Drugs / Ketorolac Tromethamine
Ketorolac Tromethamine
also known as
Toradol · Acular · ketorolac trometamol · Acuvail · NTM-001 (Ketorolac Tromethamine IV Continuous Infusion) · ketorolac · Ketorolac eye drop · NOV-1776 · +2 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 36
| 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 24 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 | 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 · 1 met primary | ||||||
| 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 Stop: Enrollment |
| Phase 3 | NCT03343392 | Nov → Dec 2017 | — | Universidade Estadual de Ponta Grossa | Completed | No outcome recorded |
| Phase 3 | NCT01471899 | Mar → Dec 2013 | — | EMS | Completed | No outcome recorded |
| Phase 3 | NCT01471886 | Mar → Oct 2013 | — | EMS | Completed | Met primary |
| Phase 3 | NCT01347853 | Jun 2003 → Jun 2005 | — | Egalet Ltd | Completed | No outcome recorded |
| Phase 414 trials · 1 met primary | ||||||
| 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 Stop: Enrollment |
| 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 Stop: Business |
| Phase 4 | NCT03052816 | Apr 2017 → Jun 2018 | pelvic organ prolapse | University Hospitals Cleveland Medical Center | Completed | Met primary |
| Phase 4 | NCT02966288 | Jan 2017 → Jan 2019 | osteoarthritis, knee | The University of Texas Health Science Center, Houston | Withdrawn | No outcome recorded Stop: Enrollment |
| 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 |
| Comparator or background therapy32 trials | ||||||
| Phase 2 | NCT04666701 Comparator | Feb 2023 → Feb 2025 | — | EMS | Withdrawn | No outcome recorded Stop: Business |
| 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 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 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 overdue | 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 | Missed primary |
| 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 | NCT01001806 Comparator | Oct → Dec 2009 | cataract | Frank A. Bucci, Jr., M.D. | Completed | No outcome recorded |
| Phase 4 | NCT01021761 Comparator | Oct → Dec 2009 | cataract | Frank A. Bucci, Jr., M.D. | Completed | No outcome recorded |
| — | 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 |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2022-11-01 | Alembic Pharmaceuticals Ltd. | Regulatory 3rd November, 2022, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals announces its second injectable product approval from its General Sterile Facility - Final Approval for Ketorolac Tromethamine Injection USP. |
| 2022-10-22 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Ketorolac Tromethamine Tablets zyduslife.com ↗
Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited) has received final approval from the United States Food and Drug Administration (USFDA) to market Ketorolac Tromethamine Tablets USP, 10 mg (USRLD: Toradol®). |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-11-01 | Alembic Pharmaceuticals Ltd. | 3rd November, 2022, Vadodara, India alembicpharmaceuticals.com ↗ |
| 2022-10-22 | Zydus Lifesciences Limited | Zydus receives final approval from the USFDA for Ketorolac Tromethamine Tablets zyduslife.com ↗ |
| 2021-05-05 | Assertio Holdings, Inc | Assertio Holdings, Inc. Partners with Cove, a Leading Migraine Telemedicine Platform, To Launch Direct to Patient Digital Campaign to Increase Accessibility of CAMBIA® (diclofenac potassium) and SPRIX® (ketorolac tromethamine) assertiotx.com ↗ |
| 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 14 cited values
Every value below carries the sentence it was read from. 70 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 | 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)” NCT05324358 ↗1“NTM-001 (Ketorolac Tromethamine IV Continuous Infusion)” NCT05382546 ↗ |
| 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 ↗ |