{"id":41443,"date":"2025-11-11T01:00:00","date_gmt":"2025-11-11T01:00:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/4820115_AE20115_0"},"modified":"2025-11-11T01:00:00","modified_gmt":"2025-11-11T01:00:00","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:\/\/transmediavictoria.net.au\/?p=41443","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 name=\"logo_release\" 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)&nbsp;announced 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>&nbsp;240 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>&nbsp;Multiple 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>&nbsp;89% in OERIS\u2122 arm vs. 82% in standard ondansetron arm<\/li>\n<li><b>Adverse events:<\/b>&nbsp;No serious or severe adverse events reported<\/li>\n<li><b>Safety:<\/b>&nbsp;Comparable 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 noopener\">www.vbshilpa.com<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections RAICHUR, India, Nov. 11, 2025 \/PRNewswire\/ &#8212; Shilpa Medicare Limited (BSE: 530549) (NSE: SHILPAMED)&nbsp;announced the successful completion of its fourth complex clinical program SMLINJ011, with positive topline Phase 3 results for Shilpa&#8217;s OERIS\u2122 (Ondansetron [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-41443","post","type-post","status-publish","format-standard","hentry","category-business-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Shilpa Medicare Announces Positive Phase 3 Results for OERIS\u2122 - A Novel Once-Weekly Ondansetron Extended-Release Injection for Chemotherapy-Induced Nausea and Vomiting (CINV) - My Blog<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/transmediavictoria.net.au\/?p=41443\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Shilpa Medicare Announces Positive Phase 3 Results for OERIS\u2122 - A Novel Once-Weekly Ondansetron Extended-Release Injection for Chemotherapy-Induced Nausea and Vomiting (CINV) - My Blog\" \/>\n<meta property=\"og:description\" content=\"Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections RAICHUR, India, Nov. 11, 2025 \/PRNewswire\/ &#8212; Shilpa Medicare Limited (BSE: 530549) (NSE: SHILPAMED)&nbsp;announced the successful completion of its fourth complex clinical program SMLINJ011, with positive topline Phase 3 results for Shilpa&#8217;s OERIS\u2122 (Ondansetron [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/transmediavictoria.net.au\/?p=41443\" \/>\n<meta property=\"og:site_name\" content=\"My Blog\" \/>\n<meta property=\"article:published_time\" content=\"2025-11-11T01:00:00+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mma.prnasia.com\/media2\/2489785\/Shilpa_Logo.jpg?p=medium600\" \/>\n<meta name=\"author\" content=\"admin_tony\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"admin_tony\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=41443#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=41443\"},\"author\":{\"name\":\"admin_tony\",\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/#\\\/schema\\\/person\\\/5b51d407d652c0aa802bea269ea5d7e7\"},\"headline\":\"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)\",\"datePublished\":\"2025-11-11T01:00:00+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=41443\"},\"wordCount\":398,\"image\":{\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=41443#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/mma.prnasia.com\\\/media2\\\/2489785\\\/Shilpa_Logo.jpg?p=medium600\",\"articleSection\":[\"Business News\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=41443\",\"url\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=41443\",\"name\":\"Shilpa Medicare Announces Positive Phase 3 Results for OERIS\u2122 - A Novel Once-Weekly Ondansetron Extended-Release Injection for Chemotherapy-Induced Nausea and Vomiting (CINV) - My Blog\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=41443#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=41443#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/mma.prnasia.com\\\/media2\\\/2489785\\\/Shilpa_Logo.jpg?p=medium600\",\"datePublished\":\"2025-11-11T01:00:00+00:00\",\"author\":{\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/#\\\/schema\\\/person\\\/5b51d407d652c0aa802bea269ea5d7e7\"},\"breadcrumb\":{\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=41443#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=41443\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=41443#primaryimage\",\"url\":\"https:\\\/\\\/mma.prnasia.com\\\/media2\\\/2489785\\\/Shilpa_Logo.jpg?p=medium600\",\"contentUrl\":\"https:\\\/\\\/mma.prnasia.com\\\/media2\\\/2489785\\\/Shilpa_Logo.jpg?p=medium600\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=41443#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/transmediavictoria.net.au\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"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)\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/#website\",\"url\":\"https:\\\/\\\/transmediavictoria.net.au\\\/\",\"name\":\"My Blog\",\"description\":\"My WordPress Blog\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/#\\\/schema\\\/person\\\/5b51d407d652c0aa802bea269ea5d7e7\",\"name\":\"admin_tony\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/102836fe5f9cd6c64e96e90e7341dbc815b7d12726a85708326dc0db40afd906?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/102836fe5f9cd6c64e96e90e7341dbc815b7d12726a85708326dc0db40afd906?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/102836fe5f9cd6c64e96e90e7341dbc815b7d12726a85708326dc0db40afd906?s=96&d=mm&r=g\",\"caption\":\"admin_tony\"},\"url\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?author=8\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Shilpa Medicare Announces Positive Phase 3 Results for OERIS\u2122 - A Novel Once-Weekly Ondansetron Extended-Release Injection for Chemotherapy-Induced Nausea and Vomiting (CINV) - My Blog","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/transmediavictoria.net.au\/?p=41443","og_locale":"en_US","og_type":"article","og_title":"Shilpa Medicare Announces Positive Phase 3 Results for OERIS\u2122 - A Novel Once-Weekly Ondansetron Extended-Release Injection for Chemotherapy-Induced Nausea and Vomiting (CINV) - My Blog","og_description":"Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections RAICHUR, India, Nov. 11, 2025 \/PRNewswire\/ &#8212; Shilpa Medicare Limited (BSE: 530549) (NSE: SHILPAMED)&nbsp;announced the successful completion of its fourth complex clinical program SMLINJ011, with positive topline Phase 3 results for Shilpa&#8217;s OERIS\u2122 (Ondansetron [&hellip;]","og_url":"https:\/\/transmediavictoria.net.au\/?p=41443","og_site_name":"My Blog","article_published_time":"2025-11-11T01:00:00+00:00","og_image":[{"url":"https:\/\/mma.prnasia.com\/media2\/2489785\/Shilpa_Logo.jpg?p=medium600","type":"","width":"","height":""}],"author":"admin_tony","twitter_card":"summary_large_image","twitter_misc":{"Written by":"admin_tony","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/transmediavictoria.net.au\/?p=41443#article","isPartOf":{"@id":"https:\/\/transmediavictoria.net.au\/?p=41443"},"author":{"name":"admin_tony","@id":"https:\/\/transmediavictoria.net.au\/#\/schema\/person\/5b51d407d652c0aa802bea269ea5d7e7"},"headline":"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)","datePublished":"2025-11-11T01:00:00+00:00","mainEntityOfPage":{"@id":"https:\/\/transmediavictoria.net.au\/?p=41443"},"wordCount":398,"image":{"@id":"https:\/\/transmediavictoria.net.au\/?p=41443#primaryimage"},"thumbnailUrl":"https:\/\/mma.prnasia.com\/media2\/2489785\/Shilpa_Logo.jpg?p=medium600","articleSection":["Business News"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/transmediavictoria.net.au\/?p=41443","url":"https:\/\/transmediavictoria.net.au\/?p=41443","name":"Shilpa Medicare Announces Positive Phase 3 Results for OERIS\u2122 - A Novel Once-Weekly Ondansetron Extended-Release Injection for Chemotherapy-Induced Nausea and Vomiting (CINV) - My Blog","isPartOf":{"@id":"https:\/\/transmediavictoria.net.au\/#website"},"primaryImageOfPage":{"@id":"https:\/\/transmediavictoria.net.au\/?p=41443#primaryimage"},"image":{"@id":"https:\/\/transmediavictoria.net.au\/?p=41443#primaryimage"},"thumbnailUrl":"https:\/\/mma.prnasia.com\/media2\/2489785\/Shilpa_Logo.jpg?p=medium600","datePublished":"2025-11-11T01:00:00+00:00","author":{"@id":"https:\/\/transmediavictoria.net.au\/#\/schema\/person\/5b51d407d652c0aa802bea269ea5d7e7"},"breadcrumb":{"@id":"https:\/\/transmediavictoria.net.au\/?p=41443#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/transmediavictoria.net.au\/?p=41443"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/transmediavictoria.net.au\/?p=41443#primaryimage","url":"https:\/\/mma.prnasia.com\/media2\/2489785\/Shilpa_Logo.jpg?p=medium600","contentUrl":"https:\/\/mma.prnasia.com\/media2\/2489785\/Shilpa_Logo.jpg?p=medium600"},{"@type":"BreadcrumbList","@id":"https:\/\/transmediavictoria.net.au\/?p=41443#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/transmediavictoria.net.au\/"},{"@type":"ListItem","position":2,"name":"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)"}]},{"@type":"WebSite","@id":"https:\/\/transmediavictoria.net.au\/#website","url":"https:\/\/transmediavictoria.net.au\/","name":"My Blog","description":"My WordPress Blog","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/transmediavictoria.net.au\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/transmediavictoria.net.au\/#\/schema\/person\/5b51d407d652c0aa802bea269ea5d7e7","name":"admin_tony","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/102836fe5f9cd6c64e96e90e7341dbc815b7d12726a85708326dc0db40afd906?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/102836fe5f9cd6c64e96e90e7341dbc815b7d12726a85708326dc0db40afd906?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/102836fe5f9cd6c64e96e90e7341dbc815b7d12726a85708326dc0db40afd906?s=96&d=mm&r=g","caption":"admin_tony"},"url":"https:\/\/transmediavictoria.net.au\/?author=8"}]}},"_links":{"self":[{"href":"https:\/\/transmediavictoria.net.au\/index.php?rest_route=\/wp\/v2\/posts\/41443","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/transmediavictoria.net.au\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/transmediavictoria.net.au\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/transmediavictoria.net.au\/index.php?rest_route=\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/transmediavictoria.net.au\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=41443"}],"version-history":[{"count":0,"href":"https:\/\/transmediavictoria.net.au\/index.php?rest_route=\/wp\/v2\/posts\/41443\/revisions"}],"wp:attachment":[{"href":"https:\/\/transmediavictoria.net.au\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=41443"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/transmediavictoria.net.au\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=41443"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/transmediavictoria.net.au\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=41443"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}