Hyundai Pharm has submitted a fresh application to the Ministry of Food and Drug Safety (MFDS) for approval of its abortion pill, Mifegymiso, on Tuesday, marking another attempt following its initial application in 2021.

Mifegymiso, a combination of mifepristone and misoprostol, is used for medically terminating pregnancies of up to nine weeks. The regimen involves taking a 200 mg mifepristone tablet to block progesterone, a hormone essential for maintaining pregnancy, followed by 800 mcg of misoprostol one to two days later to induce uterine contractions.

Clinical studies conducted in the United States and Mexico confirmed the drug's efficacy and safety, demonstrating success rates of 94.9 percent, 96.2 percent, and 97.3 percent for complete pregnancy termination without surgical intervention up to 63 days (nine weeks) gestation. Common adverse reactions included pain (93.4 percent), nausea (70.8 percent), diarrhea (59.5 percent), and fatigue (55.7 percent).

The drug, developed in collaboration with U.K.-based Linepharma International, comes in a combination pack containing one mifepristone tablet and four misoprostol tablets.

This marks Hyundai Pharm’s third attempt to bring Mifegymiso to the domestic market. 

The company’s first application in 2021 faced delays due to requests for additional safety and efficacy data, as well as legal challenges related to abortion legislation. A Constitutional Court ruling in 2019 decriminalized abortion, but the lack of updated legislation has stalled the introduction of abortion medication in Korea.

Hyundai Pharm re-applied for approval in March last year, only to face another request for revisions from the MFDS in July. 

This third application coincides with recent changes in the MFDS’s drug approval fee structure. The fee, previously set at 8.83 million won ($6,000), has risen sharply to 410 million won, aimed at expanding the approval workforce and reducing review times.

Hyundai Pharm plans to launch Mifegymiso in Korea once regulatory approval is granted.