Project Grant R01FD008458

The Food and Drug Administration awarded Novaeel Inc. $500,000 on September 20, 2025, under the Food and Drug Administration Research program (CFDA 93.103) to conduct a stability study protocol for a 0.1% estradiol Type A medicated article (Estraqua) required by the FDA Center for Veterinary Medicine for the Chemistry, Manufacturing, and Controls technical section of a New Animal Drug Application.

The recipient will evaluate the stability of INAD 012-884 under ambient conditions (25 ± 2 degrees Celsius / 60 ± 5% relative humidity) and accelerated conditions (40 ± 2 degrees Celsius / 75 ± 5% relative humidity) over several months. The study will measure appearance, estradiol level, particle size distribution, and loss upon drying over time. The medicated article will be administered in feed at a dosing rate of 5 parts per million to American eels (Anguilla rostrata) in a recirculating aquaculture system. The resulting stability data will support full FDA approval.

Performance is located at 2323 Riverside Drive, Ottawa, Ontario, Canada. The period of performance runs through August 31, 2027.