Drugs / Ketoprofen
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Ketoprofen

Small molecule

Developed for
osteoarthritis, knee · osteoarthritis · musculoskeletal system disorder · tendinitis · bursitis · lymphedema · arthropathy · chronic pain syndrome
+11 more · female reproductive system disorder · major depressive disorder · migraine disorder · osteoarthritis, hip · pharyngitis · sickle cell disease · tenosynovitis of foot and ankle · tooth disorder · upper respiratory tract disorder · sciatica · urinary tract obstruction
Investigated by
IDEA AG · Akdeniz University · Alkemira SA · Sanofi · Hisamitsu Pharmaceutical Co., Inc. · ZARS Pharma Inc.
+45 more · Centre Hospitalier Universitaire, Amiens · EMS · Kocatepe University · Manisa Celal Bayar University · McMaster University · Pamukkale University · University Hospital, Clermont-Ferrand · University Hospital, Rouen · APR Applied Pharma Research s.a. · Assistance Publique - Hôpitaux de Paris · Assiut University · Boehringer Ingelheim · Centre Hospitalier VALENCIENNES · Centre Oscar Lambret · Clinique Victor Pauchet · Club anesthésie Reanimation Obstetricale · Dompé Farmaceutici S.p.A · Fondation Apicil · Handok Inc. · IRCCS Burlo Garofolo · Imprimis Pharmaceuticals, Inc. · KAZM Pharmaceuticals Inc. · Kufa University · Luis Fernando Simoneti · M.D. Anderson Cancer Center · Mae Stone Goode Foundation · NEURO-DOL (UMR 1107 INSERM / UCA) · NHS Tayside · National Institute of Mental Health (NIMH) · Oakville Trafalgar Memorial Hospital · Rennes University Hospital · SARL BOUCHARENC, Saint-Chély d'Apcher, France · Santelys Association · Stanford University · São Paulo Research Foundation · University Hospital, Angers · University Hospital, Caen · University Hospital, Lille · University Hospital, Montpellier · University of Iowa · University of Maryland · University of Michigan · University of Rochester · Université Clermont-Auvergne, France · X-pert Med GmbH

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (2) US (FDA) ORUDIS — 1987-07-31 – 1994-01-06 fda.gov ↗
Approved US (FDA) ORUDIS — 1986-01-09 fda.gov ↗

Trials 55

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT03514810 Jan → Sep 2017 major depressive disorder Kufa University Completed No outcome recorded
Phase 1 NCT01020279 Oct 2009 → Jan 2010 musculoskeletal system disorder X-pert Med GmbH Completed No outcome recorded
Phase 1 NCT00745264 Oct 2007 → Mar 2008 — IDEA AG Completed No outcome recorded
Phase 211 trials · 1 missed
Phase 2 NCT06912763 Aug 2025 → Mar 2031 expected head and neck cancer, lymphedema M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 2 NCT06731647 Feb 2025 → Nov 2027 expected pneumothorax Centre Hospitalier Universitaire, Amiens Recruiting No outcome recorded
Phase 2 NCT05062083 Jun 2022 → Sep 2023 multiple sclerosis National Institute of Mental Health (NIMH) Terminated No outcome recorded
Phase 2 NCT02439034 Feb 2015 → Sep 2016 cervical cancer, upper aerodigestive tract neoplasm Centre Oscar Lambret Completed No outcome recorded
Phase 2 NCT02180087 Feb 2014 → Aug 2015 — University Hospital, Clermont-Ferrand Unknown Missed primary
Phase 2 NCT00647231 Mar → Aug 2008 osteoarthritis, knee Hisamitsu Pharmaceutical Co., Inc. Completed No outcome recorded
Phase 2 NCT00903994 Jun → Aug 2007 tendinitis APR Applied Pharma Research s.a. Completed No outcome recorded
Phase 2 NCT00265304 Jul 2005 → Jul 2007 osteoarthritis, knee IDEA AG Completed No outcome recorded
Phase 2 NCT00211549 Jun 2005 → ? osteoarthritis, knee IDEA AG Completed No outcome recorded
Phase 2 NCT00108810 Apr → Oct 2005 osteoarthritis, knee ZARS Pharma Inc. Completed No outcome recorded
Phase 2/32 trials · 1 missed
Phase 2/3 NCT03199417 May 2017 → May 2018 osteoarthritis, knee University of Michigan Terminated No outcome recorded Stop: Enrollment
Phase 2/3 NCT02099006 Nov 2013 → Jun 2015 female reproductive system disorder University of Rochester Completed Missed primary
Phase 324 trials · 1 met primary · 2 missed
Phase 3 NCT06202989 Sep 2024 → May 2026 — KAZM Pharmaceuticals Inc. Completed No outcome recorded
Phase 3 NCT06381063 Mar 2024 → Mar 2027 expected — Centre Hospitalier Universitaire, Amiens Recruiting No outcome recorded
Phase 3 NCT04421911 Mar → Sep 2020 osteoarthritis Handok Inc. Completed No outcome recorded
Phase 3 NCT03836807 Apr → Jul 2018 — Dompé Farmaceutici S.p.A Completed Met primary
Phase 3 NCT03025113 Mar 2018 → Nov 2019 musculoskeletal system disorder EMS Completed No outcome recorded
Phase 3 NCT02862977 Nov 2017 → Jun 2019 musculoskeletal system disorder EMS Completed No outcome recorded
Phase 3 NCT02905058 Oct 2016 → May 2017 — Assiut University Completed No outcome recorded
Phase 3 NCT01890902 Aug 2013 → Jun 2014 — Imprimis Pharmaceuticals, Inc. Withdrawn No outcome recorded
Phase 3 NCT00971581 Aug 2009 → May 2010 — Sanofi Completed No outcome recorded
Phase 3 NCT00929877 Jun 2009 → Apr 2010 — Sanofi Completed No outcome recorded
Phase 413 trials · 1 met primary
Phase 4 NCT07826988 Oct 2026 → Oct 2029 expected sickle cell disease Assistance Publique - Hôpitaux de Paris Not yet recruiting No outcome recorded
Phase 4 NCT05761015 Dec 2023 → Apr 2028 expected chronic pain syndrome, osteoarthritis, hip, osteoarthritis, knee University Hospital, Clermont-Ferrand Recruiting No outcome recorded
Phase 4 NCT03911336 Jan 2023 tooth disorder University of Iowa Withdrawn No outcome recorded
Phase 4 NCT02619695 Jun 2015 → Jan 2016 — Akdeniz University Unknown No outcome recorded
Phase 4 NCT02491736 Jun 2015 → Jan 2016 tenosynovitis of foot and ankle Akdeniz University Unknown No outcome recorded
Phase 4 NCT02730026 Jun 2015 → Dec 2016 — Luis Fernando Simoneti Completed No outcome recorded
Phase 4 NCT02491879 Jun 2015 → Jan 2016 — Akdeniz University Unknown No outcome recorded
Phase 4 NCT02393846 Feb → Jun 2015 — Akdeniz University Completed No outcome recorded
Phase 4 NCT01882530 Jul 2013 → Jan 2016 — Rennes University Hospital Terminated No outcome recorded
Phase 4 NCT01566253 Mar → Dec 2012 — University Hospital, Montpellier Completed No outcome recorded
Phase not applicable2 trials
— NCT00530387 Jul 2008 → Jul 2011 photoallergic dermatitis NHS Tayside Completed No outcome recorded
— NCT00188071 Sep 2002 → Aug 2003 — University Hospital, Angers Completed No outcome recorded
Comparator or background therapy41 trials
Phase 1 NCT07319728 Comparator May 2025 → Jan 2026 overdue osteoarthritis, knee New Valley University Active not recruiting No outcome recorded
Phase 1 NCT04802967 Comparator Feb 2021 → Mar 2022 — Dompé Farmaceutici S.p.A Completed No outcome recorded
Phase 1 NCT02156596 Comparator Feb 2013 → Dec 2017 urinary tract obstruction University of Monastir Completed No outcome recorded
Phase 2 NCT00745771 Comparator Oct 2007 → Feb 2008 — IDEA AG Completed No outcome recorded
Phase 2/3 NCT02538224 Comparator Jul 2013 → Feb 2014 chronic periodontitis Islamic Azad University, Sanandaj Completed No outcome recorded

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2013-02-19 Harrow Inc Results Imprimis Announces Successful Results from its Pharmacokinetic Study for its Impracor Topical NSAID harrow.com ↗
The application of an occlusive knee bandage with either heat or exercise following topical administration showed faster initial but lower overall plasma exposure of ketoprofen relative to non-occluded topical administration with no heat or exercise.

Evidence & citations 55 cited values

Every value below carries the sentence it was read from. 99 sources stand behind the page.

FieldValueCited text
Known as Ketoprofen “Thirty minutes before the end of surgery, nefopam 40 mg, paracetamol 1 g, and ketoprofen 100 mg will be administered intravenously, depending on the patient's comorbidities,...” NCT07207304 ↗
92

“Standard analgesia includes ketoprofen 100 mg twice daily and paracetamol 1000 mg every 8 hours for 24 hours after knee arthroplasty; morphine 10 mg IM as needed for rescue therapy.” NCT07059429 ↗

“Intraoperative administration intravenous of dipyrone 30-50 mg/Kg and or intravenous ketoprofen 100 mg or diclofenac 75 mg or ketorolac 30 mg” NCT01734954 ↗

“Multiprofen-CC™ is a multimodal topical cream including ingredients ketoprofen (10%), baclofen (5%), amitriptyline (2%), and lidocaine (5%).” NCT06202989 ↗

“Experimental - A multimodal topical cream treatment with Ketoprofen, Baclofen, Amitryptiline, and lidocaine in a carrier gel.” NCT03199417 ↗

“ketoprofen, tolperisone, symptomatic slow-acting drugs in osteoarthritis - SYSADOA - (glucosamine + chondroitin sulfate )” NCT05223946 ↗

“Each patient received one sachet that contained KLS 40 mg (equivalent to 25 mg of ketoprofen).” NCT03836807 ↗

“Both groups received intravenous analgesia with ketoprofen 100 mg regimen” NCT02239497 ↗

“2.5% ketoprofen gel (Fastjel) has been administer as 2 gr in 5 cm area.” NCT02619695 ↗

“Paracetamol 1 gram and ketoprofen 100 mg every 8 hours for 24 hours.” NCT04172272 ↗

“100 mg of ketoprofen in 50 ml volume given in 30 minutes by IV root” NCT02156596 ↗

Show 82 more sources

Known as (rs)-ketoprofen ChEMBL registry synonym — accepted as the source's own label CHEMBL571 ↗
Known as 19583RP ChEMBL registry synonym — accepted as the source's own label CHEMBL571 ↗
Known as Actron ChEMBL registry synonym — accepted as the source's own label CHEMBL571 ↗
Known as Actron ketoprofen ChEMBL registry synonym — accepted as the source's own label CHEMBL571 ↗
Known as Alrheumat ChEMBL registry synonym — accepted as the source's own label CHEMBL571 ↗
Known as Aneol ChEMBL registry synonym — accepted as the source's own label CHEMBL571 ↗
Known as Artrosilene ChEMBL registry synonym — accepted as the source's own label CHEMBL571 ↗
Known as Axorid ChEMBL registry synonym — accepted as the source's own label CHEMBL571 ↗
Known as Capisten ChEMBL registry synonym — accepted as the source's own label CHEMBL571 ↗
Known as Diractin “Epicutaneously Applied Diractin® (Ketoprofen in Transfersome® Gel)” NCT00722852 ↗
2

“Epicutaneously Applied Diractin® (Ketoprofen in Transfersome® Gel)” NCT00716547 ↗

“100 mg ketoprofen from Diractin®” NCT00745264 ↗

Known as Fastjel “2.5% ketoprofen gel (Fastjel) has been administer as 2 gr in 5 cm area.” NCT02619695 ↗
Known as Fenoket 200 ChEMBL registry synonym — accepted as the source's own label CHEMBL571 ↗
Known as HKT-500 “HKT-500 Ketoprofen Topical Patch” NCT00680784 ↗
Known as Hydratropic acid, m-benzoyl- ChEMBL registry synonym — accepted as the source's own label CHEMBL571 ↗
Known as IDEA-033 “A multicentre, randomized, placebo- and active-controlled trial comparing the efficacy and safety of topical ketoprofen in Transfersome gel (IDEA-033) with ketoprofen-free...” PMID 23542612 ↗ Mar 2013
5

“Patients treated with IDEA-033 in Study 17-007 will receive 100 mg per knee of ketoprofen gel twice daily and one placebo capsule twice daily for 52 weeks.” NCT00265304 ↗

“100 mg ketoprofen in 4.4 g transfersome gel (IDEA-033) or 4.4 g ketoprofen-free vehicle (TDT 064) topically, twice daily, for 12 weeks.” PMID 23996292 ↗ Sep 2013

NCT00316784 ↗

NCT00211549 ↗

NCT00372333 ↗

Known as Iso-k ChEMBL registry synonym — accepted as the source's own label CHEMBL571 ↗
Known as Jomethid xl ChEMBL registry synonym — accepted as the source's own label CHEMBL571 ↗
Known as Ketocid 200 ChEMBL registry synonym — accepted as the source's own label CHEMBL571 ↗
Known as Ketonal ChEMBL registry synonym — accepted as the source's own label CHEMBL571 ↗
Known as Ketoprofen l-lysinate ChEMBL registry synonym — accepted as the source's own label CHEMBL571 ↗
Known as KETOPROFEN LYSINE ChEMBL registry synonym — accepted as the source's own label CHEMBL571 ↗
Known as Ketoprofen Lysine Salt “Ketoprofen Lysine Salt Combined with Gabapentin (KLS-GABA) Compared to Ketoprofen Lysine Salt (KLS) Alone in Healthy Male Subjects” NCT04802967 ↗
Known as KETOPROFEN SODIUM ChEMBL registry synonym — accepted as the source's own label CHEMBL571 ↗
Known as Ketoprofene ChEMBL registry synonym — accepted as the source's own label CHEMBL571 ↗