INCB057643 Clinical Trials

Size	Price	Qty
2mg	USD 147
5mg	USD 227

Clinical Trials

Multiple clinical trials sponsored by Incyte Corporation have evaluated INCB057643 across early-phase clinical development, encompassing Phase 1 and Phase 1/2 protocols for advanced malignancies, solid tumors, healthy volunteers, and myeloid neoplasms including myelofibrosis, myelodysplastic syndrome, and essential thrombocythemia. Among these, a Phase 1 trial assessing safety in subjects with myeloid neoplasms remains active but non-recruiting, several Phase 1/2 trials in advanced solid tumors were terminated, and a Phase 1 bioavailability study in healthy volunteers has been completed.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04279847	ACTIVE_NOT_RECRUITING	Myelofibrosis; Myelodysplastic Syndrome; Myelodysplastic/Myeloproliferative Neoplasm Overlap Syndrome; Myeloproliferative Neoplasm; Relapsed or Refractory Primary Myelofibrosis; Secondary Myelofibrosis (Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis); ET (Essential Thrombocythemia)	Incyte Corporation	2021-02-23	PHASE1
NCT06941077	COMPLETED	Healthy Volunteers	Incyte Corporation	2025-05-12	PHASE1
NCT02959437	TERMINATED	Solid Tumors; Advanced Malignancies; Metastatic Cancer	Incyte Corporation	2017-02-27	PHASE1; PHASE2
NCT02711137	TERMINATED	Solid Tumors	Incyte Corporation	2016-05-18	PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-04-01)

Check the INCB057643 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

INCB057643 is a small-molecule inhibitor that selectively binds to the acetylated lysine recognition motifs within the bromodomains of BET proteins, thereby disrupting their interaction with acetylated histones. This blockade suppresses transcriptional signaling networks necessary for oncogenic driver expression and cellular proliferation, demonstrating potential therapeutic utility in advanced solid tumors and myeloid neoplasms such as myelofibrosis.

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>).