Roscovitine (Seliciclib) Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 470

Clinical Trials

Multiple clinical trials have evaluated Roscovitine (Seliciclib) across Phase II studies for Cushing's disease and cystic fibrosis, sponsored by academic centers, health networks, and biotechnology companies including Cedars-Sinai Medical Center, University Hospital Brest, ManRos Therapeutics, and Cyclacel Pharmaceuticals. While certain trials were terminated, active recruitment continues in a clinical trial for Cushing's disease. Together, these studies highlight ongoing efforts to establish the clinical efficacy and safety of Roscovitine in endocrine and pulmonary disorders.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03774446	RECRUITING	Cushing Disease	Cedars-Sinai Medical Center	2018-11-02	PHASE2
NCT02160730	TERMINATED	Cushings Disease	Shlomo Melmed, MD	2014-05	PHASE2
NCT02649751	TERMINATED	Cystic Fibrosis	University Hospital, Brest	2016-02-22	PHASE2
NCT02649751	Terminated	Cystic Fibrosis	University Hospital Brest\|ManRos Therapeutics\|Cyclacel Pharmaceuticals Inc.	2016-02-22	Phase 2

(data from https://clinicaltrials.gov, updated on 2025-09-11)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Roscovitine acts as a potent, ATP-competitive inhibitor of cyclin-dependent kinases Cdc2, CDK2, and CDK5, which prevents downstream substrate phosphorylation and arrests cell cycle progression at the G1/S and G2/M transitions. By suppressing aberrant cell proliferation and modulating key cell-cycle pathways, this target inhibition provides the biological basis for clinical evaluations in conditions such as Cushing's disease and cystic fibrosis.

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>).