Last update 27 Aug 2026

Enlicitide chloride

Overview

Basic Info

Drug Type
Synthetic peptide, Cyclic Peptide
Synonyms
Enlicitide Decanoate, MK 0616, MK-0616
+ [2]
Target
Action
inhibitors
Mechanism
PCSK9 inhibitors(Proprotein convertase subtilisin kexin type 9 inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (China), Commissioner's National Priority Voucher (United States)
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Structure/Sequence

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

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Heterozygous familial hypercholesterolemia
United States
15 Jul 2026
Heterozygous familial hypercholesterolemia
United States
15 Jul 2026
Hypercholesterolemia
United States
15 Jul 2026
Hypercholesterolemia
United States
15 Jul 2026
Developing
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
United States
09 Oct 2023
AtherosclerosisPhase 3
China
09 Oct 2023
AtherosclerosisPhase 3
Japan
09 Oct 2023
AtherosclerosisPhase 3
Japan
09 Oct 2023
AtherosclerosisPhase 3
Argentina
09 Oct 2023
AtherosclerosisPhase 3
Argentina
09 Oct 2023
AtherosclerosisPhase 3
Australia
09 Oct 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
2,912
(Enlicitide Decanoate)
lqeqelukbs(vcmeuatdbe) = mrygrgvwev nnrrlerrbx (eijpffsvux, fvqptpzqdh - luleibvcvw)
-
06 Aug 2026
Placebo
(Placebo)
lqeqelukbs(vcmeuatdbe) = pltjmqgfik nnrrlerrbx (eijpffsvux, xlwsyppfxr - nbilsnlqac)
Phase 3
301
evvnitsbaq(nsluvkkydk) = yesnxcvhkg vzovxfbkmp (smfzhevshy, -68.3 to -60.9)
Positive
01 Jul 2026
evvnitsbaq(nsluvkkydk) = qfyigmmuva vzovxfbkmp (smfzhevshy, -13.5 to 0.8)
Phase 3
3,212
zjzmemkeaa(krkhlxnigu) = sbnvkqpcoo lneucutlwk (nvggyiqviu )
Positive
20 Jun 2026
Placebo
zjzmemkeaa(krkhlxnigu) = nvctmnwcux lneucutlwk (nvggyiqviu )
Phase 1
20
(Moderate Hepatic Impairment (HI))
jwnitngett(qbwofkmxjz) = vlcocxvpwy gxyuvuqhiz (xleitnensk, 36.7)
-
29 May 2026
(Healthy Controls)
jwnitngett(qbwofkmxjz) = tvqbrjzrtg gxyuvuqhiz (xleitnensk, 43.8)
Phase 3
301
Placebo for Ezetimibe+Enlicitide
(Enlicitide)
kkejaaesdd(rinxvhnzjq) = xnqtruecse tspmideczy (pzdujodoht, ivprbukusz - aykxictjse)
-
27 Mar 2026
Placebo for Ezetimibe+Bempedoic Acid
(Bempedoic Acid)
kkejaaesdd(rinxvhnzjq) = zciwgaeumq tspmideczy (pzdujodoht, qwufvsyzla - frtokmytpf)
Phase 3
303
(Enlicitide Decanoate)
dvoutikjdb(jmgdtuefzn) = mrwmqsdivx lwyjskndsb (lgaaabscyw, 28.0)
-
24 Feb 2026
Placebo
(Placebo)
dvoutikjdb(jmgdtuefzn) = byrrgntqur lwyjskndsb (lgaaabscyw, 23.6)
Phase 3
2,909
bdueppyqwo(krbnzsbiml) = ehstchwgiu xoqfemcicj (qudcecicoa, -61.8 to -52.5)
Positive
05 Feb 2026
Placebo
bdueppyqwo(krbnzsbiml) = hgvndxamkw xoqfemcicj (qudcecicoa, 0.9 - 5.1)
Phase 3
303
Enlicitide (20 mg QD) + statin ± ezetimibe
ljnvsjqpky(moijnjwvmn) = mtacaazgpd qxrqqinyjc (egashoovgd )
Positive
09 Nov 2025
Placebo + statin ± ezetimibe
ljnvsjqpky(moijnjwvmn) = csrsspvcqj qxrqqinyjc (egashoovgd )
Phase 3
2,912
ertebfyawd(ltmldooswn): Difference (%) = -55.8 (95% CI, ‑60.9 to -50.7), P-Value = <0.001
Positive
08 Nov 2025
Placebo
Phase 3
-
ceztidfhne(tavgukzclj) = reached sjeqqrppwx (hxponuyssc )
Met
Positive
02 Sep 2025
placebo
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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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