Culmerciclib Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

Several Phase II clinical trials are evaluating culmerciclib across early-stage and metastatic breast cancer settings, including hormone receptor-positive/HER2-negative and HER2-positive subtypes. Sponsored by academic medical centers such as Sun Yat-Sen Memorial Hospital, Fudan University, and Shengjing Hospital, these studies investigate combination regimens with endocrine therapy, anti-HER2 targeted agents, or anlotinib for neoadjuvant therapy and brain metastases. These active trials are currently either recruiting or not yet recruiting participants.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07732491	RECRUITING	Breast Cancer; Metastastic Breast Cancer; HER2+ Advanced Breast Cancer	Sun Yat-sen University	2026-08-01	PHASE2
NCT07796880	NOT_YET_RECRUITING	HR-Positive, HER2-Negative Early-Stage Breast Cancer	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	2026-09-15	PHASE2
NCT07666555	RECRUITING	Breast Cancer	Fudan University	2026-06-06	PHASE2
NCT07616453	RECRUITING	HR+/HER2- Early Breast Cancer	Second Affiliated Hospital, Zhejiang University, School of Medicine	2026-05-06	PHASE2
NCT07795424	NOT_YET_RECRUITING	Breast Cancer; HR Positive, HER2 Positive Breast Cancer	Shengjing Hospital	2026-09-01	PHASE2
NCT07745257	NOT_YET_RECRUITING	HR-positive, HER2-negative Metastatic Breast Cancer With Brain Metastases	Sun Yat-sen University	2026-08-28	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-07-29)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Culmerciclib acts as a potent inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6), blocking retinoblastoma protein phosphorylation and inhibiting cell cycle progression from the G1 to S phase. This inhibition results in cell cycle arrest and suppressed cell proliferation, demonstrating therapeutic antineoplastic activity against hormone receptor-positive and HER2-positive breast cancers studied in clinical settings.

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>).