{"id":24136,"date":"2022-04-29T11:09:23","date_gmt":"2022-04-29T11:09:23","guid":{"rendered":"https:\/\/celonpharma.com\/?p=24136"},"modified":"2025-04-04T12:53:11","modified_gmt":"2025-04-04T12:53:11","slug":"current-report-no-9-2022-submission-of-an-application-to-the-food-and-drug-administration-fda-concerning-the-commencement-of-a-clinical-trial-for-falkieri-celons-esketamine-dpi","status":"publish","type":"post","link":"https:\/\/celon.group\/en\/2022\/04\/29\/current-report-no-9-2022-submission-of-an-application-to-the-food-and-drug-administration-fda-concerning-the-commencement-of-a-clinical-trial-for-falkieri-celons-esketamine-dpi\/","title":{"rendered":"Current report No. 9\/2022 \u2013 Submission of an application to the Food and Drug Administration (FDA) concerning the commencement of a clinical trial for Falkieri (Celon&#8217;s esketamine DPI)"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">The Management Board of Celon Pharma S.A. (the \u201cCompany\u201d) hereby informs that on April 20, 2022 an application was submitted to the Food and Drug Administration (FDA) concerning the commencement of a clinical trial for Falkieri (Celon\u2019s esketamine DPI) as a therapy for treatment-resistant bipolar depression under the so-called Investigational New Drug (IND) Application procedure. Submission of the application is a formal stage towards the commencing the clinical development of Falkieri (Celon\u2019s esketamine DPI) in the US.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Documents regarding the qualitative, pre-clinical and clinical development carried out to date was submitted alongside the application. The IND procedure can take up to several months.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Given the large size of the American market, the Management Board of the Company deems this fact to be pivotal for the development and global commercialization of the Falkieri project.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Management Board of Celon Pharma S.A. (the \u201cCompany\u201d) hereby informs that on April 20, 2022 an application was submitted to the Food and Drug Administration (FDA) concerning the commencement of a clinical trial for Falkieri (Celon\u2019s esketamine DPI) as a therapy for treatment-resistant bipolar depression under the so-called Investigational New Drug (IND) Application procedure.<a class=\"excerpt-read-more float-right\" href=\"https:\/\/celon.group\/en\/2022\/04\/29\/current-report-no-9-2022-submission-of-an-application-to-the-food-and-drug-administration-fda-concerning-the-commencement-of-a-clinical-trial-for-falkieri-celons-esketamine-dpi\/\" title=\"ReadCurrent report No. 9\/2022 \u2013 Submission of an application to the Food and Drug Administration (FDA) concerning the commencement of a clinical trial for Falkieri (Celon&#8217;s esketamine DPI)\">Read more &raquo;<\/a><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[26],"tags":[],"class_list":["post-24136","post","type-post","status-publish","format-standard","hentry","category-general-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.8.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Current report No. 9\/2022 \u2013 Submission of an application to the Food and Drug Administration (FDA) concerning the commencement of a clinical trial for Falkieri (Celon&#039;s esketamine DPI) - CelonGROUP<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"http:\/\/celon.group\/en\/2022\/04\/29\/current-report-no-9-2022-submission-of-an-application-to-the-food-and-drug-administration-fda-concerning-the-commencement-of-a-clinical-trial-for-falkieri-celons-esketamine-dpi\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Current report No. 9\/2022 \u2013 Submission of an application to the Food and Drug Administration (FDA) concerning the commencement of a clinical trial for Falkieri (Celon&#039;s esketamine DPI) - CelonGROUP\" \/>\n<meta property=\"og:description\" content=\"The Management Board of Celon Pharma S.A. (the \u201cCompany\u201d) hereby informs that on April 20, 2022 an application was submitted to the Food and Drug Administration (FDA) concerning the commencement of a clinical trial for Falkieri (Celon\u2019s esketamine DPI) as a therapy for treatment-resistant bipolar depression under the so-called Investigational New Drug (IND) Application procedure.Read more &raquo;\" \/>\n<meta property=\"og:url\" content=\"http:\/\/celon.group\/en\/2022\/04\/29\/current-report-no-9-2022-submission-of-an-application-to-the-food-and-drug-administration-fda-concerning-the-commencement-of-a-clinical-trial-for-falkieri-celons-esketamine-dpi\/\" \/>\n<meta property=\"og:site_name\" content=\"CelonGROUP\" \/>\n<meta property=\"article:published_time\" content=\"2022-04-29T11:09:23+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-04-04T12:53:11+00:00\" \/>\n<meta name=\"author\" content=\"Ma\u0142gorzata Siewierska\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Ma\u0142gorzata Siewierska\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"http:\/\/celon.group\/en\/2022\/04\/29\/current-report-no-9-2022-submission-of-an-application-to-the-food-and-drug-administration-fda-concerning-the-commencement-of-a-clinical-trial-for-falkieri-celons-esketamine-dpi\/\",\"url\":\"http:\/\/celon.group\/en\/2022\/04\/29\/current-report-no-9-2022-submission-of-an-application-to-the-food-and-drug-administration-fda-concerning-the-commencement-of-a-clinical-trial-for-falkieri-celons-esketamine-dpi\/\",\"name\":\"Current report No. 9\/2022 \u2013 Submission of an application to the Food and Drug Administration (FDA) concerning the commencement of a clinical trial for Falkieri (Celon's esketamine DPI) - CelonGROUP\",\"isPartOf\":{\"@id\":\"https:\/\/celon.group\/en\/#website\"},\"datePublished\":\"2022-04-29T11:09:23+00:00\",\"dateModified\":\"2025-04-04T12:53:11+00:00\",\"author\":{\"@id\":\"https:\/\/celon.group\/en\/#\/schema\/person\/e0ffc863fc928f3fd9bd67757492badf\"},\"breadcrumb\":{\"@id\":\"http:\/\/celon.group\/en\/2022\/04\/29\/current-report-no-9-2022-submission-of-an-application-to-the-food-and-drug-administration-fda-concerning-the-commencement-of-a-clinical-trial-for-falkieri-celons-esketamine-dpi\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"http:\/\/celon.group\/en\/2022\/04\/29\/current-report-no-9-2022-submission-of-an-application-to-the-food-and-drug-administration-fda-concerning-the-commencement-of-a-clinical-trial-for-falkieri-celons-esketamine-dpi\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"http:\/\/celon.group\/en\/2022\/04\/29\/current-report-no-9-2022-submission-of-an-application-to-the-food-and-drug-administration-fda-concerning-the-commencement-of-a-clinical-trial-for-falkieri-celons-esketamine-dpi\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/celon.group\/en\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Current report No. 9\/2022 \u2013 Submission of an application to the Food and Drug Administration (FDA) concerning the commencement of a clinical trial for Falkieri (Celon&#8217;s esketamine DPI)\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/celon.group\/en\/#website\",\"url\":\"https:\/\/celon.group\/en\/\",\"name\":\"CelonGROUP\",\"description\":\"\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/celon.group\/en\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"https:\/\/celon.group\/en\/#\/schema\/person\/e0ffc863fc928f3fd9bd67757492badf\",\"name\":\"Ma\u0142gorzata Siewierska\",\"url\":\"https:\/\/celon.group\/en\/author\/malgorzata-siewierska\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Current report No. 9\/2022 \u2013 Submission of an application to the Food and Drug Administration (FDA) concerning the commencement of a clinical trial for Falkieri (Celon's esketamine DPI) - CelonGROUP","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":"http:\/\/celon.group\/en\/2022\/04\/29\/current-report-no-9-2022-submission-of-an-application-to-the-food-and-drug-administration-fda-concerning-the-commencement-of-a-clinical-trial-for-falkieri-celons-esketamine-dpi\/","og_locale":"en_US","og_type":"article","og_title":"Current report No. 9\/2022 \u2013 Submission of an application to the Food and Drug Administration (FDA) concerning the commencement of a clinical trial for Falkieri (Celon's esketamine DPI) - CelonGROUP","og_description":"The Management Board of Celon Pharma S.A. (the \u201cCompany\u201d) hereby informs that on April 20, 2022 an application was submitted to the Food and Drug Administration (FDA) concerning the commencement of a clinical trial for Falkieri (Celon\u2019s esketamine DPI) as a therapy for treatment-resistant bipolar depression under the so-called Investigational New Drug (IND) Application procedure.Read more &raquo;","og_url":"http:\/\/celon.group\/en\/2022\/04\/29\/current-report-no-9-2022-submission-of-an-application-to-the-food-and-drug-administration-fda-concerning-the-commencement-of-a-clinical-trial-for-falkieri-celons-esketamine-dpi\/","og_site_name":"CelonGROUP","article_published_time":"2022-04-29T11:09:23+00:00","article_modified_time":"2025-04-04T12:53:11+00:00","author":"Ma\u0142gorzata Siewierska","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Ma\u0142gorzata Siewierska","Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"http:\/\/celon.group\/en\/2022\/04\/29\/current-report-no-9-2022-submission-of-an-application-to-the-food-and-drug-administration-fda-concerning-the-commencement-of-a-clinical-trial-for-falkieri-celons-esketamine-dpi\/","url":"http:\/\/celon.group\/en\/2022\/04\/29\/current-report-no-9-2022-submission-of-an-application-to-the-food-and-drug-administration-fda-concerning-the-commencement-of-a-clinical-trial-for-falkieri-celons-esketamine-dpi\/","name":"Current report No. 9\/2022 \u2013 Submission of an application to the Food and Drug Administration (FDA) concerning the commencement of a clinical trial for Falkieri (Celon's esketamine DPI) - CelonGROUP","isPartOf":{"@id":"https:\/\/celon.group\/en\/#website"},"datePublished":"2022-04-29T11:09:23+00:00","dateModified":"2025-04-04T12:53:11+00:00","author":{"@id":"https:\/\/celon.group\/en\/#\/schema\/person\/e0ffc863fc928f3fd9bd67757492badf"},"breadcrumb":{"@id":"http:\/\/celon.group\/en\/2022\/04\/29\/current-report-no-9-2022-submission-of-an-application-to-the-food-and-drug-administration-fda-concerning-the-commencement-of-a-clinical-trial-for-falkieri-celons-esketamine-dpi\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["http:\/\/celon.group\/en\/2022\/04\/29\/current-report-no-9-2022-submission-of-an-application-to-the-food-and-drug-administration-fda-concerning-the-commencement-of-a-clinical-trial-for-falkieri-celons-esketamine-dpi\/"]}]},{"@type":"BreadcrumbList","@id":"http:\/\/celon.group\/en\/2022\/04\/29\/current-report-no-9-2022-submission-of-an-application-to-the-food-and-drug-administration-fda-concerning-the-commencement-of-a-clinical-trial-for-falkieri-celons-esketamine-dpi\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/celon.group\/en\/"},{"@type":"ListItem","position":2,"name":"Current report No. 9\/2022 \u2013 Submission of an application to the Food and Drug Administration (FDA) concerning the commencement of a clinical trial for Falkieri (Celon&#8217;s esketamine DPI)"}]},{"@type":"WebSite","@id":"https:\/\/celon.group\/en\/#website","url":"https:\/\/celon.group\/en\/","name":"CelonGROUP","description":"","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/celon.group\/en\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/celon.group\/en\/#\/schema\/person\/e0ffc863fc928f3fd9bd67757492badf","name":"Ma\u0142gorzata Siewierska","url":"https:\/\/celon.group\/en\/author\/malgorzata-siewierska\/"}]}},"_links":{"self":[{"href":"https:\/\/celon.group\/en\/wp-json\/wp\/v2\/posts\/24136","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/celon.group\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/celon.group\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/celon.group\/en\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/celon.group\/en\/wp-json\/wp\/v2\/comments?post=24136"}],"version-history":[{"count":1,"href":"https:\/\/celon.group\/en\/wp-json\/wp\/v2\/posts\/24136\/revisions"}],"predecessor-version":[{"id":40203,"href":"https:\/\/celon.group\/en\/wp-json\/wp\/v2\/posts\/24136\/revisions\/40203"}],"wp:attachment":[{"href":"https:\/\/celon.group\/en\/wp-json\/wp\/v2\/media?parent=24136"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/celon.group\/en\/wp-json\/wp\/v2\/categories?post=24136"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/celon.group\/en\/wp-json\/wp\/v2\/tags?post=24136"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}