Cridanimod Clinical Trials

Size	Price	Qty
5mg	USD 147

Clinical Trials

Multiple Phase 2 clinical trials, sponsored by Xenetic Biosciences, Inc. and Kevelt AS, have evaluated cridanimod alongside progestin therapy for endometrial cancer and recurrent or persistent endometrial carcinoma. Comprising a terminated trial and a trial with unknown recruitment status, these studies assess cridanimod as a potential therapeutic strategy for advanced or treatment-refractory endometrial malignancies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03077698	TERMINATED	Endometrial Cancer	Xenetic Biosciences, Inc.	2017-06-14	PHASE2
NCT02064725	UNKNOWN	Recurrent or Persistent Endometrial Carcinoma	Kevelt AS	2014-09	PHASE2

(data from https://clinicaltrials.gov, updated on 2022-06-07)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cridanimod binds to and activates the intracellular signaling protein stimulator of interferon genes (STING), thereby triggering downstream TANK-binding kinase 1 (TBK1) and interferon regulatory factor 3 (IRF3) signaling to induce the synthesis of type I interferons, including interferon-alpha and interferon-beta. This immune activation enhances anti-tumor activity and host surveillance, offering therapeutic relevance for the treatment of endometrial cancer and recurrent or persistent endometrial carcinoma.

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>).