New drug for COVID-19 treatment? CSIR, Laxai Life begin phase II trials for Niclosamide

The Council of Scientific and Industrial Research (CSIR), in collaboration with Hyderabad-based Laxai Life Sciences Pvt Ltd, has initiated phase II clinical trials of anti-helminitic drug Niclosamide for treatment of COVID-19.

"The trial is a multi-centric, phase-II, randomized, open label clinical study to evaluate efficacy, safety and tolerability of Niclosamide for the treatment of hospitalized COVID-19 patients," the government said in a release on Sunday.

Niclosamide has been extensively used in the past for treatment of tapeworm's infection in adults as well as children. The safety profile of the drug has been tested over time and has been found safe for human consumption at different dose levels.

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The active pharmaceutical ingredient (API) for the drug is being made by Laxai Life based on improved technology developed at CSIR-Indian Institute Of Chemical Technology (IICT), Hyderabad and the lab is a partner in the clinical trials which could provide cost effective therapeutic options for patients if it is successful, CSIR-IICT Hyderabad Director Dr Srivari Chandrashekhar said.

Laxai Life CEO Dr Ram Upadhayaya said that realising the potential of Niclosamide, efforts were initiated last year itself to undertake clinical trials.

"Having received approval from drug regulator, the clinical trial has been initiated this week at different sites and is expected that the trial will be completed within 8-12 weeks. Based on successful clinical evidence generated during clinical trials in Indian studies, emergency use authorization may be sought so that more treatment options are available to COVID-19 patients," he was quoted as saying in the release.

CSIR Director General Dr Shekhar C Mande said Niclosamide is a generic, affordable drug and easily available in India, and therefore can be made available to the population.

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