Nigella sativa, commonly known as black cumin or black seeds, is an herb with a long history of use in traditional medicine, particularly in Arab countries, the Indian subcontinent, and eastern Europe. The seeds contain thymoquinone (TQ), a bioactive component responsible for its various pharmacological properties, including antioxidant, anti-inflammatory, anti-hypertensive, anti-hepatotoxic, hypoglycemic, and lipid-lowering effects. This review discusses the potential mechanisms of action of Nigella sativa and the role of pharmaceutical technology in optimizing its preparations. The market for products containing Nigella sativa is analyzed, focusing on international perspectives and specific regions like Italy. Nigella sativa has been used for over 2000 years for therapeutic and culinary purposes. It is used in traditional medical practices such as Arabian medicine and Ayurveda to treat respiratory and gastrointestinal diseases, menstrual disorders, and skin infections. In culinary applications, it is added to bread, pickles, tea, coffee, and curries, and is also used as an insect repellent and in beauty products. The phytochemical composition of Nigella sativa varies based on growing region, maturity stage, processing method, and extraction technique. Key components include terpenes and terpenoids, phytosterols, alkaloids, fatty acids, tocopherols, polyphenols, and miscellaneous components. TQ, the most abundant bioactive component, is responsible for its pharmacological activities, but its high hydrophobicity and poor solubility in aqueous media limit its oral bioavailability. New strategies, including nanotechnology, are being developed to improve TQ's bioavailability without compromising its efficacy and safety. Nigella sativa has been studied for its cardioprotective, anti-hypertensive, anti-diabetic, anti-obesity, anti-dyslipidemic, anti-oxidant, anti-inflammatory, and hepatoprotective activities. Studies have shown that it can reduce blood pressure, improve lipid profiles, enhance insulin sensitivity, and reduce inflammation. It has also been found to have beneficial effects on menopause, including reducing menopausal symptoms and improving quality of life. Safety and toxicity studies have generally shown that Nigella sativa is safe, with oral administration being safer than intraperitoneal administration due to the formation of less toxic metabolites. The essential oil is considered a "chemical of concern" by the European Food Safety Authority due to the presence of certain alkaloids. Acute and sub-chronic toxicity studies have established a safe human dosage of TQ, and clinical trials have shown no serious adverse events with moderate dosages. Overall, Nigella sativa shows promise as a natural supplement for various cardiometabolic diseases, with ongoing research focusing on optimizing its preparation and application.Nigella sativa, commonly known as black cumin or black seeds, is an herb with a long history of use in traditional medicine, particularly in Arab countries, the Indian subcontinent, and eastern Europe. The seeds contain thymoquinone (TQ), a bioactive component responsible for its various pharmacological properties, including antioxidant, anti-inflammatory, anti-hypertensive, anti-hepatotoxic, hypoglycemic, and lipid-lowering effects. This review discusses the potential mechanisms of action of Nigella sativa and the role of pharmaceutical technology in optimizing its preparations. The market for products containing Nigella sativa is analyzed, focusing on international perspectives and specific regions like Italy. Nigella sativa has been used for over 2000 years for therapeutic and culinary purposes. It is used in traditional medical practices such as Arabian medicine and Ayurveda to treat respiratory and gastrointestinal diseases, menstrual disorders, and skin infections. In culinary applications, it is added to bread, pickles, tea, coffee, and curries, and is also used as an insect repellent and in beauty products. The phytochemical composition of Nigella sativa varies based on growing region, maturity stage, processing method, and extraction technique. Key components include terpenes and terpenoids, phytosterols, alkaloids, fatty acids, tocopherols, polyphenols, and miscellaneous components. TQ, the most abundant bioactive component, is responsible for its pharmacological activities, but its high hydrophobicity and poor solubility in aqueous media limit its oral bioavailability. New strategies, including nanotechnology, are being developed to improve TQ's bioavailability without compromising its efficacy and safety. Nigella sativa has been studied for its cardioprotective, anti-hypertensive, anti-diabetic, anti-obesity, anti-dyslipidemic, anti-oxidant, anti-inflammatory, and hepatoprotective activities. Studies have shown that it can reduce blood pressure, improve lipid profiles, enhance insulin sensitivity, and reduce inflammation. It has also been found to have beneficial effects on menopause, including reducing menopausal symptoms and improving quality of life. Safety and toxicity studies have generally shown that Nigella sativa is safe, with oral administration being safer than intraperitoneal administration due to the formation of less toxic metabolites. The essential oil is considered a "chemical of concern" by the European Food Safety Authority due to the presence of certain alkaloids. Acute and sub-chronic toxicity studies have established a safe human dosage of TQ, and clinical trials have shown no serious adverse events with moderate dosages. Overall, Nigella sativa shows promise as a natural supplement for various cardiometabolic diseases, with ongoing research focusing on optimizing its preparation and application.