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
Ohio	9
Texas	9
Michigan	7
Maryland	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
Montefiore Medical Center	3

Sponsor Type

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

Last updated: April 28, 2026

Toradol (ketorolac tromethamine): Clinical-trial status, market analysis, and projection

What is Toradol and where is it approved?

Toradol is an NSAID for short-term management of moderate to severe pain, typically after surgery. The product is ketorolac tromethamine in multiple immediate- and extended-release presentations depending on market and regulatory listing. Toradol is marketed by Pfizer in many geographies under that brand name and is also widely available as generic ketorolac in most major markets (US/EU/UK/Canada and others).

Core regulatory reality: Toradol is not a late-stage pipeline drug. It is an established, off-patent NSAID. Commercial performance is driven by (1) competition from generics, (2) hospital formularies and acute-care prescribing norms, and (3) risk-management constraints that limit volume in some settings.

What does the clinical-trials landscape look like?

For an established NSAID brand like Toradol, clinical activity generally shifts from novel MOA registration studies to one or more of:

• Bioequivalence (BE) studies supporting generic entry
• Comparative effectiveness and perioperative pain-management studies
• Safety and utilization studies (real-world evidence), including adherence to dosing limits and contraindications

Public trial activity for ketorolac generally exists, but it is typically dominated by generic BE programs and clinical research that does not create a new protected product profile. A brand-level “phase 3/phase 2 development update” is therefore not the dominant signal in most datasets; the commercial signal sits more in guideline use patterns and formulary decisions than in late-stage R&D.

Practical read-through for business planning: expect trial publications and registrations, but not a credible path to renewed brand exclusivity through standard late-stage development because the active ingredient is mature and broadly generic.

What is Toradol’s market structure and value chain?

Toradol’s market behaves like a mature “acute pain” and “perioperative” NSAID franchise:

1. Buyer segments

   • Hospitals and ambulatory surgery centers (perioperative analgesia; dosing protocols)
   • Emergency departments (short-course analgesia)
   • Outpatient retail (where permitted by local labeling, often reduced by risk/benefit constraints)

2. Channel dynamics

   • In most developed markets, generic ketorolac drives price competition, keeping brand growth limited.
   • Brand share is sustained mainly by brand loyalty in formularies, procurement contracts, and perceptions of supply reliability rather than by clinical differentiation.

3. Competitive set

   • Direct therapeutic alternatives include other NSAIDs and analgesics used in acute pain pathways (including opioids in some settings), but the practical substitute in institutional procurement is generic ketorolac first.

4. Regulatory constraints that cap demand

   • Toradol labeling and NSAID class warnings drive prescribing limits, which can reduce volume in populations at risk (GI bleed, renal impairment, bleeding risk).

How does Toradol perform versus generic ketorolac in commercialization?

Because Toradol is an established molecule with extensive generic availability, incremental market growth is typically harder to capture for the brand without one of these:

• A brand-specific formulation with meaningful differentiation (rare for this molecule in most major markets)
• A new indication that changes prescribing behavior (also uncommon)
• A pricing and supply advantage via contracts or tenders

In practice, brand sales track more closely with:

• Total acute-care procedure volumes (surgery/ED visits)
• Institutional NSAID adoption rates in perioperative care pathways
• Enforcement of NSAID safety protocols and dose-limit adherence

What is the current clinical and safety posture that affects utilization?

Ketorolac (including Toradol) is subject to strong utilization controls. The market impact comes from:

• Short approved duration in many labels (to reduce risk)
• Contraindications for renal risk and bleeding risk populations
• GI risk management and NSAID stewardship programs

These constraints typically limit the “addressable pain episode” count versus broader OTC NSAID products.

Market analysis: demand drivers, headwinds, and commercial implications

Demand drivers

• High and stable volumes of surgical procedures using multimodal analgesia pathways
• Continued use of NSAIDs in perioperative settings where they reduce opioid requirements
• Ongoing hospital preference for injectable NSAIDs for immediate onset in acute pain pathways

Headwinds

• Generic substitution and price compression
• Strict dosing and duration controls reduce repeat exposure
• NSAID stewardship programs and risk-management scrutiny in hospitals

What matters for forecasting

Forecasting Toradol is less about “new trial outcomes” and more about:

• Procedure mix and acute-care volumes
• Institutional formularies and contract pricing
• Rates of generic adoption in hospital purchasing
• Duration-of-use adherence (short-course limitations)

Market projection framework for Toradol

Given mature status and generic pressure, a realistic projection is built around a “value and share” model rather than a “new patient population” model.

Base-case projection logic (directional)

• Unit demand for ketorolac products is largely stable to modestly growing with healthcare utilization.
• Revenue growth for the Toradol brand is typically lower than unit growth due to:
  • generic price erosion
  • procurement switching
  • tender cycles favoring lowest-cost suppliers

Scenario-based projection (qualitative)

• Base case: flat-to-low single-digit brand revenue growth; units steady; price remains pressured.
• Downside: faster generic substitution or tighter perioperative NSAID restrictions; brand revenue declines in line with pricing.
• Upside: stable hospital formularies and contract continuity; modest share stability and slight revenue resilience.

Key business implications for R&D and investment

1. No late-stage moat: Toradol’s active ingredient is mature and broadly generic, so “clinical trials update” will not drive a proprietary new revenue curve.
2. Commercial lever is contracting, not development: forecasting should be grounded in hospital procurement cycles and tender outcomes.
3. Monitor stewardship policy: NSAID risk protocols and perioperative analgesia guideline adherence can shift utilization volume without any new product cycle.

Key Takeaways

• Toradol (ketorolac tromethamine) is a mature NSAID with limited brand growth potential in the face of widespread generic substitution.
• Clinical trial activity around ketorolac is typically dominated by bioequivalence and comparative/safety research, not a novel late-stage development path that would renew exclusivity.
• Market performance is driven primarily by acute-care procedure volumes, hospital formularies, procurement contracting, and NSAID safety constraints.
• Forecasts for the Toradol brand should prioritize price and share dynamics over “pipeline-driven expansion.”

FAQs

Is Toradol still being actively developed in late-stage clinical trials?

Late-stage “brand-changing” development is not the primary pattern for Toradol as a mature, off-patent NSAID. Clinical activity is more commonly oriented to supporting generic entry and perioperative/real-world use research.

What most limits Toradol demand in hospitals?

Label-driven short duration of use and NSAID risk exclusions (GI, renal, and bleeding-related contraindications) constrain eligible patients and dosing exposure.

How does generic ketorolac affect Toradol’s revenue outlook?

Generic substitution compresses prices and reduces brand share, so brand revenue growth usually lags unit demand and overall acute-care utilization growth.

Where does Toradol typically see the most consistent use?

Perioperative settings and acute pain pathways in emergency and surgical care are the most consistent utilization environments, shaped by multimodal analgesia protocols.

What is the best forecasting input for Toradol revenue?

Hospital procurement and tender outcomes plus pricing versus generic ketorolac, adjusted for acute procedure volumes and NSAID stewardship enforcement.

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References

[1] U.S. Food and Drug Administration. (n.d.). Toradol (ketorolac tromethamine) prescribing information and drug label resources. FDA.
[2] U.S. Food and Drug Administration. (n.d.). Drug Trials Snapshots and FDA label/approval history resources for ketorolac tromethamine and related products. FDA.
[3] PubMed. (n.d.). Ketorolac tromethamine clinical studies and perioperative pain management publications. National Library of Medicine.
[4] NICE. (n.d.). Guidance on management of pain and perioperative analgesia principles relevant to NSAID use (NSAID prescribing context). National Institute for Health and Care Excellence.
[5] World Health Organization. (n.d.). WHO Model Lists of Essential Medicines for NSAIDs (context for established NSAID use). WHO.