#144: 🍄 Psilocybin Therapy Approved for Use in Germany Through a Newly Established Compassionate Use Program
A breakthrough for treatment-resistant depression patients who cannot wait for full regulatory approval
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🍄 Psilocybin Therapy Approved for Use in Germany Through a Newly Established Compassionate Use Program
📚 Queen’s Game
⚡️ Marble Carving Robots
#144: 🍄 Psilocybin Therapy Approved for Use in Germany Through a Newly Established Compassionate Use Program
Last week, Germany’s Federal Institute for Drugs and Medical Devices (BfArM), the German equivalent to the FDA, approved a new compassionate use program to allow legal access to psilocybin therapy prior to regulatory approval.
It is not a substitute to regulatory approval, but instead is a path for patients with serious or life-threatening illnesses to get access to drugs that are yet to be approved.
The Psychedelic Access And Research European Alliance (PAREA), a non-profit advocacy group, said compassionate use programs can compliment clinical trials by offering real-world data on these treatments and ensuring they are available to “patients who cannot wait” for full regulatory approval.
In Germany, psilocybin will only be prescribed in “justified exceptional cases,” according to the Central Institute of Mental Health (ZI) in Mannheim.
To begin, the compassionate use program will allow patients with treatment-resistant depression (TRD) to receive psilocybin therapy outside of scientific studies.
Depression is one of the most common mental illnesses in Germany.
Although there are many effective treatment methods, around 20 to 30 percent of those affected do not respond adequately to treatment and are therefore considered treatment-resistant.
In numerous scientific studies in recent years, psilocybin has shown promise in the treatment of treatment-resistant depression.
Psilocybin is thought to foster new connections between different regions of the brain, helping people let go of excessive self-focus and rumination.
A New Wave of the Psychedelic Medicine Boom
This decision from the German drug regulatory agency reflects a global growing interest in psychedelic therapies for mental health issues, such as anxiety, addiction, depression and post-traumatic stress disorder (PTSD).
In the EU, the Czech Republic legalised the medical use of psilocybin for depression in early July 2025.
Furthermore, the first EU-funded psychedelic trial (which I covered in Nina’s Notes #XX) will investigate psilocybin for palliative care, specifically if psilocybin can alleviate anxiety and depression among patients with progressive diseases such as multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS) and Parkinson's disease (PD).
Several other clinical trials for psychedelic therapies are ongoing in Europe.
However, full regulatory approval of psilocybin is not expected in Germany for several years.
How Will Patients Get Access To Psilocybin Treatment?
Two specialized clinics are now able to offer psilocybin to adults with treatment-resistant depression (TRD) through this program.
The two clinics, OVID Clinic Berlin and the Central Institute of Mental Health (ZI) in Mannheim, are allowed to treat severely depressed patients with psilocybin who have not responded to previous treatments.
Both clinics expect that demand for the treatment will significantly exceed capacity.
The compassionate use program for psilocybin therapy is led by the medical director of the OVID Clinic Berlin, Prof. Gerhard Gründer, MD, who also initiated and completed the first German phase II study on psilocybin for treatment-resistant depression.
Both clinics embed the therapy in a carefully coordinated setting with intensive therapeutic preparation, implementation, and aftercare.
The psilocybin treatment is subject to the highest medical and ethical standards and follows the official guidelines of the Federal Institute for Drugs and Medical Devices (BfArM).
The Treatment Process
Treatment with psilocybin in Mannheim and Berlin takes place exclusively on an inpatient basis.
Patients must also attend outpatient appointments, firstly to clarify the eligibility requirements and secondly for therapeutic preparation and follow-up.
In therapy, psilocybin is used in single doses in combination with accompanying psychotherapy.
The aim of the psilocybin treatment in both the Mannheim and Berlin clinics is to release rigid thought patterns, promote new insights, perspectives and behaviors and improve depressive symptoms.
The pharmaceutical PEX010, a botanical psilocybin drug candidate, is provided by Filament Health, a Canadian company that develops natural psychedelic drugs and extracts psilocybin from mushrooms.
Filament has been a leading force in Canada’s Special Access Program, supplying the vast majority of psilocybin prescribed through the country’s compassionate access pathway.
How can you become a patient?
Interested patients and physicians can find out more about the requirements on the OVID Clinic Berlin website and find the OVID clinic contact information.
If you are interested in treatment at the CIMH and believe you meet the eligibility requirements, you can contact psychedelika-studien(at)zi-mannheim.de with your consent to the storage of your data and your full contact details.
📚 Book of the Week
A Queen’s Game (A Queen’s Duet #1) by Katharine McGee
Rating: ★★★★★
I love Katharine McGee as an author. She writes fun, playful, perfect beach reads.
I devoured her series, American Royals. The fourth book in the series was the BOTW #51, which is about if America had a royal family.
With her newest historical fiction series, A Queen’s Duet, we follow the European and Russian royal families on the marriage market.
The story follows three Princesses, Alix of Hesse, Queen Victoria’s favorite granddaughter, Hélène d’Orléans, daughter of the exiled King of France, and May of Teck, who sits on the fringes of the royal world.
McGee glamourously weaves together real history with the fictional tales of these three women and their quest for love in 19th century Europe.
I think I read this one in two sittings. I loved Hélène immediately, have a soft spot for Alix and May is capable of much much more than she’s been given in life.
I can’t wait for the sequel to come out, A Queen’s Match, which publishes on November 4, 2025.
⚡️ Check This Out
A robotics startup Monumental Labs is on a mission to revive the ancient craft of stone carving, to bring sculpture and ornament back to our built environment on a mass scale.
You can start a project on their website.
Either commissioning a sculpture or starting an architecture project.
They do the design digitally with artists, then use their stone-carving robots to make the piece. It is then finished by hand.
There is definitely not a shortage of marble. So, it would be great to see this beautiful stone crafted like the ancients used to do it.
Monumental just landed a $8M funding round to put this stone option back on the building market, and to open their new office in Brooklyn.
I can’t wait to see building facades return to extravagance. I’m tired of floor to ceiling windows and metal.
Bring back the Corinthian columns please. Gimme those gargoyles.
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