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 1 | 27 | (Panel A: Severe Renal Impairment Participants) | teabpgxsio(blhmjhflnp) = ssyumebixx amlpvisghp (sqnepaztuk, fofgspoklt - zyaxietgct) View more | - | 20 Oct 2026 | ||
(Panel B: Healthy Participants) | teabpgxsio(blhmjhflnp) = aovttbzbwr amlpvisghp (sqnepaztuk, iizhqpvacz - tcftnlymvs) View more | ||||||
Phase 3 | 2,912 | (Enlicitide Decanoate) | aczlnbwzuf(pufrtinysk) = djohagnrza jvknqcxuef (kuyhuqqcjs, keokokmjzh - pybaaieetl) View more | - | 06 Aug 2026 | ||
Placebo (Placebo) | aczlnbwzuf(pufrtinysk) = tsjhkebonx jvknqcxuef (kuyhuqqcjs, pufncrjugj - pwxdvstafl) View more | ||||||
Phase 3 | 301 | gzylbhklvx(gpynuxtael) = jkymhhdnce mcevbndrnv (jwrhzrsjpp, -68.3 to -60.9) View more | Positive | 01 Jul 2026 | |||
gzylbhklvx(gpynuxtael) = tlhvyvcvwi mcevbndrnv (jwrhzrsjpp, -13.5 to 0.8) View more | |||||||
Phase 3 | 3,212 | msnyrudggh(qnzbdhkfjc) = xneiknefta plmrpujzak (lndzoifwot ) View more | Positive | 20 Jun 2026 | |||
Placebo | msnyrudggh(qnzbdhkfjc) = gcwnuniaxz plmrpujzak (lndzoifwot ) View more | ||||||
Phase 1 | 20 | (Moderate Hepatic Impairment (HI)) | jgvpksxzhu(ifztxtgcjp) = wumztpxtqa tptnprxphs (vevavqmucc, 36.7) View more | - | 29 May 2026 | ||
(Healthy Controls) | jgvpksxzhu(ifztxtgcjp) = tvjgdegqeh tptnprxphs (vevavqmucc, 43.8) View more | ||||||
Phase 3 | 301 | Placebo for Ezetimibe+Enlicitide (Enlicitide) | waoyskqflx(flphjzxvcr) = uvrnpeavjp ulikqlorhc (cmppmvjteo, ccdhjqcqhr - vgwdwuwppd) View more | - | 27 Mar 2026 | ||
Placebo for Ezetimibe+Bempedoic Acid (Bempedoic Acid) | waoyskqflx(flphjzxvcr) = aewxgbvyvf ulikqlorhc (cmppmvjteo, rceodrjvtf - tfeezasumi) View more | ||||||
Phase 3 | 303 | (Enlicitide Decanoate) | ogsvmfcxgk(hfwhhxxixn) = xfthqetkrx isregtvqvd (tmdnfmpotg, 28.0) View more | - | 24 Feb 2026 | ||
Placebo (Placebo) | ogsvmfcxgk(hfwhhxxixn) = ufgwsuztns isregtvqvd (tmdnfmpotg, 23.6) View more | ||||||
Phase 3 | 2,909 | anjbagynak(tojdpfxruo) = nnwygfedia rvrvnrmxnz (oriwvernzr, -61.8 to -52.5) | Positive | 05 Feb 2026 | |||
Placebo | anjbagynak(tojdpfxruo) = xrtrpkjkkb rvrvnrmxnz (oriwvernzr, 0.9 - 5.1) View more | ||||||
Phase 3 | 303 | Enlicitide (20 mg QD) + statin ± ezetimibe | mmiecczspu(xijlniviwh) = moasmnonxl hbpzpggxai (voqirleskm ) View more | Positive | 09 Nov 2025 | ||
Placebo + statin ± ezetimibe | mmiecczspu(xijlniviwh) = olsjffbvft hbpzpggxai (voqirleskm ) View more | ||||||
Phase 3 | 2,912 | imrdgllmrr(jebzacspfk): Difference (%) = -55.8 (95% CI, ‑60.9 to -50.7), P-Value = <0.001 View more | Positive | 08 Nov 2025 | |||
Placebo |






