Salsalate

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
Role of Inflammation in Vascular Phenotype Associated with E-cigarette Use	2024/07/05	NCT06489249	Early Phase 1	Recruiting	University of Iowa
Omega-3 Fatty Acid Lipidomics in Diabetes Peripheral Neuropathy	2021/12/23	NCT05169060	Phase 1	Recruiting	University of Iowa
Endometriosis and Microvascular Dysfunction: Role of Inflammation	2021/10/06	NCT05069740	Early Phase 1	Recruiting	Penn State University
Salsalate, Venetoclax, and Decitabine or Azacitidine for the Treatment of Acute Myeloid Leukemia or Advanced Myelodysplasia/Myeloproliferative Disease	2019/10/31	NCT04146038	Phase 2	Completed	Rutgers, The State University of New Jersey
Oral Peri-operative TIming of Metformin (or) Salsalate to Improve Non-cardiac Surgery Glucose Control	2019/01/25	NCT03816488	Phase 1	Withdrawn	McMaster University
Angiotensin II and Chronic Inflammation in Persistent Microvascular Dysfunction Following Preeclampsia	2018/03/29	NCT03482440	Early Phase 1	Completed	University of Iowa
Salsalate in Patients Mild to Moderate Alzheimer's Disease	2017/09/11	NCT03277573	Phase 1	Completed	Adam Boxer
Treating Inflammation in Polycystic Ovary Syndrome to Ameliorate Ovarian Dysfunction	2017/07/25	NCT03229408	Phase 2	Completed	University of Illinois at Chicago
The Comparison of Effect Between Salsalate and Placebo in Osteoarthritis With Nonalcoholic Fatty Liver Disease	2017/07/19	NCT03222206	Phase 4	Completed	Korea University Guro Hospital
Targeting Inflammation With Salsalate in Type 1 Diabetes Neuropathy	2016/10/18	NCT02936843	Phase 2	Completed	University of Michigan

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Salsalate	Marlex Pharmaceuticals Inc	10135-492	ORAL	500 mg in 1 1	12/18/2019
Salsalate	Marlex Pharmaceuticals Inc	10135-493	ORAL	750 mg in 1 1	12/18/2019
Salsalate	Carilion Materials Management	68151-1923	ORAL	500 mg in 1 1	7/7/2011
Salsalate	Bryant Ranch Prepack	63629-9247	ORAL	500 mg in 1 1	8/10/2020
Salsalate	Bryant Ranch Prepack	63629-8997	ORAL	750 mg in 1 1	8/10/2020
Salsalate	Proficient Rx LP	71205-983	ORAL	750 mg in 1 1	11/1/2022
Salsalate	Amneal Pharmaceuticals LLC	65162-513	ORAL	750 mg in 1 1	12/20/2023
Salsalate	Amneal Pharmaceuticals LLC	65162-512	ORAL	500 mg in 1 1	12/20/2023
Salsalate	ECI Pharmaceuticals LLC	51293-616	ORAL	750 mg in 1 1	8/26/2022
Salsalate	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
No NMPA approvals found for this drug.

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.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
DISALCID TAB 500MG	3 m pharmaceuticals, a division of 3 m canada company	02027909	Tablet - Oral	500 MG / TAB	12/31/1993
DISALCID TAB 750MG	3 m pharmaceuticals, a division of 3 m canada company	02027917	Tablet - Oral	750 MG / TAB	12/31/1993
DISALCID - TAB 750MG	3 m pharmaceuticals, a division of 3 m canada company	02186837	Tablet - Oral	750 MG	6/1/1996
DISALCID - TAB 500MG	3 m pharmaceuticals, a division of 3 m canada company	02186829	Tablet - Oral	500 MG	10/1/1996

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

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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