Penitrium Bioscience Preparing IND Submission for "Penitrium" Phase 2 Clinical Trial in the U.S.

"Preparation Based on Established Safety Data"

Penitrium Bioscience announced on July 14, 2026, that it is preparing to submit an investigational new drug (IND) application to enter Phase 2 clinical trials in the United States for its innovative drug candidate, "Penitrium."

The company plans to conduct a Phase 2 clinical trial to evaluate the anticancer efficacy of Penitrium using existing human safety data obtained from the same formulation. This formulation had previously undergone clinical trials as a COVID-19 treatment candidate, providing human dosing data. Currently, Phase 2 and 3 clinical trials are underway in Vietnam for its use as a treatment for dengue fever.

In the U.S. clinical trial, Penitrium Bioscience plans to first assess the safety of combination dosing in early patient groups step-by-step, and subsequently evaluate its anticancer effects. The optimal dosage for anticancer indications will be determined through the ongoing Phase 1 clinical trial in South Korea.

However, initiation of the U.S. Phase 2 clinical trial will be determined after the IND submission and subsequent review by the U.S. Food and Drug Administration (FDA). The FDA will review non-clinical data, human dosing experience, safety data, as well as manufacturing and quality information before making a decision.

Chairman Jo Won-dong of Penitrium Bioscience stated, "Pursuing a Phase 2 clinical trial in the U.S. does not mean bypassing any necessary safety procedures or arbitrarily skipping clinical trial phases. Our development strategy has been established based on actual human dosing data from over 300 subjects in Korea, and through planning and validation procedures led by a local U.S. CRO (Contract Research Organization) and Professor Sandip Patel." He added, "We will transparently disclose major developments, such as the IND submission and the results of the FDA review, based on verified facts."

This content was produced with the assistance of AI translation services.