Investigational Drug Supply Program

Usona Institute provides investigational products and materials to eligible academic researchers and commercial organizations to advance scientific and medical understanding of psychedelics for the common good.

Program Details

• Focus Areas: Psychedelic research including psilocybin and 5-MeO-DMT
• Eligible Applicants: Academic researchers and commercial organizations
• Geographic Scope: International (researchers responsible for compliance with region-specific requirements)
• Open Science Commitment: Researchers are highly encouraged to publish results upon study completion

Key Terms & Conditions

• All applications subject to Usona review and approval
• Regulatory and ethics board approval required
• All requests subject to material availability
• Researcher Responsibilities:
  • Material costs
  • All required regulatory submission costs
  • Shipping costs
  • Other logistical expenses
  • Compliance with region-specific requirements

What They Don't Fund

• Expanded access (not offered at this time)

Contact

• Email: invdrug@usonainstitute.org
• General Contact: Available via website contact form

Application Process

Step 1: Initial Submission
Submit the following documents:

1. Completed Usona Investigational Drug & Materials Request Form
2. Research summary on institutional letterhead including:
   • Dosing schedule (when applicable)
   • Study design/research protocol
   • Justification for requested amount
   • Regulatory process (TBD)

Step 2: Upon Request Approval
The following documentation must be provided based on type of investigational product:

For Investigational Drugs (GMP):

• Final protocol
• Informed consent form
• IRB/ethics committee approval
• Regulatory approval (e.g., FDA, MHRA, TGA approval, etc.)
• Label approval (if applicable)
• Controlled substances licensure and permitting, as applicable (psilocybin is a controlled substance in most countries)

For Investigational Materials (non-GMP):

• Final protocol
• IACUC approval for animal work, if applicable
• Controlled substances licensure and permitting, as applicable

Step 3: Usona Provides

• Standard supply agreement
• Safety Data Sheet
• 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

Important Notes

• Usona Institute does not offer protocol templates nor clinical or regulatory advisement
• Submission format via completed Usona Request Form
• No specific narrative questions listed; content determined by research summary requirements