Ibogaine Club Research Group advises FDA on trial safety

Ibogaine Club Research Group's FDA Submission

The Ibogaine Club Research Group has submitted a detailed public comment to the U.S. Food and Drug Administration (FDA) concerning the design and safety of clinical trials for ibogaine drug products. This submission, filed on October 12, 2026, responds to the FDA's Request for Information under Docket No. FDA-2026-N-10429, addressing key areas such as study design, dose selection, safety, and ethical considerations.

Focus on Cardiac Risk Management

According to the Ibogaine Club Research Group, cardiac risk management should be a priority in ibogaine clinical trials. The group suggests that cardiac risk stratification, including a 12-lead ECG, electrolyte panel, and medication review, should be mandatory before trial enrollment. This recommendation is based on a review of peer-reviewed literature, clinical trials, and treatment center protocols. The group also advises that drugs like amiodarone, which prolong the QT interval, should be excluded due to the challenges of achieving a sufficient washout period.

Additional Recommendations

The group further recommends standardized dose reporting in mg/kg ibogaine HCl-equivalent, CYP2D6 genotyping before dose escalation, and continuous cardiac telemetry during extended post-dosing observation. They also stress the importance of informing participants that a reliable ibogaine-associated mortality rate cannot be calculated due to the unknown total number of users globally. Separate monitoring criteria for psychiatric adverse events are also advised.

Why It Matters

The Ibogaine Club Research Group's recommendations aim to enhance the safety and effectiveness of ibogaine clinical trials. By focusing on cardiac risk management, the group seeks to mitigate the potential for serious harm, which has been a common factor in past fatality cases. These insights could guide the FDA in establishing robust safety protocols for future trials.

The public comment period for this docket remains open until November 20, 2026, allowing for further input from stakeholders.

About the Ibogaine Club

The Ibogaine Club is an independent resource that provides information on ibogaine treatment centers, summarizes relevant literature, and tracks legal developments. The organization does not offer medical treatment or sell ibogaine but focuses on research and data analysis.

For more information, the full comment is available on regulations.gov, and a summary is published on the Ibogaine Club's website.