Enpatoran Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

Enpatoran is evaluated across multiple clinical trials spanning Phase 1, Phase 2, and Phase 3 studies sponsored by EMD Serono Research & Development Institute, Inc. and Merck Healthcare KGaA. The clinical development landscape targets autoimmune conditions—including systemic lupus erythematosus, cutaneous lupus erythematosus, dermatomyositis, and polymyositis—alongside healthy volunteers and individuals with renal impairment. Spanning recruitment statuses from completed and active to terminated, initial Phase 1 safety and Phase 2 dose-ranging trials support currently recruiting Phase 3 studies confirming efficacy in lupus populations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07355218	RECRUITING	Systematic Lupus Erythematosus; Cutaneous Lupus Erythematosus	EMD Serono Research & Development Institute, Inc.	2026-04-01	PHASE3
NCT07332481	RECRUITING	Systemic Lupus Erythematosus (SLE); Cutaneous Lupus Erythematosus (CLE)	EMD Serono Research & Development Institute, Inc.	2026-03-10	PHASE3
NCT05540327	ACTIVE_NOT_RECRUITING	Systemic Lupus Erythematosus	Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany	2022-09-16	PHASE2
NCT06589713	COMPLETED	Renal Impairment	Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany	2024-09-24	PHASE1
NCT05650567	TERMINATED	Dermatomyositis; Polymyositis	EMD Serono Research & Development Institute, Inc.	2023-01-19	PHASE2
NCT06589726	COMPLETED	Healthy	Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany	2024-09-10	PHASE1
NCT05162586	COMPLETED	Systemic Lupus Erythematosus	EMD Serono Research & Development Institute, Inc.	2022-03-31	PHASE2
NCT05110027	COMPLETED	Healthy	Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany	2021-11-05	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-17)

Check the Enpatoran product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Enpatoran functions as a potent, selective inhibitor of Toll-like receptors 7 and 8 (TLR7/8), blocking receptor activation to inhibit downstream proinflammatory signaling cascades within innate immune cells. By dampening pathogenic endosomal TLR7/8 hyperactivation, this targeted inhibition reduces systemic inflammation and autoantibody responses, supporting its clinical evaluation for autoimmune indications such as systemic lupus erythematosus and cutaneous lupus erythematosus.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).