{"id":72254,"date":"2026-08-11T12:20:02","date_gmt":"2026-08-11T04:20:02","guid":{"rendered":"https:\/\/flcube.com\/?p=72254"},"modified":"2026-08-11T12:20:03","modified_gmt":"2026-08-11T04:20:03","slug":"astellas-submits-nda-in-japan-for-fezolinetant-a-first-in-class-nonhormonal-nk3-receptor-antagonist-for-menopausal-vasomotor-symptoms","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=72254","title":{"rendered":"Astellas Submits NDA in Japan for Fezolinetant, a First-in-Class Nonhormonal NK3 Receptor Antagonist for Menopausal Vasomotor Symptoms"},"content":{"rendered":"\n

Astellas Pharma Inc. (TYO: 4503)<\/a><\/strong> announced that it has submitted a New Drug Application (NDA)<\/strong> to Japan’s Ministry of Health, Labour and Welfare (MHLW)<\/strong> seeking approval of fezolinetant<\/strong>, a neurokinin 3 (NK3) receptor antagonist<\/strong>, for the treatment of vasomotor symptoms (VMS)<\/strong> \u2014 also known as hot flushes and sweating \u2014 associated with menopause.<\/p>\n\n\n\n

Regulatory Submission Overview<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Applicant<\/strong><\/td>Astellas Pharma Inc. (TYO: 4503)<\/td><\/tr>
Regulatory Agency<\/strong><\/td>Ministry of Health, Labour and Welfare (MHLW), Japan<\/td><\/tr>
Submission Type<\/strong><\/td>New Drug Application (NDA)<\/td><\/tr>
Product<\/strong><\/td>Fezolinetant (NK3 receptor antagonist)<\/td><\/tr>
Indication<\/strong><\/td>Vasomotor symptoms (VMS \/ hot flushes and sweating) associated with menopause<\/td><\/tr>
Submission Date<\/strong><\/td>7 Aug 2026<\/td><\/tr>
Potential Distinction<\/strong><\/td>First nonhormonal treatment in Japan targeting the NK3 receptor pathway for menopausal VMS<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Supporting Clinical Evidence<\/h2>\n\n\n\n
Evidence Source<\/th>Role in Submission<\/th><\/tr><\/thead>
Two Phase 3 STARLIGHT Studies<\/strong><\/td>Pivotal data conducted in Japanese women with VMS associated with menopause<\/td><\/tr>
Additional Japan Clinical Studies<\/strong><\/td>Supplementary data supporting the NDA package<\/td><\/tr>
Global Clinical Development Program<\/strong><\/td>Provides supportive context for the overall safety and efficacy profile<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

The submission package is anchored by the two Phase 3 STARLIGHT studies<\/strong> in Japanese women, supplemented by broader data from Astellas’ global clinical development program<\/strong> for fezolinetant.<\/p>\n\n\n\n

Drug Profile & Mechanism of Action<\/h2>\n\n\n\n