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Cardiovascular MK-0616 Enlicitide Outcomes III Study

Cardiovascular MK-0616 Enlicitide Outcomes III Study

May 18, 2026

 

 

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.

 

At RELYBO, we create chemistry for a sustainable future.

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