Dehydrocostus Lactone Clinical Trials

Size	Price	Qty
25mg	USD 170

Clinical Trials

Multiple completed clinical trials have evaluated DHE formulations across indications including migraine with or without aura, breast cancer, pregnancy, and healthy volunteer cohorts. Sponsored by industry entities—such as Satsuma Pharmaceuticals Inc., Genentech Inc., and Allergan/MAP Pharmaceuticals Inc.—and institutional sponsors like Centre Hospitalier Universitaire Dijon, these investigations primarily comprised Phase 1 studies alongside a clinical trial with a non-applicable phase classification. These Phase 1 studies specifically evaluated safety, tolerability, and pharmacokinetics.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05337254	Completed	Migraine\|Migraine With Aura\|Migraine Without Aura	Satsuma Pharmaceuticals Inc.	2021-03-05	Phase 1
NCT03874832	Completed	Migraine With Aura\|Migraine Without Aura\|Migraine	Satsuma Pharmaceuticals Inc.	2018-09-11	Phase 1
NCT03451162	Completed	Breast Cancer	Genentech Inc.	2018-04-17	Phase 1
NCT01468558	Completed	Healthy	Allergan\|MAP Pharmaceuticals Inc. a wholly owned subsidiary of Allergan	2010-07	Phase 1
NCT02862886	Completed	Pregnancy	Centre Hospitalier Universitaire Dijon	2010-07	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dehydrocostus lactone directly inhibits IKKβ activity, thereby preventing IκBα phosphorylation and degradation to suppress p50/p65 NF-κB nuclear translocation, p300 coactivator recruitment, and downstream COX-2 promoter binding. This blockage of NF-κB signaling suppresses pro-inflammatory transcriptional programs and reduces cell proliferation, offering therapeutic potential for conditions such as breast cancer.

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>).