Zydus Lifesciences has received permission from the Drugs Controller General of India (DCGI) to conduct two Phase III clinical trials of Zintrodiazine in patients with uncomplicated malaria due to Plasmodium falciparum (P. falciparum) and uncomplicated Plasmodium vivax malaria in India. The first Phase III and second Phase III trials will be multi-centre, randomised, assessor-blind, active-comparator studies to determine the efficacy, safety and tolerability of orally administered Zintrodiazine in patients with uncomplicated malaria due to P. falciparum and uncomplicated P. vivax malaria.

The first Phase III clinical trial will be conducted in 651 patients with uncomplicated malaria due to P. falciparum with the primary objective of evaluating the efficacy of Zintrodiazine as measured by PCR-adjusted adequate clinical and parasitological response (ACPR). The second Phase III clinical trial will be conducted in 390 patients with the primary objective of evaluating the efficacy of Zintrodiazine as measured by ACPR with uncomplicated malaria due to P. vivax mono-infection. Secondary endpoints in both clinical trials will include the incidence of recrudescence - the return of malaria symptoms and parasites in the blood because the original infection was not fully cleared, new infections, parasite clearance time and fever clearance time. 

Zydus Lifesciences (formerly known as Cadila Healthcare), a company limited by shares, incorporated and domiciled in India, operates as an integrated pharmaceutical company with business encompassing the entire value chain in the research, development, production, marketing and distribution of pharmaceutical products.