{"id":62986,"date":"2026-04-22T16:02:34","date_gmt":"2026-04-22T14:02:34","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/demerx-announces-fda-acceptance-of-ind-application-to-advance-dmx-1001-for-the-treatment-of-alcohol-use-disorder-aud\/"},"modified":"2026-04-22T16:02:34","modified_gmt":"2026-04-22T14:02:34","slug":"demerx-announces-fda-acceptance-of-ind-application-to-advance-dmx-1001-for-the-treatment-of-alcohol-use-disorder-aud","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/demerx-announces-fda-acceptance-of-ind-application-to-advance-dmx-1001-for-the-treatment-of-alcohol-use-disorder-aud\/","title":{"rendered":"DemeRx Announces FDA Acceptance of IND Application to Advance DMX-1001 for the Treatment of Alcohol Use Disorder (AUD)"},"content":{"rendered":"<div>\n<ul class=\"bwlistdisc\">\n<li>\n<i>DMX-1001 (oral noribogaine) is a novel neuroplastogen therapeutic that combines neuroplasticity and polypharmacology for the treatment of AUD<\/i><\/li>\n<\/ul>\n<ul class=\"bwlistdisc\">\n<li>\n<i>AUD affects more than 29 million Americans and is a leading cause of preventable death; about 60 percent of patients treated for AUD relapse to hazardous drinking within six months<\/i><\/li>\n<\/ul>\n<ul class=\"bwlistdisc\">\n<li>\n<i>Successful completion of the planned alcohol interaction trial will support Phase 2 clinical start in 2027<\/i><\/li>\n<\/ul>\n<p>MIAMI&#8211;(BUSINESS WIRE)&#8211;DemeRx, Inc., a clinical-stage biopharmaceutical company dedicated to transforming addiction therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for DMX-1001 (oral noribogaine), a novel neuroplastogen therapeutic for the treatment of alcohol use disorder (AUD).<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20260422651767\/en\/2780959\/5\/DemeRx_Logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20260422651767\/en\/2780959\/22\/DemeRx_Logo.jpg\"><\/a><br \/><a href=\"https:\/\/mms.businesswire.com\/media\/20260422651767\/en\/2780959\/5\/DemeRx_Logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20260422651767\/en\/2780959\/21\/DemeRx_Logo.jpg\"><\/a><\/p>\n<p>\nThe company recently completed a multiple ascending dose (MAD) clinical trial of DMX-1001 in healthy volunteers. Results from the MAD study demonstrated safety, tolerability, and pharmacokinetics that support advancing DMX-1001 to Phase 2 clinical trials in people with AUD. DemeRx anticipates initiating the Phase 2 clinical trial of DMX-1001 in AUD in 2027.<\/p>\n<p>\n\u201cWe are grateful to the FDA for their timely review of our IND application for DMX-1001 for the treatment of AUD. The \u2018safe to proceed\u2019 authorization marks an important milestone both for patients with AUD and the growth of our company,\u201d said Deborah Mash, Ph.D., CEO and founder of DemeRx. \u201cThere is tremendous need for innovative, disease-modifying approaches to treat alcohol and other substance use disorders and we\u2019re excited about the potential of DMX-1001 to address this serious unmet need. I am grateful for the hard work of our team at DemeRx getting us to this next stage of clinical development for DMX-1001, so that we can bring a much-needed treatment option to people struggling with addiction to alcohol or other drugs rapidly.\u201d<\/p>\n<p>\nDMX-1001 represents a novel therapeutic approach that uniquely combines neuroplasticity and polypharmacology mechanisms of action. Noribogaine is a long-acting metabolite of ibogaine. Noribogaine remains in the body for a much longer duration than ibogaine, driving long-term neuroplastic changes that help repair neural circuits damaged by chronic substance abuse.<\/p>\n<p>\nDMX-1001 is a \u201cpipeline in a drug\u201d that has rapid antidepressant and anti-anxiety effects. Alcohol use disorder is often associated with mental health disorders, including depression and anxiety which increase the risk of relapse for people in early recovery.<\/p>\n<p>\nAlcohol use disorder affects more than 29 million people in the United States and is a leading cause of preventable death. Alarmingly, fewer than five percent of those suffering from AUD receive medication, and approximately 60 percent of treated patients relapse to hazardous drinking within six months.<sup>1,2,3,4<\/sup><\/p>\n<p>\n<b>About DemeRx, Inc.<\/b><\/p>\n<p>\nDemeRx, Inc. is a pioneering clinical-stage biopharmaceutical company dedicated to transforming addiction therapeutics and improving outcomes for individuals facing substance use disorders. Leveraging advanced scientific research and strategic clinical initiatives, DemeRx focuses on DMX-1001 (oral noribogaine) as a groundbreaking solution for alcohol use disorder. For more information about DemeRx, please visit <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.demerx.com&amp;esheet=54519942&amp;newsitemid=20260422651767&amp;lan=en-US&amp;anchor=http%3A%2F%2Fwww.demerx.com&amp;index=1&amp;md5=5119a78e56f122273a724b1565d80d55\" rel=\"nofollow\" shape=\"rect\">http:\/\/www.demerx.com<\/a>.<\/p>\n<p>\nSources<\/p>\n<ol class=\"bwlistdecimal\">\n<li>\n2023 National Survey on Drug Use and Health (NSDUH) SAMHSA, Center for Behavioral Health Statistics and Quality. 2022 National Survey on Drug Use and Health. Table 5.9A\u2014Alcohol use disorder in past year: among people aged 12 or older; by age group and demographic characteristics, numbers in thousands, 2022 and 2023. [cited 2024 Aug 2]. Available from: <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.samhsa.gov%2Fdata%2Freport%2F2023-nsduh-detailed-tables&amp;esheet=54519942&amp;newsitemid=20260422651767&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.samhsa.gov%2Fdata%2Freport%2F2023-nsduh-detailed-tables&amp;index=2&amp;md5=37534211934e146fde4c2b534a3bdbd2\" rel=\"nofollow\" shape=\"rect\">https:\/\/www.samhsa.gov\/data\/report\/2023-nsduh-detailed-tables<\/a><\/li>\n<li>\nCDC. Alcohol and Public Health: Alcohol-Related Disease Impact. [Table], Annual average for United States 2020\u20132021 alcohol-attributable deaths due to excessive alcohol use, all ages. [cited 2024 Mar 13]. Available from: <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fnccd.cdc.gov%2FDPH_ARDI%2FDefault%2FReport.aspx%3FT%3DAAM%26P%3D612EF325-9B55-442B-AE0C-789B06E3A8D5%26R%3DC877B524-834A-47D5-964D-158FE519C894%26M%3DDB4DAAC0-C9B3-4F92-91A5-A5781DA85B68%26F%3D%26D%3D&amp;esheet=54519942&amp;newsitemid=20260422651767&amp;lan=en-US&amp;anchor=https%3A%2F%2Fnccd.cdc.gov%2FDPH_ARDI%2FDefault%2FReport.aspx%3FT%3DAAM%26amp%3BP%3DF1F85724-AEC5-4421-BC88-3E8899866842%26amp%3BR%3DEACE3036-77C9-4893-9F93-17A5E1FEBE01%26amp%3BM%3D7F40785C-D481-440A-970F-50EFBD21B35B%26amp%3BF%3D%26amp%3BD%3D&amp;index=3&amp;md5=388664a7048517dd1843ef12e0d9b0de\" rel=\"nofollow\" shape=\"rect\">https:\/\/nccd.cdc.gov\/DPH_ARDI\/Default\/Report.aspx?T=AAM&amp;P=F1F85724-AEC5-4421-BC88-3E8899866842&amp;R=EACE3036-77C9-4893-9F93-17A5E1FEBE01&amp;M=7F40785C-D481-440A-970F-50EFBD21B35B&amp;F=&amp;D=<\/a><\/li>\n<li>\nNIAAA: <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.niaaa.nih.gov%2Falcohols-effects-health%2Falcohol-topics%2Falcohol-facts-and-statistics%2Falcohol-treatment-united-states%23%3A~%3Atext%3DAmong%2520an%2520estimated%252028.9%2520million%2CAUD%2520in%2520the%2520past%2520year.%26text%3DAmong%2520an%2520estimated%2520757%252C000%2520youth%2CAUD%2520in%2520the%2520past%2520year.%26text%3DAmong%2520an%2520estimated%252028.1%2520million%2CAUD%2520in%2520the%2520past%2520year.%26text%3DAccording%2520to%2520the%2520Substance%2520Abuse%2CDefinitions%2520report%2520for%2520more%2520details&amp;esheet=54519942&amp;newsitemid=20260422651767&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.niaaa.nih.gov%2Falcohols-effects-health%2Falcohol-topics%2Falcohol-facts-and-statistics%2Falcohol-treatment-united-states%23%3A~%3Atext%3DAmong%2520an%2520estimated%252028.9%2520million%2CAUD%2520in%2520the%2520past%2520year.%26amp%3Btext%3DAmong%2520an%2520estimated%2520757%252C000%2520youth%2CAUD%2520in%2520the%2520past%2520year.%26amp%3Btext%3DAmong%2520an%2520estimated%252028.1%2520million%2CAUD%2520in%2520the%2520past%2520year.%26amp%3Btext%3DAccording%2520to%2520the%2520Substance%2520Abuse%2CDefinitions%2520report%2520for%2520more%2520details&amp;index=4&amp;md5=1dff2931abf8814f63db8d5330cd879d\" rel=\"nofollow\" shape=\"rect\">https:\/\/www.niaaa.nih.gov\/alcohols-effects-health\/alcohol-topics\/alcohol-facts-and-statistics\/alcohol-treatment-united-states#:~:text=Among%20an%20estimated%2028.9%20million,AUD%20in%20the%20past%20year.&amp;text=Among%20an%20estimated%20757%2C000%20youth,AUD%20in%20the%20past%20year.&amp;text=Among%20an%20estimated%2028.1%20million,AUD%20in%20the%20past%20year.&amp;text=According%20to%20the%20Substance%20Abuse,Definitions%20report%20for%20more%20details<\/a>.<\/li>\n<li>\nStillman M, Sutcliff J. Predictors of relapse in alcohol use disorder: identifying individuals most vulnerable to relapse. <i>Addict Subst Abus. <\/i>2022;1(1):3\u20138. doi: 10.46439\/addiction.1.002.<\/li>\n<\/ol>\n<p>\n\u00a0<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<b>Media contact:<br \/>\n<br \/>\n<\/b><br \/>Greig Communications<br \/>\n<br \/>Kathy Vincent<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;&#97;&#x69;&#108;t&#x6f;&#58;k&#x61;&#116;&#x68;&#x79;&#64;&#x67;&#114;e&#x69;&#103;&#x63;&#x6f;m&#x6d;&#117;n&#x69;&#99;a&#x74;&#105;&#x6f;&#110;s&#x2e;&#99;o&#x6d;\" rel=\"nofollow\" shape=\"rect\">&#x6b;&#x61;&#x74;&#x68;&#x79;&#x40;&#x67;&#x72;&#x65;&#x69;&#x67;&#99;&#111;&#109;&#109;&#117;&#110;&#105;cation&#x73;&#x2e;&#x63;&#x6f;&#x6d;<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>DMX-1001 (oral noribogaine) is a novel neuroplastogen therapeutic that combines neuroplasticity and polypharmacology for the treatment of AUD AUD affects more than 29 million Americans and is a leading cause of preventable death; about 60 percent of patients treated for AUD relapse to hazardous drinking within six months Successful completion of the planned alcohol interaction &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/demerx-announces-fda-acceptance-of-ind-application-to-advance-dmx-1001-for-the-treatment-of-alcohol-use-disorder-aud\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-62986","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>DemeRx Announces FDA Acceptance of IND Application to Advance DMX-1001 for the Treatment of Alcohol Use Disorder (AUD) - Pharma Trend<\/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:\/\/pharma-trend.com\/en\/demerx-announces-fda-acceptance-of-ind-application-to-advance-dmx-1001-for-the-treatment-of-alcohol-use-disorder-aud\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"DemeRx Announces FDA Acceptance of IND Application to Advance DMX-1001 for the Treatment of Alcohol Use Disorder (AUD) - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"DMX-1001 (oral noribogaine) is a novel neuroplastogen therapeutic that combines neuroplasticity and polypharmacology for the treatment of AUD AUD affects more than 29 million Americans and is a leading cause of preventable death; about 60 percent of patients treated for AUD relapse to hazardous drinking within six months Successful completion of the planned alcohol interaction ... 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