Nilutamide, sold under the brand names Nilandron and Anandron, is a nonsteroidal antiandrogen (NSAA) which is used in the treatment of prostate cancer. It has also been studied as a component of feminizing hormone therapy for transgender women and to trea + some more technical info. Nilutamide is a competitive antagonist at the androgen receptor that prevents activation by testosterone and dihydrotestosterone, reducing androgen-driven gene transcription in target tissues. Chemically it is a small-molecule aryl-substituted imide with high oral bioavailability and predominantly hepatic metabolism to polar metabolites that are eliminated in urine and feces. Clinically it is administered orally and used as part of combined androgen blockade in advanced prostate carcinoma; pharmacology-relevant safety signals include hepatotoxicity monitoring, visual disturbances, and rare pulmonary toxicity that require baseline and periodic clinical and laboratory assessment. Analytical control of nilutamide API batches uses validated HPLC and LC-MS methods for assay, related substances, and degradants, and specification limits are set to ensure purity, potency and consistent pharmacokinetics.
Parent: Nilutamide
Parent: Nilutamide
Parent: Nilutamide
Parent: Nilutamide
The impurity profile for nilutamide typically comprises process-related starting materials, positional isomers, reduction products of the nitroaryl moiety, N-oxide or hydroxylated metabolites, and trace oxidative or ring-modified degradants; residual solvents and inorganic impurities are controlled per ICH guidelines. Typical quantitative acceptance criteria used in manufacturing specifications are: individual identified related compounds limited to 0.10 to 0.20 percent w/w, unspecified impurities at or below a reporting threshold of 0.05 percent w/w, and total impurities generally not exceeding 0.5 percent w/w; higher limits may be set for well-characterized, qualified impurities following toxicological assessment. Release testing normally includes batch-specific LC-based assays to quantify each related substance, a mass balance for total impurity, and limits for heavy metals and residual solvents aligned to regulatory requirements.
Nilutamide is used primarily in the treatment of metastatic or advanced prostate cancer as a nonsteroidal antiandrogen, usually as part of combined androgen blockade; it has also been evaluated as a component of feminizing hormone regimens in transgender women in clinical studies.
Nilutamide is classified as a nonsteroidal antiandrogen, an androgen receptor antagonist that blocks the action of androgens at their receptor.
Cost varies by country, dose, brand versus generic status, and payer coverage; where commercially available, out-of-pocket prices for a one-month supply can range widely and may be approximately in the low tens to several hundred US dollars; for an exact price check local pharmacies, hospital formularies or suppliers and consider insurance or national health coverage.
Yes, hot flashes are a common androgen-deprivation related adverse effect and can occur with nilutamide therapy because blocking androgen signaling alters thermoregulatory and endocrine balance; management strategies include symptomatic treatment and review of the overall treatment plan with the prescribing clinician.
