Clinical Trials

Numerous clinical trials, spanning Early Phase 1 through Phase 3, evaluate liothyronine sodium across diverse indications including hypothyroidism, bipolar depression, thyroid cancer, acute respiratory distress syndrome, pediatric brain tumors, and congenital heart defects. Sponsored by academic medical centers, health networks, pharmaceutical companies, and research consortia, these investigations comprise completed, active, and currently recruiting studies. These trials evaluate liothyronine both as an adjunctive treatment for depressive disorders and for its systemic and tissue-specific physiological effects in pulmonary and metabolic conditions.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07346157 RECRUITING
Medulloblastoma; Medulloblastoma, Childhood; Medulloblastoma Recurrent
Sabine Mueller, MD, PhD
 2026-08-21 PHASE1; PHASE2
NCT07568574 ENROLLING_BY_INVITATION
Safety and Impact of Medically Supervised Performance Enhancing Substance Usage in Healthy Elite Athletes
Enhanced Emirates Limited
 2026-03-12
NCT05682482 RECRUITING
Autoimmune Hypothyroidism
M. Medici
 2022-10-07 PHASE3
NCT06731764 RECRUITING
Hypothyroidism
UConn Health
 2024-12-10 PHASE2; PHASE3
NCT07424183 NOT_YET_RECRUITING
Hypothyroidism Primary
University of Pennsylvania
 2026-11 PHASE2
NCT04115514 ACTIVE_NOT_RECRUITING
ARDS, Human; Lung, Wet; Thyroid; Pulmonary Edema; Lung Inflammation
University of Minnesota
 2020-03-30 PHASE2
NCT04743661 ACTIVE_NOT_RECRUITING
Recurrent Medulloblastoma; Recurrent Ependymoma
Pediatric Brain Tumor Consortium
 2022-04-04 PHASE2
NCT04111536 COMPLETED
Heart Failure With Preserved Ejection Fraction; Low Triiodothyronine Syndrome
University of Pennsylvania
 2020-03-08 PHASE1; PHASE2
NCT04112316 COMPLETED
Heart Failure With Reduced Ejection Fraction (HFrEF); Low T3 Syndrome
University of Pennsylvania
 2020-02-11 PHASE1; PHASE2
NCT04782856 COMPLETED
Thyroid Goiter; Hypothyroidism; Thyroid Cancer
Virginia Commonwealth University
 2020-10-28 PHASE2
NCT05017610 WITHDRAWN
Recurrent Glioblastoma; Recurrent Gliosarcoma
Emory University
 2021-10-20 EARLY_PHASE1
NCT03053115 COMPLETED
Hypothyroidism
Azienda USL Modena
 2017-03-14 PHASE2; PHASE3
NCT03627611 COMPLETED
Hypothyroidism; Biomarkers; Endocrine System Diseases
Oslo University Hospital
 2018-08-14 PHASE2
NCT02399475 COMPLETED
Subclinical Hypothyroidism
University of Pennsylvania
 2015-01-01
NCT03098433 COMPLETED
Healthy
Virginia Commonwealth University
 2017-10-20 PHASE1; PHASE2
NCT02457897 COMPLETED
Insulin Resistance; Diabetes Mellitus; Abnormal Glucose Metabolism
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2015-04-17 PHASE2
NCT02317926 UNKNOWN
Hypothyroidism
Walter Reed National Military Medical Center
 2015-05
NCT00788307 TERMINATED
Prostate Cancer
Mayo Clinic
 2008-11-03 PHASE1
NCT02506751 COMPLETED
Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Secondary Progressive; Multiple Sclerosis, Primary Progressive
Johns Hopkins University
 2015-07 PHASE1
NCT02760056 COMPLETED
Multiple Sclerosis
Oregon Health and Science University
 2016-06-06 PHASE1
NCT01182285 COMPLETED
Thyroid Neoplasm
National Cancer Institute (NCI)
 2010-09-24 PHASE2
NCT02222532 COMPLETED
Postoperative; Dysfunction Following Cardiac Surgery
National Cardiovascular Center Harapan Kita Hospital Indonesia
 2013-06 PHASE3
NCT01800617 COMPLETED
Hypothyroidism
Ipe, LLC
 2013-03 PHASE2
NCT01481402 COMPLETED
Heart Failure; Low T3 Syndrome
Jens Faber
 2011-07
NCT00106119 COMPLETED
Thyroid Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2005-03 PHASE2
NCT01581463 COMPLETED
Healthy
Ipe, LLC
 2012-04 PHASE1
NCT00790738 COMPLETED
Depression; Bipolar Disorder
Northwell Health
 2008-07 PHASE3
NCT01153360 COMPLETED
Non-thyroidal Illness Syndrome
Yonsei University
 2010-06
NCT00488644 TERMINATED
Hypothyroidism; Brain Tumor
M.D. Anderson Cancer Center
 2006-02
NCT00978055 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
 2007-10 PHASE1
NCT00027417 COMPLETED
Heart Defects, Congenital
Michael Portman
 2001-04 PHASE3
NCT00223158 COMPLETED
Thyroid Cancer
Patrice Perron
 2003-09
NCT00004828 COMPLETED
Tricuspid Atresia; Heart Defects, Congenital
FDA Office of Orphan Products Development
 1994-12 PHASE1
NCT00004062 COMPLETED
Head and Neck Cancer
Lucille P. Markey Cancer Center at University of Kentucky
 1999-07 PHASE1
NCT00562367 COMPLETED
Major Depressive Disorder
Massachusetts General Hospital
 2001-10

(data from https://clinicaltrials.gov, updated on 2026-08-24)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Liothyronine sodium binds directly to nuclear thyroid hormone receptors, which regulates downstream transcriptional networks governing cellular oxidative metabolism and energy expenditure. This receptor activation increases the basal metabolic rate and protein synthesis, providing clinical benefit in restoring endocrine homeostasis in hypothyroidism and serving as an adjunct therapy in major depression.

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>).

Jump to

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