Overview
Nabumetone was originally developed as a non-acidic non-steroidal anti-inflammatory drug (NSAID). It was thought to avoid trapping of the drug in the stomach by making it unable to dissociate into ions which was believed to reduce GI toxicity by limiting local action. While slightly reduced, possibly due to a degree of cyclooxygenase-2 selectivity (COX-2), nabumetone still produces significant adverse effects in the GI tract. The molecule itself is a pro-drug with its 6-methoxy-2-naphthylacetic acid (6-MNA) metabolite acting as a potent COX inhibitor similar in structure to naproxen. Nabumetone was developed by Smithkline Beecham under the trade name Relafen and first received FDA approval in December, 1991.
Indication
Indicated for: 1) Symptomatic relief in rheumatoid arthritis. 2) Symptomatic relief in osteoarthritis.
Associated Conditions
- Osteoarthritis (OA)
- Rheumatoid Arthritis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2010/07/19 | Phase 1 | Completed | |||
2010/07/19 | Phase 1 | Completed | |||
2009/03/19 | Phase 1 | Completed | |||
2009/03/19 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Unit Dose Services | 50436-6046 | ORAL | 500 mg in 1 1 | 4/1/2015 | |
| ScieGen Pharmaceuticals Inc | 50228-465 | ORAL | 500 mg in 1 1 | 2/2/2022 | |
| Bryant Ranch Prepack | 71335-2292 | ORAL | 500 mg in 1 1 | 2/2/2022 | |
| Bryant Ranch Prepack | 71335-0754 | ORAL | 750 mg in 1 1 | 2/27/2019 | |
| H.J. Harkins Company, Inc. | 52959-650 | ORAL | 500 mg in 1 1 | 12/20/2011 | |
| Amneal Pharmaceuticals of New York LLC | 0115-1658 | ORAL | 750 mg in 1 1 | 4/22/2019 | |
| Bryant Ranch Prepack | 72162-1557 | ORAL | 500 mg in 1 1 | 2/8/2024 | |
| Chartwell RX, LLC | 62135-146 | ORAL | 750 mg in 1 1 | 1/20/2023 | |
| Proficient Rx LP | 71205-030 | ORAL | 500 mg in 1 1 | 12/1/2022 | |
| RxChange Co. | 33358-252 | ORAL | 750 mg in 1 1 | 11/13/2014 |
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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Nabumetone Dispersible Tablets | 国药准字H20030697 | 化学药品 | 片剂 | 8/13/2020 | |
| Nabumetone Dispersible Tablets | 国药准字H20051281 | 化学药品 | 片剂 | 5/15/2020 | |
| Nabumetone Dispersible Tablets | 国药准字H20040166 | 化学药品 | 片剂 | 1/15/2020 | |
| Nabumetone Oral Suspension | 国药准字H20163214 | 化学药品 | 口服混悬剂 | 5/10/2021 | |
| Nabumetone Oral Suspension | 国药准字H20041835 | 化学药品 | 口服混悬剂 | 6/24/2020 | |
| Nabumetone Oral Suspension | 国药准字H20041576 | 化学药品 | 口服混悬剂 | 1/4/2024 | |
| Nabumetone Granules | 国药准字H20060103 | 化学药品 | 颗粒剂 | 8/5/2020 | |
| Nabumetone Capsules | 国药准字H51022613 | 化学药品 | 胶囊剂 | 11/9/2020 | |
| Nabumetone Capsules | 国药准字H11022490 | 化学药品 | 胶囊剂 | 10/16/2020 | |
| Nabumetone Capsules | 国药准字H43020280 | 化学药品 | 胶囊剂 | 9/27/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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