CLINICAL TRIALS PROFILE FOR TORADOL

All Clinical Trials for TORADOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00006070 ↗	Etanercept (Enbrel) to Treat Pain and Swelling After Third Molar Extraction	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 2	2000-07-01	This study will evaluate the effects of the anti-inflammatory drug etanercept (Enbrel) on relieving pain and swelling after oral surgery. The Food and Drug Administration has approved Enbrel for treating symptoms of rheumatoid arthritis, including pain. Healthy volunteers 16 to 35 years of age who require third molar (wisdom teeth) extractions may be eligible for this study. Participants must not be allergic to aspirin or to non-steroidal anti-inflammatory drugs (NSAIDs). Candidates will be screened for eligibility with a medical history and oral examination, including X-rays if needed. Participation in the study requires four clinic visits: two for surgery and two for follow-up: Visit 1: Patients will have ultrasound pictures taken to measure cheek size. One hour before surgery, they will receive a dose of either 25 milligrams (mg) of Enbrel; 15 mg of the standard pain medicine Toradol; or a placebo (salt-water) through an arm vein. A local injection of an anesthetic (lidocaine) will be given before surgery to numb the mouth, and a sedative (Versed) will be infused through a vein to induce sleepiness. When the anesthetic takes effect, a small piece of tissue will be removed from the inside of the cheek, and then the upper and lower molars on one side of the mouth will be extracted. After surgery, a small piece of tubing will be placed in the lower extraction site, from which samples will be collected to measure chemicals involved in pain and inflammation. Patients will stay in the clinic for 4 hours after surgery while the anesthetic wears off and will complete pain questionnaires during that time. If, an hour after surgery, patients have pain that is not relieved by the treatment given before surgery, they may receive acetaminophen (Tylenol) and codeine for pain. Another biopsy will be taken (under local anesthetic) from the inside of the cheek when pain occurs or at the end of the 4-hour observation period. The tubing then will be removed and the patient discharged with Tylenol and codeine for pain. Visit 2: Patients will return to the clinic in the morning 48 hours after the oral surgery for a 1- to 2-hour visit. They will fill out questionnaires, undergo ultrasound imaging of both cheeks and have another biopsy taken from the inside of the cheek on the operated side. Visits 3 and 4: Three weeks after the first surgery patients will schedule extraction of the two wisdom teeth on the other side of the mouth, and the procedures for visits 1 and 2 will be repeated.
NCT00008476 ↗	Capsaicin to Control Pain Following Third Molar Extraction	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 2	2001-01-01	This study will test the effectiveness of the drug capsaicin in controlling pain after third molar (wisdom tooth) extraction. Capsaicin, the ingredient in chili peppers that makes them "hot," belongs to a class of drugs called vanilloids, which have been found to temporarily inactivate pain-sensing nerves. Healthy normal volunteers between 16 and 40 years of age who require third molar (wisdom tooth) extraction may be eligible for this study. Participants will undergo the following procedures in three visits: Visit 1: Patients will have touch (sensory) testing by the following three methods: 1) a warm sensor applied to the gums and the patient will rate when they first feel heat and when the heat feels painful; 2) the bristles of a small paint brush will be gently stroked across the gums, and the patient will say whether it feels painful; 3) a light touch will be applied to the gums with a small needle, and the patient will rate the pain intensity following the touch. After testing, patients will be numbed with a local anesthetic (bupivacaine) and then capsaicin or placebo (an inactive solution) will be injected next to the tooth. The tooth then will be extracted one day later. Visit 2: Patients will return to the clinic after 24 hours to repeat the same type of sensory testing. After testing, patients will be sedated and numbed with a local anesthetic (lidocaine) and given an intravenous injection of either saline or ketorolac (30 mg). After the extraction, pain ratings will be recorded every 20 minutes, for up to 6 hours. During this time, patients will be monitored for numbness, pain, side effects and vital signs (heart rate, blood pressure, respiration, etc.). Those who request pain medicine will receive acetaminophen and codeine. Patients will be required to stay for up to 3 more hours after this and then they will then be discharged with pain medicine. Visit 3: Patients will return to the clinic after another 48 hours to repeat the same sensory testing. Remaining wisdom teeth will be removed "off-study" at least three weeks following the first visit.
NCT00088686 ↗	Capsaicin to Control Pain Following Third Molar Extraction	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 2	2004-07-01	Capsaicin to Control Pain Following Third Molar Extraction Summary: This study will test the effectiveness of the drug capsaicin in controlling pain after third molar (wisdom tooth) extraction. Capsaicin, the ingredient in chili peppers that makes them "hot," belongs to a class of drugs called vanilloids, which have been found to temporarily inactivate pain-sensing nerves. If capsaicin alleviates pain in dental surgery, it may have potential for use in many types of surgery and painful illnesses. Healthy normal volunteers between 16 and 40 years of age who require third molar (wisdom tooth) extraction may be eligible for this study. Participants undergo the following procedures in three visits: Visit 1 Patients have touch (sensory) testing inside the mouth using three methods: 1) applying a temperature probe onto the gums and having the patient rate how warm it is; 2) applying a gentle stroke across the gums with the bristles of a small paint brush and having the patient say whether or not it feels painful; and 3) applying a light touch to the gums with a small needle and having the patient rate the pain intensity following the touch. Following touch testing, the patient's mouth is numbed with an anesthetic and a small piece of gum tissue next to the lower wisdom tooth is removed (biopsied). Then, a small amount of either capsaicin or placebo (saline, or salt water) is injected next to the wisdom tooth. Visit 2 Following repeat the touch testing, patients are sedated with an injection of midazolam. They then have another biopsy under local anesthesia on the same side of the mouth as the first biopsy. Their mouth is again numbed with an anesthetic, and they are given either a pain-relieving medicine called Toradol or a placebo injected into the arm. One lower wisdom tooth is then extracted. After the extraction, pain ratings are recorded every 20 minutes for up to 6 hours. During this time, patients are monitored for vital signs, numbness, pain, and side effects. Patients who request pain-relief medication are given acetaminophen and codeine. At the end of the study, they are discharged from the clinic and given acetaminophen and codeine to take at home, as instructed. They are provided a pain diary to record pain ratings and any adverse reactions that might occur until the last visit. Visit 3 Patients return for a follow-up evaluation 48 hours after discharge from the clinic. At the end of the evaluation, they are discharged home with flurbiprofen for pain relief. Remaining wisdom teeth are removed "off-study" no sooner than 1 week following the first visit.
NCT00115336 ↗	Ketorolac Versus Ibuprofen to Treat Painful Episodes of Sickle Cell Disease	Terminated	National Heart, Lung, and Blood Institute (NHLBI)	Phase 4	2005-01-01	The purpose of this study is to compare ketorolac, a potent, non-steroidal anti-inflammatory drug (NSAID), with ibuprofen, a commonly used NSAID, for the treatment of the painful crisis of sickle cell disease (SCD).
NCT00115336 ↗	Ketorolac Versus Ibuprofen to Treat Painful Episodes of Sickle Cell Disease	Terminated	University of Texas Southwestern Medical Center	Phase 4	2005-01-01	The purpose of this study is to compare ketorolac, a potent, non-steroidal anti-inflammatory drug (NSAID), with ibuprofen, a commonly used NSAID, for the treatment of the painful crisis of sickle cell disease (SCD).
NCT00115336 ↗	Ketorolac Versus Ibuprofen to Treat Painful Episodes of Sickle Cell Disease	Terminated	Children's Hospital Medical Center, Cincinnati	Phase 4	2005-01-01	The purpose of this study is to compare ketorolac, a potent, non-steroidal anti-inflammatory drug (NSAID), with ibuprofen, a commonly used NSAID, for the treatment of the painful crisis of sickle cell disease (SCD).
NCT00115752 ↗	Genetic Basis For Variation In NSAID Analgesia In A Clinical Model Of Acute Pain	Completed	National Institute of Nursing Research (NINR)	Phase 2	2005-06-20	This study will evaluate how genetic makeup contributes to the variation in people regarding their sensitivity to and experience of pain. Scientists believe that differences in information found in genes may explain why an analgesic drug, that is, one that treats pain, works effectively for some people but not for others. The study will explore pain that is acute (fast and short period). Knowledge gained from this ongoing study may permit development of an individualized analgesic drug prescription. Patients ages 16 to 35 who are in good health and have been referred for removal of impacted wisdom teeth; who are not allergic to aspirin or other nonsteroidal anti-inflammatory drugs (known as NSAIDs), sulfites, or certain anesthetics; who are not pregnant or nursing; and who are willing to have a biopsy before and after dental surgery are eligible for this study. Patients will come to the clinic for one test visit and one treatment visit. During the first visit, a questionnaire will evaluate patients' psychological state, including mood and depression. There will be a clinical examination of their wisdom teeth. A blood sample of 10 milliliters (about 0.4 ounces) will be collected from the forearm to provide DNA material containing genes stored in cells. The primary genetic analysis will be done at NIH, although the DNA collected might also be sent to a laboratory outside NIH. DNA samples will be coded so that names of patients cannot be traced. During the second visit, two of the patients' lower wisdom teeth will be removed. Patients will be given a local anesthetic in the mouth and a sedative given through a vein in the arm. While the mouth is numb, a small piece of tissue will be removed from inside the cheek, near the wisdom tooth. It is the first biopsy. After the two wisdom teeth are removed, a small piece of tubing will be placed into both sides of the mouth where the teeth were removed. Every 20 minutes, for the next 3 hours, the researchers will collect inflammatory fluid from the tubing, to measure the chemicals thought to cause pain and swelling. Also every 20 minutes, patients will rate the pain they feel by answering questions. If there is pain before 3 hours following surgery, they will receive a dose of fentanyl to relieve moderate to severe pain. A second biopsy will occur 3 hours after surgery, to measure changes in chemicals produced in response to surgery. Immediately afterward, patients will receive 30 mg of ketorolac (Toradol) whether or not pain is felt. They will answer questionnaires about pain for 3 hours after receiving the drug, to rate how well it works. They will stay at the clinic up to 6 hours after the surgery. If pain is not relieved with ketorolac, patients will receive a one-time dose of tramadol, a pain medication for moderate to severe pain. After the study procedures are completed, patients will receive pain medication for pain after surgery. Patients will be monitored closely, because all drugs have side effects. Ketorolac is a nonsteroidal anti-inflammatory drug, one that may cause gastrointestinal upset. Fentanyl is a powerful narcotic drug that is safe at the dosage used in this study, but stomach upset, dizziness, and breathing trouble may occur. Also, risks from the biopsy include discomfort from injecting the numbing medicine, infection, and bleeding. There may be discomfort from the sedative injected into the vein, and there may be bruising. Benefits from participating are having wisdom teeth removed at no cost as well as close monitoring before and after surgery. There are no plans to give patients the results of genetic tests or questionnaires. Years of research may be needed before such information has the chance to become meaningful.

Clinical Trial Conditions for TORADOL

Condition Name

Condition Name for TORADOL
Intervention	Trials
Pain, Postoperative	18
Pain	16
Opioid Use	9
Postoperative Pain	7

Condition MeSH

Condition MeSH for TORADOL
Intervention	Trials
Pain, Postoperative	36
Osteoarthritis	9
Migraine Disorders	7
Rotator Cuff Injuries	6

Clinical Trial Locations for TORADOL

Trials by Country

Trials by Country for TORADOL
Location	Trials
United States	108
Canada	6
Iran, Islamic Republic of	4
Pakistan	3
Denmark	3

Trials by US State

Trials by US State for TORADOL
Location	Trials
New York	20
Texas	9
Ohio	9
Maryland	7
Michigan	7

Clinical Trial Progress for TORADOL

Clinical Trial Phase

Clinical Trial Phase for TORADOL
Clinical Trial Phase	Trials
PHASE3	2
Phase 4	67
Phase 3	14

Clinical Trial Status

Clinical Trial Status for TORADOL
Clinical Trial Phase	Trials
Completed	70
Recruiting	21
Unknown status	15

Clinical Trial Sponsors for TORADOL

Sponsor Name

Sponsor Name for TORADOL
Sponsor	Trials
University of Texas Southwestern Medical Center	4
Henry Ford Health System	4
National Institute of Dental and Craniofacial Research (NIDCR)	3

Sponsor Type

Sponsor Type for TORADOL
Sponsor	Trials
Other	157
NIH	8
Industry	8

Last updated: July 28, 2026

Toradol (ketorolac tromethamine) clinical trials update, market analysis, and pricing/exclusivity projection

Toradol is the brand name for ketorolac tromethamine, a short-term analgesic used primarily for moderate-to-severe acute pain. In the US, ketorolac is off-patent and widely genericized; the brand market is driven by formulary positioning, conversion to generics, and contract pricing rather than exclusivity. Clinical trial activity is limited for new molecular entities, with most recent studies focused on comparative safety, perioperative analgesia protocols, dosing/route comparisons, and substitution or label-expansion work that does not create meaningful brand differentiation.

Current commercial posture (high level): Ketorolac’s market is mature and price-compressed. Near-term growth is driven more by hospital purchasing patterns, guideline adherence, and opioid-sparing protocols than by new product entrants. Any “Toradol” projections should be modeled as a contracting or flat share scenario against generics, with upside tied to institutional uptake of specific formulations (notably injectable/IM/IV where applicable) and local formulary status.

Scope note: “Toradol” is not a single unique drug patent estate that remains protected; it reflects a branded presentation of an off-patent active ingredient. A defensible projection hinges on (1) ongoing trial relevance for dosing/route, (2) whether any non-obvious patent thickets exist in specific dosage forms or methods of use, and (3) regulatory status by presentation. Without these presentation-specific details, projections are necessarily generic-commodity oriented rather than exclusivity-driven.

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What clinical trials are happening for Toradol (ketorolac tromethamine) right now?

Best-fit characterization of the current clinical evidence pipeline: The ketorolac brand narrative in clinical development is not dominated by new Phase 3 efficacy trials for an NDA-breaking indication. Trial activity typically concentrates on:

• Perioperative multimodal analgesia comparisons (ketorolac vs other NSAIDs, vs opioids, or as an adjunct).
• Safety and utilization studies tied to renal risk, GI bleeding risk, and bleeding risk in surgical populations.
• Route and dosing optimization (IV vs IM vs oral alternatives where label supports conversion).
• Population-specific analyses (pediatrics, geriatrics, specific surgeries).

Where to look for actionable updates in a “trial monitoring” workflow

• Registrations in ClinicalTrials.gov for “ketorolac,” “ketorolac tromethamine,” and “Toradol” using filters for recruiting/not yet recruiting.
• Interventional pain-management studies with perioperative or emergency department endpoints.
• Trials describing conversion from parenteral ketorolac to oral NSAIDs or ER opioid-sparing pathways.
• Comparative safety endpoints: bleeding, renal biomarkers, GI adverse events, thrombotic events in surgical cohorts.

What these trials typically change commercially

• Protocol adoption in hospital formularies is more common than label expansions that sustain premium pricing.
• Trial results can support stewardship programs and order-set standardization, which protects volume but not margin if generics dominate.

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Is Toradol still protected by patents, and when does exclusivity end?

Core market reality: Ketorolac tromethamine has long since passed composition-of-matter protection for the active ingredient. The practical question for “exclusivity” is not whether a molecule is protected, but whether any presentation-specific or method-of-use patents create barriers to AB-rated generic substitution, or whether any FDA exclusivities apply to a specific NDA/BLA presentation.

Practical exclusivity levers that can matter despite genericization

• Patent-protected dosing regimens or specific formulations (if any remain listed for a Toradol presentation).
• Any non-obvious formulation differences that preserve a brand’s label exclusivity or create technical switching costs.
• Pediatric exclusivity is unlikely given the age of the active ingredient unless tied to a very specific, late-breaking supplemental filing.
• Regulatory exclusivities are rarely sustained for mature analgesic APIs unless coupled with significant formulation/endpoint innovations.

Bottom line for projections: For most markets, “Toradol” behaves like a mature generic-commodity brand. Any price maintenance typically comes from contracts, procurement constraints, or formulary preference rather than enforceable exclusivity periods.

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What does the Orange Book status of Toradol imply for generic entry risk?

Interpretation for business planning: If Toradol’s labeled presentations are predominantly or fully AB-substitutable to generics, then Paragraph IV challenges are not a key driver. Generic entry risk is instead “already realized,” and the brand competes through:

• Contract pricing and tender outcomes
• Distributor relationships
• Supply continuity
• Preferred formulary placement

What to expect in a mature ketorolac segment

• Multiple ANDA approvals across dosage forms (as applicable).
• Frequent price changes around commodity NSAIDs.
• Limited differentiation that would sustain brand premiums absent specific managed-care or hospital buying arrangements.

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How large is the Toradol market, and what segment drives sales?

Revenue drivers in a mature injectable/acute analgesic niche

• In-hospital utilization for acute pain and perioperative care.
• Emergency department usage patterns.
• Conversion protocols between parenteral and oral pain control.
• Avoidance of opioid exposure via multimodal regimens.

Segmentation that materially impacts forecasting

• Route: injectable vs oral (where label and product availability align).
• Setting: hospital inpatient, ED, ambulatory surgery.
• Conversion pathways: order-set adherence to multimodal analgesia and opioid-sparing policies.
• Contracting: group purchasing organizations and hospital formularies.

Projection structure

• Start with total ketorolac demand growth (often low single digits in developed markets).
• Apply brand share decay consistent with generic penetration.
• Add a modest volume protection factor tied to institutional “preferred” status if Toradol is the formulary brand under contract.
• Model price per unit erosion toward generic ASP levels.

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Toradol vs generic ketorolac: how does the competitive landscape affect price and share?

Brand vs generic economics

• Generics compress wholesale acquisition cost and tender-winning ASPs.
• Brand premiums persist only when a contract, service-level requirement, or institutional preference outweighs lower-cost substitution.

Typical battlefield for mature NSAID brands

• Local formularies that retain a branded option despite generic availability.
• Narrow stock-keeping unit strategies by institutions (single preferred supplier).
• Internal hospital policies on substitution and automatic interchange rules.

Implications

• Share retention is possible if Toradol is designated as preferred under a supply agreement.
• Margin resilience is less likely without enforceable IP or a special formulation advantage.

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What formulations of Toradol matter for IP and differentiation?

Presentation-specific logic used by buyers and patent counsel

• Injectable presentations (IV/IM) drive perioperative and acute care use and can remain institutionally “sticky” if a single product is standardized.
• Oral ketorolac (if part of the brand’s current portfolio in a specific jurisdiction) shifts the competitive set to oral NSAID generics and payor-driven substitution.

How this affects R&D and trial relevance

• New trials often target “use-case fit” in protocols, not new chemical entities.
• Formulation and stability work may still appear, but it rarely changes the overall genericization of the active ingredient.

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What patent litigation affects Toradol (ketorolac tromethamine)?

In a mature generic environment

• The most consequential litigations for ketorolac are generally historic and not a near-term driver unless new supplemental patents were asserted or new formulations introduced late.
• The typical near-term pattern is not “brand vs generic first entry,” but rather contract-driven competition after generic entry.

Business consequence for planning

• Litigation is not the primary near-term lever. Procurement and formulary decisions dominate.

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When do generic versions of Toradol enter, and what launch scenarios are realistic?

Expected scenario in mature markets

• Generics are already present. New “launch events” mostly reflect remaining ANDA approvals for underserved strengths/routes, plus incremental price and availability improvements.
• The launch risk for Toradol is not a single cliff event; it is ongoing share dilution when contracts cycle.

Scenario modeling approach

• Base case: continued share erosion offset by volume stability in preferred-supplier contracts.
• Downside: losing preferred formulary status to a lower-cost supplier during tender cycles.
• Upside: maintaining preferred status, with stable volume and less aggressive price under contract renewal.

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How strong is the Toradol (ketorolac) patent estate, and where could it still matter?

Strength assessment in practical terms

• Composition-of-matter is not the issue in 2026 for ketorolac.
• The only potential pockets that can matter are:
  • Method-of-use claims tied to specific administration schedules (if any survive and are listed for the relevant NDA presentation).
  • Formulation/process patents covering a particular injectable or packaging format (if any are still active).
  • Pediatric or specific labeling claims in a late supplemental filing (unlikely to be material for brand economics at this stage).

Commercial implication

• Even if residual patents exist, their ability to protect meaningful revenue depends on whether they block AB substitution for the exact brand presentation used in hospitals.

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What FDA regulatory status does Toradol have, and how does it shape market access?

Regulatory reality for mature APIs

• Toradol is regulated as a small-molecule drug. Access for generics is via ANDAs with AB rating to the reference product unless specific listed patents or exclusivities block entry.
• For procurement, FDA status is less important than:
  • Availability and supply reliability
  • Label parity and substitution policy
  • Hospital safety monitoring requirements

Practical outcome

• FDA status generally enables broad generic availability; market differentiation is contractual.

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Key Takeaways

• Toradol is a mature ketorolac tromethamine brand competing in a generic-dominated analgesic market; current growth is driven by protocol adoption and formulary positioning, not by molecular exclusivity.
• Clinical trial activity is likely focused on comparative perioperative analgesia, dosing/route optimization, and safety outcomes, which supports protocol use more than premium pricing.
• Generic entry risk is largely already realized; the near-term threat is contract cycling and ongoing ASP compression rather than a single patent cliff.
• Forecasting should emphasize brand share drift vs generic substitution, price erosion toward generic ASP, and volume stability tied to preferred supplier status.

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FAQs

1. What are the most common endpoints in ketorolac perioperative clinical trials?
2. Do hospitals switch from Toradol to generic ketorolac automatically under interchange policies?
3. Which dosing and route comparisons most often influence protocol adoption for ketorolac?
4. How do renal and bleeding risk safety findings change ketorolac order-set usage?
5. What contracting dynamics most affect Toradol’s branded share in US hospitals?

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References (APA)

1. U.S. Food and Drug Administration. (n.d.). Drug approvals and databases (Drugs@FDA, Orange Book).
2. National Library of Medicine. (n.d.). ClinicalTrials.gov.
3. Prescribing information for ketorolac tromethamine (Toradol) in US-approved labeling sources.