Inhibikase Gets Pre-NDA Meeting with the FDA for IkT-001Pro

 Pre-NDA Meeting to discuss requirements for a 505(b)(2) NDA submission for IkT-001Pro in up to eight blood and stomach cancer indications -

- Bioequivalence to 400 mg and 600 mg imatinib mesylate completed with minimal adverse events -

Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (“Inhibikase” or “Company”), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson's disease, Parkinson's-related disorders and other diseases of the Abelson Tyrosine Kinases, today announced the U.S. Food and Drug Administration has granted a pre-New Drug Application (pre-NDA) meeting to be held in January 2024 to discuss the requirements for approval of IkT-001Pro and to review the data establishing doses of IkT-001Pro bioequivalent to 400 mg and 600 mg imatinib mesylate. The Company expects to provide an update following the meeting.

https://www.biospace.com/article/releases/inhibikase-therapeutics-granted-pre-nda-meeting-with-the-fda-for-ikt-001pro/