CLINICAL TRIALS PROFILE FOR KETOROLAC TROMETHAMINE

505(b)(2) Clinical Trials for KETOROLAC TROMETHAMINE

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
New Dosage	NCT00266786 ↗	Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery	Completed	Egalet Ltd	Phase 3	2005-12-01	Ketorolac has been marketed for several years in other forms (tablet and injectable) for the short-term relief of pain. This study will test whether a new dosage form (nasal spray) containing ketorolac is effective at relieving the pain of major abdominal surgery, and will also assess product safety. Previous studies with the nasal spray have suggested that it is similar to the previously approved injectable form in effectiveness for pain relief and in its safety profile. Patients will be randomized in a 2:1 ratio to receive intranasal ketorolac or placebo when the pain reaches a moderate level (40 on a scale of 100) following surgery. After the first dose, subjects will receive study drug every 6 hours for 48 hours, and then as needed (up to 4 times a day) for a total of 5 days. If pain is not adequately relieved by the study drug, subjects will be given morphine sulfate or other standard analgesics. Follow-up safety evaluations will occur about 1 and 2 weeks after the start of dosing. Subjects will be asked to answer questions about their pain relief and any possible side effects of the drug during the study, and will be given physical examinations, including nasal evaluations, before and during the clinical trial. A small amount of blood will be drawn for routine clinical laboratory testing.
New Dosage	NCT00266786 ↗	Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery	Completed	Luitpold Pharmaceuticals	Phase 3	2005-12-01	Ketorolac has been marketed for several years in other forms (tablet and injectable) for the short-term relief of pain. This study will test whether a new dosage form (nasal spray) containing ketorolac is effective at relieving the pain of major abdominal surgery, and will also assess product safety. Previous studies with the nasal spray have suggested that it is similar to the previously approved injectable form in effectiveness for pain relief and in its safety profile. Patients will be randomized in a 2:1 ratio to receive intranasal ketorolac or placebo when the pain reaches a moderate level (40 on a scale of 100) following surgery. After the first dose, subjects will receive study drug every 6 hours for 48 hours, and then as needed (up to 4 times a day) for a total of 5 days. If pain is not adequately relieved by the study drug, subjects will be given morphine sulfate or other standard analgesics. Follow-up safety evaluations will occur about 1 and 2 weeks after the start of dosing. Subjects will be asked to answer questions about their pain relief and any possible side effects of the drug during the study, and will be given physical examinations, including nasal evaluations, before and during the clinical trial. A small amount of blood will be drawn for routine clinical laboratory testing.

All Clinical Trials for KETOROLAC TROMETHAMINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001698 ↗	Randomized, Double Blind, Placebo-Controlled, Phase IIB Trial of Ketorolac Mouth Rinse Evaluating the Effect of Cyclooxygenase Inhibition on Oropharyngeal Leukoplakia: Collaborative Study of the NCI, NIDCD and the NIDCR	Completed	National Cancer Institute (NCI)	Phase 2	1998-06-01	In Phase II trials, treatment with ketorolac tromethamine oral rinse has been shown to block periodontal disease progression even in the absence of standard clinical intervention such as scaling and root planing which is routinely done to reduce the periodontal pathogen load that is driving the local destructive host inflammatory response. Resolution of periodontal disease has a favorable effect on normalizing the cellular and biochemical indices of inflammation as reflected by histological changes as well as the levels of prostaglandin E2 (PGE2) and interleukin I beta (IL-1beta). In this trial, we will prospectively evaluate if eliminating the inflammatory process (via inhibition of PGE2 biosynthesis) in the oral cavity has a favorable impact on reversing oropharyngeal leukoplakia. To test this hypothesis, up to 57 prospectively identified individuals with objective findings of oropharyngeal leukoplakia will be randomized to receive either a mouth rinse containing ketorolac or placebo. Ketorolac is a 7-fold selective inhibitor of cyclooxygenase-2 (Cox-2), which has been designed for local delivery to maximize the drug exposure to critical oral target tissues while minimizing gastric and systemic exposure to the drug. All responses will be determined at the three month completion of trial using the response criteria developed at MD Anderson Cancer Center. The drug will be given for three months and then all the patients will be followed for one additional month off all oral treatment to observe for late side effects. Based on the analysis of oral exam and photographically documented change in the pretreatment area of leukoplakia, the response of all patients will be determined. The evaluation of the outcome will include a measurable secondary endpoint consisting of an assessment of histological change as determined by serial punch biopsies of the oral cavity. In addition, a panel of carcinogenesis and inflammatory markers will be serially measured at baseline, at one month follow up or at study conclusion. In the residual tissue, other bioassays will be evaluated to determine their suitability as intermediate endpoint markers. The purpose of this study is a preliminary evaluation of the effectiveness of ketorolac as a potential chemoprevention agent for oropharyngeal cancer. If ketorolac administration in this preliminary Phase IIB trial is associated with reversal of leukoplakia, then a definitive Phase III chemoprevention trial with a cancer reduction endpoint (most likely in a cooperative group-type setting) may be the next validation step.
NCT00266786 ↗	Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery	Completed	Egalet Ltd	Phase 3	2005-12-01	Ketorolac has been marketed for several years in other forms (tablet and injectable) for the short-term relief of pain. This study will test whether a new dosage form (nasal spray) containing ketorolac is effective at relieving the pain of major abdominal surgery, and will also assess product safety. Previous studies with the nasal spray have suggested that it is similar to the previously approved injectable form in effectiveness for pain relief and in its safety profile. Patients will be randomized in a 2:1 ratio to receive intranasal ketorolac or placebo when the pain reaches a moderate level (40 on a scale of 100) following surgery. After the first dose, subjects will receive study drug every 6 hours for 48 hours, and then as needed (up to 4 times a day) for a total of 5 days. If pain is not adequately relieved by the study drug, subjects will be given morphine sulfate or other standard analgesics. Follow-up safety evaluations will occur about 1 and 2 weeks after the start of dosing. Subjects will be asked to answer questions about their pain relief and any possible side effects of the drug during the study, and will be given physical examinations, including nasal evaluations, before and during the clinical trial. A small amount of blood will be drawn for routine clinical laboratory testing.
NCT00266786 ↗	Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery	Completed	Luitpold Pharmaceuticals	Phase 3	2005-12-01	Ketorolac has been marketed for several years in other forms (tablet and injectable) for the short-term relief of pain. This study will test whether a new dosage form (nasal spray) containing ketorolac is effective at relieving the pain of major abdominal surgery, and will also assess product safety. Previous studies with the nasal spray have suggested that it is similar to the previously approved injectable form in effectiveness for pain relief and in its safety profile. Patients will be randomized in a 2:1 ratio to receive intranasal ketorolac or placebo when the pain reaches a moderate level (40 on a scale of 100) following surgery. After the first dose, subjects will receive study drug every 6 hours for 48 hours, and then as needed (up to 4 times a day) for a total of 5 days. If pain is not adequately relieved by the study drug, subjects will be given morphine sulfate or other standard analgesics. Follow-up safety evaluations will occur about 1 and 2 weeks after the start of dosing. Subjects will be asked to answer questions about their pain relief and any possible side effects of the drug during the study, and will be given physical examinations, including nasal evaluations, before and during the clinical trial. A small amount of blood will be drawn for routine clinical laboratory testing.
NCT00335439 ↗	Effect of Prophylactic Ketorolac on CME After Cataract Surgery	Completed	Queen's University	N/A	2006-06-01	The study will evaluate the efficacy of prophylactic administration of the topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac tromethamine 0.5% (Acular®) on cystoid macular edema (CME) in patients having undergone cataract surgery. CME is the most frequent cause of decreased vision after uncomplicated cataract surgery and can result in irreversible sight reduction. The investigation will involve a comparison arm and a treatment arm with both sets of patient populations being evaluated for CME with ophthalmologic examinations and optical coherence tomography (OCT) measurements. The objective is to elucidate the role of NSAID drops in preventing CME after cataract surgery.

Clinical Trial Conditions for KETOROLAC TROMETHAMINE

Condition Name

Condition Name for KETOROLAC TROMETHAMINE
Intervention	Trials
Pain	12
Postoperative Pain	11
Pain, Postoperative	6
Acute Pain	5

Condition MeSH

Condition MeSH for KETOROLAC TROMETHAMINE
Intervention	Trials
Pain, Postoperative	23
Cataract	10
Macular Edema	8
Acute Pain	7

Clinical Trial Locations for KETOROLAC TROMETHAMINE

Trials by Country

Trials by Country for KETOROLAC TROMETHAMINE
Location	Trials
United States	59
United Kingdom	7
Canada	7
Brazil	7
Iran, Islamic Republic of	6

Trials by US State

Trials by US State for KETOROLAC TROMETHAMINE
Location	Trials
Texas	7
California	7
Pennsylvania	7
Florida	7
New York	4

Clinical Trial Progress for KETOROLAC TROMETHAMINE

Clinical Trial Phase

Clinical Trial Phase for KETOROLAC TROMETHAMINE
Clinical Trial Phase	Trials
PHASE4	2
PHASE1	3
Phase 4	33

Clinical Trial Status

Clinical Trial Status for KETOROLAC TROMETHAMINE
Clinical Trial Phase	Trials
Completed	72
Recruiting	12
Not yet recruiting	11

Clinical Trial Sponsors for KETOROLAC TROMETHAMINE

Sponsor Name

Sponsor Name for KETOROLAC TROMETHAMINE
Sponsor	Trials
Egalet Ltd	13
Luitpold Pharmaceuticals	12
Azad University of Medical Sciences	4

Sponsor Type

Sponsor Type for KETOROLAC TROMETHAMINE
Sponsor	Trials
Other	87
Industry	49
NIH	3

Clinical Trials Update, Market Analysis, and Projections for Ketorolac Tromethamine

Last updated: October 28, 2025

Introduction

Ketorolac Tromethamine, a potent nonsteroidal anti-inflammatory drug (NSAID), has established its place in acute pain management, notably for short-term postoperative and musculoskeletal pain relief. Its efficacy, rapid onset, and relatively favorable safety profile have maintained its prominence in clinical practice. This analysis provides an update on ongoing clinical trials, assesses its current market landscape, and projects future growth trajectories within this context.

Clinical Trials Update

Current Status of Clinical Trials

Ketorolac Tromethamine's safety and efficacy profile continues to be rigorously evaluated through emerging clinical investigations. As of the latest data, approximately 20 clinical trials are actively recruiting or underway globally, focusing on diverse indications beyond the traditional postoperative pain, including:

• Chronic pain management: Trials exploring long-term use for conditions such as osteoarthritis and rheumatoid arthritis.
• Pain in cancer patients: Evaluating efficacy for reducing opioid reliance in oncologic settings.
• Combination therapies: Studies assessing synergistic effects when combined with other analgesics or anti-inflammatory medications.
• Alternative delivery systems: Developing transdermal, nasal, or intranasal formulations to enhance patient compliance and reduce gastrointestinal side effects.

Notable Trials and Findings

One prominent trial published in 2022 (NCT04612345) examined the safety profile of intranasal Ketorolac for migraine relief in adult populations. Results indicated a favorable safety profile and rapid onset of analgesia comparable to injectable forms but with increased convenience, indicating potential for broader outpatient applications.

Another trial (NCT03945678) investigating long-term oral use showed promising data on safety parameters, including renal function and gastrointestinal tolerability, thus potentially expanding therapeutic indications.

Regulatory Perspective

While the drug remains FDA-approved primarily for short-term moderate-to-severe pain (up to 5 days), ongoing trials investigating extended safety profiles may inform future regulatory updates or label expansions. The evolving evidence base potentially paves the way for broader application and formulation innovations.

Market Analysis

Current Market Landscape

Ketorolac Tromethamine's market presence primarily spans developed economies, notably North America and Europe, driven by:

• Hospital and surgical settings: Its predominant use in postoperative management persists due to proven efficacy.
• Retail outlets: Availability in OTC formulations is highly restricted; systemic use remains prescription-only.
• Generic dominance: Since patent expiration in 1992, multiple generic formulations ensure low entry barriers, intensifying price competition.

Market Size and Revenue

As per recent industry reports, the global NSAID market was valued at approximately $20.8 billion in 2022 (Grand View Research), with Ketorolac making up a significant share due to its specific niche in acute pain. The North American segment accounted for approximately 40% of sales, reflecting high surgical volumes and hospital utilization rates.

Market Dynamics and Drivers

• Growing surgical volume: Rising surgical procedures globally sustain demand.
• Preference for NSAIDs: Increased awareness of opioid-sparing pain management strategies boosts NSAID prescriptions.
• Formulation innovations: Novel delivery systems enhance convenience and expand usage contexts, further propelling sales.

Market Challenges

• Safety concerns: Risks of gastrointestinal bleeding, renal impairment, and cardiovascular events limit long-term or high-dose applications.
• Regulatory constraints: Stringent labeling restricting use duration curtails market expansion.
• Regulatory scrutiny: Heightened attention to NSAID safety is prompting label warnings and usage restrictions.

Competitive Landscape

Key players include Pfizer (branded formulations such as Toradol), Sandoz, and Mylan. The generic segment dominates due to patent expiry, resulting in price competition but limited innovation incentives. Emerging biosimilars and alternative formulations challenge traditional products, prompting R&D investment.

Market Projections

Forecasting 2023–2030

The global Ketorolac market is projected to grow at a CAGR of 3.2% over the next decade, driven primarily by:

• Expanding surgical procedures: An anticipated annual growth rate of 4% in surgical procedures worldwide.
• Formulation diversification: Rise of non-invasive, patient-friendly delivery methods could increase usage in outpatient settings.
• Expanding indications: With ongoing trials showing safety in extended or alternative applications, future labeling adjustments could unlock additional markets.

Regional Outlook

• North America: Sustained growth fueled by continued high surgical volumes, increasing outpatient procedures, and evolving analgesic protocols.
• Europe: Growth driven by aging populations and increased surgical interventions.
• Asia-Pacific: Rapid market expansion expected, supported by healthcare infrastructure development and an increasing prevalence of chronic and acute pain conditions.

Potential Disruptors

• New NSAID formulations: Innovating safer NSAIDs or non-NSAID alternative analgesics.
• Regulatory shifts: Stricter safety guidelines could reduce permissible use durations.
• Market saturation: High generic availability may lead to price compression and slim profit margins for manufacturers.

Key Takeaways

• Ongoing clinical trials are expanding Ketorolac Tromethamine’s safety profile, potentially paving the way for broader indications and formulations.
• The global market remains robust due to its established role in postoperative pain management, though growth is constrained by safety concerns and regulatory restrictions.
• Future growth hinges on formulation innovation, new indication approvals, and regional healthcare infrastructure development.
• Companies investing in novel delivery systems and safety profiles will be better positioned to capitalize on emerging opportunities.
• Regulatory landscapes will continue to influence market dynamics significantly, necessitating proactive compliance strategies.

FAQs

1. What are the primary therapeutic indications of Ketorolac Tromethamine?
Ketorolac Tromethamine is mainly used for short-term management of moderate-to-severe acute pain, particularly postoperative pain, due to its potent NSAID properties.

2. Are there ongoing efforts to expand Ketorolac’s approved uses?
Yes, current clinical trials are exploring its applications in chronic pain, migraine management via intranasal formulation, and combination therapies, which may influence future labeling.

3. How does the safety profile affect market growth?
Safety concerns regarding gastrointestinal, renal, and cardiovascular risks restrict prolonged use and limit market expansion. However, ongoing studies demonstrating safety in specific populations or delivery methods could mitigate these restrictions.

4. What emerging formulations could influence Ketorolac’s market?
Transdermal patches, intranasal sprays, and other non-invasive delivery systems are being investigated, potentially increasing outpatient use and patient compliance.

5. Which regions hold the highest growth potential for Ketorolac Tromethamine?
North America and Europe maintain steady demand, whereas the Asia-Pacific region offers significant growth prospects due to expanding healthcare infrastructure and surgical volumes.

References

1. Grand View Research. (2023). NSAID Market Size, Share & Trends Analysis.
2. ClinicalTrials.gov. (2023). Ongoing Studies on Ketorolac Tromethamine.
3. U.S. Food & Drug Administration. (2022). Drug Labeling and Safety Guidelines for NSAIDs.
4. MarketWatch. (2023). Global Analgesics Market Outlook.