CLINICAL TRIALS PROFILE FOR IBUPROFEN

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.
OTC	NCT00267293 ↗	Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever	Completed	Children Youth and Family Consortium	Phase 4	2006-01-01	Currently, when a child has fever either ibuprofen (e.g. Motrin, Advil) or acetaminophen (e.g. Tylenol) is given. Both Ibuprofen and Acetaminophen are approved for over the counter use for treatment of fever by the Food and Drug Administration (FDA). This study hopes to determine whether giving both medications together is better than giving one medication alone for the treatment of fever.
OTC	NCT00267293 ↗	Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever	Completed	Penn State University	Phase 4	2006-01-01	Currently, when a child has fever either ibuprofen (e.g. Motrin, Advil) or acetaminophen (e.g. Tylenol) is given. Both Ibuprofen and Acetaminophen are approved for over the counter use for treatment of fever by the Food and Drug Administration (FDA). This study hopes to determine whether giving both medications together is better than giving one medication alone for the treatment of fever.
OTC	NCT00402493 ↗	Study to Determine if Taking OTC Non-Steroidal Anti-Inflammatory Affects Eye Pressure in Patients Using Glaucoma Drops	Completed	Pfizer	N/A	2006-12-01	The Purpose of This Study is to Determine if Taking an Over the Counter Non-Steroidal Anti-Inflammatory(Ibuprofen)has an Effect on Eye Pressure in Patients using Brimonidine(Alphagan)and Latanoprost(Xalatan) eye drops.
OTC	NCT00402493 ↗	Study to Determine if Taking OTC Non-Steroidal Anti-Inflammatory Affects Eye Pressure in Patients Using Glaucoma Drops	Completed	Philadelphia Eye Associates	N/A	2006-12-01	The Purpose of This Study is to Determine if Taking an Over the Counter Non-Steroidal Anti-Inflammatory(Ibuprofen)has an Effect on Eye Pressure in Patients using Brimonidine(Alphagan)and Latanoprost(Xalatan) eye drops.

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.
NCT00000728 ↗	Phase I Trial of the Combination of Zidovudine and Recombinant Interleukin-2 in Patients With Persistent Generalized Lymphadenopathy	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To evaluate the short-term effects of administering zidovudine ( AZT ) at the same time with increasing doses of aldesleukin ( interleukin-2; IL-2 ) in patients with persistent generalized lymphadenopathy syndrome ( PGL ). The effects to be studied include safety or toxicity, how quickly the drugs are used in the body, effects on the immune system, effects on HIV, concentrations in body fluids, and how quickly the drugs are cleared by the kidneys. The trial will establish the maximum tolerated dose ( MTD ) and will be a pilot study to determine the dose that has the greatest effect in the immune system. AZT has been shown to be effective in HIV-related disease. IL-2 has been shown to increase immune responses and correct immune problems caused by HIV in the test tube. IL-2 has also been effective in treating Kaposi's sarcoma in a number of patients. Because of the clinical activities of these two drugs and because their toxicities and mechanisms of action do not overlap, it may be beneficial to combine the two drugs with their antiviral and immune stimulatory effects.
NCT00001005 ↗	A Study of Zidovudine Plus Interleukin-2 in HIV-Infected Patients Who Have No Symptoms of Infection But Who Have Tender Lymph Nodes	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	AMENDED: To investigate whether subcutaneous (SC) injection of IL-2 produces biological responses which parallel those observed with IV dosing. Original design: To evaluate the short-term effects of combined administration of zidovudine (AZT) and increasing doses of recombinant interleukin-2 (aldesleukin; IL-2) in patients infected with HIV, who have lymphadenopathy, but who are otherwise asymptomatic (no other symptoms). The first phase of this clinical trial will establish maximum tolerated dose ( MTD ). How quickly the drugs get into the blood and how long they remain there (pharmacokinetics) will also be studied at each dose as well as the effect on HIV. Since AZT has no effect on cells that contain inactive virus (latently infected cells) and these cells may act as viral reservoirs, that a second agent that can destroy these infected cells would be useful in combination with AZT. The different activities of AZT and IL-2, as well as the non-overlapping nature of their mechanisms of action and toxicity, increase the theoretical benefits of combining AZT, a drug which has clinically significant activity in HIV-related disease but cannot eliminate infected cells, with IL-2, a drug which may enhance anti-HIV immunity, destroy chronically infected cells, and allow immune recognition of latently infected cells.
NCT00002276 ↗	The Effects of AZT and Ibuprofen on HIV-Infected Patients With Hemophilia	Completed	University of Pittsburgh	N/A	1969-12-31	To determine if platelet dysfunction and/or pharmacologic drug interaction occurs in patients taking both AZT and ibuprofen, which might account for enhanced bleeding tendency.
NCT00004440 ↗	Study of Ibuprofen to Preserve Lung Function in Patients With Cystic Fibrosis	Completed	Case Western Reserve University	N/A	1996-08-01	OBJECTIVES: I. Determine the effect of different doses of ibuprofen on neutrophil (polymorphonuclear leukocyte; PMN) delivery to a mucosal surface (the oral mucosa) in patients with cystic fibrosis and healthy controls. II. Determine the duration of effect (and possible rebound effect) of ibuprofen on PMN delivery to a mucosal surface in these patients.

Clinical Trial Conditions for IBUPROFEN

Condition Name

Condition Name for IBUPROFEN
Intervention	Trials
Pain	110
Pain, Postoperative	45
Postoperative Pain	45
Healthy	36

Condition MeSH

Condition MeSH for IBUPROFEN
Intervention	Trials
Pain, Postoperative	152
Ductus Arteriosus, Patent	46
Osteoarthritis	42
Acute Pain	39

Clinical Trial Locations for IBUPROFEN

Trials by Country

Trials by Country for IBUPROFEN
Location	Trials
United States	997
United Kingdom	93
Canada	85
Germany	45
Spain	40

Trials by US State

Trials by US State for IBUPROFEN
Location	Trials
California	84
Texas	72
Pennsylvania	57
New York	55
Florida	43

Clinical Trial Progress for IBUPROFEN

Clinical Trial Phase

Clinical Trial Phase for IBUPROFEN
Clinical Trial Phase	Trials
PHASE4	31
PHASE3	15
PHASE2	15

Clinical Trial Status

Clinical Trial Status for IBUPROFEN
Clinical Trial Phase	Trials
Completed	523
Recruiting	152
Not yet recruiting	72

Clinical Trial Sponsors for IBUPROFEN

Sponsor Name

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

Sponsor Type

Sponsor Type for IBUPROFEN
Sponsor	Trials
Other	1018
Industry	320
U.S. Fed	38

Ibuprofen: Clinical Trial Status, Market Analysis, and Revenue Projection

Last updated: April 26, 2026

What is ibuprofen and where is it used clinically?

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used for pain, fever, and inflammation. It is marketed globally in multiple oral and topical forms (tablets, capsules, suspension, effervescent, gel, and combination products), and it is widely available as over-the-counter and prescription medicine depending on jurisdiction and dosage.

Core indications with consistent clinical demand

• Pain (mild to moderate): headache, dental pain, musculoskeletal pain, menstrual cramps.
• Inflammation: osteoarthritis and rheumatoid arthritis pain control.
• Fever and inflammatory symptoms: viral illness symptomatic relief in many markets.

Regulatory status Ibuprofen is an established off-patent active ingredient in most countries. Market exclusivity is largely driven by:

• Fixed-dose combinations and specific formulations (where patents may exist).
• Brand-specific line extensions (e.g., pediatric dosing, sustained release, topical gels).
• Country-level product-specific approvals rather than active ingredient monopoly.

What clinical trials are active for ibuprofen?

Ibuprofen’s clinical trial landscape is dominated by:

• Pediatric formulations and dosing studies.
• Bioequivalence and pharmacokinetic studies for generic/manufacturing changes.
• Safety studies and observational registries rather than new molecular entity trials.

High-level trial pattern

• Formulation/PK/Bioequivalence: frequent, short-duration studies.
• Pediatric: dosing confirmation for age bands and tolerability.
• Real-world safety: gastrointestinal (GI), renal, cardiovascular risk characterization in typical use.

No single global registry snapshot is stable enough to name “active trials” and endpoints without a real-time database pull. For a business assessment, ibuprofen’s R&D value is typically in incremental formulation IP and lifecycle management rather than late-stage efficacy discovery.

What is the current market size and how is the category structured?

Ibuprofen sits in the broad global NSAID market, which is split by:

• OTC and Rx channels.
• Oral products (dominant) and topical products (smaller but growing in some markets).
• Monoproduct and combination products (notably with paracetamol/acetaminophen and caffeine in some countries).

Market structure drivers

• Broad consumer awareness and established switching behavior.
• Price competition from generics, which compresses net prices.
• Margin retention through:
  • Higher-value formulation niches (liquid pediatric, topical gels, sustained release).
  • Premium brand positioning where reimbursement or clinician preference supports higher ASPs.

How does ibuprofen compete versus other NSAIDs and analgesics?

Ibuprofen competes against:

• Other OTC analgesics: paracetamol/acetaminophen.
• Other NSAIDs: naproxen, diclofenac (especially topical), aspirin.
• Adjuncts: cold and flu combination products.

Competitive behavior in OTC

• Category demand is stable because ibuprofen is a first-line product for fever and common pain.
• Market share shifts are primarily driven by price, pack size promotions, and brand trust.
• Clinical differentiation is limited because the active ingredient is shared across competitors.

What is the profit model for ibuprofen in an off-patent world?

With the active ingredient off-patent in most geographies, revenue opportunity concentrates in:

• Brand and distribution power: sustaining shelf presence.
• Formulation differentiation: pediatric liquids, taste-masked formulations, topical delivery, and convenience formats.
• Manufacturing efficiency: scale and cost-down to defend margins against generics.
• Regulatory strategy: product line extensions that remain distinct in label and use case.

What are the practical implications for R&D strategy?

For investment-grade evaluation, ibuprofen R&D is generally:

• Lifecycle-focused: formulation, pediatric dosing, new delivery routes.
• Evidence generation-focused: pragmatic safety and tolerability studies, comparative effectiveness in typical care settings.
• Regulatory-focused: bioequivalence and quality upgrades tied to manufacturing changes.

Late-stage “new use” programs are possible but usually face high likelihood that payers and physicians treat ibuprofen as interchangeable with other NSAIDs, limiting willingness to pay.

Market Projection

What is the demand outlook for ibuprofen through 2030?

Demand is expected to track:

• Population growth and aging (higher arthritis burden).
• Persistent OTC self-medication for acute pain and fever.
• Slow shift toward topical NSAIDs in musculoskeletal pain where clinicians and consumers accept localized therapy.

Net effect: global volume can remain resilient, while value growth depends on inflation, channel mix, and the ability to maintain ASP via differentiated formulations.

What revenue growth path is most realistic for investors?

Because ibuprofen is largely generic, revenue growth hinges on company-level levers:

• geographic distribution and contracts,
• pack mix and formulation mix,
• channel strategy (pharmacy vs mass vs online),
• premiumization of topical/pediatric and combination products.

A realistic projection framework for ibuprofen companies is:

• Base-case: modest value growth, stable volume, margin pressure from generics.
• Upside: share gains via branded OTC strategy or expansion of topical and pediatric formulations.
• Downside: higher competitive intensity, regulatory pressure on OTC access, or adverse safety perception affecting self-medication.

How to model ibuprofen revenues and margins (investment lens)

Use a three-block model:

1. Market volume: number of units consumed (oral tablets, liquid doses, topical tubes).
2. Net price (ASP): after discounts and channel rebates.
3. Product mix: share of topical and branded lines vs low-price generics.

Revenue equation

• Revenue = Total units x blended net price

EBITDA bridge drivers

• Gross margin: influenced by manufacturing cost, formulation premium, and competitive intensity.
• Operating expenses: brand investment in OTC and distribution costs.
• Regulatory and pharmacovigilance: modest relative to new molecular entities.

Key Takeaways

• Ibuprofen is a mature, mostly off-patent NSAID; clinical development is dominated by formulation, pediatric dosing, bioequivalence, and real-world safety evidence.
• Market growth is constrained by generic competition; value depends on net price defense and mix shifts toward topical and higher-value formulation formats.
• Investment thesis for ibuprofen concentrates on execution in branded OTC presence, differentiated formulations, and cost-efficient manufacturing rather than new-efficacy clinical trials.

FAQs

1) Is ibuprofen still being studied in clinical trials?

Yes, clinical activity mainly covers formulation, dosing (including pediatric), pharmacokinetics/bioequivalence, and safety/real-world effectiveness studies rather than new molecular entity development.

2) What indications drive the largest ibuprofen demand?

Common pain and fever, plus chronic musculoskeletal pain such as osteoarthritis, drive most demand. Pediatric fever and pain dosing also supports recurring utilization in many markets.

3) Can ibuprofen create patent-protected revenue?

Active ingredient patents are mostly expired in most regions. Companies typically rely on formulation-specific IP, combinations, delivery systems, and product line extensions where allowed by local patent law and regulatory exclusivity.

4) How do competitors affect ibuprofen pricing?

Generic entrants compress net prices quickly. Competitive pressure is strongest in core oral OTC forms; differentiation tends to hold ASP better in topical and pediatric convenience formats.

5) What is the highest-leverage business strategy for ibuprofen?

Maintaining share through distribution and brand presence, optimizing product mix toward higher-value formulations, and sustaining manufacturing cost advantages.

References

1. Food and Drug Administration. Ibuprofen Drug Approval Reports and labeling information. U.S. FDA website.
2. European Medicines Agency. Public assessment reports and EPAR-related product information for ibuprofen-containing medicines. EMA website.
3. World Health Organization. NSAIDs and general information on analgesic/antipyretic medicines. WHO website.
4. U.S. National Library of Medicine. ClinicalTrials.gov database (ibuprofen search results and trial records). NIH/NLM website.