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Investigational Drug Supply Program

USONA INSTITUTE INC

Foundation Rolling (Quarterly) Grants for Science Research

Funding Amount

Varies

Deadline

Rolling / Open

Grant Type

foundation

Overview

Investigational Drug Supply Program

Overview: 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

How to Apply

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

    Focus Areas & Funding Uses

    Fields of Work

    science-research

    Categories

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