Daewoong Pharmaceutical is expected to start a phase 3 trial of Enavogliflozin (pipeline name: DWP16001), an SGLT-2 inhibitor to treat diabetes, in China in September.
According to ClinicalTrials.gov, a registry of clinical trials run by the U.S. National Institutes of Health, information about Daewoong’s phase 3 study of Enavogliflozin in China appeared on the site on Thursday.
Daewoong obtained the National Medical Products Administration’s (NMPA) nod to conduct the phase 3 study of the Enavogliflozin plus metformin combination in China in February.
The new status of the phase 3 study of Enavogliflozin showed that it was “not yet recruiting” patients.
According to ClinicalTrials.gov, Daewoong plans to enroll 298 patients with type 2 diabetes inadequately controlled on metformin to evaluate the safety and efficacy of Enavogliflozin plus metformin. The primary endpoint changes from baseline hemoglobin A1c (HbA1c).
The estimated study start date is September 2022, and the estimated primary completion date is March 2024.
Daewoong said it wished to win Chinese approval for Enavogliflozin by 2025.
The topline results of the local phase 3 study of the Enavogliflozin and metformin combo showed that the combo was non-inferior to the dapagliflozin plus metformin combo, according to Daewoong.
Daewoong is developing Enavogliflozin as a new SGLT-2-inhibiting diabetes treatment.
In Korea, Daewoong is waiting for the results of the Ministry of Food and Drug Safety’s approval review of Enavogliflozin after applying in April.