Celastrol (Tripterine) Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 370

Clinical Trials

Multiple clinical trials evaluate celastrol across health and dermatological applications, including general safety evaluations, sperm motility safety, dandruff, and scalp seborrhoeic dermatitis. Sponsored by both industry entities, such as Legend Labz Inc., and academic institutions, including Seoul National University Bundang Hospital, these studies feature non-applicable trial phases. Current recruitment statuses across these trials encompass recruiting, completed, and unknown states.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07459023	COMPLETED	Dandruff; Seborrhoeic Dermatitis of the Scalp	Seoul National University Bundang Hospital	2025-07-01
NCT05494112	UNKNOWN	Safety	Legend Labz, Inc.	2022-05-25
NCT05413226	UNKNOWN	Safety Issues	Legend Labz, Inc.	2021-09-28
NCT05494112	Recruiting	Safety	Legend Labz Inc.	2022-05-25	Not Applicable
NCT05413226	Recruiting	Safety Issues	Legend Labz Inc.	2021-09-28	Not Applicable

(data from https://clinicaltrials.gov, updated on 2026-03-09)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Celastrol potently inhibits the chymotrypsin-like activity of the 20S proteasome and suppresses LPS-induced inflammatory cytokine release, triggering ROS/JNK pathway activation to induce apoptosis and autophagy. This dual modulation of proteasomal function and pro-inflammatory signaling underlies its therapeutic activity, directly supporting its clinical evaluation for safety and dermatological conditions such as seborrhoeic dermatitis of the scalp and dandruff.

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>).