Goitrin Clinical Trials

Size	Price	Qty
1mg	USD 127

Clinical Trials

Several clinical trials evaluate interventions across hematologic malignancies, neuropsychiatric conditions, and cardiovascular disorders, encompassing indications such as myelodysplastic syndromes, acute myeloid leukemia, non-Hodgkin lymphoma, anxiety, depression, post-traumatic stress disorder, and essential hypertension. Sponsored by academic institutions like the University of California, San Diego, and pharmaceutical entities including Novartis, Newel Health SRL, and Juventas Cell Therapy Ltd., these investigations primarily comprise early-phase (Phase 1/2 or non-applicable) evaluations. Currently, recruitment statuses across these studies are designated as either not yet recruiting or withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05367401	Withdrawn	Myelodysplastic Syndromes\|Acute Myeloid Leukemia	Novartis Pharmaceuticals\|Novartis	2024-12-20	Phase 1\|Phase 2
NCT06273527	Not yet recruiting	Anxiety Disorders\|Depression\|Post Traumatic Stress Disorder	University of California San Diego	2024-11	Not Applicable
NCT06091176	Not yet recruiting	Essential Hypertension\|Primary Hypertension	Newel Health SRL	2024-11-01	Not Applicable
NCT06005649	Not yet recruiting	Non-hodgkin Lymphoma	Juventas Cell Therapy Ltd.	2024-08-31	Phase 1\|Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Goitrin functions as an active natural compound that suppresses bacterial endotoxin and viral signaling cascades, thereby blocking downstream inflammatory mediator release and reducing oxidative cellular stress. By attenuating these pathogenic signaling pathways and associated cell damage, Goitrin exhibits therapeutic relevance in controlling inflammatory and systemic responses relevant to conditions evaluated in clinical trials, including hematologic malignancies like acute myeloid leukemia and vascular disorders such as essential hypertension.

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>).