Enpatoran

Phase 3Small molecule

Merck & Co.

Enpatoran is one of 12 small molecule programs targeting Lupus Erythematosus. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Lupus ErythematosusRecruiting

Systemic Lupus Erythematosus (SLE)Recruiting

Lupus ErythematosusPhase 3

Recruiting

Systemic Lupus Erythematosus (SLE)Phase 3

Recruiting

Competition

Competitive Landscape

13 competitors in Lupus Erythematosus

#DrugCompanyPhaseTrials

Cibinqo

Venclexta

Vibramycin

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

Approved

1 4

Lipitor

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

Phase 3

1 5

Plaquenil

Alnylam Pharmaceuticals

Phase 2

1 6

Nicotinamide

MMetro International Biotech, LLC

Phase 2

1 7

Telitacicept

VVor Biopharma

Phase 2

1 8

Enpatoran

Merck & Co.

Phase 3

1 9

Atacicept

PF-04236921

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

Timeline

Expected Milestones

Q3 2026

Phase 1Recruiting

Renal Impairment

NCT06589713

Q2 2029

Phase 3Recruiting

Systemic Lupus Erythematosus (SLE)

NCT07332481

Phase 3Recruiting

Lupus Erythematosus

NCT07355218

Clinical

Trials by Indication[1]

Cardiac Repolarization1 trial

A TQT Study to Investigate the Effect of Enpatoran on Cardiac Repolarization in Healthy Participants

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT06589726·40 enrolled

SLE1 trial

The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)

Completed· EMD Serono Research & Development Institute, Inc. logo

EMD Serono Research & Development Institute, Inc.·Phase 2·NCT05162586·456 enrolled

Renal Impairment1 trial

Effect of Renal Impairment on Enpatoran Pharmacokinetics

Recruiting· Merck & Co. logo

Merck & Co.·Phase 1·NCT06589713·40 enrolled

Lupus Erythematosus1 trial

A Phase 3, Randomized, Double-Blind,Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants With Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care (ELOWEN-2)

Recruiting· EMD Serono Research & Development Institute, Inc. logo

EMD Serono Research & Development Institute, Inc.·Phase 3·NCT07355218·202 enrolled

Systemic Lupus Erythematosus (SLE)1 trial

Recruiting· EMD Serono Research & Development Institute, Inc. logo

EMD Serono Research & Development Institute, Inc.·Phase 3·NCT07332481·202 enrolled

1 more indication

Unspecified1 trial

Enpatoran Human Mass Balance and Absolute Bioavailability Study

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT05110027·7 enrolled

Sources

References

[1]
ClinicalTrials.gov — 6 trial records for Enpatoran. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Enpatoran compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Enpatoran. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Merck & Co. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Merck & Co.

Enpatoran

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q2 2029

Trials by Indication[1]

Cardiac Repolarization1 trial

SLE1 trial

Renal Impairment1 trial

Lupus Erythematosus1 trial

Systemic Lupus Erythematosus (SLE)1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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