Lipfendra

(Enlicitide Decanoate)

Phase 3

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Lipfendra is one of 19 small molecule programs targeting Hyperlipidemia. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

HyperlipidemiaNot yet recruiting

Heterozygous Familial Hypercholesterolemia (hefh)Recruiting

HyperlipidemiaPhase 3

Not yet recruiting

Heterozygous Familial Hypercholesterolemia (hefh)Preclinical

Recruiting

Competition

Competitive Landscape

25 competitors in Hyperlipidemia

#DrugCompanyPhaseTrials

Crestor

AstraZeneca

Approved

7 2

Lipitor

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

8 3

Mounjaro

Ozempic

Leqvio

Niacor

Pravachol

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Approved

1 8

Livalo

MMedicure

Approved

1 9

Topamax

WWim Janssens

Approved

—10

Januvia

ZZydus Therapeutics Inc.

Approved

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Phase 3Not yet recruiting

Hyperlipidemia

NCT07821944

Q1 2037

PreclinicalRecruiting

Heterozygous Familial Hypercholesterolemia (hefh)

NCT07058077

Clinical

Trials by Indication[1]

Hyperlipidemia1 trial

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Enlicitide Decanoate in Adults With Hyperlipidemia in India

Not yet recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT07821944·150 enrolled

Heterozygous Familial Hypercholesterolemia (HeFH)1 trial

An Operationally Seamless Phase 2/3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Enlicitide Decanoate in Pediatric Participants With Heterozygous Familial Hypercholesterolemia

Recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT07058077·153 enrolled

Hypercholesterolemia1 trial

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Hypercholesterolemia

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT05952856·2,912 enrolled

Regulatory

FDA Approval Timeline[4]

Jul 14, 2026

LIPFENDRA

NDA NDA220848

Sources

References

[1]
ClinicalTrials.gov — 3 trial records for Enlicitide Decanoate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Enlicitide Decanoate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Enlicitide Decanoate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA220848). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Lipfendra. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Highest Phase: Phase 3[1]
Company: CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Patent Landscape[5]

Patent Cliff

Feb 3, 2040

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11427616Feb 3, 2040

Lipfendra

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Q1 2037

Trials by Indication[1]

Hyperlipidemia1 trial

Heterozygous Familial Hypercholesterolemia (HeFH)1 trial

Hypercholesterolemia1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Related News