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NFL-101 is an investigational botanical drug being developed by NFL Biosciences for smoking cessation. [5, 12] It is a standardized, nicotine-free, aqueous extract of tobacco leaves administered via two subcutaneous injections. [2, 6, 9] The drug's mechanism is distinct from traditional therapies; instead of targeting nicotinic receptors, it modulates the immune system. [1, 2] It is believed to reactivate tobacco-associated immune memory, inducing both innate and adaptive immune responses, including the production of anti-tobacco IgG antibodies. [1, 3] This immune modulation is thought to reduce smoking-related neuroinflammation in key brain regions and help normalize brain function altered by chronic tobacco use, thereby reducing craving and the satisfaction derived from smoking. [1, 2, 4] Clinical trials have shown that NFL-101 can increase smoking abstinence rates compared to placebo and is well-tolerated. [3, 4]
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