XL019 Clinical Trials

Size	Price	Qty
5mg	USD 297
25mg	USD 970

Clinical Trials

XL019 was evaluated in several Phase 1 dose-escalation clinical trials sponsored by Exelixis to assess its safety, pharmacokinetics, and pharmacodynamics in patients with myeloproliferative disorders, specifically polycythemia vera, myelofibrosis, and essential thrombocythemia. However, recruitment for these studies was terminated, effectively halting early-stage clinical evaluation during Phase 1. Consequently, no active or recruiting clinical trials are presently listed on record for this agent.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00595829	TERMINATED	Polycythemia Vera	Exelixis	2007-12	PHASE1
NCT00595829	Terminated	Polycythemia Vera	Exelixis	2007-12	Phase 1
NCT00522574	Terminated	Myeloproliferative Disorders\|Myelofibrosis\|Polycythemia Vera\|Thrombocythemia Essential	Exelixis	2007-08	Phase 1
NCT00522574	TERMINATED	Myeloproliferative Disorders; Myelofibrosis; Polycythemia Vera; Thrombocythemia, Essential	Exelixis	2007-08	PHASE1

(data from https://clinicaltrials.gov, updated on 2015-08-21)

Check the XL019 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

XL019 selectively binds to Janus kinase 2 (JAK2), potently blocking its enzymatic activity and preventing the phosphorylation of downstream signal transducer and activator of transcription (STAT) proteins. By disrupting this oncogenic signaling cascade, XL019 suppresses hyperactive cellular proliferation and promotes apoptosis in dependent cell populations, which is directly relevant to controlling pathological cell growth in myeloproliferative disorders such as polycythemia vera, myelofibrosis, and essential thrombocythemia.

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>).