Andrographolide Clinical Trials

Size	Price	Qty
50mg	USD 147
200mg	USD 247

Clinical Trials

Several clinical trials evaluate the therapeutic potential of andrographolide and its derivatives across acute tonsillitis, acute bronchitis, acute exacerbations of chronic bronchitis, and primary and secondary progressive multiple sclerosis. Spearheaded by industry sponsors including Jiangxi Qingfeng Pharmaceutical Co. Ltd. and Innobioscience SpA, these Phase 1, Phase 2, and Phase 4 investigations assess the compound's safety, tolerability, and efficacy as monotherapy or combination treatment. All identified trials currently exhibit an unknown recruitment status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03134443	UNKNOWN	Acute Tonsillitis	Jiangxi Qingfeng Pharmaceutical Co. Ltd.	2016-12-01	PHASE4
NCT03132623	UNKNOWN	Acute Bronchitis	Jiangxi Qingfeng Pharmaceutical Co. Ltd.	2016-12-01	PHASE4
NCT03132610	UNKNOWN	Acute Exacerbation of Chronic Bronchitis	Jiangxi Qingfeng Pharmaceutical Co. Ltd.	2016-12-01	PHASE4
NCT02273635	UNKNOWN	Primary Progressive Multiple Sclerosis; Multiple Sclerosis, Secondary Progressive	Innobioscience SpA	2014-09	PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2017-05-01)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Andrographolide modulates key inflammatory pathways by inhibiting NF-κB activation and downregulating pro-inflammatory cytokine expression, thereby reducing cellular inflammatory responses. This suppression of immune signaling provides a mechanistic rationale for its clinical evaluation in treating acute respiratory infections, such as bronchitis and tonsillitis, as well as neurodegenerative diseases like progressive multiple sclerosis.

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>).