Investigator Initiated Trials

Investigator Initiated Trials (IIT)

Through our Investigator Initiated Trial (IIT) program, Alkermes seeks to support investigator research designed and conducted by independent physicians and scientists. Since the beginning of the IIT program in 2008, Alkermes has supported over 30 trials which have ranged in indication from use in alcohol and opioid dependent populations to methamphetamine and cocaine use. Alkermes typically provides either study drug and/or placebo to those IIT programs it supports, but has in limited instances also provided financial support as well. The vast majority of the research we support is based in the U.S. with experienced researchers that have secured funding throughout a government agency.

IIT applications are reviewed by a cross functional team of medical and scientific staff to consider patient safety, operational feasibility, scientific merit and alignment with Alkermes research goals and needs. Applications can be submitted in one of two ways:

  • A pre-protocol submission where your application will serve as your proposal, but you have not developed a protocol yet, or
  • A protocol submission where your protocol is already developed and ready for review. To complete an application, please login here.

Please be aware that Alkermes cannot guarantee support for IIT program applications and all decisions regarding such support will be made at Alkermes’ sole discretion.

Application Submission Cut-Off Date Quarterly Meeting Review
September 15 Q4
December 15 Q1
March 15 Q2
June 15 Q3