Ireland
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Priya Life Science Compound trial record
Compound · clinical trials

Enpatoran clinical trials

Also listed in trial records as M5049, M5049 medium
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 4 trials in our USA, China, Germany, Spain, Poland, Brazil, South Korea, Taiwan, Australia, Israel, UK, Italy, Belgium, Switzerland, Japan, France, Czechia, Canada and Mexico registers that name Enpatoran as an intervention. Synced 10 Nov 2026
4Current trials
2Recruiting now
2Lead sponsors
19Country registers
At a glance

Enpatoran is named as an intervention in 4 current clinical trials in our USA, China, Germany, Spain, Poland, Brazil, South Korea, Taiwan, Australia, Israel, UK, Italy, Belgium, Switzerland, Japan, France, Czechia, Canada and Mexico registers. 2 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is EMD Serono Research & Development Institute, Inc (3). The most-studied condition is Systemic Lupus Erythematosus (SLE).

How Enpatoran works

All drug targets →
  • Toll-like receptor 8 antagonist Antagonist
    Target: TLR8 toll like receptor 8
    ChEMBL only
  • Toll-like receptor 7 antagonist Antagonist
    Target: TLR7 toll like receptor 7
    ✓ In ChEMBL and the Guide to Pharmacology
Other medicines acting on TLR8
Other medicines acting on TLR7
Diseases it has been tested for in clinical trials, by furthest phase
  • Lupus erythematosusPhase 3
  • Cutaneous lupus erythematosusPhase 2
  • DermatomyositisPhase 2
  • Discoid lupus erythematosusPhase 2
  • PolymyositisPhase 2
  • Systemic lupus erythematosusPhase 2

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4802159, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 11307, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Patient leaflets for Enpatoran

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-approved labels, including patient and medication guides.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Trials by status

  • Recruiting250%
  • Not yet open125%
  • Active, closed125%

Trials by phase

  • Phase 3375%
  • Phase 2125%
01

Clinical trials of Enpatoran

4 trials
StudyPhaseStatusLead sponsorRegisters
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
NCT07332481 · Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
Phase 3 Recruiting EMD Serono Research & Development Institute, Inc UK, USA, China, Germany, France, Spain, Italy, Belgium, Poland, Switzerland, Brazil, Japan, South Korea, Taiwan, Australia, Israel
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
NCT07355218 · Systematic Lupus Erythematosus, Cutaneous Lupus Erythematosus
Phase 3 Recruiting EMD Serono Research & Development Institute, Inc UK, USA, China, Germany, Spain, Italy, Belgium, Poland, Switzerland, Czechia, Canada, Brazil, South Korea, Taiwan, Australia, Israel
A Long-Term Extension (LTE) Study Of Enpatoran In Cutaneous Manifestations Of Lupus With Or Without Systemic Disease [Elowen-LTE]
NCT07840287 · Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
Phase 3 Not yet open EMD Serono Research & Development Institute, Inc USA, Germany
The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)
NCT05540327 · Systemic Lupus Erythematosus
Phase 2 Active, closed Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany USA, China, Spain, Poland, Brazil, Mexico, Japan, South Korea, Taiwan, Australia, Israel

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Conditions studied with Enpatoran

5 conditions
Systemic Lupus Erythematosus (SLE)2Cutaneous Lupus Erythematosus (CLE)2Systematic Lupus Erythematosus1Cutaneous Lupus Erythematosus1Systemic Lupus Erythematosus1
05

Related compounds

06

Questions about Enpatoran trials

How many clinical trials are testing Enpatoran?

4 current trials in our USA, China, Germany, Spain, Poland, Brazil, South Korea, Taiwan, Australia, Israel, UK, Italy, Belgium, Switzerland, Japan, France, Czechia, Canada and Mexico registers name Enpatoran (also registered as M5049) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.

Are Enpatoran trials recruiting patients?

Yes. 2 of the 4 trials are recruiting: 2 with sites in USA, 2 with sites in China, 2 with sites in Germany, 2 with sites in Spain, 2 with sites in Poland, 2 with sites in Brazil, 2 with sites in South Korea, 2 with sites in Taiwan, 2 with sites in Australia, 2 with sites in Israel, 2 with sites in UK, 2 with sites in Italy, 2 with sites in Belgium, 2 with sites in Switzerland, 1 with sites in Japan, 1 with sites in France, 1 with sites in Czechia and 1 with sites in Canada. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Enpatoran clinical trials?

EMD Serono Research & Development Institute, Inc (3) and Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany (1). The number in brackets is how many trials each organisation leads.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Enpatoran works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Enpatoran works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Enpatoran (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.