Big changes ahead for Oregon’s psilocybin agency, New bill seeks to turn Trump’s psychedelics executive order into permanent law

Plus: Compass Pathways announces new Phase 3 results, and Lawsuit against LSD company Definium is dismissed

Happy Friday and welcome back to The Microdose, an independent journalism newsletter brought to you by the U.C. Berkeley Center for the Science of Psychedelics.

An industry in flux as Oregon plans to merge its psilocybin services with the state’s medical marijuana program amidst budget shortfalls

On July 1, Oregon’s public health department announced that the state’s psilocybin services program would merge with its medical marijuana program. The transition into a new single unit, which will be called the Oregon Psilocybin and Medical Cannabis Section, is anticipated to be completed by September 1, 2026.

Amidst budget shortfalls, Oregon’s public health department has had to take measures to reduce expenses by letting vacant positions remain unfilled and cutting non-personnel costs. The aims of merging the psilocybin and marijuana programs are to increase efficiency and reduce costs. The state’s public health department has also proposed doubling certain psilocybin industry fees. Because the psilocybin program is supported by fees, it must raise fees to keep up with rising costs, said Oregon Health Authority spokesperson Erica Heartquist in an email, according to Oregon Capital Chronicle.

With the proposed fees, psilocybin service centers and manufacturers would incur annual fees of $20,000, up from $10,000. Facilitators who oversee psilocybin trips would pay an annual fee of $4,000, up from $2,000. Reductions in fees for nonprofits, veterans, and low-income people have also been targeted for elimination.

Industry leaders have decried these proposed fee hikes, pointing to ongoing issues with psilocybin service center closures and declining business. The state has thus far issued licenses to 39 psilocybin service centers, and state figures show that half of those licenses have either expired or been surrendered. In January, the New York Times reported that one third of Oregon’s psilocybin service centers have closed.

Dr. Eric Lee, who runs Space Psychedelic Clinic, told the Oregon Capital Chronicle that costs of psilocybin sessions, which typically range from $850 to $3,000, have limited access for many people. “There is a vast segment of the population that will just never be able to use legal psychedelics, because of the price point,” Lee said. “I think it’s a huge part of why the business is failing.”

New bill seeks to turn Trump’s psychedelics executive order into permanent law

Federal lawmakers are rushing to get psychedelics legislation introduced to ensure that President Donald Trump’s April executive order aimed at expediting approvals and access to psychedelic-assisted therapies is codified into law. Without a law enacted by Congress, any executive order can be rescinded by the next sitting president.

On June 30, members of Congress led by Morgan Luttrell (R-TX), along with Lou Correa (D-CA), Jack Bergman (R-MI), and Michael McCaul (R-TX), introduced the Initiating Biomedical Outcomes to Garner Advancements into Innovative Neuroplastogen Efficacy (IBOGAINE) Act.

The IBOGAINE Act contains key parts of Trump’s executive order, with additions to ensure veteran care, including mandated progress reports developed by the Under Secretary for Health of the Department of Veterans Affairs. Reports would be due to congressional veterans affairs committees 60 days after the law is enacted and biannually thereafter, and they would need to include updates on clinical trial activities and outcomes, the number of veterans enrolled in treatment programs and clinical trials, and recommendations for improvements for veteran access. The Under Secretary for Health of the Department of Veterans Affairs would also need to create a workforce readiness plan to assess training and clinical capacity and to ensure that treatments are accessible to all veterans.

Also on June 30, Representative Abe Hamadeh (R-AZ) introduced the Veterans and Service Members PTSD Emerging Treatment Review Act (HR 9547) with co-sponsors Rep. Don Bacon (R-NE), Rep. Dan Crenshaw (R-TX), and Rep. Seth Moulton (D-MA). The bill would direct the Pentagon to provide Congress with comprehensive data on clinical research and service-related treatments for PTSD to aid decisionmaking on military readiness, health, and veteran care.

While HR 9547 was referred to the House Committee on Armed Services, the IBOGAINE Act was referred to three committees — Energy and Commerce, Judiciary, and Veterans’ Affairs. A bill under review by multiple committees enables members with diverse expertise to weigh in, but these complex bills often take longer to get through the legislative process.

Compass Pathways announces results of ongoing second psilocybin Phase 3 trial, strengthening case for FDA approval

On July 7, UK-based psychedelics company Compass Pathways announced new results for its second ongoing Phase 3 COMP006 clinical trial using the company’s formulation of synthetic psilocybin, called COMP360, for treatment-resistent depression. The study participants, of which there are nearly 600, have experienced depressive episodes lasting, on average, more than three years, prior to enrolling in the study. Participants’ depression symptoms were assessed using a standard clinical measure of depression called the Montgomery-Åsberg Depression Rating Scale (MADRS).

While the study results have not been peer reviewed, in a press release the company stated that 39% of participants who received two 25 mg doses achieved a clinically meaningful reduction in MADRS scores of more than or equal to 25% by week 6, following two fixed doses of COMP360. The new results appear to be better than the results of the first Phase 3 trial that the company released in February, in which just 25% of participants who were given one 25 mg dose experienced a clinically meaningful reduction in MADRS scores.

In April, the U.S. Food and Drug Administration granted Compass a New Drug Application rolling review request, which allows drug companies to incrementally submit data for agency evaluation. The FDA also awarded Compass’s proprietary synthetic psilocybin COMP360 a Commissioner’s National Priority Voucher. Both initiatives are designed to get drugs to market faster.

With its rolling data submission allowance and initial FDA review underway, Compass says it’s on track to complete its final submission before the end of the year. Subject to FDA approval and Drug Enforcement Administration (DEA) rescheduling of the drug, Compass anticipates launching its new treatment in the first half of 2027.

Dismissed lawsuit buoys Definium amidst positive LSD Phase 3 results — but clinicians question psychedelic therapy implementation

On July 1, federal judge Gregory Williams dismissed a lawsuit against New York City-based Definium Therapeutics, which is developing a formulation of LSD to treat anxiety and depression. The lawsuit was filed by Signant Health Holding Corp, which alleged that LSD company Definium Therapeutics shared trade secrets with competitor EMA Wellness. Judge Williams said Signant failed to “meaningfully distinguish the alleged protected information from general business information.” According to Reuters, a Signant spokesperson said that the company will refile its lawsuit, adding requested details.

Definium, formerly known as MindMed, had contracted Signant in 2021 to help run its Phase 2 clinical trial using its LSD formulation MM120 (now called DT120) to treat anxiety and depression. Definium switched contractors in 2024, hiring EMA Wellness to help run its Phase 3 clinical trials.

News of the dismissed lawsuit came shortly after Definium released positive Phase 3 results for DT120 in the treatment of major depressive disorder. Participants’ depression symptoms were assessed using a standard clinical measure of depression called the Montgomery-Åsberg Depression Rating Scale (MADRS). The results showed a significant improvement in depression symptoms, with MADRS scores for study participants falling on average by 13 points. A decrease of 6 points is considered a clinically significant reduction in depression symptoms.

While these results are promising, obstacles lie ahead for Definium and other companies with psychedelic compounds in the drug approval pipeline. “Definium’s MADRS numbers are real,” writes Moe Alsumidaie, reporting for The Clinical Trial Vanguard. Still, Alsumidaie went on to describe some clinicians’ concerns. “What is in dispute is whether those numbers, generated in a controlled clinical trial with therapy protocols, will replicate in the licensed clinic down the road where the psychiatrist has thirty minutes, the integration therapist is not reimbursed, and the patient spent the session alone on a recliner with noise-canceling headphones.”

• On Wednesday night, the Massachusetts House passed a $561 million economic development bill that includes a five-year pilot program that would allow licensed mental health care clinics to offer on-site psychedelic treatments, reports the Boston Globe. The bill now goes to the state Senate.

• A 203-page Ibogaine Investigator’s Brochure was published by the Multidisciplinary Association for Psychedelic Studies (MAPS). In a press release the non-profit group said that the brochure serves as an open-access, comprehensive resource guide of scientific and regulatory information “to ensure that ibogaine research isn’t limited to pharmaceutical companies alone, and to bring the public along as the field advances.”

• Yale’s state-funded psilocybin and MDMA pilot program expanded to more patients after a Connecticut law took effect July 1. The pilot program, enacted in 2022, was initially limited to retired first responders, veterans, individuals from a historically underserved community and health care workers with serious or life-threatening mental or behavioral health conditions. Now, patients who are at least 18 years old and meet eligibility criteria can apply.

• Mongabay’s Jenny Gonzalez reports on a “secret Amazon species” that may be key to creating a sustainable supply of ibogaine. Brazilian researcher Ricardo Marques discovered the plant and is guarding its identity for what he declares are commercial and ecological reasons. Marques says the plant contains a chemical precursor that can be extracted and transformed into ibogaine, using methods that enable the plant to regenerate. As global demand for ibogaine increases, the discovery may help protect Tabernanthe iboga (iboga), a slow-growing shrub.

• In a Q&A with Drug Discovery & Development, Jonathan Bound, who has underwritten companies in the psychedelics sector, breaks down insurance issues related to psychedelic treatments.

• “My spouse’s collapse is not an anomaly. It’s a warning,” writes Laura Zam in the Los Angeles Times. Her husband Kurt suffered a nervous breakdown after participating in an MDMA therapy clinical trial. He had been diagnosed with pancreatic cancer, and sought MDMA therapy to process his fear of recurrence and long-term anxiety. Three years after his breakdown, and after hospitalizations, Kurt is now recovering. Zam, who also enrolled in an MDMA trial, says psychedelic medicine was transformative for her, but cautions the field, after witnessing “what happens when promise outpaces support systems.”

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