RELUGOLIX (TAK-385) Market: Information, Figures and Analytical Insights 2021-2030

The RELUGOLIX (TAK-385) Market report is a compilation of first-hand information, qualitative and quantitative assessment by industry analysts, inputs from industry experts and industry participants across the value chain. The report provides an in-depth analysis of parent market trends, macro-economic indicators and governing factors along with market attractiveness as per segments. The report also maps the qualitative impact of various market factors on market segments and geographies. We analyzed the impact of COVID-19 (Corona Virus) on the product industry chain based on the upstream and downstream markets, on various regions and major countries and on the future development of the industry are pointed out.

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Myovant's relugolix wins FDA approval for advanced prostate cancer care

Dec. 18, 2020: Following a priority review of the oral hormone therapy Orgovyx (relugolix), developed by Myovant Sciences GmbH, the FDA has approved its use for adults with advanced prostate cancer, setting the stage for commercialization of the drug in the first of three indications for which it has been developed. More than 190,000 cases of prostate cancer are expected to be diagnosed in the U.S. this year, according to the American Cancer Society.

Current FDA-approved treatments for advanced prostate cancer focus on androgen deprivation and are injected or placed as small implants under the skin. The approval of Orgovyx marks a first in its class and may eliminate some patients' need to visit the clinic for treatments that require administration by a health care provider, said Richard Pazdur, FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases.

Overview:

Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces ovarian estradiol, a hormone known to stimulate the growth of uterine fibroids and endometriosis, and testicular testosterone, a hormone known to stimulate the growth of prostate cancer. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under regulatory review in Europe and the U.S. for women with uterine fibroids and is under development for women with endometriosis. Relugolix monotherapy tablet (120 mg) is under regulatory review in the U.S. for men with advanced prostate cancer.

TAK-385 is a highly-selective, oral, non-peptide gonadotropin-releasing hormone antagonist being investigated as a possible prostate cancer treatment. Objective: Evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-385 on luteinizing hormone and testosterone. Design, setting, and participants: A three-part, randomized, double-blind, placebo-controlled, phase 1 dose-escalation study in 176 healthy male UK volunteers. Interventions: Part 1, single doses of TAK-385 (0 [placebo], 80, 120, 180, or 360 mg); Part 2, 14-day TAK-385 (40, 80, or 180 mg) daily; Part 3, 28-day TAK-385 or placebo (40 [with loading dose], 60, 80, or 160 mg) daily. Parts 2 and 3 included men aged 40-70 years. Main outcome measures: Plasma concentrations of TAK-385, luteinizing hormone, and testosterone. Results: Oral TAK-385 was readily absorbed, and steady-state was reached in ≤14 days. Food reduced TAK-385 systemic exposure by 47%-52%. Mean serum testosterone levels declined ≤6 hours after TAK-385 administration. Loading doses up to 360 mg day 1, or 360 mg day 1 followed by 240 mg day 2 reduced the time to achieve castrate testosterone levels from ≥7 to 4 ng/mL. Following discontinuation of TAK-385 on day 28, testosterone levels normalized in most subjects in ≤28 days. Common adverse events included bradycardia, headache, and hot flush (all grade ≤2). Conclusions: Oral TAK-385 (40-180 mg/day) was well tolerated and effectively lowered testosterone in healthy men. Planned phase 2 doses in men with hormone sensitive prostate cancer are 80 and 120 mg/day.

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