Neotuberostemonine Clinical Trials

Size	Price	Qty
5mg	USD 429
25mg	USD 1,287

Clinical Trials

Several clinical trials across diverse phases evaluate conditions such as educational problems, Respiratory Syncytial Virus, and Type II Diabetes Mellitus with neurological manifestations. These initiatives are led by academic and industry sponsors, including Stanford University, Pfizer, and the Health Education Research Foundation. Among these, an actively recruiting Phase 3 trial sponsored by Pfizer focuses on Respiratory Syncytial Virus, whereas additional studies evaluating augmented reality resuscitation assessment and diabetic peripheral neuropathy are not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06326450	Not yet recruiting	Educational Problems	Stanford University	2024-06-01	Not Applicable
NCT05906173	Not yet recruiting	Educational Problems	Stanford University	2024-06-01	Not Applicable
NCT05940103	Not yet recruiting	Educational Problems	Stanford University	2024-06-01	Not Applicable
NCT06325657	Recruiting	Respiratory Syncytial Virus	Pfizer	2024-03-12	Phase 3
NCT06101368	Not yet recruiting	Type II Diabetes Mellitus With Neurological Manifestations	Health Education Research Foundation (HERF)	2024-01-01	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Neotuberostemonine interacts with pulmonary inflammatory pathways to block downstream biochemical signaling necessary for M2 macrophage polarization. This reduction in macrophage activation suppresses pro-fibrotic cellular responses and tissue remodeling, mitigating excessive airway inflammation in clinical trial conditions such as Respiratory Syncytial Virus 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>).