Dehydroandrographolide Succinate Clinical Trials

Size	Price	Qty
1mg	USD 127

Clinical Trials

Multiple clinical trials evaluate applications associated with this compound profile across diverse clinical conditions, including gender dysphoria as well as inflammatory and metabolic disorders such as juvenile idiopathic arthritis, rheumatoid arthritis, and obesity. Encompassing Phase 1 and non-applicable phase investigations, these studies currently hold a recruitment status of not yet recruiting. Research sponsors overseeing these trials include academic and federal institutes, specifically the University of Wisconsin-Madison, Duke University, and the National Institute of Arthritis and Musculoskeletal and Skin Diseases.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05903911	Not yet recruiting	Gender Dysphoria	University of Wisconsin Madison	2024-10	Not Applicable
NCT04585711	Not yet recruiting	Juvenile Idiopathic Arthritis\|Rheumatoid Arthritis\|Obesity	Duke University\|National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	2024-07-01	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dehydroandrographolide succinate binds key pro-inflammatory mediators and microbial targets, blocking downstream NF-κB signaling and viral replication cascades to inhibit cellular cytokine release and pathogen propagation. By reducing pathological immune activation and viral burden, the compound exhibits therapeutic relevance across infectious diseases and chronic inflammatory disorders, including rheumatoid arthritis and juvenile idiopathic arthritis.

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>).