Etoricoxib

Overview

Etoricoxib is a new COX-2 selective inhibitor. Current therapeutic indications are: treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, chronic low back pain, acute pain and gout. Like any other COX-2 selective inhibitor, Etoricoxib selectively inhibits isoform 2 of cyclo-oxigenase enzyme (COX-2) to reduce the generation of prostaglandins (PGs) from arachidonic acid. It is approved in more than 60 countries worldwide but not in the US.

Indication

For the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, chronic low back pain, acute pain and gout.

Associated Conditions

Ankylosing Spondylitis (AS)
Gout
Osteoarthritis (OA)
Rheumatoid Arthritis
Moderate Pain

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Efficacy Anda Safety of Etoricoxib With Betamethasone for the Treatment of Acute Gout Arthritis	2025/03/25	NCT06863701	Phase 3	Recruiting	Laboratorios Silanes S.A. de C.V.
Efficacy and Safety of Etoricoxib/Tizanidine Versus Etoricoxib for Acute Low Back Pain Associated to Muscle Spasm	2025/03/07	NCT06863662	Phase 3	Recruiting	Laboratorios Silanes S.A. de C.V.
Efficacy and Safety of Etoricoxib/Cyanocobalamin Versus Etoricoxib for Acute Low Back Pain	2024/07/24	NCT06517823	Phase 3	Completed	Laboratorios Silanes S.A. de C.V.
The Effect of Pregabalin and Etoricoxib on Pain Alone Versus in Combination	2024/05/06	NCT06401499	Phase 4	Not yet recruiting	Muhammad Ilyas
Immediate Analgesic Effects of Cheek Acupuncture for Acute Gouty Arthritis	2023/08/21	NCT06001112	Not Applicable	Completed	Guangdong Provincial Hospital of Traditional Chinese Medicine
Effect of Preemptive Etoricoxib and Dexamethasone on Wound Healing and Clinical Parameters After Third Molar Surgery	2023/03/30	NCT05791721	Phase 4	Completed	University of Belgrade
Fixed-dose Combination of Etoricoxib + Cyclobenzaprine for Pain Relief After Third Molar Extraction in Brazil	2023/01/13	NCT05683574	Phase 3	Withdrawn	Eurofarma Laboratorios S.A.
Bioequivalence Study of Etoricoxib in Healthy Adult Subjects Under Fasting Condition	2022/09/08	NCT05532280	Phase 1	Completed	Future University in Egypt
Comparative Bioavailability Study Between Etoricoxib and Tramadol, Administered Individually or in Combination	2022/09/08	NCT05533073	Phase 1	Completed	Laboratorios Silanes S.A. de C.V.
Biomarkers for Prediction of Analgesic Efficacy in Knee OA.	2022/02/25	NCT05256342	Not Applicable	Completed	Rambam Health Care Campus

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

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
COXETA FC TABLETS 90MG	TEVA Gyógyszergyár Zrt. (Teva Pharmaceutical Works Private Limited Company)	SIN16212P	TABLET, FILM COATED	90mg	5/28/2021
ETORICOXIB MEVON FILM-COATED TABLETS 120 mg	Atlantic Pharma – Produções Farmacêuticas, S.A.	SIN16181P	TABLET, FILM COATED	120.00 mg	5/5/2021
INTORICOXIB FILM COATED TABLET 60MG	Rontis Hellas Medical and Pharmaceutical Products S.A.	SIN16168P	TABLET, FILM COATED	60.000 mg	4/23/2021
ARCOXIA TABLET 120 mg	Rovi Pharma Industrial Services S.A., PT Organon Pharma Indonesia Tbk (Primary and Secondary Packager)	SIN12103P	TABLET, FILM COATED	120 mg	10/18/2002
ETORIDEX FILM-COATED TABLETS 120MG	Dexcel Pharma Technologies Ltd., Dexcel Ltd. (Primary and Secondary Packager)	SIN16244P	TABLET, FILM COATED	120.0mg	6/21/2021
ETORI-60 FILM COATED TABLETS 60 MG	MICRO LABS LIMITED	SIN16901P	TABLET, FILM COATED	60 mg	11/30/2023
ETOXIB FILM-COATED TABLETS 30MG	Krka, d.d., Novo mesto, Unichem Laboratories Limited, Krka, tovarna zdravil, d.d.	SIN16126P	TABLET, FILM COATED	30.00mg	3/19/2021
ETOSHINE FILM COATED TABLETS 120MG	SUN PHARMACEUTICAL INDUSTRIES LIMITED	SIN16235P	TABLET, FILM COATED	120.00mg	6/10/2021
ETORIDEX FILM-COATED TABLETS 60MG	Dexcel Pharma Technologies Ltd., Dexcel Ltd. (Primary and Secondary Packager)	SIN16246P	TABLET, FILM COATED	60.0mg	6/21/2021
ETOXIB FILM-COATED TABLETS 120MG	Krka, d.d., Novo mesto, Unichem Laboratories Limited, Krka, tovarna zdravil, d.d.	SIN16123P	TABLET, FILM COATED	120.00mg	3/19/2021

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
APTOXIA TABLETS 120MG	N/A	synco (h.k.) limited	N/A	N/A	9/24/2018

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
E-COXIP etoricoxib 120 mg tablet blister pack	281552	Cipla Australia Pty Ltd	Medicine	A	10/18/2017
CIPLA ETORICOXIB etoricoxib 60 mg tablet bottle	281586	Cipla Australia Pty Ltd	Medicine	A	10/18/2017
E-COXIP etoricoxib 60 mg tablet blister pack	281682	Cipla Australia Pty Ltd	Medicine	A	10/18/2017
ETORICIP etoricoxib 30 mg tablet blister pack	281557	Cipla Australia Pty Ltd	Medicine	A	10/18/2017
ETORICIP etoricoxib 90 mg tablet blister pack	281686	Cipla Australia Pty Ltd	Medicine	A	10/18/2017
E-COXIP etoricoxib 30 mg tablet blister pack	281559	Cipla Australia Pty Ltd	Medicine	A	10/18/2017
ETORICIP etoricoxib 30 mg tablet bottle	281558	Cipla Australia Pty Ltd	Medicine	A	10/18/2017
E-COXIP etoricoxib 90 mg tablet blister pack	281688	Cipla Australia Pty Ltd	Medicine	A	10/18/2017
CIPLA ETORICOXIB etoricoxib 30 mg tablet bottle	281555	Cipla Australia Pty Ltd	Medicine	A	10/18/2017
ETORICIP etoricoxib 60 mg tablet bottle	281681	Cipla Australia Pty Ltd	Medicine	A	10/18/2017

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
ETORICOXIB AUROBINDO 30 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Laboratorios Aurobindo S.L.U.	82004	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
ETORICOXIB GOBENS 120 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Laboratorios Normon S.A.	82068	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
ACOXXEL 90 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Organon Salud S.L.	71589	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
ETORICOXIB NORMON 90 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Laboratorios Normon S.A.	81930	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
BALIXUM 30 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Laboratorio Stada S.L.	84235	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
ETORICOXIB STADA 90 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Laboratorio Stada S.L.	81219	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
ETORICOXIB VIATRIS 60 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Viatris Limited	80373	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
TORIXIB 120 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Neuraxpharm Spain S.L.	80672	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
ETORICOXIB PENSA 90 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Towa Pharmaceutical S.A.	81757	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
ETORICOXIB SANDOZ 30 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Sandoz Farmaceutica S.A.	80265	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

AI-Powered Research

Premium Access