Korea's Daewon Pharmaceutical said Thursday it has wrapped up a phase 1 trial in Vietnam for DW1021, a combination painkiller that pairs Pelubi (pelubiprofen) -- Korea's 12th new drug -- with tramadol, an opioid and serotonin-norepinephrine reuptake inhibitor.

According to the company, it is the first time a Korean drugmaker has run a phase 1 study in Vietnam. 

The trial was authorized by Vietnam’s Ministry of Health and conducted at the Clinical Trial and Bioequivalence Study Center at Hai Phong University of Medicine and Pharmacy.

DW1021 binds pelubiprofen and tramadol into an ion complex designed to deliver synergistic pain relief while lowering tramadol exposure, which could help limit side effects. 

Results from the trial in Vietnamese adults showed pharmacokinetics consistent with Korean patients, no food effect despite the extended-release formulation, and good safety and tolerability. No additional clinical data were disclosed in Thursday’s release.

Daewon is betting on Pelubi’s domestic track record to build credibility abroad. First approved in Korea as the country’s 12th new drug, Pelubi has become the top-prescribed NSAID in its class, the company noted.

The new combination, Daewon said, represents a stepping stone into Southeast Asia’s fast-growing pharmerging market, estimated at $20 billion across six countries in 2023. Vietnam alone accounts for about $7 billion, expanding at more than 7 percent annually over the past decade.

Based on the phase 1 success, Daewon said it plans to pursue additional local trials and marketing approval in Vietnam. “This trial represents a major milestone for Daewon’s entry into pharmerging markets, starting with Southeast Asia,” a company spokesperson said in the release. “We aim to showcase the excellence of Korean-developed medicines and set an example for successful global expansion.”