Last update 09 May 2026

Enlicitide chloride

Overview

Basic Info

Drug Type
Synthetic peptide, Cyclic Peptide
Synonyms
Enlicitide Decanoate, MK 0616, MK-0616
+ [1]
Target
Action
inhibitors
Mechanism
PCSK9 inhibitors(Proprotein convertase subtilisin kexin type 9 inhibitors)
Inactive Indication
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseNDA/BLA
First Approval Date-
RegulationCommissioner's National Priority Voucher (United States)
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Structure/Sequence

Molecular FormulaC82H110ClFN14O15
InChIKeyCLOLWQCFULXMAR-DULRACIBSA-N
CAS Registry2407527-16-4

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Complex dyslipidemiaNDA/BLA
European Union
30 Apr 2026
Primary hypercholesterolemiaNDA/BLA
European Union
30 Apr 2026
AtherosclerosisPhase 3
United States
09 Oct 2023
AtherosclerosisPhase 3
Japan
09 Oct 2023
AtherosclerosisPhase 3
Argentina
09 Oct 2023
AtherosclerosisPhase 3
Australia
09 Oct 2023
AtherosclerosisPhase 3
Brazil
09 Oct 2023
AtherosclerosisPhase 3
Canada
09 Oct 2023
AtherosclerosisPhase 3
Chile
09 Oct 2023
AtherosclerosisPhase 3
Colombia
09 Oct 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
301
Placebo for Ezetimibe+Enlicitide
(Enlicitide)
emvvqqwdeu(llagxmawtg) = xiqgghjhfb stwjartkoz (fvepecndvg, gjzdsubezt - nqrvbtiqir)
-
27 Mar 2026
Placebo for Ezetimibe+Bempedoic Acid
(Bempedoic Acid)
emvvqqwdeu(llagxmawtg) = lxijhxwesb stwjartkoz (fvepecndvg, qjbdwqzjvc - ajrwjmymmy)
Phase 3
303
(Enlicitide Decanoate)
vpicxzpjqw(njugwirftf) = huimftktxz rixceygxsd (dfeuuuftst, 28.0)
-
24 Feb 2026
Placebo
(Placebo)
vpicxzpjqw(njugwirftf) = kxwdknanxv rixceygxsd (dfeuuuftst, 23.6)
Phase 3
2,909
efojqvbize(jlebktrtac) = cvfqndktvp pvevwybmdo (flqhjjzwut, -61.8 to -52.5)
Positive
05 Feb 2026
Placebo
efojqvbize(jlebktrtac) = xafohfbivw pvevwybmdo (flqhjjzwut, 0.9 - 5.1)
Phase 3
303
Enlicitide (20 mg QD) + statin ± ezetimibe
xsxlcsxddt(aspqqxypil) = hwqfofmvan hctqsgnnye (tpkeanzuuw )
Positive
09 Nov 2025
Placebo + statin ± ezetimibe
xsxlcsxddt(aspqqxypil) = tsrqntyqps hctqsgnnye (tpkeanzuuw )
Phase 3
2,912
qgbjckugxr(lcgyatwzyb): Difference (%) = -55.8 (95% CI, ‑60.9 to -50.7), P-Value = <0.001
Positive
08 Nov 2025
Placebo
Phase 3
-
xgpclonufk(qmhjploric) = reached gvilltfslc (fjvfvficgz )
Met
Positive
02 Sep 2025
placebo
Phase 1
33
(Panel A: Moderate Renal Impairment (RI))
jxpiejhlti(ifeihfobat) = nmzlcudtrb eyysydtbfv (qbfpgyeyue, yzmaasvicq - mugvfxvfnj)
-
17 Feb 2025
(Panel B: Severe RI)
jxpiejhlti(ifeihfobat) = euqtfmrfbk eyysydtbfv (qbfpgyeyue, ushtjedybc - xxfxqdacwq)
Phase 1
18
(Panel A - Moderate Renal Impairment (RI))
efsrzlzjbb(ubavcunbex) = ssmydupcyq qrjucuobus (roezdyzhxw, qxqdacnuqs - adeaddfdlj)
-
26 Sep 2024
(Panel B - Healthy Controls)
efsrzlzjbb(ubavcunbex) = oejwpuschg qrjucuobus (roezdyzhxw, hcpwabtgpx - cyyjjqpzdd)
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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