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
California	7
Pennsylvania	7
Florida	7
Texas	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

KETOROLAC TROMETHAMINE Market Analysis and Financial Projection

Last updated: April 23, 2026

Clinical Trials Update, Market Analysis and Projection: Ketorolac Tromethamine

Ketorolac tromethamine is an established, multi-formulation NSAID with a long global clinical and commercial footprint. In the US, it is marketed as immediate-release ketorolac tromethamine injection, oral tablets, and nasal solution (spray), and it is used for short-term management of moderate to severe pain. Market growth is constrained by maturity, generic penetration, and labeling limits on duration of use.

What is the current clinical-trial landscape for ketorolac tromethamine?

The clinical-trials signal for ketorolac tromethamine is dominated by legacy studies, small formulation/route work, and comparative or pharmacokinetic efforts that do not typically create new regulatory endpoints. Current activity is largely incremental rather than pipeline-defining.

Trial types observed in the ketorolac tromethamine clinical record (by pattern)

• Formulation and route comparisons (oral vs nasal vs injection), including bioavailability and onset-of-action characterization.
• Dose-ranging and analgesic efficacy comparisons for specific procedural or post-operative contexts.
• Safety and tolerability evaluations aligned with NSAID risks (GI bleeding, renal effects, cardiovascular risk, and boxed warnings tied to duration limits).

Regulatory framing that continues to shape “new” trials

• NSAID class risk management drives study inclusion/exclusion criteria and endpoint selection (bleeding risk, renal markers, pain intensity scales).
• US prescribing guidance continues to restrict ketorolac to short-term use (commonly capped at 5 days for adults in US labeling), which narrows clinical study design space for “beyond-label” indications.

US label constraints that limit expansion via clinical trials

• Duration: short-term use limitation (adult labeling).
• Route and formulation: specific indications tied to formulation (oral vs injection vs nasal).
• Population: exclusions or heightened precautions in patients at GI bleed risk, renal impairment, or with certain co-medications.

Which clinical endpoints and outcome patterns dominate ketorolac tromethamine studies?

Across trials, endpoints cluster around:

• Pain intensity reduction (typically using standard pain scales such as VAS or similar patient-reported measures).
• Time to meaningful analgesia (onset and early pain control).
• Rescue medication use and proportion of responders (pain relief without additional dosing).
• Safety endpoints: incidence of adverse events and lab changes linked to NSAID class risks.

What “success” looks like in these studies

• Non-inferiority or superiority vs comparators like opioids, other NSAIDs, or placebo for short-horizon pain control.
• Demonstration that onset aligns with clinical need (especially for nasal/oral faster pain control claims).
• Safety profile consistent with existing label risk mitigation and duration limits.

How does ketorolac tromethamine’s market position translate into near-term R&D value?

Ketorolac is mature and largely generics-led. Near-term R&D that creates value tends to be:

• Product differentiation via route (nasal vs oral), device integration, or formulation bioequivalence improvements.
• Patient-channel optimization (peri-operative, ED settings, discharge prescriptions) rather than new mechanism-of-action claims.
• Lifecycle extensions that reduce cost or improve administration logistics.

In practice, “new trial” value is higher when it supports:

• Access and reimbursement positioning in high-volume care settings.
• Manufacturing robustness and supply reliability.
• Differentiated administration (e.g., nasal) where convenience affects uptake.

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Market Analysis

How is ketorolac tromethamine sold today (US channel reality)?

Ketorolac tromethamine sells through:

• Hospital and ambulatory surgery channels for injection use.
• ED and discharge pain protocols where short-term NSAID therapy is a common component.
• Retail pharmacy for oral generics and, where available, nasal solution.

Product structure

• Injection: short-term post-operative and acute pain use with controlled duration.
• Oral tablets: outpatient and short-duration analgesia.
• Nasal solution: fast-acting analgesia positioning for appropriate acute pain contexts.

What drives demand?

Demand drivers are largely utilization and substitution mechanics rather than therapeutic re-invention:

• Volume of surgical and procedural care where post-op pain management is standardized.
• ED presentation rates for acute pain (with protocol adherence).
• Generic price erosion (reduces value growth but preserves unit demand).

Primary demand constraints

• Label caps on duration reduce the incremental addressable population for longer-course pain.
• NSAID contraindication prevalence (GI risk, renal risk, high-risk comorbidity) restricts eligible patients.
• Competitive substitution from other low-cost NSAIDs and analgesics.

How does generic competition shape pricing and margins?

Ketorolac tromethamine faces strong generic competition across major markets. The result typically is:

• Low price per unit relative to branded analgesics.
• Limited differentiation-based premium pricing unless administration method (nasal delivery) creates channel preference.

Implications for investment or R&D

• Value creation is tied to distribution, contracting, and manufacturing execution.
• Clinical differentiation alone rarely supports premium economics in a mature generic-heavy NSAID category.

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Projection

What is the most likely market trajectory for ketorolac tromethamine?

A mature NSAID with strong generic coverage tends to show:

• Stable or modest unit growth driven by procedural volumes and ED utilization.
• Flat-to-low revenue growth due to price pressure and periodic generics entry.
• Product mix shifts toward routes that match operational workflows (e.g., nasal for ease in certain settings) without expanding total category demand materially.

Directional projection (scenario-free)

• Unit demand: steady, supported by continuing procedural and acute pain use.
• Revenue growth: constrained by generic price erosion and short-duration labeling.
• Mix: potential minor share gains for convenient administration formats, with the ceiling set by labeling and contraindications.

Where is the growth ceiling?

• Clinical: short-term maximum duration limits scaling in chronic-ish pain pathways.
• Safety: contraindications limit the eligible population, especially in older patients and patients with comorbidities.
• Economics: generic competition compresses ability to monetize incremental differentiation.

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Key Takeaways

• Ketorolac tromethamine is mature with incremental clinical activity focused on formulation, route, and protocol-aligned endpoints rather than new disease-area breakthroughs.
• Market growth is primarily utilization-driven and constrained by NSAID class risk management and short-term duration labeling.
• Competitive dynamics remain the dominant factor: generics cap pricing and limit premium returns from clinical differentiation.
• Near-term R&D value concentrates on administration convenience, supply reliability, and contracting-driven access rather than transformative therapeutic claims.

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FAQs

1) Is ketorolac tromethamine still actively studied in clinical trials?

Yes, activity persists, mainly as route/formulation and comparative studies aligned with existing NSAID labeling and safety risk frameworks.

2) What endpoints matter most in ketorolac tromethamine efficacy trials?

Pain intensity reduction, time to early meaningful analgesia, rescue medication use, and safety outcomes tied to GI, renal, and overall NSAID risk.

3) Why do label duration limits matter for market projection?

They directly cap how long patients can take ketorolac in standard prescribing pathways, reducing addressable demand expansion.

4) What market lever creates more value than clinical differentiation?

For a mature, generic-heavy NSAID, contracting, distribution access, and manufacturing execution typically have more impact on realized revenue than small clinical differences.

5) Does nasal or route innovation change the market outlook materially?

It can shift product mix within the category but has limited ability to expand the total addressable market due to safety, contraindications, and short-term use constraints.

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References (APA)

[1] U.S. Food and Drug Administration. (n.d.). Drug approval reports and labeling for ketorolac tromethamine products. FDA. https://www.fda.gov/drugs
[2] U.S. National Library of Medicine. (n.d.). Ketorolac tromethamine clinical trials (search results). ClinicalTrials.gov. https://clinicaltrials.gov/
[3] DailyMed. (n.d.). Ketorolac tromethamine prescribing information and boxed warnings. NIH. https://dailymed.nlm.nih.gov/