Caulophylline (N-Methylcytisine) Clinical Trials

Size	Price	Qty
1mg	USD 117

Clinical Trials

Several clinical trials sponsored by academic and industrial entities evaluate a broad spectrum of medical conditions, including pediatric cerebral palsy, ventilator-induced lung injury, rhinoplasty, tobacco cessation, and malignancies of the breast, lung, and gastrointestinal tract. Spanning Early Phase 1 through observational designs, these studies encompass recruiting, completed, and withdrawn recruitment statuses. Evaluated interventions include the Mollii Suit, diaphragmatic electrical monitoring, povidone-iodine mucosal effects, and biomarker alterations during smoking abstinence.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06302790	Recruiting	Mollii Suit\|Cerebral Palsy	Kırıkkale University\|Gazi University	2024-03-01	Not Applicable
NCT05689476	Recruiting	Work of Breathing\|Lung Transplantation\|Neurally Adjusted Ventilatory Assist\|Ventilator-Induced Lung Injury	University of Padova	2022-12-27	Not Applicable
NCT04457765	Withdrawn	Rhinoplasty	Boston Medical Center	2021-04	Early Phase 1
NCT04979013	Completed	Smoking\|Smoking Cessation\|Tobacco Use	RAI Services Company	2019-05-30	Not Applicable
NCT02012699	Recruiting	Pancreatic Cancer\|Thyroid Cancer\|Lung Cancer\|Esophageal Cancer\|Thymus Cancer\|Colon Cancer\|Rectal Cancer\|Gastrointestinal Stromal Tumors\|Anal Cancer\|Bile Duct Cancer\|Duodenal Cancer\|Gallbladder Cancer\|Gastric Cancer\|Liver Cancer\|Small Intestine Cancer\|Peritoneal Surface Malignancies\|Familial Adenomatous Polyposis\|Lynch Syndrome\|Bladder Cancer\|Kidney Cancer\|Penile Cancer\|Prostate Cancer\|Testicular Cancer\|Ureter Cancer\|Urethral Cancer\|Hypopharyngeal Cancer\|Laryngeal Cancer\|Lip Cancer\|Oral Cavity Cancer\|Nasopharyngeal Cancer\|Oropharyngeal Cancer\|Paranasal Sinus Cancer\|Nasal Cavity Cancer\|Salivary Gland Cancer\|Skin Cancer\|Central Nervous System Tumor\|Central Nervous System Cancer\|Mesothelioma\|Breast Cancer\|Leukemia\|Melanoma\|Sarcoma\|Unknown Primary Tumor\|Multiple Myeloma\|Ovarian Cancer\|Endometrial Cancer\|Vaginal Cancer\|Neuroendocrine Tumors\|Plasma Cell Dyscrasia\|Healthy Control	University of Nebraska	2013-11-01	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Caulophylline selectively binds to nicotinic acetylcholine receptors with a Kd of 50 nM and inhibits IκB and IKK phosphorylation, which blocks downstream NF-κB activation and reduces myeloperoxidase activity to dampen cellular inflammatory cascades. By suppressing pro-inflammatory signaling and targeting central nicotinic receptors, this compound offers mechanistic relevance to clinical studies evaluating smoking cessation, respiratory mechanics in lung injury, and chronic inflammatory conditions.

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>).