Cirtuvivint Clinical Trials

Size	Price	Qty
5mg	USD 490
25mg	USD 1,470

Clinical Trials

Multiple early-phase clinical trials—specifically Phase 1, Phase 1/2, and Phase 2—are evaluating Cirtuvivint as monotherapy or combination therapy for advanced solid tumors, soft tissue sarcoma, small-cell lung cancer, gynecologic malignancies, acute myeloid leukemia, and myelodysplastic syndromes. Sponsored by commercial entities such as Biosplice Therapeutics Inc. alongside academic and national research networks including the National Cancer Institute, Washington University School of Medicine, the University of Colorado, and SELNET, these protocols currently hold recruiting or active not recruiting statuses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06856499	RECRUITING	Endometrioid Ovarian Cancer; Primary Peritoneal Cancer; Fallopian Tube Cancer	University of Colorado, Denver	2025-12-08	PHASE1
NCT07155200	RECRUITING	Small-cell Lung Cancer; Small Cell Lung Carcinoma; Small Cell Lung Cancer	Washington University School of Medicine	2025-12-18	PHASE1; PHASE2
NCT06484062	RECRUITING	Acute Myeloid Leukemia; Myelodysplastic Syndrome; Myelodysplastic Syndrome/Acute Myeloid Leukemia; Recurrent Acute Myeloid Leukemia; Recurrent Myelodysplastic Syndrome; Recurrent Myelodysplastic Syndrome/Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia; Refractory Myelodysplastic Syndrome; Refractory Myelodysplastic Syndrome/Acute Myeloid Leukemia	National Cancer Institute (NCI)	2025-08-15	PHASE1
NCT07032285	RECRUITING	Soft Tissue Sarcoma (STS)	Asociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas	2025-01-15	PHASE2
NCT03355066	Active not recruiting	Solid Tumor Adult	Biosplice Therapeutics Inc.	2017-11-06	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-07-24)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cirtuvivint selectively binds to and inhibits CDC-like kinase (CLK) and dual-specificity tyrosine-regulated kinase (DYRK), thereby blocking serine and arginine-rich splicing factor (SRSF) phosphorylation and disrupting mRNA spliceosome activity and Wnt pathway signaling. This biochemical blockade impairs oncogenic mRNA splicing and downstream tumor cell proliferation, providing the mechanistic rationale for inhibiting disease progression in clinical trial conditions such as solid tumors, soft tissue sarcoma, small-cell lung cancer, acute myeloid leukemia, and myelodysplastic syndromes.

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>).