In an effort to further the scientific understanding of psychedelic compounds for medical use, we have launched an investigational drug supply program. Through our program, qualified researchers can request certain drug products and materials.
To confirm your eligibility for our drug supply program, please complete this feasibility survey.
Mydecine can provide the following investigational drugs and materials to eligible researchers:
- cGMP psilocybin for clinical studies
- Bulk form
- Stackable 5mg capsules
- cGMP MDMA for clinical studies
- Bulk form
- cGMP niacin as a matching active placebo for clinical studies
- Characterized non-GMP psilocybin
- Bulk form
- Characterized non-GMP MDMA
- Bulk form
All applications for investigational drugs and materials are subject to regulatory and ethics approval, Mydecine approval, and the terms and conditions of the investigational drug or investigational materials supply agreement. All requests are subject to site and study feasibility and material availability.
The researcher is responsible for all required regulatory submission costs (if applicable), shipping costs, and other logistical expenses. Please note that compliance with region-specific requirements (e.g., QP certification) is also the responsibility of the researcher.
To begin the process, please complete this request form.
Upon request approval, the following documentation must also be provided:
- A summary of the research on institutional letterhead including:
- Dosing schedule (when applicable)
- Study design/research protocol
- Justification for requested amount
- Controlled substances licensure
- IACUC approval for animal studies, if applicable
- Informed consent form
- IRB/ethics committee approval
- Final protocol
- Regulatory approval (e.g. IND, CTA, etc.)
- Controlled substances licensure, as applicable (psilocybin is a controlled substance in most countries)
Mydecine will provide the following documentation:
- Standard supply agreement
- Psilocybin safety data sheet
- Certificate of analysis (cGMP) or other statement of analysis (non-GMP)
- Necessary drug-related regulatory submission information (cGMP)
- Investigator’s Brochure
Mydecine does not offer protocol templates, clinical, or regulatory advice.
For questions or additional information, please contact firstname.lastname@example.org.
THIS WEBPAGE DOES NOT CONTAIN MEDICAL ADVICE. The content appearing in this announcement is intended to provide information to the reader. Mydecine Innovations Group, Inc. is not providing or offering medical or psychological advice or services. The information contained herein should not be considered complete. It is not a substitute for professional medical advice, diagnosis, or treatment. Nothing herein should be used without consultation and advice from medical or other health care professionals. The information contained herein is general in nature. It does not cover all possible uses, actions, precautions, or interactions of the medical treatments discussed. The content is not intended as medical advice .Mydecine Innovations Group, Inc. specifically disclaims all responsibility for any liability loss or risk, personal or otherwise, that may, does or will result from the direct or indirect use and application of any of the content in this announcement or any website where this announcement appears. In no event will Mydecine Innovations Group, Inc., its subsidiaries, agents, or employees be liable for any damages, including but not limited to incidental or consequential damages, personal injury, wrongful death, lost profits or business interruption resulting from any information contained herein.