
On March 30, 2026, Merck (MSD) announced the results of the Phase III CORALreef AddOn study of MK-0616 Enlicitide. This is an active comparator trial designed to evaluate the efficacy and safety of enlicitide decanoate versus other oral non-statin lipid-lowering therapies, when added to background statin therapy, in adult patients with hypercholesterolemia who have a history of atherosclerotic cardiovascular disease (ASCVD) or are at risk of developing ASCVD. This marks the third positive Phase III study for enlicitide decanoate.
Heart-related diseases are the top cause of death worldwide. Right now, common cholesterol-lowering treatments include statins, other pills that block cholesterol absorption, and injectable PCSK9 inhibitors. But most of them are still only available as injectable formulations. If approved by the U.S. FDA, enlicitide is poised to become the world’s first oral PCSK9 inhibitor, offering a convenient new treatment option for patients with hypercholesterolemia.
MK0616 Enlicitide chloride
| Target: | PCSK9 |
| Originator: | Merck Sharp & Dohme Corp. |
| Developers: | Merck Sharp & Dohme (China) R&D Co., Ltd. |
| Indications Under Development: | Complex Dyslipidemia |
| Highest R&D Phase: | Marketing Authorization Application Submitted |
| First Approval Date: | / |
| First Approved Country/Region: | / |
MK0616 Enlicitide Starting Materials and Intermediates
| Intermediates Name | CAS NO. |
| 4-Bromo-3-fluoro-2-methylaniline | 127408-03-1 |
| 5-Bromo-4-fluoro-1H-indazole | 1082041-85-7 |
| Ethyl 5-bromo-1H-indole-2-carboxylate | 16732-70-0 |
| 5-bromo-2-indolecarboxylic acid | 7254-19-5 |
| (S)-3-Aminobutanenitrile hydrochloride | 1073666-54-2 |
| 4-Bromo-2,6-dimethylfluorobenzene | 99725-44-7 |
| 3-Fluoro-2-methylaniline | 443-86-7 |
RELYBO is committed to providing global customers with high-purity, high-quality MK0616 Enlicitide chloride intermediates with stable supply from kilogram to ton cales, accelerating the innovation and commercialization.
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