The Central Drug Research Institute (CDRI), the public sector premier institution for drug discovery, will soon start Phase 1 clinical trials of a candidate drug against malaria and another one to fight diabetes.
The institute has developed and licensed the anti-hyperglycemic candidate drug (CDR134F194) to TVC Sky Shop Ltd., Mumbai. The process of formulation of the drug in a GMP certified company is in progress. The single dose and multi-dose Phase- I clinical trial will be initiated soon at KEM Hospital & Seth GS Medical College in Mumbai. The permission for the trials was already given by the Drugs Controller General of India (DCGI), sources said.
Another candidate drug developed by the CDRI and waiting for the trials is in the therapeutic area of malaria. The single dose pharmacokinetic study in healthy volunteers as per revised protocol approved by DCGI was completed at PGIMER, Chandigarh for the CDRI compound 97/78 (Anti-malarial agent). A total of 16 volunteers completed the trial. The blood samples were analysed inthe Pharmacokinetics & Metabolism division and the final report on single dose pharmacokinetic study submitted to IPCA, Mumbai.
The multiple dose Phase- 1 trials will commence at the same PGIMER soon after procuring the formulation from the IPCA, which has the license for the product. The required regulatory clearance for the trial also had been obtained, sources added.
One of the key achievements in the recent past by the premier institute was the completion of advanced trials for a tuberculosis drug -- Picroliv (Hepatoprotective agent). Phase III Clinical Trial in patients of Tuberculosis on Multi Drug Therapy (MDT) has been completed at two centers. Clinical trial reports of both enters have been compiled already. 260 patients at CSM Medical University, Lucknow and 113 patients at Seth G. S. Medical College and KEM Hospitals, Mumbai took part in the trials.
The CDRI had also developed another anti-malarial agent and has been licensed to IPCA. The preclinical data is under compilation for IND submission in collaboration with the company now.