{"id":452190,"date":"2026-04-24T21:09:12","date_gmt":"2026-04-24T21:09:12","guid":{"rendered":"https:\/\/www.europesays.com\/ie\/452190\/"},"modified":"2026-04-24T21:09:12","modified_gmt":"2026-04-24T21:09:12","slug":"fda-grants-priority-review-for-3-psychedelic-drugs-in-line-with-recent-donald-trump-order","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/ie\/452190\/","title":{"rendered":"FDA grants priority review for 3 psychedelic drugs in line with recent Donald Trump order"},"content":{"rendered":"

The Food and Drug Administration (FDA) on Friday granted fast-track\u00a0review to three companies\u00a0studying psychedelic therapies<\/a> to treat depression and post-traumatic stress disorder\u00a0(PTSD),\u00a0the latest step by the Trump administration toward\u00a0possible approval.\u00a0<\/p>\n

The\u00a0agency did not\u00a0disclose\u00a0the specific companies\u00a0that were granted priority review vouchers. Two companies are studying\u00a0psilocybin; one\u00a0for\u00a0treatment-resistant\u00a0depression\u00a0(TRD)\u00a0and the other for treatment of major depressive disorder.\u00a0<\/p>\n

A third company is studying\u00a0methylone, a drug\u00a0similar to\u00a0MDMA, for\u00a0PTSD.\u00a0\u00a0<\/p>\n

\u201cAs this field moves forward, it is critical that their development is grounded in sound science and rigorous clinical evidence,\u201d FDA Commissioner Marty\u00a0Makaray\u00a0said in a statement. \u201cWe owe it to our nation\u2019s veterans and all Americans who are suffering from these conditions to evaluate these potential therapies with urgency.\u201d\u00a0<\/p>\n

Companies selected for the voucher program will be entitled to a shortened\u00a0review\u00a0time following filing of a New Drug Application.\u00a0<\/p>\n

Shortly after the FDA announcement, Compass Pathways issued a press release announcing it had received one of the vouchers for its psilocybin-based candidate for TRD.\u00a0<\/p>\n

\u201cWe are honored and grateful to be selected for the CNPV which is a clear validation of both the urgent unmet need facing millions of people living with treatment resistant depression and the innovative science of COMP360,\u201d which is the\u00a0company\u2019s\u00a0proprietary formulation of synthetic psilocybin, said Kabir Nath, chief executive officer of Compass Pathways.\u00a0<\/p>\n

In addition, the administration said it is allowing an early phase clinical study<\/a> of\u00a0a derivative of ibogaine to move forward. Miami-based\u00a0DemeRx\u00a0NB will research\u00a0noribogaine\u00a0hydrochloride as a potential treatment for alcohol use disorder.\u00a0<\/p>\n

This is the first instance in which the FDA has allowed a clinical study in the U.S. of a derivative of ibogaine, a psychoactive derived from the African\u00a0Tabernanthe\u00a0iboga shrub.\u00a0The\u00a0move does not mean the treatment has been approved or found to be safe or effective.\u00a0\u00a0<\/p>\n

\u201cWe are accelerating the research, approval, and responsible access to promising mental health treatments \u2013 including psychedelic therapies like ibogaine \u2013 to confront our nation\u2019s mental health crisis head-on, especially for our veterans,\u201d Health and Human Services Secretary Robert F. Kennedy Jr. said in a statement Friday.\u00a0<\/p>\n

The vouchers were awarded following President Trump\u2019s executive order last Saturday<\/a> directing federal agencies to loosen restrictions and speed up research into psychedelic drugs.\u00a0\u00a0<\/p>\n

Most psychedelics are\u00a0currently classified as Schedule I by the Drug Enforcement Administration \u2014 the strictest category \u2013 reserved for substances that\u00a0have\u00a0\u201cno currently accepted medical use and a high potential for abuse.\u201d\u00a0<\/p>\n

Copyright 2026 Nexstar Media Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.<\/p>\n","protected":false},"excerpt":{"rendered":"The Food and Drug Administration (FDA) on Friday granted fast-track\u00a0review to three companies\u00a0studying psychedelic therapies to treat depression…\n","protected":false},"author":2,"featured_media":452191,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[274],"tags":[199277,18,2898,135,197802,19,17,462,33145,3160,33613,1787,199278],"class_list":["post-452190","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medication","tag-compass-pathways","tag-eire","tag-fda","tag-health","tag-ibogaine","tag-ie","tag-ireland","tag-medication","tag-psychedelics","tag-ptsd","tag-treatment-resistant-depression","tag-trump-administration","tag-trump-executive-orders"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@ie\/116461736142188351","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/posts\/452190","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/comments?post=452190"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/posts\/452190\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/media\/452191"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/media?parent=452190"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/categories?post=452190"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/tags?post=452190"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}