Seclidemstat (SP-2577) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Seclidemstat (SP-2577) has been evaluated in several Phase 1 and Phase 1/2 clinical trials sponsored by academic and industry entities across diverse oncologic conditions, including advanced solid tumors, soft tissue sarcomas such as Ewing sarcoma, hematologic malignancies, and SWI/SNF-mutant gynecologic cancers. Recruitment is complete for studies in advanced solid tumors, while trials targeting sarcomas and hematologic disorders remain active but non-recruiting. Conversely, an exploratory evaluation in select gynecologic malignancies was withdrawn prior to study completion.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04734990	ACTIVE_NOT_RECRUITING	Chronic Myelomonocytic Leukemia-0; Chronic Myelomonocytic Leukemia-1; Chronic Myelomonocytic Leukemia-2; Myelodysplastic Syndrome; Recurrent Chronic Myelomonocytic Leukemia; Recurrent Myelodysplastic Syndrome	M.D. Anderson Cancer Center	2021-07-07	PHASE1; PHASE2
NCT05266196	UNKNOWN	Ewing Sarcoma; Myxoid Liposarcoma; Desmoplastic Small Round Cell Tumor; Extraskeletal Myxoid Chondrosarcoma; Angiomatoid Fibrous Histiocytoma; Clear Cell Sarcoma; Myoepithelial Tumor; Low Grade Fibromyxoid Sarcoma; Sclerosing Epithelioid Fibrosarcoma	Salarius Pharmaceuticals, LLC	2022-01-15	PHASE1; PHASE2
NCT03600649	UNKNOWN	Ewing Sarcoma; Myxoid Liposarcoma; Sarcoma,Soft Tissue; Desmoplastic Small Round Cell Tumor; Extraskeletal Myxoid Chondrosarcoma; Angiomatoid Fibrous Histiocytoma; Clear Cell Sarcoma; Primary Pulmonary Myxoid Sarcoma; Myoepithelial Tumor; Sclerosing Epithelioid Fibrosarcoma; Fibromyxoid Tumor	Salarius Pharmaceuticals, LLC	2018-06-04	PHASE1
NCT04611139	WITHDRAWN	SCCOHT; Ovarian Clear Cell Tumor; Ovarian Endometrioid Adenocarcinoma; Endometrial Cancer	HonorHealth Research Institute	2021-12-31	PHASE1
NCT04611139	Withdrawn	SCCOHT\|Ovarian Clear Cell Tumor\|Ovarian Endometrioid Adenocarcinoma\|Endometrial Cancer	HonorHealth Research Institute\|Merck Sharp & Dohme LLC\|Salarius Pharmaceuticals LLC	2021-12-31	Phase 1
NCT03895684	COMPLETED	Advanced Solid Tumors	Salarius Pharmaceuticals, LLC	2019-06-25	PHASE1
NCT03895684	Completed	Advanced Solid Tumors	Salarius Pharmaceuticals LLC	2019-06-25	Phase 1
NCT03600649	Active not recruiting	Ewing Sarcoma\|Myxoid Liposarcoma\|SarcomaSoft Tissue\|Desmoplastic Small Round Cell Tumor\|Extraskeletal Myxoid Chondrosarcoma\|Angiomatoid Fibrous Histiocytoma\|Clear Cell Sarcoma\|Primary Pulmonary Myxoid Sarcoma\|Myoepithelial Tumor\|Sclerosing Epithelioid Fibrosarcoma\|Fibromyxoid Tumor	Salarius Pharmaceuticals LLC\|National Pediatric Cancer Foundation	2018-06-04	Phase 1

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

Check the Seclidemstat (SP-2577) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Seclidemstat (SP-2577) selectively binds to lysine-specific demethylase 1 (LSD1/KDM1A) with an IC50 of 13 nM, thereby inhibiting its enzymatic histone demethylase activity and disrupting oncogenic transcriptional regulatory complexes. This epigenetic blockade alters gene expression programs to inhibit cancer cell proliferation and trigger differentiation or apoptosis, providing the mechanistic basis for its clinical investigation in conditions such as advanced solid tumors, Ewing sarcoma, and myelodysplastic syndromes.

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>).