FHD-286 (Camibirstat) Clinical Trials

Size	Price	Qty
5mg	USD 370
25mg	USD 970

Clinical Trials

Multiple clinical trials evaluate FHD-286 (camibirstat) across Phase 1 and Phase 2 studies for hematologic malignancies and solid tumors. Industry sponsor Foghorn Therapeutics Inc. initiated Phase 1 trials in advanced hematologic malignancies—including acute myeloid leukemia, myelodysplastic syndromes, and chronic myelomonocytic leukemia (active, not recruiting)—and a terminated trial in metastatic uveal melanoma. Additionally, academic institutions lead a recruiting Phase 1 combination trial with low-dose decitabine and venetoclax at Montefiore Medical Center and a Dana-Farber Cancer Institute–sponsored Phase 2 study in POU2F3-positive small cell lung cancer that is not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07283094	RECRUITING	Acute Myeloid Leukemia; Myelodysplastic Syndrome	Montefiore Medical Center	2026-02-03	PHASE1
NCT07551635	NOT_YET_RECRUITING	Small Cell Lung Cancer	Dana-Farber Cancer Institute	2026-09-04	PHASE2
NCT04891757	ACTIVE_NOT_RECRUITING	Advanced Hematologic Malignancy; Relapsed Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia; Relapsed Myelodysplastic Syndromes; Refractory Myelodysplastic Syndromes; Relapsed Chronic Myelomonocytic Leukemia; Refractory Chronic Myelomonocytic Leukemia	Foghorn Therapeutics Inc.	2021-06-14	PHASE1
NCT04879017	TERMINATED	Metastatic Uveal Melanoma	Foghorn Therapeutics Inc.	2021-05-11	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-03-03)

Check the FHD-286 (Camibirstat) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Camibirstat (FHD-286) selectively inhibits the BRG1 and BRM ATPase subunits of the BAF chromatin remodeling complex, disrupting ATP-dependent nucleosome positioning and transcriptional activation required for oncogenic gene expression programs. This targeted disruption suppresses aberrant chromatin accessibility and halts neoplastic cell proliferation, demonstrating clinical relevance in BAF-dependent malignancies such as acute myeloid leukemia and small cell lung cancer under clinical evaluation.

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>).