Drugs / Ketorolac Tromethamine
Ketorolac Tromethamine
also known as
Toradol · Acular · ketorolac trometamol · Acuvail · NTM-001 (Ketorolac Tromethamine IV Continuous Infusion) · Ketolorac · ketorolac · Ketorolac eye drop · +3 more
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | ACULAR | — | 1996-09-18 – 2002-02-08 | fda.gov ↗ |
| Label expansion | US (FDA) | TORADOL | — | 1994-12-07 | fda.gov ↗ |
| Approved | US (FDA) | TORADOL | — | 1989-11-30 | fda.gov ↗ |
Trials 37 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03513770 | Aug 2019 → Nov 2026 expected | — | Milton S. Hershey Medical Center | Recruiting | No outcome recorded |
| Phase 17 trials | ||||||
| Phase 1 | NCT06273813 | Feb → Dec 2024 | gout | Novilla Pharmaceuticals | Unknown | No outcome recorded |
| Phase 1 | NCT05382546 | May → Jul 2022 | — | Nuance Pharma (shanghai) Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT04733326 | Sep 2021 → Mar 2023 | — | Cairo University | Completed | No outcome recorded |
| Phase 1 | NCT04439396 | Jun 2020 → Jan 2023 | — | Carilion Clinic | Completed | No outcome recorded |
| Phase 1 | NCT01365611 | Feb → May 2007 | — | Egalet Ltd | Completed | No outcome recorded |
| Phase 1 | NCT01363089 | Jan → Mar 2007 | — | Egalet Ltd | Completed | No outcome recorded |
| Phase 1 | NCT01363063 | Dec 2006 → Feb 2007 | — | Egalet Ltd | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT06584188 | Apr 2026 overdue | — | Ain Shams University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06616922 | Nov 2021 → Jun 2023 | bacterial conjunctivitis | NTC srl | Completed | No outcome recorded |
| Phase 2 | NCT05355597 | Jan 2021 → Mar 2025 | musculoskeletal system disorder, soft tissue neoplasm | Atlantic Health System | Terminated | No outcome recorded |
| Phase 2 | NCT00483717 | Jul 2007 → Jan 2008 | migraine disorder | Egalet Ltd | Completed | No outcome recorded |
| Phase 2 | NCT01351090 | ? → Oct 2007 | — | American Regent, Inc. | Completed | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT06160778 | May 2024 → Jan 2029 expected | appendicitis | University of Calgary | Recruiting | No outcome recorded |
| Phase 3 | NCT05641363 | Jun 2023 → Apr 2025 | appendicitis, gallbladder disorder, migraine disorder, urinary tract obstruction | Hamilton Health Sciences Corporation | Completed | No outcome recorded |
| Phase 3 | NCT05324358 | Dec 2022 → Sep 2024 | — | Neumentum, Inc. | Suspended | No outcome recorded |
| Phase 3 | NCT03343392 | Nov → Dec 2017 | — | Universidade Estadual de Ponta Grossa | Completed | No outcome recorded |
| Phase 3 | NCT01471886 | Mar → Oct 2013 | — | EMS | Completed | No outcome recorded |
| Phase 3 | NCT01471899 | Mar → Dec 2013 | — | EMS | Completed | No outcome recorded |
| Phase 3 | NCT01347853 | Jun 2003 → Jun 2005 | — | Egalet Ltd | Completed | No outcome recorded |
| Phase 414 trials | ||||||
| Phase 4 | NCT05413902 | Apr 2021 → Jan 2022 | — | University of Puerto Rico | Completed | No outcome recorded |
| Phase 4 | NCT04444830 | Jan → Sep 2021 | female stress incontinence, pelvic organ prolapse | University of Louisville | Withdrawn | No outcome recorded |
| Phase 4 | NCT04246697 | Nov 2019 → Jun 2021 | head and neck cancer | University of Kansas Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT03007381 | Nov 2017 → Jan 2019 | female breast carcinoma | Nova Scotia Health Authority | Withdrawn | No outcome recorded |
| Phase 4 | NCT03052816 | Apr 2017 → Jun 2018 | pelvic organ prolapse | University Hospitals Cleveland Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT02966288 | Jan 2017 → Jan 2019 | osteoarthritis, knee | The University of Texas Health Science Center, Houston | Withdrawn | No outcome recorded |
| Phase 4 | NCT02313675 | May 2015 → May 2017 | carpal tunnel syndrome | John Fowler | Completed | No outcome recorded |
| Phase 4 | NCT02638831 | Mar → Nov 2013 | osteoarthritis, knee | Dr. Reddy's Laboratories Limited | Completed | No outcome recorded |
| Phase 4 | NCT02000401 | May 2012 → Jul 2013 | interstitial cystitis | Citrus Valley Medical Research, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT01596166 | Feb 2012 → Apr 2014 | migraine with aura, migraine without aura | University of Alberta | Completed | No outcome recorded |
| Phase 4 | NCT02000388 | Feb 2012 → Dec 2013 | — | Citrus Valley Medical Research, Inc. | Unknown | No outcome recorded |
| Phase 4 | NCT00469690 | May 2007 → May 2008 | cataract | Innovative Medical | Completed | No outcome recorded |
| Phase 4 | NCT00634972 | Nov 2005 → Aug 2008 | blindness (disorder), retinal detachment, retinopathy of prematurity | University of South Alabama | Terminated | No outcome recorded |
| Phase 4 | NCT02642718 | Apr → Oct 2001 | — | Hospital Arquitecto Marcide | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT02940405 | Jan → Oct 2017 | pulpitis | Cairo University | Unknown | No outcome recorded |
| — | NCT00504283 | Feb → Oct 2007 | nephrolithiasis | Dartmouth-Hitchcock Medical Center | Completed | No outcome recorded |
| — | NCT00335439 | Jun 2006 → May 2007 | cystoid macular edema | Queen's University | Completed | No outcome recorded |
Also used as a comparator or background therapy in 32 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 26 trials | ||||||
| Phase 2 | NCT04666701 Comparator | Feb 2023 → Feb 2025 | — | EMS | Withdrawn | No outcome recorded |
| Phase 2 | NCT02923687 Comparator | Sep 2016 → Mar 2017 | pulpitis | Azad University of Medical Sciences | Completed | No outcome recorded |
| Phase 2 | NCT02601911 Comparator | Sep 2015 → May 2016 | pulpitis | Azad University of Medical Sciences | Completed | No outcome recorded |
| Phase 2 | NCT02536430 Comparator | Mar → Jun 2015 | — | Nahid Mohammadzadeh Akhlaghi | Completed | No outcome recorded |
| Phase 2 | NCT00907114 Comparator | Jun 2009 → Mar 2015 | macular retinal edema, proliferative diabetic retinopathy | Hospital Juarez de Mexico | Completed | No outcome recorded |
| Phase 2 | NCT01015235 Comparator | Dec 2008 → Feb 2010 | — | KAI Pharmaceuticals | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT02473198 Background | Jan 2014 → Feb 2017 | osteoarthritis | The New England Baptist Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT01436032 Comparator | Oct 2011 → Mar 2012 | — | Alkermes, Inc. | Terminated | No outcome recorded |
| Phase 418 trials | ||||||
| Phase 4 | NCT06935331 Background | Oct 2025 → Dec 2026 expected | adolescent idiopathic scoliosis | OrthoCarolina Research Institute, Inc. | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT06113211 Background | Oct 2024 → Sep 2026 expected | disease of bone structure, substance-related disorder | Henry Ford Health System | Recruiting | No outcome recorded |
| Phase 4 | NCT06395428 Comparator | Jul 2024 → Apr 2025 overdue | chronic pain syndrome | Western Michigan University School of Medicine | Recruiting | No outcome recorded |
| Phase 4 | NCT05231460 Comparator | Feb 2022 → Jun 2026 overdue | neuropathy, painful | University of Arizona | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT04766996 Background | May → Dec 2021 | substance-related disorder | Emory University | Terminated | No outcome recorded |
| Phase 4 | NCT04554862 Comparator | Oct 2019 → Sep 2020 | — | Fayoum University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03383328 Comparator | Feb 2018 → Dec 2019 | cystoid macular edema | Line Kessel | Completed | No outcome recorded |
| Phase 4 | NCT03394001 Comparator | Jan → Jun 2018 | — | Ain Shams University | Unknown | No outcome recorded |
| Phase 4 | NCT02902770 Comparator | Oct 2016 → Oct 2018 | — | Antonios Likourezos | Completed | No outcome recorded |
| Phase 4 | NCT03540030 Comparator | Sep 2016 → Mar 2019 | avascular necrosis, osteoarthritis, rotator cuff syndrome, substance-related disorder | OrthoCarolina Research Institute, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT02658149 Comparator | May 2016 → May 2017 | osteoarthritis | Corewell Health East | Completed | No outcome recorded |
| Phase 4 | NCT02819908 Comparator | Sep 2015 → Apr 2016 | uveal disorder | Eye Center of North Florida | Completed | No outcome recorded |
| Phase 4 | NCT02219581 Background | Oct 2014 → Dec 2015 | osteoarthritis | Thomas L Bradbury | Terminated | No outcome recorded |
| Phase 4 | NCT02067078 Comparator | Feb → Dec 2014 | — | Regionshospitalet Silkeborg | Completed | No outcome recorded |
| Phase 4 | NCT01542190 Comparator | Feb 2011 → Dec 2012 | cystoid macular edema | University of Campinas, Brazil | Completed | No outcome recorded |
| Phase 4 | NCT01023724 Comparator | Dec 2009 → Jan 2010 | anterior uveitis | Bucci Laser Vision Institute | Completed | No outcome recorded |
| Phase 4 | NCT01021761 Comparator | Oct → Dec 2009 | cataract | Frank A. Bucci, Jr., M.D. | Completed | No outcome recorded |
| Phase 4 | NCT01001806 Comparator | Oct → Dec 2009 | cataract | Frank A. Bucci, Jr., M.D. | Completed | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT03224637 Comparator | Jul 2014 → Dec 2015 | chronic pain syndrome, osteoarthritis, knee | Assiut University | Completed | No outcome recorded |
| — | NCT02295189 Comparator | Jan 2013 → May 2014 | osteoarthritis, knee | San Antonio Military Medical Center | Completed | No outcome recorded |
| — | NCT01640171 Background | Jul 2012 → Sep 2013 | age-related macular degeneration, central retinal vein occlusion, diabetic macular edema | Retina Vitreous Associates of Florida | Completed | No outcome recorded |
| — | NCT01230463 Comparator | Sep 2010 → Sep 2011 | — | University of Calgary | Unknown | No outcome recorded |
| — | NCT01042093 Comparator | Jan 2010 → Jul 2011 | osteoarthritis, knee | Towson Orthopaedic Associates | Completed | No outcome recorded |
| — | NCT01339624 Comparator | Jan → Sep 2009 | — | Valduce Hospital | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2011-05-18 | Daiichi Sankyo | Regency Therapeutics and Daiichi Sankyo Announce Launch and Commercial Availability of SPRIX(R) (ketorolac tromethamine) Nasal Spray daiichisankyo.com ↗ |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 71 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ketorolac Tromethamine | “An option in this regard is a topical formulation of prednisolone acetate, moxifloxacin hydrochloride and ketorolac tromethamine (PredMoxiKetorolac), given for one week...” NCT02819908 ↗47“patients received either the acetaminophen 750 mg (Paracetamol 750 mg, Bioativa compounding pharmacy, Cascavel, PR, Brasil) and ketorolac tromethamine oral 10 mg (Toragesic® 10...” NCT03343392 ↗ |
| Known as | Acular | “ketorolac tromethamine 0.5% (Acular®)” NCT00335439 ↗ |
| Known as | Acuvail | “Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)” NCT01021761 ↗ |
| Known as | Ketolorac | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05355597 ↗ |
| Known as | ketorolac | “The ice packs, Tylenol, and Toradol regimen consists of around-the-clock ice packs, around-the-clock oral acetaminophen, around-the-clock intravenous ketorolac, and intravenous...” PMID 31201808 ↗ Jun 2019 |
| Known as | Ketorolac eye drop | “ACULAR® (Ketorolac eye drop) is a member of nonsteroidal anti-inflammatory drugs (NSAIDs) available for toipcal ocular use.” NCT00634972 ↗ |
| Known as | ketorolac trometamol | “Ketorolac trometamol (KT) is a nonnarcotic, peripherally acting nonsteroidal anti-inflammatory drug” PMID 27382251 ↗ Jun 20162“Ketorolactrometamol 5 mg/ml eye drops are administered 3 times pr. day” NCT03383328 ↗ “Levofloxacin + Ketorolac Trometamol 0.5+0.5% w/v eye drops solution” NCT06616922 ↗ |
| Known as | NOV-1776 | “topically applied transcutaneous ketorolac tromethamine gel 12.5% (w/w) (NOV-1776)” NCT06273813 ↗ |
| Known as | NTM-001 (Ketorolac Tromethamine IV Continuous Infusion) | “NTM-001 (Ketorolac Tromethamine IV Continuous Infusion)” NCT05382546 ↗1“NTM-001 (Ketorolac Tromethamine IV Continuous Infusion)” NCT05324358 ↗ |
| Known as | Sprix | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04444830 ↗ |
| Known as | Toradol | “* Toradol: 30mg q 6hr for 6 total doses. 1st dose given intraoperatively at incision. The dose is 15 mg for older patients or if creatinine clearance (CrCl) is low.” NCT02219581 ↗14“Toradol has been extensively studied in a multitude of surgeries including spinal, obstetric, orthopedic, urologic, and gynecologic.” NCT03052816 ↗ “Epinephrine 1mg (1mL), 0.5% ropivacaine (60mL), Acetaminophen 1000mg IV, Toradol 30mg (1ml)” NCT06113211 ↗ “Intrafascial injection of clonidine, epinephrine, ropivacaine, and toradol solution” NCT06935331 ↗ “perioperative dose of ketorolac (Toradol, 15mg)” NCT04439396 ↗ “* Toradol 15mg q6h” NCT05231460 ↗ |
| Known as | Toragesic | “patients received either the acetaminophen 750 mg (Paracetamol 750 mg, Bioativa compounding pharmacy, Cascavel, PR, Brasil) and ketorolac tromethamine oral 10 mg (Toragesic® 10...” NCT03343392 ↗ |
| Action | Inhibit | “ACULAR acts as prostaglandin inhibitor” NCT00634972 ↗ |
| Modality | Small molecule | “Ketorolac tromethamine is an NSAID” NCT03007381 ↗ |
| Route | Topical | “topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac tromethamine 0.5% (Acular®)” NCT00335439 ↗ |