Triptolide Clinical Trials

Size	Price	Qty
1mg	USD 147
5mg	USD 370

Clinical Trials

Several clinical trials have evaluated triptolide across Phase 1 through Phase 3 studies, focusing on treatment-naive and acute HIV-1 infections, autosomal dominant polycystic kidney disease, and advanced non-small cell lung cancer. Sponsored predominantly by major academic medical centers such as Peking Union Medical College Hospital, Shanghai Changzheng Hospital, and City of Hope Medical Center, these evaluations encompass varied recruitment statuses, including completed, active but not recruiting, terminated, and unknown. Completed studies have specifically investigated critical outcomes such as viral suppression and immune biomarkers.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05166616	ACTIVE_NOT_RECRUITING	Advanced Lung Non-Small Cell Carcinoma; Locally Advanced Lung Non-Small Cell Carcinoma; Stage III Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8; Unresectable Lung Non-Small Cell Carcinoma	City of Hope Medical Center	2022-03-07	PHASE1
NCT03403569	COMPLETED	HIV-infection/AIDS	Peking Union Medical College Hospital	2018-09-01	PHASE3
NCT02219672	UNKNOWN	AIDS/HIV PROBLEM	Peking Union Medical College	2014-07	PHASE3
NCT02115659	UNKNOWN	Autosomal Dominant Polycystic Kidney Disease (ADPKD)	Shanghai Changzheng Hospital	2014-04	PHASE3
NCT01817283	UNKNOWN	HIV	LI Taisheng	2013-01	PHASE1; PHASE2
NCT00801268	TERMINATED	Polycystic Kidney	Zhi-Hong Liu, M.D.	2008-11

(data from https://clinicaltrials.gov, updated on 2026-03-05)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Triptolide functions by inhibiting NF-κB through the disruption of p65/CBP interactions, reducing p65 protein levels, abrogating HSF1 transactivation, and downregulating MDM2 to trigger p53-independent apoptosis. This multi-targeted pathway blockade suppresses aberrant cellular proliferation, inflammatory signaling, and viral activation, providing a therapeutic rationale for its study in non-small cell lung cancer, autosomal dominant polycystic kidney disease, and HIV-1 infection.

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>).