Omilancor (BT-11) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 390

Clinical Trials

NImmune Biopharma has sponsored multiple clinical trials evaluating Omilancor (BT-11) in healthy volunteers and patients with ulcerative colitis, Crohn's disease, and eosinophilic esophagitis. Phase 1 research included a clinical trial assessing dose-escalation safety in healthy subjects alongside a clinical trial in eosinophilic esophagitis that was withdrawn. In Phase 2, a clinical trial in ulcerative colitis was successfully completed, whereas several clinical trials in moderate-to-severe Crohn's disease were terminated or withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03870334	TERMINATED	Crohn's Disease	NImmune Biopharma	2021-05-05	PHASE2
NCT04835168	WITHDRAWN	Eosinophilic Esophagitis	NImmune Biopharma	2022-01-30	PHASE1
NCT05057273	WITHDRAWN	Crohn's Disease	NImmune Biopharma	2021-11	PHASE2
NCT03861143	COMPLETED	Ulcerative Colitis	NImmune Biopharma	2019-08-14	PHASE2
NCT03860571	COMPLETED	Normal Healthy Volunteers	NImmune Biopharma	2018-07-06	PHASE1

(data from https://clinicaltrials.gov, updated on 2023-12-04)

Check the Omilancor (BT-11) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Omilancor (BT-11) selectively binds lanthionine synthetase C-like 2 with a dissociation constant of 7.7 µM, activating downstream anti-inflammatory signaling cascades to reduce pro-inflammatory cytokine secretion and modulate mucosal immune cell responses. This targeted pathway activation dampens local intestinal immune activity, offering therapeutic potential for gastrointestinal inflammatory conditions such as Crohn's disease and ulcerative colitis.

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>).