Orphan Disease Grants


The FDA has funding opportunities for clinical trials for drugs (and devices) that treat low-prevalence diseases known as Orphan Diseases. Applications for Orphan Disease grants are due in February.

Funding Opportunity:

Phase 1 studies are eligible for grants of up to $200,000 per year for up to three years.
Phase 2 and 3 studies are eligible for grants of up to $400,000 per year for up to four years.
Amounts are for total costs (direct plus indirect).
  • The disease prevalence in the US for the population that the drug is intended to treat must be less than 200,000.

  • The proposed clinical protocol should be submitted to the applicable FDA IND/IDE review division a minimum of 30 days before the grant application deadline and must be under an active IND or IDE (i.e., not on clinical hold).

  • The company must have available an adequate supply of the drug to be studied to conduct the trial.

West Rock Associates knows how to help you produce the specific kind of proposal the FDA seeks to fund. If you would like our help with your Orphan Disease grant application, give us a call at 617-524-3102, or email us at neilkrieger@comcast.net.