Clinical Trials

Numerous clinical trials across Phase 1, Phase 2, and Phase 3 are currently evaluating Bomedemstat (IMG-7289) in hematologic malignancies and myeloproliferative neoplasms—including essential thrombocythemia, myelofibrosis, polycythemia vera, and acute myeloid leukemia—as well as small cell lung carcinoma. Development is driven by pharmaceutical sponsors such as Imago BioSciences and Merck Sharp & Dohme, alongside academic medical centers including The University of Hong Kong and the University of Washington. Trial statuses range from completed Phase 2 studies to actively recruiting and upcoming Phase 3 investigations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06351631 RECRUITING
Thrombocythemia, Essential; Primary Myelofibrosis; Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis; Polycythemia Vera
Merck Sharp & Dohme LLC
 2024-05-23 PHASE3
NCT07722611 NOT_YET_RECRUITING
Polycythemia Vera
Merck Sharp & Dohme LLC
 2026-09-21 PHASE2; PHASE3
NCT07424950 NOT_YET_RECRUITING
Myelofibrosis
United Lincolnshire Hospitals NHS Trust
 2026-11-01 PHASE2
NCT06456346 ACTIVE_NOT_RECRUITING
Essential Thrombocythemia
Merck Sharp & Dohme LLC
 2024-07-16 PHASE3
NCT06079879 ACTIVE_NOT_RECRUITING
Essential Thrombocythemia
Merck Sharp & Dohme LLC
 2023-12-31 PHASE3
NCT05597306 RECRUITING
Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia; Acute Myeloid Leukemia, in Relapse
Terrence J Bradley, MD
 2022-11-19 PHASE1
NCT07049939 COMPLETED
Hepatic Insufficiency
Merck Sharp & Dohme LLC
 2025-08-20 PHASE1
NCT05558696 COMPLETED
Polycythemia Vera
Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
 2023-09-07 PHASE2
NCT06596668 COMPLETED
Healthy
Merck Sharp & Dohme LLC
 2024-10-02 PHASE1
NCT05569538 UNKNOWN
Myelofibrosis
The University of Hong Kong
 2022-12-01 PHASE2
NCT05223920 COMPLETED
Thrombocythemia, Essential; Primary Myelofibrosis
Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
 2021-12-15 PHASE2
NCT05191797 TERMINATED
Extensive Stage Lung Small Cell Carcinoma; Limited Stage Lung Small Cell Carcinoma
University of Washington
 2022-04-11 PHASE1; PHASE2
NCT04254978 COMPLETED
Essential Thrombocythemia
Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
 2020-09-08 PHASE2
NCT03136185 COMPLETED
Myelofibrosis; Post-polycythemia Vera Myelofibrosis (PPV-MF); Post-essential Thrombocythemia Myelofibrosis (PET-MF); Primary Myelofibrosis (PMF)
Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
 2017-07-18 PHASE1; PHASE2
NCT02842827 COMPLETED
Acute Myeloid Leukemia; Myelodysplastic Syndrome
Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
 2016-10-06 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-04-02)

Check the Bomedemstat (IMG-7289) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bomedemstat (IMG-7289) is an orally active, irreversible inhibitor of lysine-specific demethylase 1 (LSD1) that blocks histone demethylation, thereby elevating H3K4 and H3K9 methylation levels to alter epigenetic gene transcription, suppress neoplastic proliferation, and trigger apoptotic cell death. This targeted chromatin remodeling interrupts oncogenic gene expression, suppressing tumor burden and providing clinical utility in hematologic malignancies such as essential thrombocythemia, myelofibrosis, and acute myeloid 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>).

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Note: Technical data last updated: Sep 1, 2026.