Ketoprofen

Overview

Ketoprofen, a propionic acid derivative, is a nonsteroidal anti-inflammatory agent (NSAIA) with analgesic and antipyretic properties.

Indication

For symptomatic treatment of acute and chronic rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, primary dysmenorrhea and mild to moderate pain associated with musculotendinous trauma (sprains and strains), postoperative (including dental surgery) or postpartum pain.

Associated Conditions

Ankylosing Spondylitis (AS)
Migraine
Mild pain
Osteoarthritis (OA)
Post Partum Pain
Postoperative pain
Primary Dysmenorrhoea
Rheumatoid Arthritis
Moderate Pain

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Reversing External-beam Radiotherapy-associated Fibrosis Syndrome: an Interventional Bayesian Adaptive Randomized-controlled Orphan Drug Platform Trial for Orodental Sequelae (Reverse-fibrose)	2025/04/06	NCT06912763	Phase 2	Not yet recruiting	M.D. Anderson Cancer Center
Non-steroidal Anti-inflammatory in Cardiac Surgery	2024/04/24	NCT06381063	Phase 3	Recruiting	Centre Hospitalier Universitaire, Amiens
PET Imaging of Cyclooxygenase in Multiple Sclerosis	2021/09/30	NCT05062083	Phase 2	Terminated	National Institute of Mental Health (NIMH)
A Study on Ketoprofen Lysine Salt (KLS) + Gabapentin (GABA) vs KLS to Investigate Their Pharmacodynamic in Healthy Males	2021/03/17	NCT04802967	Phase 1	Completed	Dompé Farmaceutici S.p.A
Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room	2021/01/27	NCT04726592	Phase 3	Terminated	Assistance Publique - Hôpitaux de Paris
Bioequivalence of Ketoprofen Oral Gel vs Ketoprofen Lysine Salt as Granules for Oral Solution	2020/12/21	NCT04678076	Phase 1	Completed	Aziende Chimiche Riunite Angelini Francesco S.p.A
Ketoprofen With or Without Vaginal Isonicotinic Acid Hydrazide Prior to Hysterosalpingography	2020/08/05	NCT04500470	Not Applicable	Completed	Aswan University Hospital
A Study to Assess Efficacy and Safety of the Ketoprofen vs Diclofenac	2020/06/09	NCT04421911	Phase 3	Completed	Handok Inc.
Lymphedema Treatment Registry	2020/02/17	NCT04272372	N/A	Not yet recruiting	Ege University
Sphenopalatine Blockade Versus Clinical Treatment	2019/11/04	NCT04148846	Not Applicable	UNKNOWN	University of Sao Paulo General Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Draxxin KP	Zoetis Inc.	54771-2155	SUBCUTANEOUS	120 mg in 1 mL	5/23/2025
Ketoprofen	Misemer Pharmaceuticals, Inc.	0276-0507	ORAL	75 mg in 1 1	5/26/2025
Ketoprofen	Misemer Pharmaceuticals, Inc.	0276-0506	ORAL	50 mg in 1 1	2/1/2024
Ketoprofen	Misemer Pharmaceuticals, Inc.	0276-0504	ORAL	25 mg in 1 1	2/1/2024

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
FASTUM GEL 2.5%	A. MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.L.	SIN06755P	GEL	2.5 g/100 g	1/4/1992
PRONALGES 50 TABLET 50 mg	PT DEXA MEDICA	SIN12115P	ENTERIC COATED TABLET	50 mg	10/31/2002
PRONALGES 100 TABLET 100 mg	PT DEXA MEDICA	SIN12153P	ENTERIC COATED TABLET	100 mg	12/23/2002
HARUFEN PLASTER 30MG	SINIL Pharmaceutical Co., Ltd.	SIN16447P	PLASTER	30 mg	3/21/2022
KEFENTECH PLASTER 30 mg/sheet	JEIL HEALTH SCIENCE	SIN10768P	PLASTER	30 mg/sheet	2/25/1999
KETOFEN GEL 2.5% w/w	Hovid Bhd	SIN15748P	GEL	2.50%w/w	7/18/2019
KEFENTECH AIR 30 MG/SHEET	JEIL HEALTH SCIENCE	SIN15212P	PLASTER	30 MG/SHEET	4/18/2017
KENHANCER PLASTER 30 mg/sheet	GC BIOPHARMA CORP.	SIN10769P	PLASTER	30 mg/sheet	2/25/1999
KETOTOP PAIN RELIEF PLASTER 30MG	HANDOK INC	SIN15832P	PLASTER	30mg	10/17/2019
ALKETO PLASTER 30 MG	Sinil Pharmaceutical Co., Ltd.	SIN14989P	PLASTER	30.000 mg	4/15/2016

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Ketoprofen Capsules	广州白云山明兴制药有限公司	国药准字H44023622	化学药品	胶囊剂	4/9/2024
Ketoprofen Capsules	山西晋新双鹤药业有限责任公司	国药准字H14022411	化学药品	胶囊剂	3/9/2020
Ketoprofen Capsules	北京曙光药业有限责任公司	国药准字H11022117	化学药品	胶囊剂	7/30/2020
Ketoprofen Capsules	哈尔滨市龙生北药生物工程股份有限公司	国药准字H23023012	化学药品	胶囊剂	3/24/2020
Ketoprofen Capsules	江苏悦兴药业有限公司	国药准字H32025881	化学药品	胶囊剂	8/24/2020
Ketoprofen Capsules	西安科力药业有限公司	国药准字H61022755	化学药品	胶囊剂	6/17/2020
Ketoprofen Capsules	江苏华阳制药有限公司	国药准字H32025960	化学药品	胶囊剂	9/2/2020
Ketoprofen Capsules	吉林龙泰制药股份有限公司	国药准字H22026777	化学药品	胶囊剂	8/19/2020
Ketoprofen Capsules	山西双雁药业有限公司	国药准字H14022767	化学药品	胶囊剂	6/16/2021
Ketoprofen Capsules	西安利君制药有限责任公司	国药准字H61022749	化学药品	胶囊剂	12/11/2020

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
PAINKILL PATCH 30MG	N/A	EUGENPHARM INTERNATIONAL LIMITED	N/A	N/A	12/24/2010
HOHOTAPE MEDICAL PLASTER 30MG	N/A	BEST UNITED MARKETING LIMITED	N/A	N/A	3/6/2025
TON PE JING PLASTER 30MG	N/A	BEST UNITED MARKETING LIMITED	N/A	N/A	4/30/2021
TARFEN MEDICAL PLASTER 30MG	N/A	BEST UNITED MARKETING LIMITED	N/A	N/A	3/6/2025
KETOFEN CAP 50MG	N/A	WILCOME PHARMACEUTICAL COMPANY LIMITED	N/A	N/A	11/12/1982

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
ORUDIS SR ketoprofen 200mg capsule blister pack	27535	Sanofi-Aventis Australia Pty Ltd	Medicine	A	10/21/1991
ORUVAIL SR ketoprofen 200mg capsule blister pack	42422	Sanofi-Aventis Australia Pty Ltd	Medicine	A	1/7/1993

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