Iadademstat (ORY-1001) Dihydrochloride Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 570

Clinical Trials

Multiple clinical trials are evaluating iadademstat in Phase 1 and Phase 2 studies for hematologic malignancies and solid tumors, including acute myeloid leukemia, myelodysplastic syndromes, myeloproliferative neoplasms, and small-cell lung cancer. These early-stage investigations assess iadademstat as monotherapy or alongside agents such as azacitidine, venetoclax, or immune checkpoint inhibitors. Sponsored by industry developers, academic centers, and government entities—including Oryzon Genomics, Yale University, OHSU Knight Cancer Institute, and the National Cancer Institute—recruitment statuses vary from actively recruiting to suspended or terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07113691	RECRUITING	Extensive Stage Small Cell Lung Cancer (ES-SCLC)	Yale University	2026-01-20	PHASE1
NCT06287775	RECRUITING	Extensive Stage Lung Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8	National Cancer Institute (NCI)	2025-04-08	PHASE1; PHASE2
NCT06661915	RECRUITING	Accelerated Phase Myeloproliferative Neoplasm; Blast Phase Myeloproliferative Neoplasm; Essential Thrombocythemia; Myelodysplastic/Myeloproliferative Neoplasm; Myeloproliferative Neoplasm, Not Otherwise Specified; Polycythemia Vera; Primary Myelofibrosis; Secondary Myelofibrosis	National Cancer Institute (NCI)	2025-08-14	PHASE2
NCT06514261	SUSPENDED	Acute Myeloid Leukemia	National Cancer Institute (NCI)	2024-12-18	PHASE1
NCT06357182	RECRUITING	Acute Myeloid Leukemia; Myelodysplastic Syndrome/Acute Myeloid Leukemia	OHSU Knight Cancer Institute	2024-08-22	PHASE1
NCT06502145	RECRUITING	Myelodysplastic Syndromes	Medical College of Wisconsin	2025-01-10	PHASE1
NCT05546580	ACTIVE_NOT_RECRUITING	Acute Myeloid Leukemia, in Relapse; Acute Myeloid Leukemia Refractory	Oryzon Genomics S.A.	2022-11-14	PHASE1
NCT05420636	TERMINATED	Small-cell Lung Cancer; Neuroendocrine Carcinoma	Fox Chase Cancer Center	2022-12-21	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-03-27)

Check the Iadademstat (ORY-1001) Dihydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Iadademstat selectively binds to and potently inhibits lysine-specific demethylase 1 (LSD1/KDM1A), preventing the demethylation of histone H3 lysine 4 (H3K4) and disrupting transcriptional complexes required for oncogenic cell proliferation. By promoting cellular differentiation and reactivating apoptotic pathways, this epigenetic blockade suppresses tumor growth, providing therapeutic rationale for ongoing clinical studies in acute myeloid leukemia and small-cell lung cancer.

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>).