Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Enpatoran · 2 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| Enpatoran | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Control Group 1 (Normal Renal Function) | EXPERIMENTAL | - |
| Group 2 (Impaired Renal Function) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Enpatoran | DRUG | Participants will receive a dose of Enpatoran orally twice daily from Day 1 to Day 168. |
| Placebo | DRUG | Participants will receive a single oral dose of a placebo matching Enpatoran tablet twice daily from Day 1 to Day 168. |
| Standard of care (SoC) | DRUG | Participants will receive Investigator-recommended SoC. |
Inclusion Criteria * Vaccinations are up to date according to local guidelines/recommendations. Recombinant zoster vaccination is encouraged but not mandatory. * Participants with diagnosis of Discoid Lupus Erythematosus (DLE) and/or Subacute Cutaneous Lupus Erythematosus (SCLE) documented in medic...
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Enpatoran is an investigational small molecule being developed for renal impairment and systemic lupus erythematosus (SLE). It is also being studied in cutaneous lupus erythematosus (CLE) with or without systemic disease. The drug is in clinical development and has not been approved by the FDA.
Enpatoran is being developed by Merck & Company, Inc., traded on the New York Stock Exchange under the ticker MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in renal impairment and lupus indications.
Enpatoran is in Phase 1 clinical development for renal impairment, with a completed pharmacokinetic study. Additionally, a Phase 3 trial is recruiting participants with cutaneous manifestations of lupus, with or without systemic disease. The drug is investigational and not yet FDA approved.
Enpatoran has two clinical trials. NCT06589713 is a completed Phase 1 study on the effect of renal impairment on enpatoran pharmacokinetics in Germany. NCT07332481 is a recruiting Phase 3 study in the United States, Japan, and Switzerland for participants with cutaneous lupus manifestations with or without systemic disease.
Enpatoran is not FDA approved. It is an investigational drug in clinical development. The FDA has granted it Breakthrough Therapy designation, which is intended to expedite development and review for serious conditions. The drug is currently being evaluated in clinical trials.