Clinical Trials

Multiple Phase 1 and Phase 2 clinical trials sponsored by Celgene and Bristol-Myers Squibb have evaluated CC-90001 across various indications, including idiopathic pulmonary fibrosis, non-alcoholic fatty liver disease, liver cirrhosis, hepatic impairment, and advanced solid tumors, as well as in healthy subjects. While several Phase 1 safety, pharmacokinetic, and tolerability studies were completed, Phase 2 efficacy evaluations in pulmonary fibrosis and liver disease were ultimately terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05625412 COMPLETED
Advanced Solid Tumors
Bristol-Myers Squibb
 2022-12-09 PHASE1
NCT03142191 TERMINATED
Idiopathic Pulmonary Fibrosis; Fibrosis; Idiopathic Interstitial Pneumonias; Pathologic Processes; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases
Celgene
 2017-07-26 PHASE2
NCT04048876 TERMINATED
Non-alcoholic Fatty Liver Disease; Liver Cirrhosis
Celgene
 2019-08-14 PHASE2
NCT04655898 COMPLETED
Healthy Volunteer
Celgene
 2020-12-16 PHASE1
NCT03958864 COMPLETED
Healthy Volunteer
Celgene
 2019-04-04 PHASE1
NCT03742882 COMPLETED
Hepatic Impairment
Celgene
 2018-12-06 PHASE1
NCT03363815 COMPLETED
Heathy Volunteer
Celgene
 2017-12-04 PHASE1
NCT02510937 COMPLETED
Pulmonary Fibrosis
Celgene
 2015-08-05 PHASE1
NCT02321644 COMPLETED
Healthy Subjects
Celgene Corporation
 2014-11 PHASE1
NCT02110420 COMPLETED
Healthy Volunteers
Celgene Corporation
 2014-02 PHASE1

(data from https://clinicaltrials.gov, updated on 2025-06-13)

Check the CC-90001 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

CC-90001 selectively binds to and inhibits c-Jun N-terminal kinase 1 (JNK1) over JNK2, blocking downstream phosphorylation of c-Jun and suppressing pro-inflammatory and pro-fibrotic signaling cascades. This inhibition attenuates extracellular matrix accumulation and cellular transformation, providing a therapeutic rationale for evaluating CC-90001 in clinical trials for fibrotic conditions such as idiopathic pulmonary fibrosis, liver cirrhosis, and advanced solid tumors.

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>).

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Note: Technical data last updated: Sep 1, 2026.