Clinical Trials

Numerous clinical trials evaluate the therapeutic efficacy and metabolic effects of L-thyroxine across various endocrine and systemic conditions, predominantly hypothyroidism—including congenital and subclinical forms—as well as insulin resistance, bipolar depression, and autosomal dominant polycystic kidney disease. Ranging across Phase 2, Phase 3, and Phase 4, these studies involve both academic sponsors like Charite University and Assiut University and industry entities like Sention Therapeutics LLC. Recruitment statuses across these trials encompass completed, recruiting, active not recruiting, and not yet recruiting studies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07393165 RECRUITING
Levothyroxine; Cardiac Function; Children; Subclinical Hypothyroidism
Tanta University
 2025-05-24
NCT06660823 COMPLETED
Cardiac Surgery Intensive Care Treatment; Delayed Recovery From Anaesthesia; Euthyroid Sick Syndrome; Cardiac Surgery Requiring Cardiopulmonary Bypass
Ain Shams University
 2024-11-30 PHASE3
NCT06096454 Not yet recruiting
Hypothyroidism|Insulin Resistance
Assiut University
 2023-11-20 Phase 4
NCT01848171 UNKNOWN
Hypothyroidism; Thyroid Diseases; Endocrine System Diseases
Shandong Provincial Hospital
 2013-07 PHASE4
NCT05918497 Active not recruiting
Different Regimens in Treatment of Hypothyroidism During Fasting in Ramadan
Sohag University
 2023-04-25 --
NCT05646420 Completed
Autosomal Dominant Polycystic Kidney
Mario Negri Institute for Pharmacological Research
 2023-02-01 Not Applicable
NCT05421468 UNKNOWN
Hypothyroidism
King Abdullah International Medical Research Center
 2022-03-14
NCT06135948 COMPLETED
L-thyroxine
Emirates Health Services (EHS)
 2022-03-15 PHASE4
NCT01831869 UNKNOWN
Hypothyroidism; Thyroid Diseases; Endocrine System Diseases
Shandong Provincial Hospital
 2013-04 PHASE4
NCT05412979 Active not recruiting
Hypothyroidism
Sention Therapeutics LLC
 2022-04-29 Phase 2
NCT06135948 Completed
L-thyroxine
Emirates Health Services (EHS)|University of Sharjah
 2022-03-15 Phase 4
NCT04712760 Unknown status
Congenital Hypothyroidism
Central Hospital Nancy France
 2021-02-22 --
NCT02917863 UNKNOWN
Hypothyroidism
Meyer Children's Hospital IRCCS
 2016-05 PHASE4
NCT01465867 COMPLETED
Pregnancy; Infertility; Auto-immune Thyroiditis
University of Roma La Sapienza
 2012-04
NCT01306227 COMPLETED
Hypothyroxinemia
Centre Hospitalier Universitaire, Amiens
 2006-09-01 PHASE3
NCT01916304 COMPLETED
Hypothyroidism
Takeda
 2013-07 PHASE2
NCT00565864 COMPLETED
Hypothyroidism
Oregon Health and Science University
 2008-08 PHASE4
NCT01528839 COMPLETED
Bipolar Disorder
Charite University, Berlin, Germany
 2004-03 PHASE2; PHASE3
NCT00524238 COMPLETED
Hypothyroidism
University of Aarhus
 2004-03
NCT00715572 COMPLETED
Hypothyroidism
I.M. Sechenov First Moscow State Medical University
 2002-03

(data from https://clinicaltrials.gov, updated on 2026-02-06)

Check the L-Thyroxine (Levothyroxine) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

L-Thyroxine binds to intracellular thyroid hormone receptors to modulate transcriptional activity and downregulate the production of pituitary thyroid-stimulating hormone. This gene expression cascade restores basal metabolic rate and standard cellular oxygen consumption, directly counteracting metabolic insufficiency in clinical conditions such as hypothyroidism and subclinical thyroid 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>).

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Note: Technical data last updated: Sep 1, 2026.