Investigator Initiated Research

Endo may provide support in the form of study drug and/or funding in response to an unsolicited, independent research that meet our standards of quality and compliance. All proposals must be unsolicited, original research, which complements, and does not duplicate or conflict with Endo’s ongoing research and development plan.

Current Research Areas of Interest
  • Endocrinology
    • Central Precocious Puberty (CPP)
  • Orthopedics
    • Dupytren’s Contracture
  • Urology and Men's Health

Endo accepts submission for both clinical (interventional and observational) and preclinical studies (in vitro and animal).

IIR support can be provided in the form of financial support, product supply or both.

Submission Process

The Endo Investigator Initiated Research grant is open to all U.S. physicians, researchers and institutions. In order to ensure adequate review, proposals must be received 90 days prior to the anticipated start of the study. No proposal can be submitted past the initiation of the study.

Endo accepts brief concept submissions to gauge Endo’s interest in the proposed research. If the concept submission is of interest, the Investigator will be invited to submit a full study proposal with a complete study protocol for further review and consideration. An interest in the concept proposal does not guarantee approval of the subsequent full study submission.

To submit a concept proposal for consideration, please click on this link and choose the correct application from the drop down. Please complete all mandatory fields and ensure information requested for concept or full submission listed below is included in your submission. Additional documents can be uploaded into the Grant portal.

The following information is required when submitting a concept submission or if requested a full submission:

Concept Proposal Submission

Basic Information

  • Contact Information including Investigator and or Sub-Investigator's CV
  • Estimated study cost

Study Information

  • Support Type: Drug or Monetary
  • Study Subjects: Animal or Human
  • Title of Proposal
  • Hypothesis
  • Primary Objective
  • Brief Inclusion and Exclusion Criteria
  • # of Subjects
  • Treatment Regimen
  • Proposed Endpoints

Full Study Proposal Submission

Basic Information

  • Contact Information including Investigator and or sub PI’s CV
  • Copy of DEA/Medical License
  • Organization and Payee Information
    • Please note that the funds will be provided only to the organization listed in the application as the Payee.
    • No funds or product will be provided directly to the Investigator.

Study Information

  • Support Type: Drug or Monetary
  • Study Type: Single center/multi center, Phase I-IV
  • Study Subjects: Animal or Human; number estimated
  • Title of Proposal
  • Hypothesis
  • Study Design (e.g. placebo or open-label, cohorts or groups, study duration, etc.)
  • Inclusion and exclusion criteria
  • Study drugs or Treatment Regimen
  • Endpoints (primary and/or secondary)
  • Statistical analysis plan (as applicable)
  • Estimated timeline
  • Itemized detailed budget
Review Process

Endo will acknowledge receipt of all submissions. The proposals are reviewed by a committee of Endo’s medical and scientific personnel within R&D on a regular basis. A formal notification on the status of an application will be sent once a decision is reached. Time for review will depend on completeness of the submission. Endo makes no guarantee that it will approve all requests received via the portal. Endo support for any Independent Investigator Initiated Research Grant in no way implies any obligation toward and is not in any way connected to the recommendation or prescribing of Endo products.

Budget and Overhead Costs:

  • A detailed budget must be submitted with the Full Submission.
  • An itemized budget detailing study related expenses that are commensurate with fair market value is required for review of the Full Submission.
  • Reasonable direct study cost. Endo will only pay reasonable overhead for total direct study costs.
  • Indirect study costs should be applicable to study (e.g. IRB review fees, equipment expenses). (Overhead will not be paid on indirect study costs.)
  • Endo will not support cost for IIR that has already been completed or activities not related to the IIR.

Endo Requirements Before Initiation of IIR Study:

After approval to fund a full submission, there are several documents that Endo requires before it can initiate support (drug and/or funding). Endo requires the following:

  • Fully executed IIR agreement*
  • Institutional Review Board (IRB)/Ethics Committee (EC) Approval Documentation (IRB/EC approval letter, IRB/EC approved study protocol and IRB/EC approved informed consent form, (as applicable) or IRB/EC waiver documentation
  • Documentation of Investigational New Drug (IND)/Clinical Trials Application (CTA) or an exemption, if applicable
  • Institutional Animal Care and Use Committee (IACUC) approval (applicable to animal studies)
  • Final study protocol
  • Registration on, if applicable
The IIR Agreement will outline all contractual obligations of Endo and Investigator. No product or funds will be sent to any institution until receipt by Endo of all executed requested documents. It is the responsibility of the requesting institution to ensure all documentation requested is provided within 2 months of being approved to prevent the approval from being revoked.