Companies that manufacture MDMA and psilocybin for patients in other countries are looking to use their experience to access the potential U.S. market.
Fueled by rising policy support, unmet need and Big Pharma interest, psychedelic medicine is pushing toward the mainstream. Yet the path forward is littered with challenges, including the burdens imposed by additional U.S. regulations that apply to controlled substances. As the American market starts to take shape, manufacturers in countries that relaxed their rules earlier want to leverage their experience to win possible market share.
This year will likely serve as a landmark in the long-gestating reemergence of psychedelics for treating serious mental illness in the U.S. Within a few months, President Donald Trump ordered U.S. agencies to accelerate access to psychedelics, the FDA finalized guidance on clinical trials of the drugs and Eli Lilly moved into the space by acquiring AtaiBeckley for $3.8 billion. Meanwhile, Resilient Pharmaceuticals—formerly known as Lykos Therapeutics—refiled for approval of its MDMA therapy without running the new trial requested by the FDA in a complete response letter.
“The U.S. ... executive order from a couple months ago fast tracking approval for these drugs is really encouraging,” Sam Watson, CEO of BLS Pharmaceuticals, a life sciences company and manufacturer based in Australia, told BioSpace. “I expect European countries to start taking it more seriously and following suit.”
The U.S. currently classifies MDMA and psilocybin as Schedule I substances, indicating that there is no currently accepted medical use for the drug and a high potential for abuse. Other countries have different classifications for MDMA—which while not a classic psychedelic, can be used to assist mental health therapy—and the magic mushroom–derived psilocybin.
In 2022, Canada amended its regulations to allow healthcare practitioners to request access to restricted drugs, including MDMA and psilocybin. The following year, Australia rescheduled MDMA and psilocybin to permit prescribing for post-traumatic stress disorder and treatment-resistant depression, respectively.
The changes created demand for companies able to supply MDMA and psilocybin in compliance with the good manufacturing practices (GMPs) that cover pharmaceutical production. Australia’s BLS Pharmaceuticals is among these companies. Having established capacity to serve the Australian market, BLS now aspires to expand its manufacturing footprint globally.
“Given we’ve got the manufacturing infrastructure, the supply chain, we can supply to market a GMP-released pharmaceutical medicine—we can now export that overseas,” BLS CEO Watson said. “We can start supplying trials in the U.S., the U.K., Germany, Switzerland. That’s the next step for us.”
Unlocking the US
Optimi Health, a Canadian manufacturer of MDMA and psilocybin, recently used its IPO paperwork to set out what it will take to bring psychedelics to the U.S. The manufacturing process must meet the FDA’s GMP standards. Importers need a Drug Enforcement Administration (DEA) registration and a permit from the federal agency for each shipment, confirming compliance with U.S. regulations.
Optimi’s IPO is fueling its efforts to enter the U.S., although the company told investors the market will likely take 12 months to unlock. For now, MDMA and psilocybin face “a significant degree” of DEA regulation because they are considered Schedule I substances, Optimi said.
Rescheduling could open up the market. In preparation, Optimi plans to ensure that its manufacturing practices align with both Health Canada and FDA requirements. The company has two 10,000-square-foot, pharmaceutical-grade mushroom cultivation and drug processing facilities in British Columbia and has a Health Canada license for buying or making controlled materials used to synthesize MDMA.
“The Canadians are quite far ahead in actually making the compounds,” Watson said. BLS sources APIs from U.S.-Canadian companies and does “the higher-value product manufacturing” under its GMP license, Watson said. Australian production of MDMA and psilocybin is shaped by quality standards for the drugs that the country’s regulatory agency published in 2024. The documents “laid a very solid framework,” Watson said.
Building on those foundations, BLS is “very well positioned” to serve international markets from its base in Australia, Watson said, but is also working to add manufacturing capacity in Europe. The company is building a facility in the U.K. As well as using the site to supply medicinal cannabis, BLS intends to apply for a license to make MDMA and psilocybin products at the facility, Watson said.
The next chapter
Evidence that therapy assisted by MDMA or psilocybin can benefit patients has helped fuel interest in using psychedelics to treat serious mental illnesses. Yet access to the drugs could be limited even if the regulatory barriers clear, given the potential for clinics’ capacity to constrain uptake. The MDMA therapy that the FDA rejected in 2024 was given at three sessions, each lasting about eight hours.
AtaiBeckley, the biotech Lilly is buying, sought to mitigate such concerns by designing its formulation of the single-dose psychedelic 5-MeO-DMT to be given in a two-hour session. Watson sees an opportunity for delivery mechanisms and compounds that improve psychedelic administration, and believes that manufacturing capabilities established to support MDMA and psilocybin will remain relevant as the market evolves.
“The infrastructure is built to make these sorts of products. Any data we’re collecting now on the existing APIs and delivery mechanisms is obviously going to help when building new delivery mechanisms, and potentially with the analogs,” Watson said. “That’s really the big opportunity for us, to start developing our own proprietary delivery mechanisms and compounds.”
