As many as eight candidate drugs including those for diabetes and malaria are under advanced stages of development in the Central Drugs Research Institute (CDRI), Lucknow. The premier institute also could identify eight potential leads through researches during the last financial year.
According to the summary of work done during the last financial year, a candidate drug (CDR 134D123) against diabetes has gone through the phase-I single and multiple dose studies. Report has been submitted to AYUSH department and has been referred to Extra Ayurvedic Pharmacopoeia Committee for inclusion. It has been licensed to Mumbai-based TVC Sky Shop for commercialisation.
The phase-III clinical trials have been completed at CSSMU, Lucknow and Seth GS Medical College and KEM Hospital, Mumbai for the candidate drug Picroliv against liver disorder. It has been transferred to DIL, Mumbai, the report said.
The permission for extended clinical trials is being awaited from the DCGI for the candidate drug called 80-574+Atorvastatin, licensed to Cadila Pharmaceuticals, for treating dyslipidemia. Two candidate drugs against malaria are also at advanced stages of development. The drug '97-98', licensed to IPCA Labs of Mumbai has already gone through phase-I single dose clinical study. DCGI has approved for single dose pharmacokinetic study in healthy volunteers as per revised protocol. Pre-clinical data under compilation for IND submission for another anti-malarial drug '99-411' also transferred to IPCA, according to the report.
Modified dossier has been submitted to DCGI with regard to a candidate drug 'CDR 134F194', licensed to TVC Sky Shot Ltd, aimed at treating diabetes and dyslipidemia. The CDRI is also preparing IND application for a herbal candidate drug against stroke. This has been already transferred to Themis Medicare Ltd, Mumbai for commercialisation, the report said.
The CDRI also has identified leads towards developing drugs to treat osteoporosis, bone fracture, diabetes, thrombosis, cancer and tuberculosis. Single dose toxicity study in rat and mice by oral route was completed in the case of `S-007-1500’ to treat osteoporosis and collaboration with industry partner was under negotiation. Likewise, '914-K058' in the same therapeutic category was also in a similar stage of development. Six other leads identified by the institute are open for licensing still, the report said.