Stemregenin 1 (SR1) Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 370

Clinical Trials

Multiple clinical trials spanning Phase 1, Phase 2, and Phase 1/2 evaluate indications across hematologic malignancies—including acute myeloid, acute lymphocytic, and chronic myelogenous leukemias, as well as myelodysplasia—alongside psoriasis, Lyme disease, muscle spasticity, and healthy volunteers. Sponsored by commercial entities such as Galderma R&D, ModernaTX, Inc., and Otsuka Pharmaceutical, as well as academic institutions like the Masonic Cancer Center at the University of Minnesota, these studies encompass completed, terminated, and withdrawn recruitment statuses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05975099	COMPLETED	Lyme Disease	ModernaTX, Inc.	2023-07-26	PHASE1; PHASE2
NCT04925921	COMPLETED	Wrinkle; Benign Pigmented Lesion	AVAVA, Inc.	2021-05-10
NCT02765997	WITHDRAWN	Acute Myeloid Leukemia; Acute Lymphocytic Leukemia; Chronic Myelogenous Leukemia; Myelodysplasia	Masonic Cancer Center, University of Minnesota	2017-04	PHASE2
NCT03885882	COMPLETED	Healthy Subjects	Eisai Co., Ltd.	2019-04-13	PHASE1
NCT02827513	TERMINATED	Adult Attention-deficit Hyperactivity Disorder (ADHD)	Otsuka Pharmaceutical Development & Commercialization, Inc.	2015-12	PHASE1
NCT01744808	COMPLETED	Normal, Healthy Volunteers	Otsuka Pharmaceutical Development & Commercialization, Inc.	2013-02-01	PHASE1
NCT00557973	COMPLETED	Muscle Spasticity	XenoPort, Inc.	2007-12	PHASE2
NCT00934323	COMPLETED	Healthy	Handok Inc.	2008-10	PHASE1
NCT00763555	Completed	Psoriasis	Galderma R&D	2008-09	Phase 2

(data from https://clinicaltrials.gov, updated on 2026-07-30)

Check the Stemregenin 1 (SR1) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Stemregenin 1 (SR1) selectively binds and inhibits the aryl hydrocarbon receptor (AhR) with an IC50 of 127 nM, blocking ligand-induced nuclear translocation and suppressing downstream target gene transcription. This pathway inhibition promotes the ex vivo expansion of hematopoietic progenitor cells, offering therapeutic relevance for hematologic conditions such as acute myeloid leukemia and myelodysplastic syndromes evaluated in clinical trials.

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>).