Drugs / Enlicitide Decanoate
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | LIPFENDRA | — | 2026-07-15 | fda.gov ↗ |
Trials 13 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials | ||||||
| Phase 1 | NCT06625814 | Jul → Aug 2024 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06772792 | Apr → Jun 2024 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06772779 | Apr → Jun 2024 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06691906 | Mar → May 2024 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06699329 | Jan → May 2024 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06699355 | Nov → Dec 2023 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06658652 | Oct → Dec 2023 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT05934292 | Jul 2023 → Jan 2024 | hyperlipidemia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06592339 | Oct → Dec 2022 | hyperlipoproteinemia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07058077 | Aug 2025 → Dec 2033 expected | familial hypercholesterolemia | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT06492291 | Aug 2024 → Oct 2028 expected | — | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06008756 | Oct 2023 → Nov 2029 expected | arteriosclerosis disorder, hyperlipidemia | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05952856 | Aug 2023 → Jul 2025 | familial hypercholesterolemia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Enlicitide Decanoate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07058077 ↗ |
| Known as | MK-0616 | “Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor)” NCT05934292 ↗ |
| Action | Inhibit | “PCSK9 Inhibitor” NCT05934292 ↗ |
| Route | Oral | “single dose orally” NCT05934292 ↗ |
| Target | PCSK9 | “oral PCSK9 inhibitor enlicitide” PMID 41879224 ↗ Feb 2026 |