Rhelion Life Sciences Announces Filament Health is Planning a Stability Program for IBEX011, Its Naturally Derived Ibogaine Drug Candidate
Rhea-AI Summary
Rhelion Life Sciences (TRUFF) announced that subsidiary Filament Health has begun planning a stability program for IBEX011, its naturally derived, GMP ibogaine drug candidate, in response to growing demand for standardized ibogaine for regulated clinical research.
IBEX011 is described as a Nagoya Protocol-compliant, total-alkaloid iboga extract produced via Filament’s proprietary extraction, purification and stabilization methods, the same platform used for psilocybin candidate PEX010. Rhelion links this initiative to rising U.S. interest in ibogaine, including federal and state research funding and policy actions. Filament already supplies PEX010 to more than 80 academic and philanthropic studies worldwide and holds 77 issued patents across 13 patent families. Ibogaine remains a Schedule I substance and IBEX011 has not been authorized for clinical trials.
Positive
- Planning stability program for IBEX011 to support GMP, standardized ibogaine supply
- PEX010 platform experience across more than 80 research and compassionate access studies worldwide
- 77 issued patents across 13 patent families acquired with Filament Health portfolio
- Nagoya Protocol-compliant iboga supply chain and benefit-sharing framework with Gabon
Negative
- Ibogaine remains a Schedule I controlled substance and is not approved by FDA, Health Canada or other regulators
- IBEX011 is investigational and has not been authorized for use in any clinical trial
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Filament Health has begun planning a stability program for IBEX011, its naturally derived botanical ibogaine drug candidate, in response to growing demand for GMP quality, standardized ibogaine for clinical research.
Toronto, Ontario--(Newsfile Corp. - September 10, 2026) - Rhelion Life Sciences Corp. (CSE: RHEL) (FSE: 4YX0) (OTCQB: TRUFF) ("Rhelion" or the "Company") an Ontario-based organization advancing innovation and research within the legal psychedelic sector. Through its wholly owned subsidiary Filament Health Corp. ("Filament"), the Company develops, manufactures and supplies PEX010, its patented, standardized, GMP manufactured botanical psilocybin drug candidate, to clinical research and compassionate access programs at leading institutions worldwide.
The Company is pleased to announce that Filament has begun planning a stability program for IBEX011, its naturally derived ibogaine drug candidate.
Ibogaine is a naturally occurring alkaloid found in the root bark of Tabernanthe iboga, a shrub native to Central Africa with a long history of traditional use by the Bwiti people of Gabon. Interest in its therapeutic potential, particularly in substance use disorder and in conditions affecting military veterans, has accelerated significantly in the United States over the past year. Recent activity has included an Executive Order signed in April 2026 directing the acceleration of medical treatments for serious mental illness and naming ibogaine specifically, associated research funding through the U.S. Department of Health and Human Services, and state level programs funding ibogaine clinical trials. On August 18, 2026, Trump announced that the University of Miami had donated its original 1994 ibogaine Investigational New Drug application to the U.S. federal government, giving broader access to that foundational FDA authorization to speed ibogaine's development as a medical treatment. On September 9, 2026, U.S. Health and Human Services Secretary Robert F. Kennedy Jr. announced a recorded conversation with ibogaine advocate W. Bryan Hubbard on the future of psychedelic medicine, scheduled for release on September 10, 2026.
The Company believes this activity is creating substantial and currently unmet demand for pharmaceutical grade, standardized ibogaine suitable for use in regulated clinical research.
In May 2023, Filament announced the completion of what it described as the first Nagoya Protocol-compliant import of Tabernanthe iboga root from Gabon to its Metro Vancouver research and development facility.
The botanical material was imported for analysis and development into a standardized total-alkaloid iboga extract. The import was authorized under a benefit-sharing framework intended to support the responsible and equitable use of botanical resources originating in Gabon. In 2024, IBEX011 was announced as a Nagoya Protocol-compliant GMP extract of Tabernanthe iboga. IBEX011 is a total alkaloid iboga extract produced using Filament's proprietary extraction, purification and stabilization methods, the same platform used to produce PEX010.
"There is real and growing interest in ibogaine, and what the field does not yet have is a reliable source of GMP quality, standardized material," said Todd Shapiro, Chief Executive Officer and Director of Rhelion Life Sciences. "That is exactly the problem Filament has spent years learning how to solve. With extraction and stabilization expertise, we have a proven model with PEX010 across more than 80 studies worldwide. Beginning to plan a stability program for IBEX011 is an exciting next step, and we intend to be ready when researchers and governments come looking for ibogaine they can trust."
PEX010, Filament Health's botanical psilocybin drug candidate, underscores Filament's position as a leading supplier of pharmaceutical grade natural psychedelics, supporting more than 80 academic and philanthropic research studies worldwide. On April 30, 2026, the Company completed its previously announced acquisition of Filament Health Corp., including its portfolio of 77 issued patents across 13 patent families.
Ibogaine is a Schedule I controlled substance in the United States and is not approved by the U.S. Food and Drug Administration, Health Canada or any other regulatory authority for any indication. IBEX011 is an investigational drug candidate and has not been authorized for use in any clinical trial.
About Rhelion Life Sciences:
Rhelion Life Sciences is a science and research led company advancing the natural psychedelic drug discovery and development sector. Through its wholly owned subsidiary Filament Health Corp., the Company is developing naturally derived psilocybin drug candidates, including its patented PEX010, and supporting clinical research and compassionate use programs with leading institutions around the world.
For additional information:
Todd Shapiro
Chief Executive Officer & Director
Tel: 647-204-7129
Email: todd@rhelion.com
Website: www.Rhelion.com
Cautionary Statement Regarding Forward-Looking Statements
This press release contains certain "forward-looking information" within the meaning of applicable Canadian securities legislation. Such forward-looking information and forward-looking statements are not representative of historical facts or information or current conditions but instead represent only the Company's beliefs regarding future events, plans or objectives, many of which, by their nature, are inherently uncertain and outside of the Company's control. Often, but not always, forward-looking statements and information can be identified by the use of words such as "plans", "expects" or "does not expect", "is expected", "estimates", "intends", "anticipates" or "does not anticipate", or "believes", or variations of such words and phrases or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Examples of such information include statements with respect to: the planning, design, initiation, scope, timing and completion of the stability program for IBEX011; the anticipated results of the stability program and the establishment of a shelf life for IBEX011; the expected demand for GMP quality, standardized, naturally derived ibogaine; the continued development of IBEX011 and the Company's broader research and development programs; the potential supply of IBEX011 to clinical research; the therapeutic potential of ibogaine in substance use disorder and other indications; the effect of United States federal and state regulatory and funding developments relating to psychedelic drugs, including ibogaine; the completed acquisition of Filament Health and the expected integration of Filament's clinical infrastructure and intellectual property; and the future development, commercialization, and regulatory approval of IBEX011.
Forward-looking information in this news release is based on certain assumptions and expected future events, namely: the continued ability of Filament to source Nagoya Protocol compliant raw material and to extract, produce and supply IBEX011; the ability to design and complete a stability program on the anticipated terms; the ability to obtain and maintain any required regulatory permits and approvals, including dealer's licence, clinical trial, ethics, import and export authorizations; the continued availability of capital and personnel to advance the program; and general business, market and economic conditions. Risks, uncertainties and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information, namely: regulatory or enforcement developments affecting the legal framework for ibogaine supply and research; the risk that the stability program is not initiated, funded or completed as anticipated; the risk that stability results do not support the intended shelf life, specification or use of IBEX011; the risk that anticipated demand for GMP quality ibogaine does not materialize as expected; the known cardiac safety risks associated with ibogaine and the effect of those risks on the pace and design of clinical research; delays in regulatory permitting, including dealer's licence, import and export authorizations; the risk that integration of Filament Health is not completed as anticipated; and adverse changes in the regulatory or political landscape affecting psychedelic research and access.
Although the Company believes that the assumptions and factors used in preparing, and the expectations contained in, the forward-looking information and statements are reasonable, undue reliance should not be placed on such information and statements, and no assurance or guarantee can be given that such forward-looking information and statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information and statements. The forward-looking information and forward-looking statements contained in this press release are made as of the date of this press release, and the Company does not undertake to update any forward-looking information and/or forward-looking statements that are contained or referenced herein, except in accordance with applicable securities laws.
Source: Rhelion Life Sciences Corp.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/313819
FAQ
What is IBEX011 and how is it produced?
IBEX011 is described as a Nagoya Protocol-compliant, GMP extract of Tabernanthe iboga, formulated as a total-alkaloid iboga extract. It is produced using Filament Health’s proprietary extraction, purification and stabilization methods, the same platform that is used to manufacture its psilocybin drug candidate PEX010.
How did Rhelion secure access to iboga plant material for IBEX011?
In May 2023, Filament completed what it described as the first Nagoya Protocol-compliant import of Tabernanthe iboga root from Gabon to its Metro Vancouver research and development facility. The material was imported for analysis and development into a standardized total-alkaloid iboga extract under a benefit-sharing framework designed to support responsible and equitable use of botanical resources from Gabon.
What role does PEX010 play in Filament Health’s business?
PEX010 is Filament Health’s patented, standardized, GMP-manufactured botanical psilocybin drug candidate. It is supplied to clinical research and compassionate access programs at leading institutions worldwide and supports more than 80 academic and philanthropic studies, underscoring the company’s position as a supplier of pharmaceutical-grade natural psychedelics.
What is Rhelion’s relationship with Filament Health and its patent portfolio?
Rhelion Life Sciences owns Filament Health through a wholly owned subsidiary structure. On April 30, 2026, Rhelion completed its previously announced acquisition of Filament Health, including Filament’s portfolio of 77 issued patents across 13 patent families.