DSP5336 Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

Sponsored by Sumitomo Pharma America, Inc., multiple clinical trials are actively recruiting to evaluate the therapeutic potential and pharmacokinetic profile of DSP5336. These Phase 1 and Phase 1/2 studies target advanced hematologic malignancies, including acute myeloid leukemia, acute lymphocytic leukemia, multiple myeloma, and myelodysplastic syndromes. The clinical program includes assessments of dose escalation and expansion, as well as the compound's oral absorption, metabolism, and excretion in patients with relapsed or refractory blood neoplasms.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04988555	RECRUITING	Leukemia, Myeloid, Acute; Leukemia, Lymphocytic, Acute; Multiple Myeloma; Myelodysplastic Syndromes	Sumitomo Pharma America, Inc.	2022-02-28	PHASE1; PHASE2
NCT07444268	RECRUITING	Advanced Hematologic Malignancies	Sumitomo Pharma America, Inc.	2026-03-26	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-03-24)

Check the DSP5336 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

DSP5336 is a small-molecule inhibitor that selectively disrupts the interaction between menin and MLL (mixed-lineage leukemia) proteins, thereby suppressing downstream leukemogenic transcription programs and arresting target cell proliferation. By disrupting this oncogenic transcriptional complex to promote cellular differentiation and induce apoptosis, DSP5336 provides a targeted therapeutic strategy for advanced hematologic malignancies including acute myeloid leukemia and acute lymphocytic 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>).