Merck Submits New Drug Application for Oral PCSK9 Inhibitor Enlicitide in China

Merck & Co. (MRK.US) has submitted a new drug application in China for enlicitide, an oral PCSK9 inhibitor that could become the first of its kind to reach the market if approved.

The China Center for Drug Evaluation accepted Merck's application on July 9, 2026, according to the regulatory agency's website. The drug, developed under the code name MK-0616, is designed as an oral macrocyclic peptide inhibitor targeting PCSK9, a protein that regulates cholesterol levels in the blood.

Enlicitide aims to deliver low-density lipoprotein cholesterol reduction comparable to injectable PCSK9 monoclonal antibodies while maintaining a safety profile similar to placebo, Merck said in a press release. The company is evaluating the drug's efficacy and safety through the comprehensive CORALreef clinical trial program, which includes CORALreef Outcomes, CORALreef HeFH, CORALreef Lipids, and CORALreef AddOn studies.

If approved, enlicitide would represent a significant shift in cholesterol management. Current PCSK9-targeting therapies approved in China include seven injectable drugs: evolocumab, alirocumab, inclisiran sodium, tolecimab, inucimab, angoricimab, and rucasimab, according to the Insight database.

Among those seven, inclisiran sodium stands apart as a small interfering RNA therapy rather than a monoclonal antibody. After the first two doses, patients receive inclisiran just once every six months, offering more convenient dosing than other injectable options.

Three additional PCSK9-targeting drugs are currently under regulatory review in China: tacavacimab from Shenzhen Salubris Pharmaceuticals Co., Ltd., ledacicibep from Everest Medicines Limited, and enlicitide from Merck.

The oral formulation could address a key barrier to PCSK9 inhibitor adoption. While injectable therapies have proven effective at lowering LDL cholesterol, patient preference for oral medications and the convenience of daily pills over injections could expand access to this class of drugs.

Merck's application, classified as a Class 1 new drug for import, lists the applicant as Merck Sharp & Dohme LLC with MSD International GmbH's Singapore branch involved in the submission. The regulatory filing number is JXHS2600075.