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 |
|---|---|---|---|---|---|
2025/03/25 | Phase 3 | Recruiting | |||
2025/03/07 | Phase 3 | Recruiting | |||
2024/07/24 | Phase 3 | Completed | |||
2024/05/06 | Phase 4 | Not yet recruiting | Muhammad Ilyas | ||
2023/08/21 | Not Applicable | Completed | Guangdong Provincial Hospital of Traditional Chinese Medicine | ||
2023/03/30 | Phase 4 | Completed | |||
2023/01/13 | Phase 3 | Withdrawn | Eurofarma Laboratorios S.A. | ||
2022/09/08 | Phase 1 | Completed | |||
2022/09/08 | Phase 1 | Completed | |||
2022/02/25 | Not Applicable | Completed |
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 | SIN16212P | TABLET, FILM COATED | 90mg | 5/28/2021 | |
| ETORICOXIB MEVON FILM-COATED TABLETS 120 mg | SIN16181P | TABLET, FILM COATED | 120.00 mg | 5/5/2021 | |
| INTORICOXIB FILM COATED TABLET 60MG | SIN16168P | TABLET, FILM COATED | 60.000 mg | 4/23/2021 | |
| ARCOXIA TABLET 120 mg | SIN12103P | TABLET, FILM COATED | 120 mg | 10/18/2002 | |
| ETORIDEX FILM-COATED TABLETS 120MG | SIN16244P | TABLET, FILM COATED | 120.0mg | 6/21/2021 | |
| ETORI-60 FILM COATED TABLETS 60 MG | SIN16901P | TABLET, FILM COATED | 60 mg | 11/30/2023 | |
| ETOXIB FILM-COATED TABLETS 30MG | SIN16126P | TABLET, FILM COATED | 30.00mg | 3/19/2021 | |
| ETOSHINE FILM COATED TABLETS 120MG | SIN16235P | TABLET, FILM COATED | 120.00mg | 6/10/2021 | |
| ETORIDEX FILM-COATED TABLETS 60MG | SIN16246P | TABLET, FILM COATED | 60.0mg | 6/21/2021 | |
| ETOXIB FILM-COATED TABLETS 120MG | SIN16123P | TABLET, FILM COATED | 120.00mg | 3/19/2021 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Etoricoxib Tablets | 国药准字H20193302 | 化学药品 | 片剂 | 11/4/2019 | |
| Etoricoxib Tablets | 国药准字H20213897 | 化学药品 | 片剂 | 11/24/2021 | |
| Etoricoxib Tablets | 国药准字H20254037 | 化学药品 | 片剂 | 4/30/2025 | |
| Etoricoxib Tablets | 国药准字H20254038 | 化学药品 | 片剂 | 4/30/2025 | |
| Etoricoxib Tablets | 国药准字H20253148 | 化学药品 | 片剂 | 1/14/2025 | |
| Etoricoxib Tablets | 国药准字H20253147 | 化学药品 | 片剂 | 1/14/2025 | |
| Etoricoxib Tablets | 国药准字H20193303 | 化学药品 | 片剂 | 11/4/2019 | |
| Etoricoxib Tablets | 国药准字H20234007 | 化学药品 | 片剂 | 8/1/2023 | |
| Etoricoxib Tablets | 国药准字H20253146 | 化学药品 | 片剂 | 1/14/2025 | |
| Etoricoxib Tablets | 国药准字HJ20230114 | 化学药品 | 片剂 | 10/18/2023 |
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 | Medicine | A | 10/18/2017 | |
| CIPLA ETORICOXIB etoricoxib 60 mg tablet bottle | 281586 | Medicine | A | 10/18/2017 | |
| E-COXIP etoricoxib 60 mg tablet blister pack | 281682 | Medicine | A | 10/18/2017 | |
| ETORICIP etoricoxib 30 mg tablet blister pack | 281557 | Medicine | A | 10/18/2017 | |
| ETORICIP etoricoxib 90 mg tablet blister pack | 281686 | Medicine | A | 10/18/2017 | |
| E-COXIP etoricoxib 30 mg tablet blister pack | 281559 | Medicine | A | 10/18/2017 | |
| ETORICIP etoricoxib 30 mg tablet bottle | 281558 | Medicine | A | 10/18/2017 | |
| E-COXIP etoricoxib 90 mg tablet blister pack | 281688 | Medicine | A | 10/18/2017 | |
| CIPLA ETORICOXIB etoricoxib 30 mg tablet bottle | 281555 | Medicine | A | 10/18/2017 | |
| ETORICIP etoricoxib 60 mg tablet bottle | 281681 | Medicine | A | 10/18/2017 |
Help Us Improve
Your feedback helps us provide better drug information and insights.