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Nicolon is an oral delayed-release nicotine capsule developed by S.L.A. Pharma (UK) Ltd for the treatment of mild-to-moderate ulcerative colitis. Its active ingredient is nicotine (specifically nicotine tartrate), formulated for ileo-colonic (delayed/modified) release so that the drug is delivered directly to the site of disease in the colon rather than being absorbed systemically in the upper gastrointestinal tract. This targeted delivery approach is intended to maximize local therapeutic effect while minimizing the systemic side effects (such as nausea, headache, and light-headedness) that have been associated with other nicotine delivery routes such as transdermal patches. The rationale for nicotine in ulcerative colitis is epidemiological: ulcerative colitis is predominantly a disease of non-smokers, and nicotine has demonstrated therapeutic value in active disease. Nicolon is a small molecule (non-biologic) formulation. It has been investigated in a Phase 2 open-label dose-finding study to determine a well-tolerated dosing schedule and evaluate its safety in adults with mild-to-moderate stable ulcerative colitis. The biological target of nicotine in this context is not fully established, but nicotinic acetylcholine receptors in the colonic mucosa are implicated.
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