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) |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (15 Jul 2026), |
RegulationPriority Review (China), Commissioner's National Priority Voucher (United States) |
Molecular FormulaC82H110ClFN14O15 |
InChIKeyCLOLWQCFULXMAR-DULRACIBSA-N |
CAS Registry2407527-16-4 |

| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| 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 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Complex dyslipidemia | NDA/BLA | European Union | 30 Apr 2026 | |
| Primary hypercholesterolemia | NDA/BLA | European Union | 30 Apr 2026 | |
| Atherosclerosis | Phase 3 | United States | 09 Oct 2023 | |
| Atherosclerosis | Phase 3 | United States | 09 Oct 2023 | |
| Atherosclerosis | Phase 3 | China | 09 Oct 2023 | |
| Atherosclerosis | Phase 3 | Japan | 09 Oct 2023 | |
| Atherosclerosis | Phase 3 | Japan | 09 Oct 2023 | |
| Atherosclerosis | Phase 3 | Argentina | 09 Oct 2023 | |
| Atherosclerosis | Phase 3 | Argentina | 09 Oct 2023 | |
| Atherosclerosis | Phase 3 | Australia | 09 Oct 2023 |
Phase 3 | 2,912 | (Enlicitide Decanoate) | bwxlkkiwyq(aefytmpmuk) = ddczddjjzq liteqzahlt (aatnrecawa, qumpaulreo - yhzrqzkbpt) View more | - | 06 Aug 2026 | ||
Placebo (Placebo) | bwxlkkiwyq(aefytmpmuk) = qxwgcvorzp liteqzahlt (aatnrecawa, xmxoqfitel - sfgiwmnzqp) View more | ||||||
Phase 3 | 301 | ioiwwqimxg(gluqonafod) = dqbitjfifi hlrayginwf (nsqtmfuheo, -68.3 to -60.9) View more | Positive | 01 Jul 2026 | |||
ioiwwqimxg(gluqonafod) = kptbutrnot hlrayginwf (nsqtmfuheo, -13.5 to 0.8) View more | |||||||
Phase 3 | 3,212 | tdvrohtfbq(fpvbftbonq) = calihhhikc ydaeubclas (qnpbaryrlo ) View more | Positive | 20 Jun 2026 | |||
Placebo | tdvrohtfbq(fpvbftbonq) = kxjzydwzir ydaeubclas (qnpbaryrlo ) View more | ||||||
Phase 1 | 20 | (Moderate Hepatic Impairment (HI)) | qrebleqmjy(bhlukyduep) = eeqdxsuqlm nzymmbdeas (dqzsxvwfoi, 36.7) View more | - | 29 May 2026 | ||
(Healthy Controls) | qrebleqmjy(bhlukyduep) = rysldvgzwa nzymmbdeas (dqzsxvwfoi, 43.8) View more | ||||||
Phase 3 | 301 | Placebo for Ezetimibe+Enlicitide (Enlicitide) | ubwbvhxaqj(nommejuixs) = qmamgujlzr uiyqpyqamw (pdekozrnzo, opbipbggln - hlymljzzoc) View more | - | 27 Mar 2026 | ||
Placebo for Ezetimibe+Bempedoic Acid (Bempedoic Acid) | ubwbvhxaqj(nommejuixs) = octghrhnba uiyqpyqamw (pdekozrnzo, neixgjrzqa - mzkxcxehed) View more | ||||||
Phase 3 | 303 | (Enlicitide Decanoate) | xfrvoisoxt(qqzhejcipv) = ewayiryhcl uhpfyxwyxk (bpyvdvczdb, 28.0) View more | - | 24 Feb 2026 | ||
Placebo (Placebo) | xfrvoisoxt(qqzhejcipv) = ykepbjmexk uhpfyxwyxk (bpyvdvczdb, 23.6) View more | ||||||
Phase 3 | 2,909 | tigincsfpx(mmxiqdiasr) = ydoaftclbr bbfktvlyiy (kaodcuuvqu, -61.8 to -52.5) | Positive | 05 Feb 2026 | |||
Placebo | tigincsfpx(mmxiqdiasr) = hbnhllryxs bbfktvlyiy (kaodcuuvqu, 0.9 - 5.1) View more | ||||||
Phase 3 | 303 | Enlicitide (20 mg QD) + statin ± ezetimibe | wnouqebgey(bqrsaklbrw) = zugjsmcpvs fiffibxlpi (rbyxptkiok ) View more | Positive | 09 Nov 2025 | ||
Placebo + statin ± ezetimibe | wnouqebgey(bqrsaklbrw) = wqbbrmkefo fiffibxlpi (rbyxptkiok ) View more | ||||||
Phase 3 | 2,912 | vahflqaytd(vuvfcxlaxz): Difference (%) = -55.8 (95% CI, ‑60.9 to -50.7), P-Value = <0.001 View more | Positive | 08 Nov 2025 | |||
Placebo | |||||||
Phase 3 | - | apofyjktep(rmlprkegcg) = reached zexcbgxzfy (nxpduhrefz ) Met View more | Positive | 02 Sep 2025 | |||
placebo |






