{"id":38238,"date":"2025-11-11T12:51:25","date_gmt":"2025-11-11T05:51:25","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=38238"},"modified":"2025-11-11T12:51:25","modified_gmt":"2025-11-11T05:51:25","slug":"shilpa-medicare-announces-positive-phase-3-results-for-oeris-a-novel-once-weekly-ondansetron-extended-release-injection-for-chemotherapy-induced-nausea-and-vomiting-cinv","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=38238","title":{"rendered":"Shilpa Medicare Announces Positive Phase 3 Results for OERIS\u2122 &#8212; A Novel Once-Weekly Ondansetron Extended-Release Injection for Chemotherapy-Induced Nausea and Vomiting (CINV)"},"content":{"rendered":"<table border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/2489785\/Shilpa_Logo.jpg?p=medium600\" border=\"0\" alt=\"\" title=\"logo\" hspace=\"0\" vspace=\"0\" width=\"118\" \/><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><b>Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections<\/b><\/p>\n<p><span class=\"legendSpanClass\">RAICHUR, <span class=\"xn-location\">India<\/span><\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">Nov. 11, 2025<\/span><\/span> \/PRNewswire\/ &#8212; <b>Shilpa Medicare Limited<\/b> (BSE: 530549) (NSE: SHILPAMED)\u00a0announced the successful completion of its <b>fourth complex clinical program SMLINJ011<\/b>, with positive topline Phase 3 results for <b>Shilpa&#8217;s OERIS\u2122 (Ondansetron Extended-Release Injection)<\/b>\u2014an innovative formulation designed to improve prophylaxis of chemotherapy-induced nausea and vomiting (CINV).<\/p>\n<p>This milestone underscores Shilpa&#8217;s growing leadership in <b>differentiated drug-delivery systems<\/b> and <b>oncology supportive-care therapeutics<\/b>, reflecting the company&#8217;s commitment to advancing patient-centric innovation.<\/p>\n<p><b>Study Overview <\/b><\/p>\n<p>A <b>Phase III, multicenter, randomized, double-blind, non-inferiority trial<\/b> was conducted across multiple oncology centers in <span class=\"xn-location\">India<\/span> to compare <b>OERIS\u2122<\/b> with conventional ondansetron injections in 240 patients receiving moderately or highly emetogenic chemotherapy.<\/p>\n<p><b>Design &amp; Endpoints<\/b><\/p>\n<ul type=\"disc\">\n<li><b>Population:<\/b>\u00a0240 patients with CINV<\/li>\n<li><b>Primary Endpoint:<\/b> Complete response (no emesis episodes through 120 hours post-chemotherapy)<\/li>\n<li><b>Comparator:<\/b>\u00a0Multiple doses of conventional ondansetron injection<\/li>\n<li><b>Secondary Endpoints:<\/b> Safety profile, delayed-phase response, patient tolerability<\/li>\n<\/ul>\n<p><b>Results<\/b><\/p>\n<ul type=\"disc\">\n<li><b>Complete response:<\/b>\u00a089% in OERIS\u2122 arm vs. 82% in standard ondansetron arm<\/li>\n<li><b>Adverse events:<\/b>\u00a0No serious or severe adverse events reported<\/li>\n<li><b>Safety:<\/b>\u00a0Comparable or better tolerability than conventional therapy<\/li>\n<\/ul>\n<p><b>Transformative Innovation<\/b><br \/>OERIS\u2122 offers extended antiemetic coverage through a single injection that effectively prevents both acute and delayed CINV for up to five days, eliminating the need for multiple daily doses or oral follow-ups. This innovation enhances patient convenience, improves compliance, and streamlines clinical workflow.<\/p>\n<p>&#8220;We are proud to announce the successful completion of this pivotal Phase 3 study,&#8221; said <b>Mr. Vishnukant Bhutada<\/b>, <b>Managing Director, Shilpa Medicare Limited<\/b>. &#8220;OERIS\u2122 exemplifies Shilpa&#8217;s ability to combine scientific innovation with patient-centric design, strengthening our oncology-supportive-care portfolio and our vision to become a global leader in specialty pharmaceuticals.&#8221;<\/p>\n<p><b>Next Steps<\/b><br \/>Shilpa plans to file for regulatory approval with <b>the DCGI and pursue global registration<\/b> and commercialization through the <b>505(b)(2)<\/b> pathway in the US and other key markets.<\/p>\n<p><b>About CINV<\/b><br \/>CINV affects up to 70\u201380% of patients undergoing chemotherapy, representing a market of approximately <span class=\"xn-money\">USD 375 million<\/span>. Poorly controlled CINV can lead to treatment discontinuation and reduced quality of life, underscoring need for long-acting therapies such as OERIS\u2122.<\/p>\n<p><b>About Shilpa Medicare Limited<\/b><br \/><b>Shilpa Medicare <\/b>is a leading Indian pharmaceutical company specializing in APIs, formulations, and biologics across oncology and specialty segments. For more information, visit <a href=\"https:\/\/www.vbshilpa.com\/\" target=\"_blank\" rel=\"nofollow\">www.vbshilpa.com<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"<p><!-- wp:html --><\/p>\n<table border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/2489785\/Shilpa_Logo.jpg?p=medium600\" border=\"0\" alt=\"\" title=\"logo\" hspace=\"0\" vspace=\"0\" width=\"118\" \/><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><b>Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections<\/b><\/p>\n<p><span class=\"legendSpanClass\">RAICHUR, <span class=\"xn-location\">India<\/span><\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">Nov. 11, 2025<\/span><\/span> \/PRNewswire\/ &#8212; <b>Shilpa Medicare Limited<\/b> (BSE: 530549) (NSE: SHILPAMED)\u00a0announced the successful completion of its <b>fourth complex clinical program SMLINJ011<\/b>, with positive topline Phase 3 results for <b>Shilpa&#8217;s OERIS\u2122 (Ondansetron Extended-Release Injection)<\/b>\u2014an innovative formulation designed to improve prophylaxis of chemotherapy-induced nausea and vomiting (CINV).<\/p>\n<p>This milestone underscores Shilpa&#8217;s growing leadership in <b>differentiated drug-delivery systems<\/b> and <b>oncology supportive-care therapeutics<\/b>, reflecting the company&#8217;s commitment to advancing patient-centric innovation.<\/p>\n<p><b>Study Overview <\/b><\/p>\n<p>A <b>Phase III, multicenter, randomized, double-blind, non-inferiority trial<\/b> was conducted across multiple oncology centers in <span class=\"xn-location\">India<\/span> to compare <b>OERIS\u2122<\/b> with conventional ondansetron injections in 240 patients receiving moderately or highly emetogenic chemotherapy.<\/p>\n<p><b>Design &amp; Endpoints<\/b><\/p>\n<ul type=\"disc\">\n<li><b>Population:<\/b>\u00a0240 patients with CINV<\/li>\n<li><b>Primary Endpoint:<\/b> Complete response (no emesis episodes through 120 hours post-chemotherapy)<\/li>\n<li><b>Comparator:<\/b>\u00a0Multiple doses of conventional ondansetron injection<\/li>\n<li><b>Secondary Endpoints:<\/b> Safety profile, delayed-phase response, patient tolerability<\/li>\n<\/ul>\n<p><b>Results<\/b><\/p>\n<ul type=\"disc\">\n<li><b>Complete response:<\/b>\u00a089% in OERIS\u2122 arm vs. 82% in standard ondansetron arm<\/li>\n<li><b>Adverse events:<\/b>\u00a0No serious or severe adverse events reported<\/li>\n<li><b>Safety:<\/b>\u00a0Comparable or better tolerability than conventional therapy<\/li>\n<\/ul>\n<p><b>Transformative Innovation<\/b><br \/>OERIS\u2122 offers extended antiemetic coverage through a single injection that effectively prevents both acute and delayed CINV for up to five days, eliminating the need for multiple daily doses or oral follow-ups. This innovation enhances patient convenience, improves compliance, and streamlines clinical workflow.<\/p>\n<p>&#8220;We are proud to announce the successful completion of this pivotal Phase 3 study,&#8221; said <b>Mr. Vishnukant Bhutada<\/b>, <b>Managing Director, Shilpa Medicare Limited<\/b>. &#8220;OERIS\u2122 exemplifies Shilpa&#8217;s ability to combine scientific innovation with patient-centric design, strengthening our oncology-supportive-care portfolio and our vision to become a global leader in specialty pharmaceuticals.&#8221;<\/p>\n<p><b>Next Steps<\/b><br \/>Shilpa plans to file for regulatory approval with <b>the DCGI and pursue global registration<\/b> and commercialization through the <b>505(b)(2)<\/b> pathway in the US and other key markets.<\/p>\n<p><b>About CINV<\/b><br \/>CINV affects up to 70\u201380% of patients undergoing chemotherapy, representing a market of approximately <span class=\"xn-money\">USD 375 million<\/span>. Poorly controlled CINV can lead to treatment discontinuation and reduced quality of life, underscoring need for long-acting therapies such as OERIS\u2122.<\/p>\n<p><b>About Shilpa Medicare Limited<\/b><br \/><b>Shilpa Medicare <\/b>is a leading Indian pharmaceutical company specializing in APIs, formulations, and biologics across oncology and specialty segments. For more information, visit <a href=\"https:\/\/www.vbshilpa.com\/\" target=\"_blank\" rel=\"nofollow\">www.vbshilpa.com<\/a>.<\/p>\n<p><!-- \/wp:html --><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":[],"rop_publish_now_history":[],"rop_publish_now_status":"pending","footnotes":""},"categories":[5,7,1],"tags":[],"class_list":["post-38238","post","type-post","status-publish","format-standard","hentry","category-cision-pr-newswire","category-cision-pr-newswire-en","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/38238","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=38238"}],"version-history":[{"count":0,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/38238\/revisions"}],"wp:attachment":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=38238"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=38238"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=38238"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}