CDEK
← All drugs Report issue

ketoprofen

Trade name: orudis

Small moleculeapproved

Approved

Jan 9, 1986

Ketoprofen is a drug belonging to the family of non-steroidal anti-inflammatory drugs. Ketoprofen, was synthesized in France by Rhône-Poulenc chemists in 1967, and introduced in 1973 in France and the United Kingdom for antiinflammatory use. Ketoprofen selectively inhibits isoform-I of cyclo-oxygenase, COX-1. Ketoprofen has shown to be an excellent choice of drug for the treatment of chronic pain in patients with osteoarthritis, rheumatoid arthritis. In addition Ketoprofen is prescribed for management of pain (acute forms of pain, traumatic and post-surgical pain) and also indicated for treatment of primary dysmenorrhea — NCATS

Clinical trial activity

85 trials · 74 clinical orgs · 13 marketing orgs

Phase 1
8
Phase 2
46
Phase 3
37
Phase 4
19

Earliest trial started Sep 1, 1998 (NCT02178293)

Timeline

1980s

  1. Jan 9, 1986

    American Home Products — Earliest FDA Approval

  2. Jan 9, 1986

    American Home Products — NDA Secondary Org

  3. Jan 9, 1986

    American Home Products — NDA Organization

1990s

  1. Dec 22, 1992

    Teva — Marketing Organization

  2. Jan 29, 1993

    Heritage Pharma — Marketing Organization

  3. Jan 29, 1993

    Misemer Pharmaceutical — Marketing Organization

  4. Oct 6, 1995

    Bayer — NDA Secondary Org

  5. Oct 6, 1995

    Wyeth — NDA Secondary Org

  6. Dec 29, 1995

    Rising Pharmaceuticals — Marketing Organization

  7. Dec 29, 1995

    Aurobindo Pharma — Marketing Organization

  8. Dec 31, 1996

    Mylan — Marketing Organization

  9. Dec 10, 1997

    Alkermes — Marketing Organization

  10. Mar 24, 1999

    Actavis — Marketing Organization

2000s

  1. Feb 7, 2002

    Perrigo — Marketing Organization

  2. Jan 1, 2004

    Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 2005

    Earliest Phase 2 Sponsor(trial)

  4. Jan 1, 2007

    Earliest Phase 1 Sponsor(trial)

  5. Nov 25, 2009

    Novartis — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJan 9, 1986

Chemistry & pharmacology

Loading structure…

SMILES

[Na+].CC(C([O-])=O)C1=CC=CC(=C1)C(=O)C2=CC=CC=C2
Mol. weight
276.2624 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • 2-(3-benzoylphenyl)propionic acid
  • 2-(3-benzoylphenyl)propionic acid
  • 3-(4-biphenylcarbonyl)propionic acid
  • 3-(4-biphenylylcarbonyl)propionic acid
  • 3-(4-biphenylylcarbonyl)propionic acid
  • 3-(4-phenylbenzoyl)propionic acid
  • 3-(4-phenylbenzoyl)propionic acid
  • 3-benzoyl-alpha-methylbenzeneacetic acid
  • 3-benzoyl-alpha-methylbenzeneacetic acid
  • 3-benzoylhydratropic acid
  • 3-benzoylhydratropic acid
  • 3-benzoyl-α-methylbenzeneacetic acid
  • 3-benzoyl-α-methylbenzeneacetic acid
  • actron
  • actron
  • alrheumat
  • alrheumat
  • axorid
  • diractin
  • fenoket 200
  • hkt-500
  • jomethid xl
  • ketocid 200
  • ketonal
  • ketonal
  • ketoprofen
  • ketoprofen
  • ketoprofen
  • ketoprofen
  • ketoprofen
  • ketoprofen
  • ketoprofen
  • ketoprofen
  • ketoprofen
  • ketoprofene
  • ketoprophen
  • ketotard 200 xl
  • ketovail
  • ketozip 200 xl
  • l'acide (benzoyl-3-phenyl)-2-propionique
  • l'acide (benzoyl-3-phenyl)-2-propionique
  • larafen
  • larafen cr
  • lederfen
  • lederfen
  • m-benzoylhydratropic acid
  • m-benzoylhydratropic acid
  • nexcede
  • orudis
  • orudis
  • orudis
  • orudis 100
  • orudis kt
  • orudis kt
  • orudis (tn)
  • orudis (tn)
  • oruvail
  • oruvail
  • oruvail 100
  • oruvail 150
  • oruvail 200
  • oruvail im
  • powergel
  • r.p. 19583
  • r.p. 19583
  • rp 19583
  • rp 19583
  • rp 19583
  • rp 19583
  • rp 19583
  • rp 19583
  • rp-19583
  • rp-19583
  • rp-19583
  • (rs)2-(3-benzoylphenyl)-propionic acid
  • tiloket
  • tiloket cr
  • valket 200 retard

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06912763Phase 2Aug 8, 2025University of Texas at Houston
NCT06731647Phase 2Nov 12, 2024Rouen Normandy University, University of Picardie Jules Verne, Valenciennes Hospital Centre
NCT05840406N/AApr 1, 2024University Hospital "Sestre Milosrdnice"
NCT06381063N/AMar 27, 2024Rouen Normandy University, University of Lille, University of Picardie Jules Verne
NCT04726592Phase 3Jul 8, 2021Assistance Publique - Hôpitaux de Paris
NCT04802967Phase 1Feb 8, 2021Dompe Pharmaceuticals, MAC Clinical Research
NCT04622813Phase 3Dec 31, 2020American University of Beirut
NCT04500470N/ASep 1, 2020Aswan University
NCT04421911Phase 3Apr 6, 2020Handok Pharmaceuticals Co., Ltd.
NCT04361695N/AFeb 27, 2020Russian Society of Colorectal Surgeons
NCT04172272N/ASep 24, 2019General Hospital Pula, University Hospital, Rijeka
NCT04148846N/ASep 20, 2019University of Sao Paulo
NCT04678076Phase 1Jul 23, 2018Angelini, Cross Research S.A.
NCT03836807Phase 3Apr 4, 2018Dompe Pharmaceuticals
NCT03585374Phase 3Feb 8, 2018Bioikos Ambiente Srl, Mundipharma, Università degli Studi di Firenze
NCT03404908Phase 4Feb 7, 2018Medical University of Lublin
NCT03244540Phase 4Sep 4, 2017Medical University of Lublin
NCT02862977Phase 3Sep 1, 2017EMS S/A
NCT03025113Phase 3Sep 1, 2017EMS S/A
NCT03199417Phase 2/Phase 3 (Phase 3)May 1, 2017McMaster University, Oakville Trafalgar Memorial Hospital, University of Michigan
Showing 20 of 85 trials
Page 1 / 5

Organizations

Research & Development (74)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
IDEA AGFor profit9932004
Endo PharmaceuticalsFor profit5522006
Hisamitsu Pharmaceutical Co., Inc.For profit5522007
SanofiFor profit5522008
Akdeniz UniversityAcademic/Hospital4412015
Pamukkale UniversityAcademic/Hospital4012015
PPDFor profit4012006
X-pert Med GmbHFor profit4132004
Dompe PharmaceuticalsFor profit3322014
Harrow HealthFor profit3312008
Medical University of LublinAcademic/Hospital3312016
Zars Pharma Inc.For profit3322005
Assiut UniversityAcademic/Hospital2212016
Behar, Caren, M.D.Academic/Hospital2212009
Celal Bayar UniversityAcademic/Hospital2012015
Cross Research S.A.For profit2012014
EMS S/AFor profit2212017
Kocatepe UniversityAcademic/Hospital2012015
New York Medical CollegeAcademic/Hospital2012009
Rouen Normandy UniversityAcademic/Hospital2022024
74 organizations
Page 1 / 4

Marketing (15)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGMar 24, 1999
AlkermesFor profitMKTGDec 10, 1997
American Home ProductsFor profitNDA2Jan 9, 1986
American Home ProductsFor profitNDAJan 9, 1986
Aurobindo PharmaFor profitMKTGDec 29, 1995
BayerFor profitNDA2Oct 6, 1995
Heritage PharmaFor profitMKTGJan 29, 1993
Misemer PharmaceuticalFor profitMKTGJan 29, 1993
MylanFor profitMKTGDec 31, 1996
NovartisFor profitNDA2Nov 25, 2009
PerrigoFor profitMKTGFeb 7, 2002
Rising PharmaceuticalsFor profitMKTGDec 29, 1995
TevaFor profitMKTGDec 22, 1992
WyethFor profitNDA2Oct 6, 1995
WyethFor profitSYNSep 24, 1993