Tanzisertib Hydrochloride (CC-930) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 497

Clinical Trials

Multiple clinical trials sponsored by Celgene evaluated Tanzisertib (CC-930) for the treatment of inflammatory and fibrotic conditions, including discoid lupus, idiopathic pulmonary fibrosis, and related interstitial lung diseases. These Phase II studies investigated the compound's safety, tolerability, pharmacokinetics, and biological activity. However, recruitment across these clinical trials was terminated, and clinical evaluation was discontinued.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01466725	TERMINATED	Discoid Lupus	Celgene	2011-11-01	PHASE2
NCT01203943	TERMINATED	Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis; Fibrosis; Interstitial Lung Disease; Lung Diseases, Interstitial	Celgene	2011-01-01	PHASE2
NCT01466725	Terminated	Discoid Lupus	Celgene	2011-11-01	Phase 2

(data from https://clinicaltrials.gov, updated on 2019-11-19)

Check the Tanzisertib Hydrochloride (CC-930) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tanzisertib Hydrochloride acts as an ATP-competitive inhibitor of c-Jun N-terminal kinase (JNK), directly suppressing JNK-mediated phosphorylation of the downstream protein substrate c-Jun across JNK isoforms with high selectivity over other mitogen-activated protein kinases. By preventing AP-1-driven gene transcription and pro-inflammatory signaling cascades, the molecule blunts extracellular matrix accumulation and cellular stress responses underlying pathological fibrotic and inflammatory conditions such as idiopathic pulmonary fibrosis and discoid lupus.

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>).