Drugs / Flurbiprofen

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) OCUFEN 1986-12-31 fda.gov

Trials 48 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT05955885 Jul 2023 → Jul 2024 respiratory tract infectious disorder University of Melbourne Completed No outcome recorded
Phase 126 trials
Phase 1 NCT07426042 Apr → May 2026 overdue Min Kyu Park Not yet recruiting No outcome recorded
Phase 1 NCT07223671 Dec 2025 → Feb 2026 Bristol-Myers Squibb Completed No outcome recorded
Phase 1 NCT07259330 Oct 2025 → Mar 2026 SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany Completed No outcome recorded
Phase 1 NCT07235748 Oct → Dec 2025 Servier Completed No outcome recorded
Phase 1 NCT06823284 Jan → Feb 2025 Teikoku Seiyaku Co., Ltd. Completed No outcome recorded
Phase 1 NCT05932277 Jun → Sep 2023 Bristol-Myers Squibb Completed No outcome recorded
Phase 1 NCT05852769 May → Aug 2023 Bristol-Myers Squibb Completed No outcome recorded
Phase 1 NCT05981365 Apr → Oct 2023 sickle cell disease Pfizer Completed No outcome recorded
Phase 1 NCT05254548 Feb → Apr 2022 Idorsia Pharmaceuticals Ltd. Completed No outcome recorded
Phase 1 NCT05512013 Feb 2022 → Apr 2023 bone resorption disease, disease of bone structure United States Army Research Institute of Environmental Medicine Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT01026714 Nov 2009 → Aug 2010 University Hospital, Geneva Completed No outcome recorded
Phase 24 trials
Phase 2 NCT01040286 Aug 2009 → Jun 2010 periodontitis Dexcel Pharma Technologies Ltd. Completed No outcome recorded
Phase 2 NCT00425451 Aug 2008 → Jan 2009 periodontitis Dexcel Pharma Technologies Ltd. Completed No outcome recorded
Phase 2 NCT00759330 Oct 2007 → Jul 2008 chronic pain syndrome Teikoku Pharma USA, Inc. Completed No outcome recorded
Phase 2 NCT00001724 Nov 1997 → Nov 2001 National Institute of Dental and Craniofacial Research (NIDCR) Completed No outcome recorded
Phase 32 trials
Phase 3 NCT01048866 Nov 2009 → Mar 2011 pharyngitis Reckitt Benckiser Inc. Completed No outcome recorded
Phase 3 NCT01049334 Nov 2009 → Mar 2011 pharyngitis Reckitt Benckiser Inc. Completed No outcome recorded
Phase 45 trials
Phase 4 NCT06238154 Oct 2023 → Jan 2024 mouth disorder Yuzuncu Yil University Completed No outcome recorded
Phase 4 NCT06041178 Sep 2022 → May 2023 chronic periodontitis Beirut Arab University Completed No outcome recorded
Phase 4 NCT03745599 Nov 2017 → Sep 2018 Near East University, Turkey Completed No outcome recorded
Phase 4 NCT01998217 Sep 2012 → Dec 2013 pancreas disorder Changhai Hospital Completed No outcome recorded
Phase 4 NCT00519246 Feb → Dec 2007 neuropathy, painful Nanjing Medical University Completed No outcome recorded
Phase not applicable9 trials
NCT07370402 Dec 2025 → Sep 2027 expected herpes zoster Beijing Tiantan Hospital Recruiting No outcome recorded
NCT07163429 Sep 2025 → Dec 2026 expected Kittitorn Supphapipat, MD Active not recruiting No outcome recorded
NCT07416136 Apr → Aug 2025 impacted teeth, multiple Marmara University Completed No outcome recorded
NCT06531837 Aug 2024 → Jan 2026 overdue chronic pain syndrome Beijing Tiantan Hospital Not yet recruiting No outcome recorded
NCT06220175 Mar → Aug 2024 Carol Davila University of Medicine and Pharmacy Completed No outcome recorded
NCT03337945 Apr 2018 → Jun 2021 cirrhosis of liver University Hospital, Basel, Switzerland Completed No outcome recorded
NCT02789527 Nov 2015 → Apr 2017 Estella S. Poloni Completed No outcome recorded
NCT02438072 Dec 2014 → Dec 2015 depressive disorder University Hospital, Geneva Unknown No outcome recorded
NCT00162474 Sep 2003 → Dec 2030 expected Hadassah Medical Organization Recruiting No outcome recorded
Also used as a comparator or background therapy in 17 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 02 trials
Phase 0 NCT03090009 Comparator Apr 2017 → Apr 2019 mucositis Polak David Unknown No outcome recorded
Phase 0 NCT03165929 Comparator May 2016 → Feb 2017 Gazi University Completed No outcome recorded
Phase 12 trials
Phase 1 NCT05742256 Background Mar 2023 → Jul 2024 Qianfoshan Hospital Unknown No outcome recorded
Phase 1 NCT04505787 Comparator Jul → Sep 2020 SocraTec R&D GmbH Completed No outcome recorded
Phase 21 trial
Phase 2 NCT04708964 Comparator Jan → Jun 2021 Fondazione Policlinico Universitario Agostino Gemelli IRCCS Unknown No outcome recorded
Phase 45 trials
Phase 4 NCT07531147 Comparator Apr → Sep 2026 expected pharyngitis Izmir Katip Celebi University Not yet recruiting No outcome recorded
Phase 4 NCT04602845 Background Apr → Jun 2021 Peking University Completed No outcome recorded
Phase 4 NCT03171987 Comparator Jun 2017 → Mar 2021 Taipei Medical University Hospital Completed No outcome recorded
Phase 4 NCT02569905 Comparator Apr 2014 → Apr 2015 Guangxi Medical University Completed No outcome recorded
Phase 4 NCT02114463 Comparator Mar 2014 → Aug 2016 Guangzhou General Hospital of Guangzhou Military Command Unknown No outcome recorded
Phase not applicable7 trials
NCT06566794 Comparator Aug 2024 → Jan 2025 Helsinki University Central Hospital Completed No outcome recorded
NCT06000137 Background Feb 2022 → Jan 2023 Eye & ENT Hospital of Fudan University Completed No outcome recorded
NCT04976790 Comparator Oct 2021 → Feb 2022 Beijing University of Chinese Medicine Unknown No outcome recorded
NCT04507165 Comparator Aug 2020 → Jul 2021 Peking University People's Hospital Unknown No outcome recorded
NCT02784041 Background Sep 2016 → Dec 2017 osteoarthritis, knee Peking Union Medical College Hospital Unknown No outcome recorded

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 66 sources stand behind the page.

FieldValueCited text
Known as Flurbiprofen “We administered the Basel phenotyping cocktail (caffeine, efavirenz, flurbiprofen, omeprazole, metoprolol, midazolam) to patients with liver cirrhosis (n = 16 Child A, n = 15...” PMID 37328712 Jun 2023
64

“Nirogacestat 100 mg BID will be administered orally from Day 1 through Day 17 and an oral dose of CYP cocktail (CYP2B6 [bupropion 20 mg], CYP2C8 [repaglinide 0.05 mg], CYP2C9...” NCT07259330

“A CYP probe cocktail composed of approved, commercially available drugs (caffeine, flurbiprofen, omeprazole, and midazolam) will be administered concomitantly as a single-dose...” NCT07426042

“Klorhex Plus topical spray containing chlorhexidine gluconate and flurbiprofen is applied to the surgical site immediately after impacted mandibular third molar extraction and...” NCT07416136

“Ten volunteers received an oral cocktail capsule containing low doses of the probes bupropion (CYP2B6), flurbiprofen (CYP2C9), omeprazole (CYP2C19), dextromethorphan (CYP2D6),...” PMID 24722393 Apr 2014

“that is Strepsils Intensive with honey and lemon which contains flurbiprofen 8.75mg before upper GI endoscopy plus xilocaine spray improves the satisfaction score of the...” NCT06220175

“The present clinical trial will be conducted to characterise maximum observed systemic exposure of the newly developed EFHP (Test) vs. "Froben 100 mg" (Reference, containing...” NCT04505787

“The mixture contains 30ml (300mg) ropivacaine, 0.5ml (5 mg) morphine, 2 ml (50 mg) flurbiprofen and 0.5 ml of 1:1000 epinephrine, and then is diluted with 0.9% normal saline to...” NCT02784041

“Effects of BMS-955176 on the Single-dose Pharmacokinetics of Probe Substrates (Caffeine, Metoprolol, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin)...” NCT02578277

“Cocktail = Caffeine 200 mg, Metoprolol 50 mg, Montelukast 10 mg, Flurbiprofen 50 mg, Omeprazole 40 mg, Midazolam 5 mg, Digoxin 0.25 mg, and Pravastatin 40 mg” NCT02045966

“The Geneva cocktail is composed of caffeine, bupropion, flurbiprofen, omeprazole, dextromethorphan, midazolam, and fexofenadine.” PMID 32851583 Nov 2020

“Test group 1 (OCA group):oxycodone 1mg/kg + flurbiprofen 50mg + ondansetron 16mg + 0.9% normal saline diluted to 100ml” NCT05742256

Flurbiprofen 50mg was given intravenously before the skin incision and suture respectively” NCT04507165

“caffeine, dextromethorphan, flurbiprofen, midazolam, and omeprazole” NCT03720366

Flurbiprofen Axetil 50 mg i.v.” NCT00519246

Flurbiprofen (10 mg, M01AE09)” NCT02438072

“CYP2C Flurbiprofen 10 mg” NCT04814498

NCT06000137

NCT02670954

NCT06531837

NCT07531147

NCT07370402

NCT01026714

NCT05512013

NCT00001724

NCT05981365

NCT01998217

NCT03165929

NCT01049334

NCT02227173

NCT03090009

NCT02569905

NCT00964106

NCT05254548

NCT04708964

NCT07235748

NCT03131973

NCT04643249

NCT04602845

NCT04425902

NCT00920088

NCT06823284

NCT02762123

NCT02456844

NCT00759330

NCT04976790

NCT02674737

NCT07223671

NCT00162474

NCT05955885

NCT00615212

NCT03171987

NCT02391688

NCT06566794

NCT00425451

NCT07163429

NCT01048866

NCT01040286

NCT06041178

NCT06238154

NCT02114463

NCT03745599

NCT00443170

NCT05852769

NCT05932277

Known as Ansaid “This study will evaluate the effectiveness of the non-steroidal anti-inflammatory drug flurbiprofen (Ansaid® (Registered Trademark)) in relieving pain following oral surgery.” NCT00001724
Known as Flurbiprofen Axetil flurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine 30mg” NCT02114463
1

Flurbiprofen Axetil 50 mg i.v.” NCT00519246

Known as Flurbiprofen spray Flurbiprofen spray applied to the cuff of laryngeal mask airways or single-lumen tubes reduces POST severity.” NCT07163429
Known as Froben “The present clinical trial will be conducted to characterise maximum observed systemic exposure of the newly developed EFHP (Test) vs. "Froben 100 mg" (Reference, containing...” NCT04505787
Action Inhibit “flurbiprofen axetil (a cyclooxygenase inhibitor)” PMID 26547293 Nov 2015
Modality Small molecule “a chiral NSAID of the 2-arylpropionic acid class” NCT03165929
Route Other “directly into the extraction site” NCT00001724