regulatory
confidence high
sentiment positive
materiality 0.70
Bioxytran receives CDSCO approval for first-in-human ProLectin-I trial
BIOXYTRAN, INC
- India's CDSCO granted IND authorization (CT-06, No. CT/ND/03/2023) to evaluate ProLectin-I injection.
- Trial will assess safety, tolerability, PK/PD; results to guide Phase II in Long COVID and IPF.
- Separate approval from prior ProLectin-M authorization (Dec 2, 2022).
- ProLectin-I targets viral persistence and fibrosis; Long COVID affects 65-100 million worldwide.
- Trial at each site requires ethics committee approval before initiation.