Shuttle Pharmaceuticals Completes Manufacturing of API for Clinical Trial

Shuttle Pharmaceuticals Holdings, Inc., a discovery and development stage specialty pharmaceutical company, reported that TCG GreenChem has successfully completed the initial manufacturing campaign for the active pharmaceutical ingredient (API) of Ropidoxuridine for use in the company’s upcoming Phase II clinical trial in brain cancer patients undergoing radiation therapy.

Shuttle’s recent request for a Type B pre-IND meeting with the FDA on the proposed Phase II clinical trial has been approved with a goal of receiving written responses from the FDA by September 18, 2023. The company believes it remains on track to commence its Phase II study in the fourth quarter of 2023.

“Shuttle has been working with TCG GreenChem to manufacture API and University of Iowa Pharmaceuticals to develop the formulation and packaging of the drug product into capsules for clinical use,” said Shuttle Pharma’s Chairman and CEO, Anatoly Dritschilo. “Today’s announcement of successfully completing the API manufacturing is an important step in the advancement Ropidoxuridine, our lead clinical sensitizer drug candidate, towards the commencement of our upcoming Phase II clinical trial in brain cancer patients undergoing radiation therapy.