Overview
Celecoxib, a selective cyclooxygenase-2 (COX-2) inhibitor, is a nonsteroidal anti-inflammatory drug (NSAID) which is known for its decreased risk of causing gastrointestinal bleeding compared to other NSAIDS. It is used to manage symptoms of various types of arthritis pain and in familial adenomatous polyposis (FAP) to reduce precancerous polyps in the colon. It is marketed by Pfizer under the brand name Celebrex, and was initially granted FDA approval in 1998. Interestingly, selective COX-2 inhibitors (especially celecoxib), have been evaluated as potential cancer chemopreventive and therapeutic drugs in clinical trials for a variety of malignancies.
Background
Celecoxib, a selective cyclooxygenase-2 (COX-2) inhibitor, is a nonsteroidal anti-inflammatory drug (NSAID) which is known for its decreased risk of causing gastrointestinal bleeding compared to other NSAIDS. It is used to manage symptoms of various types of arthritis pain and in familial adenomatous polyposis (FAP) to reduce precancerous polyps in the colon. It is marketed by Pfizer under the brand name Celebrex, and was initially granted FDA approval in 1998. Interestingly, selective COX-2 inhibitors (especially celecoxib), have been evaluated as potential cancer chemopreventive and therapeutic drugs in clinical trials for a variety of malignancies.
Indication
Celecoxib is indicated for symptomatic treatment of adult osteoarthritis (OA) and adult rheumatoid arthritis (RA). Celecoxib is not a substitute for aspirin for cardiovascular event prophylaxis. It may be also be used to treat acute pain from various sources, juvenile rheumatoid arthritis in children over 2, ankylosing spondylitis, and primary dysmenorrhea. Celecoxib, in combination with tramadol, is indicated for the management of acute pain in adults severe enough to require an opioid analgesic and in whom alternative treatments are inadequate.
Associated Conditions
- Acute Pain
- Ankylosing Spondylitis (AS)
- Osteoarthritis (OA)
- Primary Dysmenorrhoea
- Rheumatoid Arthritis
- Rheumatoid Arthritis, Juvenile
- Severe Acute Pain
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/30 | Phase 2 | Not yet recruiting | |||
2025/04/24 | Early Phase 1 | Not yet recruiting | C17 Council | ||
2025/03/07 | Phase 3 | Recruiting | |||
2024/12/09 | Not Applicable | Recruiting | Air Force Military Medical University, China | ||
2024/11/21 | Phase 4 | Not yet recruiting | |||
2024/08/09 | Phase 3 | Recruiting | |||
2024/07/23 | Phase 3 | Completed | |||
2024/07/17 | Phase 2 | Recruiting | |||
2024/06/11 | Early Phase 1 | ENROLLING_BY_INVITATION | Xuhui Central Hospital, Shanghai | ||
2024/04/23 | Phase 4 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Advanced Rx Pharmacy of Tennessee, LLC | 80425-0096 | ORAL | 200 mg in 1 1 | 1/18/2023 | |
| Blenheim Pharmacal, Inc. | 10544-929 | ORAL | 200 mg in 1 1 | 7/20/2015 | |
| Blenheim Pharmacal, Inc. | 10544-953 | ORAL | 200 mg in 1 1 | 4/21/2016 | |
| Qingdao BAHEAL Pharmaceutical Co., Ltd. | 70247-007 | ORAL | 100 mg in 1 1 | 1/8/2024 | |
| NuCare Pharmaceuticals,Inc. | 68071-2733 | ORAL | 200 mg in 1 1 | 9/18/2023 | |
| Physicians Total Care, Inc. | 54868-5506 | ORAL | 400 mg in 1 1 | 4/24/2015 | |
| Quality Care Products LLC | 55700-613 | ORAL | 100 mg in 1 1 | 5/7/2018 | |
| Physicians Total Care, Inc. | 54868-4107 | ORAL | 100 mg in 1 1 | 4/24/2015 | |
| Blenheim Pharmacal, Inc. | 10544-967 | ORAL | 200 mg in 1 1 | 2/12/2016 | |
| RedPharm Drug, Inc. | 67296-1345 | ORAL | 200 mg in 1 1 | 1/21/2022 |
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 |
|---|---|---|---|---|---|
| SYNERRV CELECOXIB HARD CAPSULES 200MG | SIN16252P | CAPSULE | 200.00MG | 6/29/2021 | |
| BEA-COXIB CAPSULE 200MG | SIN16297P | CAPSULE | 200mg | 8/13/2021 | |
| CELEBREX CAPSULES 200 mg | SIN11241P | CAPSULE | 200 mg | 12/13/1999 | |
| CELEBREX CAPSULE 400MG | SIN13653P | CAPSULE | 400mg | 5/21/2009 | |
| ZOBREX CAPSULE 200MG | SIN16394P | CAPSULE | 200mg | 12/9/2021 | |
| Celecoxib Sandoz Capsule 200mg | SIN14560P | CAPSULE | 200mg | 6/12/2014 | |
| Estacoxib Capsule 200mg | SIN15792P | CAPSULE | 200.000mg | 8/28/2019 | |
| ACLEXA HARD CAPSULES 200MG | SIN15889P | CAPSULE | 200.00mg | 2/25/2020 | |
| HOVID-CELECOXIB CAPSULE 200MG | SIN15754P | CAPSULE | 200 MG | 7/26/2019 | |
| CELDOL 200 CAPSULES 200MG | SIN16183P | CAPSULE | 200mg | 5/6/2021 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Celecoxib Capsules | 国药准字H20249827 | 化学药品 | 胶囊剂 | 12/25/2024 | |
| Celecoxib Capsules | 国药准字HJ20140804 | 化学药品 | 胶囊剂 | 11/7/2024 | |
| Celecoxib Capsules | 国药准字HJ20140805 | 化学药品 | 胶囊剂 | 11/7/2024 | |
| Celecoxib Capsules | 国药准字H20244510 | 化学药品 | 胶囊剂 | 7/30/2024 | |
| Celecoxib Capsules | 国药准字H20213383 | 化学药品 | 胶囊剂 | 5/19/2021 | |
| Celecoxib Capsules | 国药准字J20150067 | 化学药品 | 胶囊剂 | 4/10/2020 | |
| Celecoxib Capsules | 国药准字H20234697 | 化学药品 | 胶囊剂 | 12/26/2023 | |
| Celecoxib Capsules | 国药准字H20233911 | 化学药品 | 胶囊剂 | 7/6/2023 | |
| Celecoxib Capsules | 国药准字H20203297 | 化学药品 | 胶囊剂 | 7/8/2020 | |
| Celecoxib Capsules | 国药准字H20203324 | 化学药品 | 胶囊剂 | 7/21/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| TELECEN 200 CAPSULES 200MG | N/A | N/A | N/A | 10/2/2024 | |
| CELEBREX CAP 100MG | N/A | N/A | N/A | 4/26/1999 | |
| CELECOXIB CAPSULES 200MG | N/A | N/A | N/A | 9/27/2019 | |
| CELECOLEN CAPSULES 200MG | N/A | wilcome pharmaceutical co ltd | N/A | N/A | 3/9/2017 |
| CELECOXIB CAPSULES 200MG | N/A | N/A | N/A | 7/31/2019 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ANACOXIB Celecoxib 200 mg capsule blister pack | 206835 | Medicine | A | 1/10/2014 | |
| CELECOXIB LAPL celecoxib 200 mg capsules blister pack | 196187 | Medicine | A | 6/13/2013 | |
| CELETOID Celecoxib 200 mg capsule blister pack | 206825 | Medicine | A | 1/10/2014 | |
| CELECOXIB SANDOZ celecoxib 100mg hard capsule blister pack | 210630 | Medicine | A | 5/12/2014 | |
| CELECOXIB LAPL celecoxib 100 mg capsules blister pack | 196179 | Medicine | A | 6/13/2013 | |
| Celaxib capsules 100 mg bulk EU | 302322 | Medicine | A | 4/26/2018 | |
| CELEXI Celecoxib 100 mg capsule blister pack | 206828 | Medicine | A | 1/10/2014 | |
| CELECOXIB GXP Celecoxib 100 mg capsule blister pack | 206830 | Medicine | A | 1/10/2014 | |
| CELAXIB celecoxib 200 mg capsule blister pack | 296388 | Medicine | A | 2/23/2018 | |
| CELAXIB RELIEF celecoxib 200 mg capsule blister pack | 463628 | Medicine | A | 10/3/2024 |