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Universal Ibogaine provides update on intent to file Clinical Trial Application with Health Canada and confirms securing of Ibogaine drug supply

September 04, 2025 | Last Trade: C$0.02 0.00 0.00

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 intention to file, within 90 days, an application to Health Canada to initiate clinical trials (the Clinical Trial Application, or “CTA”) with the aim of investigating Ibogaine as a promising treatment for addiction for opioid use disorder(s) (the “Trial”).

In addition, the Company has secured a reliable and compliant supply of pharmaceutical-grade Ibogaine to support the planned clinical trial program. The Company confirms that the drug has been secured and produced in full compliance with Good Manufacturing Practice (“GMP”) standards, ensuring its quality and safety. This sourcing will ensure continuous availability of the investigational drug across all trial sites, complying with regulatory standards and quality control measures.

Nick Karos, UI CEO noted “This dual milestone demonstrates our firm commitment to advancing innovative addiction therapies.  We are well-positioned to conduct rigorous, high-quality clinical studies focused on patient safety and therapeutic effectiveness.”

Further updates on progress of the planned Trial and clinical data will be provided by the Company in future disclosures.  The Company notes that there is no guarantee that the CTA will be approved once submitted.

About Universal Ibogaine Inc. 

UI is a life sciences company with a mission to transform addiction treatment using medicalized ibogaine through a planned Canadian clinical trial focused on opioid use disorder, and ultimately to utilize that treatment protocol globally through planned future licensing agreements.  UI is concurrently developing a state of the art holistic addiction treatment protocol at its Kelburn Recovery Centre (located near Winnipeg, Manitoba) that, which when paired with the planned ibogaine detox protocol, is intended to revolutionize the way we treat addiction and drastically improve the lives of individuals and families affected by addiction.  

NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER (AS THAT TERM IS DEFINED IN THE POLICIES OF THE TSX VENTURE EXCHANGE) ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS  

This news release may contain forward-looking statements and information. Forward-looking information is frequently characterized by words such as "plans", “planned”, "expect", "project", "intends", “intended”, "will", "believe", "anticipate", "estimate", "scheduled", "potential", or other similar words, or statements that certain events or conditions "may", "should" or "could" occur.  The forward-looking statements and information are based on certain key expectations and assumptions made by UI at the date the statements are made.  Although UI believes that the expectations and assumptions on which the forward-looking statements are based are reasonable, undue reliance should not be placed on the forward-looking statements because UI can give no assurance that they will prove to be correct. 

Since forward-looking statements address future events and conditions, by their very nature they involve inherent risks and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors and risks, which include, but are not limited to, risks that required regulatory approvals are not obtained. The reader is cautioned that assumptions used in the preparation of such information, although considered reasonable by UI at the time of preparation, may prove to be incorrect and readers are cautioned not to place undue reliance on forward-looking information, which speaks only to conditions as of the date hereof. UI does not undertake any obligation to release publicly any revisions to forward-looking information contained herein to reflect events or circumstances that occur after the date hereof or to reflect the occurrence of unanticipated events, except as may be required under applicable securities laws.  

Additional information identifying risks and uncertainties that could affect financial results and the Company is contained in the Company’s filings with Canadian securities regulators, which are available at www.sedar.com

For further information:  

Nick Karos, CEO

Universal Ibogaine Inc.

612-567-0770

This email address is being protected from spambots. You need JavaScript enabled to view it.

Related Linkshttps://universalibogaine.com  

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