Oxeladin Citrate Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Several clinical trials are investigating therapeutic interventions for diverse conditions, including head and neck cancer, relapsing and progressive forms of multiple sclerosis, obesity with pre-diabetes, and Parkinson's disease. Spanning Phase 3 evaluations as well as unassigned or non-applicable phases, these studies are supported by pharmaceutical companies like Sanofi, digital health entities such as Aptar Digital Health, and academic institutions including Baylor College of Medicine and Guang'anmen Hospital. Current recruitment statuses across these studies range from recruiting and enrolling by invitation to not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06385587	Not yet recruiting	Head and Neck Cancer	Aptar Digital Health	2024-05-03	--
NCT06372145	Recruiting	Relapsing Multiple Sclerosis\|Secondary Progressive Multiple Sclerosis\|Progressive Relapsing Multiple Sclerosis	Sanofi	2024-04-16	Phase 3
NCT06359418	Not yet recruiting	Obesity\|Pre-diabetes	Guang''anmen Hospital of China Academy of Chinese Medical Sciences\|Hubei Hospital of Traditional Chinese Medicine\|The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine\|Dongfang Hospital Beijing University of Chinese Medicine\|Guangdong Provincial Hospital of Traditional Chinese Medicine\|Heilongjiang Academy of traditional Chinese Medicine	2024-04-10	Not Applicable
NCT06272955	Enrolling by invitation	Parkinson Disease	Nora Vanegas\|Baylor College of Medicine	2024-01-04	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Oxeladin citrate selectively suppresses central cough centers in the medulla oblongata, blocking the downstream signal transmission of the afferent cough reflex arc without causing central respiratory depression. This central pathway inhibition attenuates involuntary smooth muscle contractions in the airway to alleviate persistent coughing, offering potential symptomatic utility across clinical settings including head and neck cancer, neurodegenerative diseases, and metabolic disorders.

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>).