Relugolix, identified by its CAS number 737789-87-6, stands as a significant active pharmaceutical ingredient (API) in modern medicine. It is an orally administered, non-peptide antagonist of the gonadotropin-releasing hormone (GnRH) receptor. This mechanism of action makes Relugolix invaluable in treating several hormone-sensitive conditions by effectively suppressing the production of sex hormones.
The primary function of Relugolix involves binding to and blocking GnRH receptors located in the pituitary gland. Normally, GnRH stimulates the pituitary to release luteinizing hormone (LH) and follicle-stimulating hormone (FSH). These hormones, in turn, signal the gonads (testes and ovaries) to produce testosterone, estrogen, and progesterone. By antagonizing the GnRH receptor, Relugolix inhibits the release of LH and FSH, leading to a significant reduction in circulating levels of these sex hormones. This hormonal suppression is the basis for its therapeutic effects in various clinical applications.
One of the key applications of Relugolix is in the treatment of advanced prostate cancer. Prostate cancer growth is often driven by testosterone. By lowering testosterone levels, Relugolix can slow or stop the progression of the disease. Clinical trials, such as the landmark HERO study, have demonstrated the efficacy and safety of Relugolix as an oral alternative to traditional injectable androgen deprivation therapies. The convenience of oral administration represents a significant advantage for patients, potentially improving adherence and quality of life compared to frequent injections.
In women's health, Relugolix is approved for managing symptoms associated with uterine fibroids and endometriosis. Both conditions are influenced by estrogen and progesterone. Uterine fibroids are non-cancerous growths in the uterus that can cause heavy bleeding, pain, and pressure. Endometriosis is a painful disorder where tissue similar to the lining of the uterus grows outside the uterus. By reducing estrogen and progesterone levels, Relugolix can decrease the size of fibroids and reduce associated bleeding, as well as alleviate the pelvic pain caused by endometriosis. In these indications, Relugolix is often prescribed as part of a combination therapy that includes lower doses of estrogen and a progestin. This 'add-back' therapy helps to mitigate potential side effects of low estrogen levels, such as bone mineral density loss and hot flashes, while maintaining the therapeutic benefits on fibroids and endometriosis symptoms. The LIBERTY program evaluated Relugolix combination therapy for uterine fibroids, while the SPIRIT program studied it for endometriosis.
The chemical profile of Relugolix is characterized by its molecular formula C29H27F2N7O5S and a molecular weight of 623.63 g/mol. It is typically supplied as a white powder with high purity levels, often specified at 99% or greater. This high assay is crucial for its pharmaceutical application. Other key characteristics include its CAS number 737789-87-6, which uniquely identifies this compound. Understanding the detailed physical and chemical properties is essential for its handling, storage, and formulation into finished drug products.
The purity of the Relugolix API is a critical factor for its suitability in pharmaceutical manufacturing. Impurities, even at low levels, can affect the safety, efficacy, and stability of the final drug product. Therefore, manufacturers of Relugolix-based medicines require API that meets stringent quality control standards and regulatory requirements set by health authorities around the globe. Reliable suppliers must demonstrate robust manufacturing processes, comprehensive analytical testing capabilities, and adherence to Good Manufacturing Practices (GMP) or equivalent quality systems.
The growing market demand for Relugolix, driven by its clinical success and patient preference for oral formulations, underscores the importance of a dependable supply chain for the API. Pharmaceutical companies need access to consistent batches of high-quality Relugolix powder to ensure uninterrupted production and meet market needs. The API serves as the foundational raw material from which tablets and other oral dosage forms are produced.
Sourcing high-quality pharmaceutical raw materials like Relugolix requires expertise and diligence. Companies looking to procure this API must navigate the global supply landscape to find a reliable manufacturer or supplier. Key considerations include the supplier's manufacturing capacity, quality assurance systems, regulatory track record, and ability to provide necessary documentation, such as Certificates of Analysis (CoA), Method of Analysis (MoA), and impurity profiles.
Information regarding the Relugolix price is typically not publicly listed and depends on various commercial factors, including order volume, required purity and particle size specifications, packaging, and contractual terms. Potential buyers interested in sourcing this material need to initiate direct inquiries with potential manufacturers or suppliers to obtain detailed quotations and discuss their specific requirements. The process to buy Relugolix API involves technical evaluation, quality audits, and negotiation to ensure both the product quality and commercial terms are satisfactory. A thorough due diligence process is recommended before making a final purchase decision to establish a long-term relationship with a trusted source capable of consistently supplying high-quality Relugolix powder for pharmaceutical applications.
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