Drugs / Enpatoran

Trials 12 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 16 trials
Phase 1 NCT06589713 Sep 2024 → Apr 2026 impaired renal function disease Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany Completed No outcome recorded
Phase 1 NCT06589726 Sep → Dec 2024 Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany Completed No outcome recorded
Phase 1 NCT05110027 Nov → Dec 2021 Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany Completed No outcome recorded
Phase 1 NCT04880213 May → Nov 2021 Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany Completed No outcome recorded
Phase 1 NCT04647708 Dec 2020 → Dec 2023 cutaneous lupus erythematosus, systemic lupus erythematosus Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany Completed No outcome recorded
Phase 1 NCT03676322 Sep 2018 → Jul 2019 Merck KGaA, Darmstadt, Germany Completed No outcome recorded
Phase 24 trials
Phase 2 NCT05650567 Jan 2023 → Jun 2025 dermatomyositis EMD Serono Research & Development Institute, Inc. Terminated No outcome recorded
Phase 2 NCT05540327 Sep 2022 → Aug 2028 expected systemic lupus erythematosus Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany Active not recruiting No outcome recorded
Phase 2 NCT05162586 Mar 2022 → Nov 2024 systemic lupus erythematosus EMD Serono Research & Development Institute, Inc. Completed No outcome recorded
Phase 2 NCT04448756 Jul 2020 → Aug 2021 COVID-19 EMD Serono Research & Development Institute, Inc. Completed No outcome recorded
Phase 32 trials
Phase 3 NCT07355218 Apr 2026 → May 2029 expected cutaneous lupus erythematosus, systemic lupus erythematosus EMD Serono Research & Development Institute, Inc. Recruiting No outcome recorded
Phase 3 NCT07332481 Mar 2026 → May 2029 expected cutaneous lupus erythematosus, systemic lupus erythematosus EMD Serono Research & Development Institute, Inc. Recruiting No outcome recorded

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 14 sources stand behind the page.

FieldValueCited text
Known as Enpatoran ClinicalTrials.gov intervention name — accepted as the source's own label NCT07332481
5

NCT06589713

NCT05110027

NCT05162586

NCT07355218

NCT06589726

Known as M5049 ClinicalTrials.gov intervention name — accepted as the source's own label NCT05650567
5

NCT04880213

NCT03676322

NCT04647708

NCT04448756

NCT05540327

Action Inhibit “a selective toll-like receptor 7/8 (TLR7/8) inhibitor” PMID 41136221 Oct 2025
Modality Small molecule “enpatoran, an oral small-molecule TLR7/8 inhibitor” PMID 42107375 May 2026
Route Oral “single ascending oral dose of M5049” NCT03676322
Target TLR7 “a selective toll-like receptor 7/8 (TLR7/8) inhibitor” PMID 41136221 Oct 2025