Universal Ibogaine Inc. provides update on intent to file Clinical Trial Application with Health Canada and confirms securing of Ibogaine drug supply
(TheNewswire)
Calgary, Alberta, September 4, 2025 – TheNewswire - Universal Ibogaine Inc.(TSXV: IBO, in USA: IBOGF, in Germany FSE:JC4) (“ UI ” or the“ Company ) is pleased to announce its intentionto file, within 90 days, an application to Health Canada to initiateclinical trials (the Clinical Trial Application, or “ CTA ”) with the aimof investigating Ibogaine as a promising treatment for addiction foropioid use disorder(s) (the “ Trial ”).
In addition, the Company has secured a reliable andcompliant supply of pharmaceutical-grade Ibogaine to support theplanned clinical trial program. The Company confirms that the drug hasbeen secured and produced in full compliance with Good ManufacturingPractice (“ GMP ”) standards, ensuring its quality and safety. Thissourcing will ensure continuous availability of the investigationaldrug across all trial sites, complying with regulatory standards andquality control measures.
Nick Karos, UI CEO noted “This dual milestonedemonstrates our firm commitment to advancing innovative addictiontherapies. We are well-positioned to conduct rigorous, high-qualityclinical studies focused on patient safety and therapeuticeffectiveness.”
Further updates on progress of the planned Trial andclinical data will be provided by the Company in future disclosures. The Company notes that there is no guarantee that the CTA will beapproved once submitted.
About Universal IbogaineInc.
UI is a life sciences company with a mission totransform addiction treatment using medicalized ibogaine through aplanned Canadian clinical trial focused on opioid use disorder, andultimately to utilize that treatment protocol globally through plannedfuture licensing agreements. UI is concurrently developing a stateof the art holistic addiction treatment protocol at its KelburnRecovery Centre (located near Winnipeg, Manitoba) that, which whenpaired with the planned ibogaine detox protocol, is intended torevolutionize the way we treat addiction and drastically improve thelives of individuals and families affected by addiction.
NEITHER THE TSX VENTURE EXCHANGE NORITS REGULATION SERVICES PROVIDER (AS THAT TERM IS DEFINED IN THEPOLICIES OF THE TSX VENTURE EXCHANGE) ACCEPTS RESPONSIBILITY FOR THEADEQUACY OR ACCURACY OF THIS RELEASE.
CAUTIONARY STATEMENT REGARDINGFORWARD-LOOKING STATEMENTS
This news release may contain forward-lookingstatements and information. Forward-looking information is frequentlycharacterized by words such as "plans", “planned”,"expect", "project", "intends",“intended”, "will", "believe","anticipate", "estimate", "scheduled","potential", or other similar words, or statements thatcertain events or conditions "may", "should" or"could" occur. The forward-looking statements andinformation are based on certain key expectations and assumptions madeby UI at the date the statements are made. Although UI believes thatthe expectations and assumptions on which the forward-lookingstatements are based are reasonable, undue reliance should not beplaced on the forward-looking statements because UI can give noassurance that they will prove to be correct.
Since forward-looking statements address future eventsand conditions, by their very nature they involve inherent risks anduncertainties. Actual results could differ materially from thosecurrently anticipated due to a number of factors and risks, whichinclude, but are not limited to, risks that required regulatoryapprovals are not obtained. The reader is cautioned that assumptionsused in the preparation of such information, although consideredreasonable by UI at the time of preparation, may prove to be incorrectand readers are cautioned not to place undue reliance onforward-looking information, which speaks only to conditions as of thedate hereof. UI does not undertake any obligation to release publiclyany revisions to forward-looking information contained herein toreflect events or circumstances that occur after the date hereof or toreflect the occurrence of unanticipated events, except as may berequired under applicable securities laws.
Additional information identifying risks anduncertainties that could affect financial results and the Company iscontained in the Company’s filings with Canadian securitiesregulators, which are available at www.sedar.com
For further information :
Nick Karos, CEO
Universal Ibogaine Inc.
612-567-0770
Nick.Karos@universalibogaine.com
RelatedLinks : https://universalibogaine.com
Copyright (c) 2025 TheNewswire - All rights reserved.
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