Research & Development
Daewoong Pharmaceutical's IND for DWN12088 receives FDA approval for phase two clinical trial
27 June 2022 -

Daewoong Pharmaceutical Co., Ltd, a South Korea-based pharmaceutical company, announced on Friday that it has received approval from the United States Food and Drug Administration (FDA) for the IND for the phase two clinical trial of DWN12088, a PRS (Prolyl-tRNA Synthetase) inhibitor for patients with idiopathic pulmonary fibrosis.

The phase two clinical trial will be carried out as a multinational clinical study simultaneously in the United States and South Korea to assess the safety and efficacy of the product. The improvement in the deteriorated forced vital capacity (FVC) will be assessed subsequent to the oral administration of the study drug or placebo for 24 weeks in 102 patients with idiopathic pulmonary fibrosis (IPF). The basis for DWN12088's phase two clinical trial has been laid by confirming the safety and pharmacokinetic properties of 162 healthy participants in multiple phase one clinical trials carried out in Australia and South Korea.

The product is claimed to be the world's first PRS inhibitory anti-fibrotic agent produced by Daewoong.

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