Dalpiciclib Clinical Trials

Size	Price	Qty
5mg	USD 570
25mg	USD 1,707

Clinical Trials

Multiple clinical trials are currently evaluating the therapeutic application and pharmacokinetics of dalpiciclib (SHR-6390) in Phase 1 development for oncological indications, specifically hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer. Supported by pharmaceutical sponsors like Jiangsu HengRui Medicine Co. Ltd. and research institutions such as Beijing 302 Hospital, these studies include an actively recruiting trial in subjects with renal impairment alongside a planned trial assessing combination therapy with chidamide post-CDK4/6 inhibitor treatment. These investigations highlight the targeted evaluation of dalpiciclib across diverse patient cohorts and therapeutic combinations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05515289	Recruiting	Breast Cancer	Jiangsu HengRui Medicine Co. Ltd.	2022-12-18	Phase 1
NCT05586841	Not yet recruiting	HR+/HER2- Advanced Breast Cancer	Beijing 302 Hospital	2022-11-01	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dalpiciclib selectively binds to cyclin-dependent kinases 4 and 6 (CDK4/6), blocking downstream phosphorylation of the tumor-suppressor retinoblastoma protein (Rb) and arresting the cell cycle at the G1 phase. This inhibition of Rb phosphorylation suppresses aberrant cellular proliferation, providing the mechanism for controlling tumor growth in breast cancer and hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer.

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>).