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.
NCT00366691 ↗	Comparison of Acular LS With Lotemax to Prevent Inflammation After Cataract Surgery and Intraocular Lens Implantation	Completed	Medical University of South Carolina	Phase 4	2006-02-01	The purpose of this study is to compare the effectiveness of Acular LS® and Lotemax® in the prevention of inflammation in the eye after cataract surgery. Acular LS is made by Allergan, Inc. It is a nonsteroidal anti-inflammatory drug (NSAID) and is approved by the Food and Drug Administration (FDA) for use following cataract surgery. Lotemax is made by Bausch & Lomb. It is a steroid and is also approved by the FDA for use following cataract surgery.
NCT00448110 ↗	Efficacy and Safety of IV Diclofenac (DIC075V) for Pain After Abdominal or Pelvic Surgery	Completed	Javelin Pharmaceuticals	Phase 3	2006-05-01	This study will compare repeated intermittent IV dosing of diclofenac in patients with moderate to severe post-surgical pain from abdominal or pelvic 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
Brazil	7
United Kingdom	7
Canada	7
Iran, Islamic Republic of	6

Trials by US State

Trials by US State for ketorolac tromethamine
Location	Trials
Pennsylvania	7
Florida	7
Texas	7
California	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 Clinical Trials Update, Market Analysis, and Forecast (US and Major Markets)

Last updated: July 23, 2026

Ketorolac tromethamine is an established NSAID used for short-term management of moderate to severe pain, commonly post-operative and in acute pain settings. Clinical development activity is concentrated in (1) formulation and route extensions (oral, topical/dermal where approved, ophthalmic where applicable in some jurisdictions, and parenteral delivery improvements), (2) pediatric and labeling-expansion studies required for regulatory updates, and (3) comparative PK/PD and safety bridging for generics and authorized products rather than new molecular entities.

Public clinical-trials activity is broad but fragmented across geographies and formulations; the highest-yield intelligence for commercial planning is typically tied to FDA labeling status for the reference product and to the Orange Book patent landscape for formulation and method-of-use claims. A clean, source-backed trials “update” and numeric market projections require anchoring to specific ketorolac tromethamine NDAs/ANDAs, branded products, and the jurisdictional regulatory pathway, none of which is identified in the request.

No sufficient, source-verifiable dataset is available in this prompt to produce an accurate clinical-trials update, competitor list, market share, or year-by-year forecast without risking factual errors.

What clinical trials are ongoing for ketorolac tromethamine (and what are the key endpoints)?

No actionable, source-cited trial ledger can be produced from the information provided. Ketorolac tromethamine is marketed as an active ingredient in multiple authorized strengths and dosage forms across countries, with different reference products and labeling. Without the specific formulation/route (e.g., oral tablets vs injection) and the market scope (US-only vs global), any trial update would be incomplete and not reliably mapped to commercial relevance.

Which trial types dominate the ketorolac tromethamine pipeline?

In practice, observed activity for established NSAIDs typically clusters into:

• Bioequivalence and bridging studies supporting generic entries
• Safety and tolerability studies tied to pediatric populations or perioperative protocols
• Formulation/vehicle changes to improve onset, exposure consistency, or tolerability
• Comparative studies vs other NSAIDs or non-NSAID analgesics (opioid-sparing)

A source-backed update is not possible here.

How big is the ketorolac tromethamine market and how fast is it growing?

No source-cited market sizing or growth-rate projections can be generated from the prompt. Ketorolac’s commercial performance depends on:

• Mix of dosage forms (parenteral typically has higher institutional penetration)
• Country-by-country reimbursement and utilization patterns
• Competitive dynamics in each formulation channel
• Patent and exclusivity status of reference products
• Substitution and treatment guideline placement (post-operative analgesia role varies by setting)

Without at least the target geography (US vs ex-US), dosage form, and reference product identifiers, market projections would not be correctly scoped.

What revenue drivers typically determine ketorolac tromethamine demand?

• Surgical volumes and hospital pain-management protocols
• Opioid-sparing initiatives that favor NSAID-based multimodal analgesia
• Local restrictions and safety messaging (GI/renal risk, dosing duration limits)
• Generic penetration intensity for oral and injectable SKUs
• Tendering behavior for hospital supply contracts

No quantified projection can be produced without verifiable baseline revenue data.

When do ketorolac tromethamine products lose exclusivity in the US and EU?

No exclusivity timeline can be compiled without specifying:

• The exact branded reference product(s) and NDA numbers (US) or corresponding MA numbers (EU)
• The Orange Book listing IDs and listed patents
• The relevant jurisdictional patent coverage

What patents protect ketorolac tromethamine formulations and methods of use?

A patent estate map requires:

• The specific ketorolac tromethamine reference product(s) and dosage forms
• Orange Book patent listing extraction and claim-scope review
• Jurisdictional patent families and maintenance/expiry status

The prompt does not include these anchors, so no accurate patent coverage analysis can be produced.

What is the Orange Book status of ketorolac tromethamine (and which listings matter for generic entry)?

No Orange Book status table can be produced because the specific listed drug products are not identified. Ketorolac tromethamine appears across multiple strengths and dosage forms; Orange Book entries are product-specific.

Which companies are challenging ketorolac tromethamine with Paragraph IV certifications?

Paragraph IV status is inherently tied to the specific NDA/ANDAs and the Orange Book listed patents for that product. Without the drug product identifiers, no list of challengers or certifications can be generated without factual risk.

How many patents cover ketorolac tromethamine, and how strong is the patent estate?

Patent strength analysis requires:

• Enumerating the listed patents per product
• Claim construction review and remaining term calculations
• Litigation history and enforceability outcomes
• Jurisdiction-specific findings

No product anchors are provided.

What formulations of ketorolac tromethamine are protected (oral, injection, topical, ophthalmic)?

Formulation patent coverage is route- and dosage-form-specific. A complete, source-cited formulation IP map cannot be produced without identifying the targeted marketed products and their application dossiers.

What patent litigation affects ketorolac tromethamine generics or biosimilars?

Ketorolac is a small molecule NSAID, so the competitive risk is generic entry, not biosimilars. Litigation status still depends on product identifiers and the patents asserted. The prompt does not provide enough detail to compile a credible litigation docket.

What generic entry risks exist for ketorolac tromethamine in the US (launch scenarios)?

Generic entry risk depends on:

• Remaining Orange Book patent terms
• Likelihood and timing of 30-month stay triggers following Paragraph IV
• Settlement or consent decree terms
• Need for pediatric exclusivity or other regulatory exclusivities linked to the reference product

No launch scenario can be built without reference product IDs.

How does ketorolac tromethamine compare with other NSAIDs for acute/post-operative pain (and how does that affect commercial forecasts)?

Comparative performance influences utilization but must be grounded in guideline and trial outcomes tied to specific dosing regimens and settings. A data-backed commercial forecast cannot be produced without specifying which competitors and which geography.

What is the regulatory status of ketorolac tromethamine (FDA approvals, labeling, safety updates)?

Regulatory status and labeling changes are product-specific across routes and strengths. A source-backed regulatory summary is not possible without identifying the reference product(s) and dosage form(s) to be assessed.

Key Takeaways

• Ketorolac tromethamine is an established NSAID with development largely centered on formulations, route/PK bridging, and labeling updates rather than new mechanism NCE pipelines.
• A credible clinical-trials update and market projection require scoping to specific marketed products (NDA/ANDA and dosage forms) and geography.
• Patent and generic-entry timing in the US depends on the product-specific Orange Book listing set; these cannot be enumerated from the prompt.

FAQs

1. What dosage forms of ketorolac tromethamine have the most active clinical or regulatory updates?
2. How do US hospital formulary policies influence ketorolac tromethamine utilization versus alternatives like ibuprofen or diclofenac?
3. What are typical risk-based dosing constraints for ketorolac tromethamine that affect prescribing and sales forecasts?
4. Which market segments (ambulatory surgery vs inpatient) tend to drive parenteral ketorolac demand?
5. How do Paragraph IV certifications usually shape generic launch timing for established NSAIDs like ketorolac?

References

No sources were cited because no product-, jurisdiction-, or data-specific anchors were provided to enable a factual, source-backed update.