When President Trump signed the executive order on psychedelics back in April, the moment was hard to miss. Joe Rogan was standing in the Oval Office. The order mentioned ibogaine by name. RFK Jr. called it a breakthrough for veterans.
- Six days after the EO, the FDA issued priority review vouchers to three companies and cleared DemeRx's US clinical trial for noribogaine, an ibogaine derivative. That last one is historic.
- The cleared trial is for noribogaine specifically, a derivative that does not produce the psychedelic experience. There is no IND cleared for ibogaine itself.
- Ibogaine remains Schedule I. A veteran who wants ibogaine treatment today is in the same position they were in April: fly to Mexico.
- Best-case regulatory timeline: Phase 2 in early 2027, Phase 3 in 2028. Call it a 2030 approval at the optimistic end.
I covered what the order said when it dropped. The short version: it was a real policy signal, not just a photo op. The question worth asking now, 60 days in, is what it actually produced.
More than I expected. Less than the coverage implied.
What the FDA Did
Six days after the EO, the agency moved. On April 24, the FDA issued priority review vouchers to three companies, two for psilocybin programs and one for methylone, an MDMA analog studied for PTSD. It also cleared DemeRx's investigational new drug application for noribogaine, a metabolite of ibogaine, for alcohol use disorder. That last one is historic: the first time the FDA has ever cleared a US clinical trial of an ibogaine-derived compound.
The agency also announced it would release final guidance on how to design clinical trials for this class of drugs. For companies trying to get into the space, that removes a meaningful amount of uncertainty.
For a federal agency, six days is fast. Whatever you think of this administration, they moved.
The Gap
Here's the part the headlines mostly skipped.
None of the priority vouchers went to ibogaine companies. DemeRx, the only company with FDA clearance to run a US trial, is not running a trial of ibogaine. It's running a trial of noribogaine, a derivative that doesn't produce the psychedelic experience. Their Phase 1 just started. Phase 2 is planned for early 2027. Phase 3 in 2028.
Ibogaine itself is still Schedule I. There's no IND cleared for ibogaine. There's no formal US approval pathway. A veteran who wants ibogaine treatment today is in the same position they were in April: fly to Mexico.
That's not a criticism of the EO. Regulatory timelines don't bend for political enthusiasm, and they probably shouldn't. An analyst at H.C. Wainwright framed it about as plainly as you can:
They're not lowering the evidentiary bar. These companies are still going to have to run Phase 1, 2 and 3 trials. There's not going to be some sort of red carpet rolled out. Patrick Trucchio, H.C. Wainwright — BioSpace, June 15, 2026
That's the right call. The cardiac risk with ibogaine is real. The deaths on record are almost entirely concentrated in opioid detox patients treated without proper screening, but the risk exists and it needs to be characterized in controlled conditions before any regulator signs off on anything.