3,5-diiodo-L-thyronine (3,5-T2) Clinical Trials

Size	Price	Qty
25mg	USD 147
1g	USD 970

Clinical Trials

Multiple clinical trials are evaluating therapeutic applications for mitral valve regurgitation, Duchenne muscular dystrophy, intervertebral disc degeneration with back pain, and pharmacokinetic profiling in healthy volunteers. Spanning Early Phase 1, Phase 1, and non-interventional protocols, these studies are sponsored by academic, government, and commercial entities, including the University of Alabama at Birmingham, Assistance Publique - Hôpitaux de Paris, the VA Office of Research and Development, and Takeda. Across these studies, the recruitment status is consistently reported as not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04795856	Not yet recruiting	Mitral Valve Regurgitation	University of Alabama at Birmingham	2027-06-18	Early Phase 1
NCT05558813	Not yet recruiting	Duchenne Muscular Dystrophy	Assistance Publique - Hôpitaux de Paris	2024-11	Not Applicable
NCT04134910	Not yet recruiting	Back Pain\|Intervertebral Disc Degeneration	VA Office of Research and Development	2024-10-01	Not Applicable
NCT06236009	Not yet recruiting	Healthy Volunteers	Takeda\|Takeda Development Center Americas Inc.	2024-09-04	Phase 1

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

Check the 3,5-diiodo-L-thyronine (3,5-T2) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

3,5-Diiodo-L-thyronine (3,5-T2) functions as an endogenous thyroid hormone metabolite that binds directly to cytochrome c oxidase and mitochondrial membranes, thereby enhancing respiratory chain activity and accelerating fatty acid beta-oxidation. This stimulation of cellular oxidative metabolism promotes lipid clearance and metabolic expenditure, demonstrating therapeutic relevance for hepatic steatosis, metabolic dysfunction, and tissue-specific degenerative disorders such as mitral valve regurgitation.

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>).