Drug intelligence / Profile preview

hydroxychloroquine + mesalamine

Development stage
Phase 2
Lead developer
Icahn School of Medicine
Modality
Small Molecules
Administration
Oral
01

Overview

Hydroxychloroquine + mesalamine is a combination therapy being investigated for the treatment of active mild to severe ulcerative colitis, particularly in patients of non-European ancestry such as African Americans and Hispanics. Hydroxychloroquine, a small molecule traditionally used for malaria and autoimmune diseases like rheumatoid arthritis, is hypothesized to act as an immunomodulator in this context by increasing the expression of CTLA-4 on regulatory T cells (CD4+CD25+CD127- Tregs), thereby enhancing their ability to suppress mucosal inflammation. Mesalamine (5-aminosalicylic acid) is a standard-of-care anti-inflammatory agent that acts locally in the colon, primarily as a PPAR-gamma agonist. This combination is being evaluated in a Phase 1/2 clinical trial led by the Icahn School of Medicine at Mount Sinai to determine if the addition of hydroxychloroquine can induce clinical and histologic remission in patients who have had an inadequate response to mesalamine monotherapy.

Other names
HCQ + mesalaminehydroxychloroquine sulfate + 5-aminosalicylic acid
02

Targets

TLR7 (Toll-like receptor 7)TLR9 (Toll-like receptor 9)CTLA-4 (Cytotoxic t-lymphocyte–associated protein 4)PPARG (Peroxisome proliferator-activated receptor gamma)

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