Daewoong Pharmaceutical violated clinical trial compliance requirements and received a one-month suspension of clinical trial activities from the Ministery of Food and Drug Safety.
When the manufacturing or packaging site for an investigational medicinal product is changed, it must be reported in advance to the Ministery of Food and Drug Safety, but Daewoong Pharmaceutical did not notify the change. This constitutes a violation of the Pharmaceutical Affairs Act and the Regulations on Safety of Drugs, etc.
The Ministery of Food and Drug Safety said on the 4th that it imposed an administrative disposition suspending clinical trial operations for one month because Daewoong Pharmaceutical conducted a clinical trial targeting patients with type 2 diabetes without obtaining approval for a protocol amendment.
The subject of the disposition is a multi-center, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of DWP16001 as an add-on therapy to insulin, with or without concomitant antihyperglycemic agents, in patients with type 2 diabetes.
This is one of the clinical trials to expand the indication (treatment scope) of the diabetes drug Envlo that Daewoong Pharmaceutical is pursuing. DWP16001 is a type 2 diabetes treatment in the SGLT-2 inhibitor class developed by Daewoong Pharmaceutical, marketed under the product name Envlo (ingredient name inavogliflozin) in 2023.
The administrative disposition period runs from today through Mar. 3.
A Daewoong Pharmaceutical official said, "We were sanctioned for not reporting in advance to the Ministery of Food and Drug Safety the change in the manufacturing and packaging site of the investigational medicinal product," adding, "This was identified in a fact-finding survey conducted after the trial ended, and it does not indicate any issues with the trial results or the drug itself."