Overview
Salsalate is a nonsteroidal anti-inflammatory agent for oral administration. Salsalate's mode of action as an anti-inflammatory and antirheumatic agent may be due to inhibition of synthesis and release of prostaglandins. The usefulness of salicylic acid, the active in vivo product of salsalate, in the treatment of arthritic disorders has been established. In contrast to aspirin, salsalate causes no greater fecal gastrointestinal blood loss than placebo. Salsalate is readily soluble in the small intestine where it is partially hydrolyzed to two molecules of salicylic acid. A significant portion of the parent compound is absorbed unchanged and undergoes rapid esterase hydrolysis in the body. The parent compound has an elimination half-life of about 1 hour. Salicylic acid (the active metabolite) biotransformation is saturated at anti-inflammatory doses of salsalate. Such capacity limited biotransformation results in an increase in the half-life of salicylic acid from 3.5 to 16 or more hours.
Indication
For relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis and related rheumatic disorders.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/07/05 | Early Phase 1 | Recruiting | |||
2021/12/23 | Phase 1 | Recruiting | |||
2021/10/06 | Early Phase 1 | Recruiting | |||
2019/10/31 | Phase 2 | Completed | |||
2019/01/25 | Phase 1 | Withdrawn | |||
2018/03/29 | Early Phase 1 | Completed | |||
2017/09/11 | Phase 1 | Completed | Adam Boxer | ||
2017/07/25 | Phase 2 | Completed | |||
2017/07/19 | Phase 4 | Completed | |||
2016/10/18 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Marlex Pharmaceuticals Inc | 10135-492 | ORAL | 500 mg in 1 1 | 12/18/2019 | |
| Marlex Pharmaceuticals Inc | 10135-493 | ORAL | 750 mg in 1 1 | 12/18/2019 | |
| Carilion Materials Management | 68151-1923 | ORAL | 500 mg in 1 1 | 7/7/2011 | |
| Bryant Ranch Prepack | 63629-9247 | ORAL | 500 mg in 1 1 | 8/10/2020 | |
| Bryant Ranch Prepack | 63629-8997 | ORAL | 750 mg in 1 1 | 8/10/2020 | |
| Proficient Rx LP | 71205-983 | ORAL | 750 mg in 1 1 | 11/1/2022 | |
| Amneal Pharmaceuticals LLC | 65162-513 | ORAL | 750 mg in 1 1 | 12/20/2023 | |
| Amneal Pharmaceuticals LLC | 65162-512 | ORAL | 500 mg in 1 1 | 12/20/2023 | |
| ECI Pharmaceuticals LLC | 51293-616 | ORAL | 750 mg in 1 1 | 8/26/2022 | |
| Bryant Ranch Prepack | 63629-9248 | ORAL | 500 mg in 1 1 | 8/10/2020 |
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 |
|---|---|---|---|---|---|
| Salsalate Tablets | 国药准字H20073468 | 化学药品 | 片剂 | 7/23/2020 |
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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