2 completed, 2 recruiting, 1 active not recruiting, 1 not yet recruiting. 3 Phase 3, 2 Phase 1, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 3 | Recruiting 2, Not yet recruiting 1 |
| Phase 1 | 2 | Completed 2 |
| Phase 2 | 2 | Active not recruiting 1, Terminated 1 |
Follow Enpatoran: new trials by email Literature Review of Enpatoran trials Research Report on Enpatoran
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Long-Term Extension (LTE) Study Of Enpatoran In Cutaneous Manifestations Of Lupus With Or Without Systemic Disease [Elowen-LTE] Enpatoran - Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE) | Phase 3 | Not yet recruiting | EMD Serono Research & Development Institute, Inc. | 404 | 2026-10-15 | 2026-09-25 |
| A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2) Enpatoran, Placebo, Standard of care (SoC) - Systematic Lupus Erythematosus, Cutaneous Lupus Erythematosus | Phase 3 | Recruiting | EMD Serono Research & Development Institute, Inc. | 202 | 2026-04-01 | 2026-10-06 |
| A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease Enpatoran, Placebo, Standard of care (SoC) - Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE) | Phase 3 | Recruiting | EMD Serono Research & Development Institute, Inc. | 202 | 2026-03-10 | 2026-10-06 |
| Effect of Renal Impairment on Enpatoran Pharmacokinetics Enpatoran - Renal Impairment | Phase 1 | Completed | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | 34 | 2024-09-24 | 2026-05-01 |
| Study of M5049 in DM and PM Participants (NEPTUNIA) M5049 dose, Placebo - Dermatomyositis, Polymyositis | Phase 2 | Terminated | EMD Serono Research & Development Institute, Inc. | 20 | 2023-01-19 | 2026-09-09 |
| The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE) M5049 low dose, M5049 medium dose, M5049 high dose - Systemic Lupus Erythematosus | Phase 2 | Active not recruiting | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | 381 | 2022-09-16 | 2026-10-15 |
| Enpatoran Human Mass Balance and Absolute Bioavailability Study Enpatoran, [14C]enpatoran microtracer, [14C]enpatoran microdose - Healthy | Phase 1 | Completed | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | 7 | 2021-11-05 | 2022-04-04 |
Lupus Erythematosus, Cutaneous (4) · Lupus Erythematosus, Discoid (4) · Lupus Erythematosus, Systemic (4) · Dermatomyositis (1) · Myositis (1) · Polymyositis (1) · Renal Insufficiency (1)
EMD Serono Research & Development Institute, Inc. (4) · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany (3)
United States (5) · Germany (4) · Poland (4) · Spain (4) · Australia (3) · Brazil (3) · Bulgaria (3) · Israel (3) · Italy (3) · Romania (3) · South Korea (3) · Taiwan (3) · China (2) · Czechia (2) · Greece (2)
2025 (2)