EXCLUSIVE: MIRA Pharmaceuticals Files FDA Application To Start Human Trials For Its Lead Pain Treatment

Benzinga12-19

On Thursday, MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) said it submitted an Investigational New Drug (IND) application to the FDA to start human trials for Ketamir-2, its novel oral ketamine analog for...

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(NASDAQ:MIRA) said it submitted an Investigational New Drug (IND) application to the FDA to start human trials for Ketamir-2, its novel oral ketamine analog for...</p>\n\n<a href=\"https://finance.yahoo.com/news/exclusive-mira-pharmaceuticals-files-fda-132507382.html\">Source Link</a>\n\n</div>\n","source":"yahoofinance","html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>EXCLUSIVE: MIRA Pharmaceuticals Files FDA Application To Start Human Trials For Its Lead Pain Treatment</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nEXCLUSIVE: MIRA Pharmaceuticals Files FDA Application To Start Human Trials For Its Lead Pain Treatment\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-12-19 21:25 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://finance.yahoo.com/news/exclusive-mira-pharmaceuticals-files-fda-132507382.html><strong>Benzinga</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>On Thursday, MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) said it submitted an Investigational New Drug (IND) application to the FDA to start human trials for Ketamir-2, its novel oral ketamine analog for...</p>\n\n<a href=\"https://finance.yahoo.com/news/exclusive-mira-pharmaceuticals-files-fda-132507382.html\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"MIRA","symbol_name":"Mira Pharma","start_time":0,"source_url":"https://finance.yahoo.com/news/exclusive-mira-pharmaceuticals-files-fda-132507382.html","article_id":"2492075921","we_media_id":null,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/XlKpU41fb7dZ50sdK1frtQ--~B/aD01NTM7dz05ODM7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/Benzinga/660745cf8b3ba74acd71ae58169044f2"],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2492075921","pubTimestamp":1734614707,"columns":[],"sourceInfo":{"source_id":"yahoofinance","name":"雅虎金融"},"weMediaInfo":null,"summary":"On Thursday, MIRA Pharmaceuticals, Inc.  said it submitted an Investigational New Drug  application to the FDA to start human trials for Ketamir-2, its novel oral ketamine analog for neuropathic pain.An IND is submitted to propose studying an unapproved drug or an approved product for a new indication or in a new patient population.The company’s IND application includes comprehensive data and reports detailing Ketamir-2’s pharmacology, pharmacokinetics, and toxicology, along with results from both in vitro and in vivo studies, including validated neuropathic pain disease models.In parallel with the submission, the company is conducting a neurotoxicity study, as required by the FDA’s written feedback, to support the initiation of human dosing in the U.S.Also Read: MIRA Pharmaceuticals’ Formulated Shows Greater Efficacy Than FDA-Approved Drug For Chemo-Induced Neuropathic Pain. MIRA is also advancing MIRA-55, with preclinical trials targeting memory, cognition, and anxiety, and plans to ","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"MIRA":"Mira Pharma","BK4007":"制药"},"translate_title":"独家：MIRA Pharmaceuticals向FDA提交申请，开始对其领先的疼痛治疗药物进行人体试验","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"MIRA":1},"content_text":"On Thursday, MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) said it submitted an Investigational New Drug (IND) application to the FDA to start human trials for Ketamir-2, its novel oral ketamine analog for neuropathic pain.\nAn IND is submitted to propose studying an unapproved drug or an approved product for a new indication or in a new patient population.\nThe company’s IND application includes comprehensive data and reports detailing Ketamir-2’s pharmacology, pharmacokinetics, and toxicology, along with results from both in vitro and in vivo studies, including validated neuropathic pain disease models.\nIn parallel with the submission, the company is conducting a neurotoxicity study, as required by the FDA’s written feedback, to support the initiation of human dosing in the U.S.\nAlso Read: MIRA Pharmaceuticals’ Formulated Shows Greater Efficacy Than FDA-Approved Drug For Chemo-Induced Neuropathic Pain\nPreclinical studies have demonstrated Ketamir-2’s ability to achieve 100% pain reversal, fully normalizing pain thresholds in validated neuropathic pain models.\nFurthermore, Ketamir-2 has shown an encouraging safety profile, with no adverse effects observed.\nThe company plans to begin Phase 1 trials outside the United States in Q1 2025 to evaluate safety, tolerability, and pharmacokinetics in healthy volunteers.\nPhase 2a trials are expected to follow in late 2025, assessing Ketamir-2’s efficacy in neuropathic pain patients.\nThe neuropathic pain market in North America, including the United States, Canada, and Mexico, is valued at $3.1 billion and is expected to grow at a 6-7% compound annual growth rate, reaching $4.5 billion by 2030.\nBeyond neuropathic pain, the company is exploring additional indications for Ketamir-2, including Major Depressive Disorder (MDD), MDD with Suicidal Ideation, and Post-Traumatic Stress Disorder.\nMIRA is also advancing MIRA-55, with preclinical trials targeting memory, cognition, and anxiety, and plans to submit an IND for MIRA-55 in 2025.\nPrice Action: MIRA stock is up 0.95% at $1.06 during the premarket session at last check Thursday.\nRead Next:\n\nLamb Weston Takes A Hit From High Manufacturing Costs And Softer Volumes, Expects Challenging Conditions Till 2026\n\nUNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets.\nGet the latest stock analysis from Benzinga?\n\nThis article EXCLUSIVE: MIRA Pharmaceuticals Files FDA Application To Start Human Trials For Its Lead Pain Treatment originally appeared on Benzinga.com\n© 2024 Benzinga.com. Benzinga does not provide investment advice. 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