# The Safety of AQUI-S 20E (10% Eugenol) as a Sedative on Clownfish at Cornell University

> **NIH FDA R01** · CORNELL UNIVERSITY · 2021 · $137,063

## Abstract

Project Summary / Abstract
Generation and dissemination of data for safe and effective therapeutic applications for minor use in major
species or for use in minor species is a priority of the FDA/CVM's Office of Minor Use and Minor Species Animal
Drug Development (OMUMS). This project addresses the need to increase the availability of fish sedatives for
marine finfish. The lack of approved drugs for marine finfish producers is threatening the growth and long-term
viability of these collective industries and the security of our food supply. Although some new aquaculture drugs
have been added to the collective finfish “medicine chest” in the past 10-15 years, the total number of FDA-
approved drugs for aquatic animals is still very limited. Researchers within the Cornell University Aquatic Animal
Health Program and USFWS Aquatic Animal Drug Approval Partnership (AADAP) program are proposing to
continue a collaboration to conduct studies to increase the number of safe and effective drugs that can be used
to benefit the U.S. aquaculture community. A target animal safety study will be conducted with a eugenol-based
sedative (AQUI-S 20E®). Cornell University’s Aquatic Animal Health Program brings a long history of conducting
research on fish therapeutants and was funded by USDA NIFA during the last two years. This grant application
proposes tasks that will be completed in partnership with the team of researchers, pathologists, statisticians, and
quality assurance personnel at both the Cornell University College of Veterinary Medicine and AADAP. This
study will evaluate the safety of AQUI-S®20E to saltwater-reared marine finfish when overexposed to either the
highest proposed efficacious dose (1×) or 1.5× the highest proposed efficacious dose. The target animal safety
study of AQUI-S 20E® will be conducted with clownfish, one of the most popular ornamental species cultured in
the U.S. The results of these safety studies, if accepted by FDA/CVM, will be used to complete the TAS technical
section data requirements for marine finfish and support a New Animal Drug Application to FDA/CVM to approve
the use of AQUI-S 20E® as a sedative for marine finfish.

## Key facts

- **NIH application ID:** 10329055
- **Project number:** 1R01FD007317-01
- **Recipient organization:** CORNELL UNIVERSITY
- **Principal Investigator:** Rodman G Getchell
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2021
- **Award amount:** $137,063
- **Award type:** 1
- **Project period:** 2021-05-01 → 2022-10-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10329055

## Citation

> US National Institutes of Health, RePORTER application 10329055, The Safety of AQUI-S 20E (10% Eugenol) as a Sedative on Clownfish at Cornell University (1R01FD007317-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10329055. Licensed CC0.

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