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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/12/02 | Early Phase 1 | UNKNOWN | |||
2021/07/20 | Phase 3 | Completed | |||
2021/04/05 | Phase 1 | UNKNOWN | |||
2020/09/25 | Phase 2 | Completed | |||
2020/07/08 | Phase 2 | UNKNOWN | Shanghai Yueyang Integrated Medicine Hospital | ||
2019/10/30 | Phase 4 | Completed | |||
2018/07/11 | Phase 4 | Completed | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | ||
2018/06/01 | Not Applicable | Completed | |||
2018/02/05 | Not Applicable | Completed | Dexa Medica Group | ||
2017/01/05 | Phase 3 | Completed | Oslo University Hospital |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ETORICOXIB ALVOGEN FILM-COATED TABLETS 120MG | SIN15488P | TABLET, FILM COATED | 120.00mg | 5/21/2018 | |
| BEATROX FILM COATED TABLET 120MG | SIN16963P | TABLET, FILM COATED | 120mg | 2/27/2024 | |
| FORSANEC FILM COATED TABLETS 90mg | SIN16753P | TABLET, FILM COATED | 90mg | 4/4/2023 | |
| ETORICOXIB AUXILTO FILM-COATED TABLETS 90MG | SIN16500P | TABLET, FILM COATED | 90mg | 5/20/2022 | |
| EXINEF TABLET 90 MG | SIN14944P | TABLET, FILM COATED | 90.0 mg | 2/5/2016 | |
| ETORICOXIB ALVOGEN FILM-COATED TABLETS 90MG | SIN15487P | TABLET, FILM COATED | 90.00mg | 5/21/2018 | |
| COXETA FC TABLETS 120MG | SIN16211P | TABLET, FILM COATED | 120 mg | 5/28/2021 | |
| ETORI-90 FILM COATED TABLETS 90 MG | SIN16902P | TABLET, FILM COATED | 90 mg | 11/30/2023 | |
| BEATROX FILM COATED TABLET 90MG | SIN16964P | TABLET, FILM COATED | 90 mg | 2/27/2024 | |
| ETOVITAE FILM COATED TABLET 120MG | SIN16210P | TABLET, FILM COATED | 120.00mg | 5/28/2021 |
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ETORICIP etoricoxib 120 mg tablet blister pack | 281550 | Medicine | A | 10/18/2017 | |
| CIPLA ETORICOXIB etoricoxib 90 mg tablet bottle | 281685 | Medicine | A | 10/18/2017 | |
| ARCOXIA etoricoxib 120mg tablet blister pack | 81458 | Medicine | A | 10/11/2002 | |
| ARCOXIA etoricoxib 60mg tablet blister pack | 81456 | Medicine | A | 10/11/2002 | |
| CIPLA ETORICOXIB etoricoxib 120 mg tablet bottle | 281549 | Medicine | A | 10/18/2017 | |
| ETORICIP etoricoxib 60 mg tablet blister pack | 281680 | Medicine | A | 10/18/2017 | |
| ETORICIP etoricoxib 120 mg tablet bottle | 281551 | Medicine | A | 10/18/2017 | |
| E-COXIP etoricoxib 60 mg tablet bottle | 281683 | Medicine | A | 10/18/2017 | |
| E-COXIP etoricoxib 90 mg tablet bottle | 281689 | Medicine | A | 10/18/2017 | |
| ARCOXIA etoricoxib 30mg tablet blister pack | 131797 | Medicine | A | 4/11/2008 |
Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| ETORICOXIB ZENTIVA 30 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 81671 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| ETORICOXIB TECNIGEN 30 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Tecnimede España Industria Farmaceutica S.A. | 82960 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| ACOXXEL 30 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | Organon Salud S.L. | 71587 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| ETORICOXIB VIR 120 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Industria Quimica Y Farmaceutica Vir S.A. | 81465 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| ETORICOXIB TAD 30 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 82829 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| ETORICOXIB COMBIX 120 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Combix S.L.U. | 81956 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| BALIXUM 60 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorio Stada S.L. | 84236 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| ARCOXIA 30 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | Organon Salud S.L. | 69376 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| ETORICOXIB GOBENS 60 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Normon S.A. | 82070 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| ETORICOXIB TAD 60 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 82830 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
Philippines FDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
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Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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