H3B-8800 Clinical Trials

Size	Price	Qty
1mg	USD 370
5mg	USD 970

Clinical Trials

A clinical trial evaluated the therapeutic application of H3B-8800 in an open-label, multicenter Phase 1 study sponsored by the biopharmaceutical company Hemavant Sciences GmbH. The trial was designed to assess the safety, pharmacokinetic, and pharmacodynamic profiles of the compound in patients with acute myeloid leukemia, myelodysplastic syndromes, or chronic myelomonocytic leukemia. However, the study's recruitment status is officially recorded as terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02841540	TERMINATED	Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic	Hemavant Sciences GmbH	2016-10-06	PHASE1

(data from https://clinicaltrials.gov, updated on 2024-02-14)

Check the H3B-8800 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

H3B-8800 directly interacts with and potently modulates the SF3b complex, altering core RNA splicing machinery to disrupt pre-mRNA processing selectively in spliceosome-mutant cells. This targeted inhibition leads to aberrant transcript accumulation and selective cytotoxicity, demonstrating potential clinical relevance for the treatment of hematologic malignancies such as acute myeloid leukemia, myelodysplastic syndromes, and chronic myelomonocytic leukemia.

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>).