Oxysophocarpine Clinical Trials

Size	Price	Qty
5mg	USD 147

Clinical Trials

Several clinical trials sponsored by academic and research institutions—including Yale University, the National Institute on Drug Abuse, National Jewish Health, and Stichting Hemato-Oncologie voor Volwassenen Nederland—are evaluating interventions across indications such as Opioid Use Disorder, high-grade B-cell Non-Hodgkin Lymphoma, corticosteroid-resistant asthma, and neonatal respiratory distress syndrome. Encompassing Phase 1, Phase 2, and non-applicable trial designs, these studies span various recruitment statuses, including recruiting, not yet recruiting, active non-recruiting, completed, and withdrawn protocols.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06160284	Not yet recruiting	Opioid Use Disorder	Yale University\|National Institute on Drug Abuse (NIDA)	2024-07	Phase 1
NCT05447286	Recruiting	Opioid Use Disorder	Yale University\|National Institute on Drug Abuse (NIDA)\|Aptinyx	2023-05-15	Phase 1
NCT03620578	Active not recruiting	Non Hodgkin Lymphoma\|Lymphoma B-Cell\|High-grade B-cell Lymphoma\|MYC Translocation\|BCL-2 Translocation	Stichting Hemato-Oncologie voor Volwassenen Nederland	2018-08-01	Phase 2
NCT02753764	Completed	Corticosteroid Resistant (CR) Asthmatics	National Jewish Health	2017-01	Phase 2
NCT01277874	Withdrawn	Respiratory Distress Syndrome\|Prematurity	University of Utah	2014-12	Not Applicable

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Oxysophocarpine targets the nuclear factor erythroid 2-related factor 2/heme oxygenase-1 (Nrf2/HO-1) signaling axis and attenuates downstream mitogen-activated protein kinase (MAPK) and nuclear factor kappa B (NF-κB) pathways, suppressing pro-inflammatory cascades and modulating cellular apoptosis. This modulation inhibits cellular metastasis and disease progression, providing a mechanistic rationale for therapeutic intervention in inflammatory and neoplastic conditions evaluated in clinical trials, such as corticosteroid-resistant asthma and high-grade B-cell lymphoma.

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>).