SEL120 (SEL120-34A) hydrochloride Clinical Trials

Size	Price	Qty
1mg	USD 147
5mg	USD 337

Clinical Trials

SEL120 (RVU120) is currently being evaluated across several clinical trials addressing hematologic malignancies and advanced solid tumors. These Phase 1 and Phase 2 studies focus on acute myeloid leukemia, high- and lower-risk myelodysplastic syndromes, and metastatic solid tumors. Sponsored by Ryvu Therapeutics SA and GCP-Service International West GmbH, the trials report recruitment statuses including active, not recruiting, and unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06243458	ACTIVE_NOT_RECRUITING	Low Risk Myelodysplastic Syndromes	GCP-Service International West GmbH	2024-09-10	PHASE2
NCT05052255	ACTIVE_NOT_RECRUITING	Advanced Solid Tumor	Ryvu Therapeutics SA	2021-08-13	PHASE1; PHASE2
NCT04021368	UNKNOWN	Acute Myeloid Leukemia; High-risk Myelodysplastic Syndrome	Ryvu Therapeutics SA	2019-09-04	PHASE1

(data from https://clinicaltrials.gov, updated on 2025-05-22)

Check the SEL120 (SEL120-34A) hydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

SEL120 hydrochloride selectively binds to and inhibits cyclin-dependent kinase 8 (CDK8) and CDK19, blocking Mediator complex kinase activity and suppressing downstream oncogenic transcriptional programs. This disruption of transcriptional regulation impairs cell proliferation and induces apoptosis in malignant cells, providing therapeutic relevance in the context of acute myeloid leukemia, myelodysplastic syndromes, 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>).