Regulatory non-compliance leads to license revocation; impact on SGLT-2 market expected to be minimal
MSD Korea’s diabetes drug Steglatro has been removed from reimbursement, further signaling the company’s retreat from Korea’s competitive diabetes therapeutics market.
The Ministry of Health and Welfare announced on November 13 that reimbursement for Steglatro 5 mg and Steglujan 5/100 mg will be suspended following the MFDS Seoul Regional Office’s decision to revoke their import licenses. The MFDS had already canceled the marketing authorizations on October 15 after MSD failed to submit required re-examination data.
Steglatro (ertugliflozin) was first approved in 2018 as a monotherapy, followed by Steglujan (ertugliflozin + sitagliptin) and the metformin combination Stegluromet in 2019. However, the portfolio struggled to gain traction, entering the market well after major SGLT-2 competitors such as AstraZeneca’s Farxiga and Boehringer Ingelheim’s Jardiance, both of which expanded into cardiovascular and renal indications. Steglatro, limited to its initial indications, failed to strengthen its commercial position.
MSD Korea began scaling down the franchise in 2023 by voluntarily withdrawing StegluroMet and one Steglatro formulation. With the remaining products now losing approval due to missing re-examination data, the entire ertugliflozin lineup has effectively exited the market.
Industry observers expect the impact on prescribing to be limited, given Steglatro’s modest market share. Although Farxiga has also exited, generics remain widely available, and alternatives such as Jardiance and Daewoong’s Envlo maintain strong market presence.
Combined with the transfer of the Januvia DPP-4 inhibitor portfolio to Chong Kun Dang, the withdrawal of Steglatro underscores MSD Korea’s step back from the frontline of the diabetes treatment market.
