Data updated: Sep 20, 2026
LIPFENDRA (enlicitide decanoate) · Merck
Approved 2026-07-15
1
Indication
--
Phase 3 Trials
1
Priority Reviews
0
Years on Market
Details
- Status
- Prescription
- First Approved
- 2026-07-15
- Routes
- ORAL
- Dosage Forms
- TABLET
LIPFENDRA Approval History
Original
New Indication
New Form
Label Update
1 FDA actions from 2026 to 2026
What LIPFENDRA Treats
1 FDA approvalsOriginally approved for its first indication in 2026 .
- Other (1)
Merck's other novel FDA approvals
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Clinical Trial Registry
14 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07058077 | 0616-029 U1111-1314-5796, 2024-519068-42-00 | Ph 2, Ph 3 | recruiting | A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029) |
| NCT06008756 | 0616-015 jRCT2071230064, 2022-502781-24-00 | Ph 3 | active not recruiting | Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes |
| NCT05952869 results posted | 0616-017 MK-0616-017, 2022-502782-14-00 | Ph 3 | completed | A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH) |
| NCT06492291 | 0616-019 2023-504922-20-00, U1111-1290-3950 | Ph 3 | active not recruiting | Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension |
| NCT05952856 results posted | 0616-013 MK-0616-013, 2022-502777-42-00 | Ph 3 | completed | A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids |
| NCT06772792 | 0616-027 MK-0616-027 | Ph 1 | completed | A Study to Evaluate the Drug-Drug Interaction Between Enlicitide Decanoate (MK-0616) and Alendronate in Healthy Adult Participants (MK-0616-027) |
| NCT05934292 results posted | 0616-020 MK-0616-020 | Ph 1 | completed | Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Renal Impairment Study (MK-0616-020) |
| NCT06772779 | 0616-026 MK-0616-026 | Ph 1 | completed | A Study of Enlicitide Decanoate (MK-0616), Warfarin, and Lisinopril in Healthy Adult Participants (MK-0616-026) |
| NCT06699329 | 0616-023 MK-0616-023 | Ph 1 | completed | A Study of Enlicitide Decanoate (MK-0616) and Semaglutide in Healthy Adult Participants (MK-0616-023) |
| NCT06699355 | 0616-024 MK-0616-024 | Ph 1 | completed | A Study to Evaluate the Drug-Drug Interaction Between Enlicitide Decanoate (MK-0616) and Atorvastatin in Healthy Adult Participants (MK-0616-024) |
| NCT06691906 | 0616-025 MK-0616-025 | Ph 1 | completed | A Clinical Study of Enlicitide Decanoate (MK-0616) in Healthy Adult Participants (MK-0616-025) |
| NCT06658652 | 0616-022 MK-0616 | Ph 1 | completed | The Effect of Food and Water Volume in Healthy Adult Participants Administered Enlicitide Decanoate (MK-0616) (MK-0616-022) |
| NCT06625814 | 0616-028 MK-0616-028 | Ph 1 | completed | A Study of Levothyroxine and Enlicitide Decanoate (MK-0616) in Healthy Adult Participants (MK-0616-028) |
| NCT07821944 | 0616-038 | Ph 3 | not yet recruiting | A Clinical Study of Enlicitide (MK-0616) in Adults With Hyperlipidemia in India (MK-0616-038) |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LIPFENDRA FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.