Forskolin (Colforsin) Clinical Trials

Size	Price	Qty
10mg	USD 147
100mg	USD 570

Clinical Trials

Several clinical trials evaluate forskolin across respiratory and ophthalmological conditions, including cystic fibrosis, idiopathic dilation of the bronchi, primary open-angle glaucoma, and elevated intraocular pressure. Sponsored by academic institutions, university hospitals, and pharmaceutical organizations, these studies assess CFTR activation, epithelial transport, and intraocular pressure reduction. Operating under non-standard or unspecified phase classifications, their recruitment statuses range from completed to withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04254705	Withdrawn	Cystic Fibrosis	Universitaire Ziekenhuizen KU Leuven\|Vertex Pharmaceuticals Incorporated\|KU Leuven\|University of Lisbon	2020-03-01	Not Applicable
NCT02807415	Completed	Cystic Fibrosis	Hannover Medical School\|Heidelberg University\|University of Giessen	2016-06-01	--
NCT02586883	Completed	Idiopathic Dilation of the Bronchi	Assistance Publique - Hôpitaux de Paris	2016-03-29	Not Applicable
NCT03652090	Completed	Cystic Fibrosis	Institut National de la Santé Et de la Recherche Médicale France\|ABCF2	2010-09-01	--
NCT01254006	COMPLETED	Glaucoma	University of Roma La Sapienza

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Forskolin directly binds to and activates eukaryotic adenylyl cyclase, stimulating the intracellular conversion of ATP to cyclic AMP and elevating downstream protein kinase A signaling without requiring cell-surface receptor activation. This sustained elevation of cyclic AMP promotes smooth muscle relaxation, enhances epithelial fluid transport, and decreases aqueous humor secretion, providing a mechanistic rationale for its investigation in cystic fibrosis, bronchial disorders, and glaucoma.

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>).