of phenytoin-a medication used to treat patients with seizures. Normal healthy volunteers 21 years of age or older may be eligible for this 40-day study. Candidates will provide a medical history and undergo a physical examination and routine blood tests. Women of childbearing age must use a reliable form of birth control other than oral contraceptives ("the pill"). For at least 2 weeks before the study and throughout its duration, study participants may not have any of the following: 1) medications that can affect platelet function (e.g., aspirin, Motrin, Advil, Nuprin, ibuprofen, etc.); 2) alcoholic beverages; 3) grapefruit and grapefruit juice; and 4) all medications except those given by study personnel. On day 1 of the study, subjects take one 500-mg dose of phenytoin at 8:00 A.M.. On an empty stomach. (Subjects fast the night before taking the phenytoin and are allowed to eat breakfast 2 hours after the dose). Blood samples are drawn just before dosing and again at 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 32, 48, 72 and 96 hours after the dose. Blood drawn on this first study day is collected through a catheter (small plastic tube) placed in a vein to avoid multiple needlesticks. After the 12-hour sample is collected, the subject goes home and then returns to the clinic for the remaining blood draws, which are taken by direct needlestick. When the blood sampling is completed, subjects begin ginkgo therapy. The NIH Clinical Center provides participants a supply of 60-mg capsules of ginkgo to take twice a day (at 8 A.M. and 8 P.M..) for 4 weeks. At the end of the 4 weeks, subjects are given a second dose of phenytoin as described above and repeat the blood sampling procedure. Subjects continue taking ginkgo during this second phenytoin study.
OTC NCT00245375 ↗ A Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery Completed McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. N/A 2005-01-01 Increasingly in general surgery, the investigators are conducting outpatient day surgery. Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America. These patients all require some form of analgesia which can be taken at home in the first few days after the surgery. The current standard at the investigators' centre and many others in the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent opioids such as oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed medication (Tylenol #3®) is often poorly tolerated by patients, has several undesirable side effects, and may not provide effective pain relief. In the investigators' experience, non-steroidal anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home analgesic regimen. Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain medication. They hope to show that a combination of ibuprofen and acetaminophen is better for pain relief after these procedures. The combination of acetaminophen and ibuprofen would be a safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices of surgeons are old habits, it will require a very convincing argument to get them to change their practices. A randomized controlled trial comparing these two regimens, the investigators hope, would be a powerful enough argument. The hypothesis of this study, therefore, is that the pain control provided by a combination of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day). This study will attempt to enroll 150 patients in total. Eligible patients will be identified by their attending surgeon and contacted by study personnel. Patients who enroll in the study will undergo their surgery in the usual manner. After the surgery, in the recovery room, once they are ready to go home, they will be randomized to receive combination A or B and be given a week's worth of pain medication. They will then go home and take this medication as directed. They will record their pain intensity and pain relief once per day using a diary provided in the study package. One week after their surgery, they will return to the hospital clinic and be seen by the study nurse. They will hand over the diary and any unused medication. They will also be asked several questions regarding their overall satisfaction, incidence of side effects, and how long until they were pain free. The risks of participating in this study are minimal from the risks inherent to the procedures and medications the patients would receive within the standard of care. Ibuprofen is a commonly used NSAID which is widely available over the counter and has an established safety profile. The most common adverse effects of ibuprofen and other NSAIDs are gastrointestinal bleeding and ulceration. Other less common adverse effects include nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and cognitive dysfunction. The investigators' patients will be selected to exclude those most at risk for these complications (see exclusion criteria). Acetaminophen has few side effects, with no adverse effects on platelet function and no evidence of gastric irritation.
OTC NCT00245375 ↗ A Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery Completed Nova Scotia Health Authority N/A 2005-01-01 Increasingly in general surgery, the investigators are conducting outpatient day surgery. Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America. These patients all require some form of analgesia which can be taken at home in the first few days after the surgery. The current standard at the investigators' centre and many others in the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent opioids such as oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed medication (Tylenol #3®) is often poorly tolerated by patients, has several undesirable side effects, and may not provide effective pain relief. In the investigators' experience, non-steroidal anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home analgesic regimen. Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain medication. They hope to show that a combination of ibuprofen and acetaminophen is better for pain relief after these procedures. The combination of acetaminophen and ibuprofen would be a safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices of surgeons are old habits, it will require a very convincing argument to get them to change their practices. A randomized controlled trial comparing these two regimens, the investigators hope, would be a powerful enough argument. The hypothesis of this study, therefore, is that the pain control provided by a combination of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day). This study will attempt to enroll 150 patients in total. Eligible patients will be identified by their attending surgeon and contacted by study personnel. Patients who enroll in the study will undergo their surgery in the usual manner. After the surgery, in the recovery room, once they are ready to go home, they will be randomized to receive combination A or B and be given a week's worth of pain medication. They will then go home and take this medication as directed. They will record their pain intensity and pain relief once per day using a diary provided in the study package. One week after their surgery, they will return to the hospital clinic and be seen by the study nurse. They will hand over the diary and any unused medication. They will also be asked several questions regarding their overall satisfaction, incidence of side effects, and how long until they were pain free. The risks of participating in this study are minimal from the risks inherent to the procedures and medications the patients would receive within the standard of care. Ibuprofen is a commonly used NSAID which is widely available over the counter and has an established safety profile. The most common adverse effects of ibuprofen and other NSAIDs are gastrointestinal bleeding and ulceration. Other less common adverse effects include nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and cognitive dysfunction. The investigators' patients will be selected to exclude those most at risk for these complications (see exclusion criteria). Acetaminophen has few side effects, with no adverse effects on platelet function and no evidence of gastric irritation.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Ibuprofen

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000574 ↗ Ibuprofen in Sepsis Study Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1990-09-01 To determine the effects of ibuprofen on mortality, development and reversal of shock, and adult respiratory distress syndrome, and on Lung Parenchymal Injury Score in adult patients with serious infection.
NCT00000574 ↗ Ibuprofen in Sepsis Study Completed Vanderbilt University Phase 3 1990-09-01 To determine the effects of ibuprofen on mortality, development and reversal of shock, and adult respiratory distress syndrome, and on Lung Parenchymal Injury Score in adult patients with serious infection.
NCT00000574 ↗ Ibuprofen in Sepsis Study Completed Vanderbilt University Medical Center Phase 3 1990-09-01 To determine the effects of ibuprofen on mortality, development and reversal of shock, and adult respiratory distress syndrome, and on Lung Parenchymal Injury Score in adult patients with serious infection.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ibuprofen

Condition Name

Condition Name for Ibuprofen
Intervention Trials
Pain 104
Pain, Postoperative 42
Postoperative Pain 37
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Condition MeSH

Condition MeSH for Ibuprofen
Intervention Trials
Pain, Postoperative 124
Ductus Arteriosus, Patent 43
Osteoarthritis 41
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Clinical Trial Locations for Ibuprofen

Trials by Country

Trials by Country for Ibuprofen
Location Trials
United States 958
United Kingdom 93
Canada 76
Germany 45
Spain 37
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Trials by US State

Trials by US State for Ibuprofen
Location Trials
California 78
Texas 67
New York 55
Pennsylvania 53
Utah 43
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Clinical Trial Progress for Ibuprofen

Clinical Trial Phase

Clinical Trial Phase for Ibuprofen
Clinical Trial Phase Trials
Phase 4 270
Phase 3 148
Phase 2/Phase 3 28
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Clinical Trial Status

Clinical Trial Status for Ibuprofen
Clinical Trial Phase Trials
Completed 494
Recruiting 123
Not yet recruiting 72
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Clinical Trial Sponsors for Ibuprofen

Sponsor Name

Sponsor Name for Ibuprofen
Sponsor Trials
Pfizer 44
Merck Sharp & Dohme Corp. 18
Cumberland Pharmaceuticals 17
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Sponsor Type

Sponsor Type for Ibuprofen
Sponsor Trials
Other 916
Industry 313
U.S. Fed 38
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Ibuprofen: Clinical Trials, Market Analysis, and Projections

Introduction to Ibuprofen

Ibuprofen, a widely used nonsteroidal anti-inflammatory drug (NSAID), is known for its efficacy in alleviating pain, fever, and inflammation. It is available over-the-counter (OTC) and in prescription strengths, making it a staple in both household medicine cabinets and clinical settings.

Clinical Trials Update

Current Clinical Development

Ibuprofen is currently under clinical development by PLx Pharma Winddown, specifically for the treatment of inflammation. This development is in Phase II, a critical stage where the drug's efficacy and side effects are closely monitored.

  • Phase Transition Success Rate (PTSR): According to GlobalData, Phase II drugs for inflammation have a 38% phase transition success rate for progressing into Phase III. This benchmark provides a context for the likelihood of ibuprofen's advancement in clinical trials[1].

Specific Trials and Studies

One notable study involves the comparison of ibuprofen chewable tablets versus ibuprofen suspension in febrile children. This trial, though not widely published, focuses on the efficacy and pharmacokinetic/pharmacodynamic profile of these different formulations.

  • Trial Details: The study, sponsored by Kenvue, involves the therapeutic areas of pain, inflammation, and fever. While detailed results are not publicly available, such studies are crucial for optimizing ibuprofen's delivery and effectiveness in various patient populations[4].

Market Analysis

Global Market Size and Growth

The global ibuprofen market is substantial and growing. Here are some key statistics:

  • Current Market Size: As of 2024, the global ibuprofen market size is estimated to be around USD 121.6 million[2][3].
  • Forecasted Growth: The market is expected to expand at a compound annual growth rate (CAGR) of 7.8% to 8.5% from 2024 to 2031/2033, reaching approximately USD 215.24 million to USD 205.6 million by the end of the forecast period[2][3].

Regional Market Breakdown

The market is segmented across various regions, each with its own growth trajectory:

  • North America: This region holds more than 40% of the global revenue, with a market size of USD 48.64 million in 2024 and a CAGR of 6.7% from 2024 to 2031[2].
  • Europe: Europe accounts for over 30% of the global revenue, with a market size of USD 36.48 million in 2024 and a CAGR of 7.0% from 2024 to 2031[2].
  • Asia Pacific: This region holds around 23% of the global revenue, with a market size of USD 27.97 million in 2024 and a CAGR of 10.5% from 2024 to 2031[2].
  • Latin America and Middle East & Africa: These regions also show significant growth, with CAGRs of 7.9% and 8.2%, respectively, from 2024 to 2031[2].

Market Segmentation

The ibuprofen market is segmented based on various factors:

  • Formulations: Tablets dominate the market with a 41.6% share in 2023, followed by capsules, syrups, injections, and other forms. The ease of use and convenience of tablets contribute to their market lead[3].
  • Applications: Rheumatoid arthritis and osteoarthritis are the leading application areas, capturing over 30.8% of the market share in 2023. Cancer-related applications and general pain relief also constitute significant segments[3].

Market Drivers and Challenges

Key Drivers

Several factors drive the growth of the ibuprofen market:

  • Increasing Chronic Pain Conditions: The rising prevalence of chronic pain conditions such as rheumatoid arthritis and osteoarthritis increases the demand for ibuprofen[3][5].
  • Aging Population: An aging population contributes to higher healthcare needs, including the use of NSAIDs like ibuprofen[3][5].
  • Self-Medication Trend: The trend towards self-medication for minor ailments boosts the demand for OTC ibuprofen products[3][5].

Regulatory Challenges

Despite the growth drivers, the market faces regulatory challenges:

  • Regulatory Scrutiny: Strict regulatory approval processes can limit the introduction of new and innovative ibuprofen products to the market[3].

Opportunities for Growth

Emerging Markets

Emerging markets present significant growth opportunities due to:

  • Increased Healthcare Awareness: Rising healthcare awareness and expanding access to healthcare in these regions drive market growth[3].
  • Rising Disposable Incomes: Growing disposable incomes in emerging markets increase the purchasing power for healthcare products, including ibuprofen[3].

Innovations in Drug Delivery Systems

Advancements in drug delivery systems, such as sustained-release formulations and novel dosage forms, can enhance patient compliance and convenience, driving the adoption of these innovative products[3].

Expansion of OTC Market

The expansion of the OTC market provides a substantial growth avenue for ibuprofen, as consumers increasingly prefer self-medication for minor ailments[3].

Key Takeaways

  • Clinical Trials: Ibuprofen is in Phase II clinical trials for inflammation, with a 38% phase transition success rate benchmark.
  • Market Size and Growth: The global ibuprofen market is valued at USD 121.6 million in 2024 and is expected to grow at a CAGR of 7.8% to 8.5% until 2031/2033.
  • Regional Breakdown: North America, Europe, and Asia Pacific are significant markets, each with distinct growth rates.
  • Market Drivers: Increasing chronic pain conditions, an aging population, and the self-medication trend drive market growth.
  • Regulatory Challenges: Regulatory scrutiny and approval processes pose challenges to market growth.
  • Growth Opportunities: Emerging markets, innovations in drug delivery systems, and the expansion of the OTC market offer potential for further growth.

FAQs

What is the current phase of ibuprofen clinical trials for inflammation?

Ibuprofen is currently in Phase II clinical trials for the treatment of inflammation, with a phase transition success rate benchmark of 38% for progressing into Phase III[1].

What is the projected growth rate of the global ibuprofen market?

The global ibuprofen market is expected to grow at a compound annual growth rate (CAGR) of 7.8% to 8.5% from 2024 to 2031/2033[2][3].

Which regions dominate the ibuprofen market?

North America, Europe, and Asia Pacific are the dominant regions in the ibuprofen market, with North America holding over 40% of the global revenue[2].

What are the main drivers of the ibuprofen market growth?

The main drivers include increasing chronic pain conditions, an aging population, and the trend towards self-medication for minor ailments[3][5].

What are the regulatory challenges facing the ibuprofen market?

Regulatory scrutiny and strict approval processes pose challenges to the introduction of new and innovative ibuprofen products to the market[3].

What opportunities exist for the growth of the ibuprofen market?

Emerging markets, innovations in drug delivery systems, and the expansion of the OTC market present significant growth opportunities for ibuprofen[3].

Sources

  1. Pharmaceutical Technology: "Ibuprofen by PLx Pharma Winddown for Inflammation: Likelihood of Approval and Phase Transition Success Rate Model"[1].
  2. Cognitive Market Research: "Global Ibuprofen Market Report 2024"[2].
  3. Market.US: "Ibuprofen Market Size, Share, Growth | CAGR Of 7.8%"[3].
  4. Yale University: "Efficacy and pharmacokinetic/pharmacodynamic profile of ibuprofen chewable tablets versus ibuprofen suspension in febrile children"[4].
  5. Straits Research: "Global Ibuprofen Market Size, Top Share, CAGR of 2.44%, Report"[5].

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