US government funds development of psychedelic ibogaine while the drug remains illegal, Mark Cuban's Cost Plus Drugs to lay domestic manufacturing groundwork for future trials, Kennedy promises record drug approval process as FDA flags serious safety concerns

The US Department of Health and Human Services will invest up to $4.9 million in ibogaine, a psychedelic that remains illegal in the United States, Health Secretary Robert F. Kennedy Jr. announced on November 12. The money, routed through the Advanced Research Projects Agency for Health, pays for regulatory and manufacturing groundwork for clinical trials that have not yet begun — trials intended to test whether ibogaine can treat post-traumatic stress disorder and other mental illnesses. The Mark Cuban Cost Plus Drug Company will lay the foundation for a domestically manufactured, single-molecule ibogaine product for those trials.

The arrangement runs through private companies at every step. Beond Inc., which has treated patients with ibogaine in Mexico — where the substance is not prohibited — will hand its treatment data to the government. "That is going to allow us to dramatically accelerate the clinical trial process," Kennedy told reporters in Washington. "So we're going to have, I think, a record drug approval process."

The regulatory groundwork began months before the announcement. President Donald Trump signed an executive order in April directing agencies to open access to ibogaine and other drugs for people with mental illnesses. The Food and Drug Administration then said it would speed up review of three psychedelic drugs and allow a clinical study of an ibogaine derivative to move forward, and in October it asked the public for comments and data to inform ibogaine research, including dose selection. The National Institute of Mental Health has announced up to $20 million for research into rapid-acting psychotropic drugs such as ketamine, and Kennedy said separate federal funding to study ibogaine as an addiction treatment will be announced before the end of the year.

The FDA's own review chief has struck a more cautious note. "With ibogaine, there are important scientific questions as well as serious safety concerns," said Dr. Michael Davis, director of the FDA's Center for Drug Evaluation and Research. "We are seeking high-quality data and input that can help inform clinical research while putting patient safety first." Kennedy, who oversees that agency, set the standard himself: researchers must establish whether ibogaine helps patients, identify who might benefit, determine whether the benefits justify the risks, and investigate how long any improvement lasts. "We will judge this work by the quality of the evidence," he said.

The initial funding commitments span five years and will not be renewed unless certain milestones are reached. Veterans Affairs Secretary Doug Collins appeared alongside Kennedy at the briefing, and ARPA-H senior adviser Al Bugazia said reports of successful ibogaine treatments were "too promising to ignore," pledging results "in years, not decades."

The drug the government is now paying to develop remains illegal in the United States.