Drugs / Liothyronine
Liothyronine
also known as
L-T3 · Liothyronine Sodium · Cytomel · BCT303 · cytomel (liothyronine) · L-3,5,3'-triiodothyronine · L-triiodothyronine · Thyromax · +1 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | CYTOMEL | — | 1956-05-08 | fda.gov ↗ |
Trials 22
1955195619571958195919601961196219631964196519661967196819691970197119721973197419751976197719781979198019811982198319841985198619871988198919901991199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027202820292030203120322033
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05017610 | Oct 2021 → Oct 2022 | gliosarcoma | Emory University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 12 trials | ||||||
| Phase 1 | NCT02506751 | Jul 2015 → Sep 2017 | primary progressive multiple sclerosis, relapsing-remitting multiple sclerosis, secondary progressive multiple sclerosis | Johns Hopkins University | Completed | No outcome recorded |
| Phase 1 | NCT00004828 | Dec 1994 → Dec 1997 | tricuspid atresia | FDA Office of Orphan Products Development | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT07346157 | Aug 2026 → Mar 2031 expected | childhood medulloblastoma | Sabine Mueller, MD, PhD | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03098433 | Oct 2017 → Jun 2019 | — | Virginia Commonwealth University | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT07424183 | Jun 2026 → Jun 2027 expected | hypothyroidism | University of Pennsylvania | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04782856 | Oct 2020 → Apr 2023 | goiter, hypothyroidism, thyroid cancer | Virginia Commonwealth University | Completed | No outcome recorded |
| Phase 2 | NCT04115514 | Mar 2020 → Oct 2026 expected | acute respiratory distress syndrome, pulmonary edema, thyroid gland disorder | University of Minnesota | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03627611 | Aug 2018 → Jun 2020 | hypothyroidism | Oslo University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02457897 | Apr 2015 → Sep 2018 | diabetes mellitus | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Phase 2 | NCT01800617 | Mar 2013 → Jul 2014 | hypothyroidism | Ipe, LLC | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT06731764 | Dec 2024 → Dec 2027 expected | hypothyroidism | UConn Health | Recruiting | No outcome recorded |
| Phase 2/3 | NCT03053115 | Mar 2017 → Sep 2021 | hypothyroidism | Azienda USL Modena | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT02320669 | Nov 2014 → Oct 2019 | congenital heart defects, multiple types | Seattle Children's Hospital | Completed | No outcome recorded |
| Phase 3 | NCT00790738 | Jul 2008 → Jul 2012 | bipolar disorder, depressive disorder | Northwell Health | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT00221494 | Jan 2004 → Jun 2006 | depressive disorder | Mark Frye | Withdrawn | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT02399475 | Jan 2015 → Sep 2019 | hypothyroidism | University of Pennsylvania | Completed | No outcome recorded |
| — | NCT01481402 | Jul 2011 → Feb 2014 | euthyroid sick syndrome, heart failure | Jens Faber | Completed | No outcome recorded |
| — | NCT01153360 | Jun 2010 → Aug 2011 | euthyroid sick syndrome | Yonsei University | Completed | No outcome recorded |
| — | NCT00488644 | Feb 2006 → Mar 2010 | brain neoplasm, hypothyroidism | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT00223158 | Sep 2003 → May 2005 | thyroid cancer | Patrice Perron | Completed | No outcome recorded |
| — | NCT00562367 | Oct 2001 → Sep 2004 | major depressive disorder | Massachusetts General Hospital | Completed | No outcome recorded |
| Comparator or background therapy14 trials | ||||||
| Phase 1 | NCT02760056 Comparator | Jun 2016 → Jan 2017 | multiple sclerosis | Oregon Health and Science University | Completed | No outcome recorded |
| Phase 1 | NCT01581463 Comparator | Apr → Aug 2012 | — | Ipe, LLC | Completed | No outcome recorded |
| Phase 1 | NCT00788307 Background | Nov 2008 → Feb 2018 | prostate cancer | Mayo Clinic | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00978055 Comparator | Oct → Dec 2007 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT00004062 Background | Jul 1999 → Aug 2006 | head and neck cancer | Lucille P. Markey Cancer Center at University of Kentucky | Completed | No outcome recorded |
| Phase 1/2 | NCT04111536 Comparator | Mar 2020 → Oct 2023 | diastolic heart failure, euthyroid sick syndrome | University of Pennsylvania | Completed | No outcome recorded |
| Phase 1/2 | NCT04112316 Comparator | Feb 2020 → Oct 2023 | systolic heart failure, thyroid hormone metabolism, abnormal, 3 | University of Pennsylvania | Completed | No outcome recorded |
| Phase 2 | NCT04743661 Background | Apr 2022 → Mar 2026 overdue | ependymoma, medulloblastoma | Pediatric Brain Tumor Consortium | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01182285 Comparator | Sep 2010 → Sep 2015 | thyroid cancer | National Cancer Institute (NCI) | Completed | Missed primary |
| Phase 2 | NCT00106119 Comparator | Mar 2005 → Nov 2013 | thyroid gland disorder | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Phase 3 | NCT05894954 Background | Jul 2023 → Oct 2025 | cognitive impairment with or without cerebellar ataxia, dementia | Alzheimer's Prevention and Reversal Project, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT05682482 Comparator | Oct 2022 → Jan 2028 expected | hypothyroidism | M. Medici | Recruiting | No outcome recorded |
| — | NCT07568574 Background | Mar 2026 → May 2028 expected | — | Enhanced Emirates Limited | Enrolling by invitation | No outcome recorded |
| — | NCT02317926 Comparator | May 2015 → May 2018 | hypothyroidism | Walter Reed National Military Medical Center | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2025-10-06 | Zydus Lifesciences Limited | Regulatory Zydus receives approval from Health Canada for Liothyronine tablets 5 mcg and 25 mcg zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received NOC (Notice of Compliance) from Health Canada for generic Liothyronine tablets 5 mcg and 25 mcg. |
| 2021-01-23 | Zydus Lifesciences Limited | Regulatory Zydus Cadila receives final approval from USFDA for Liothyronine Sodium Tablets zyduslife.com ↗
Zydus Cadila has received final approval from the USFDA to market Liothyronine Sodium Tablets USP, 5 mcg, 25 mcg, and 50 mcg (US RLD: Cytomel Tablets). |
| 2017-10-19 | Titan Pharmaceuticals | Results Titan Pharmaceuticals Presents Non-Clinical Data From Liothyronine (L-T3) Implant Studies titanpharm.com ↗
The data indicate that these ProNeura implants continuously released L-T3 dose dependently for more than six months, providing important initial in vivo information for the potential development as a treatment of hypothyroidism. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-10-06 | Zydus Lifesciences Limited | Zydus receives approval from Health Canada for Liothyronine tablets 5 mcg and 25 mcg zyduslife.com ↗ |
| 2021-01-23 | Zydus Lifesciences Limited | Zydus Cadila receives final approval from USFDA for Liothyronine Sodium Tablets zyduslife.com ↗ |
| 2017-10-19 | Titan Pharmaceuticals | Titan Pharmaceuticals Presents Non-Clinical Data From Liothyronine (L-T3) Implant Studies titanpharm.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 39 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Liothyronine | “The study goals are: 1.) To assess whether the simultaneous commencement of liothyronine or pindolol to an SSRI can accelerate the treatment response (i.e. faster rate of...” NCT00221494 ↗29“Atrophic subtype support may include: estradiol, progesterone, testosterone, DHEA, pregnenolone, levothyroxine, liothyronine, hydrocortisone.” NCT05894954 ↗ |
| Known as | BCT303 | “This preparation of T3 is called Thyromax® or BCT303.” NCT01800617 ↗ |
| Known as | Cytomel | “Cytomel (liothyronine) 25-50 mcg/day for 4 weeks” NCT00562367 ↗ |
| Known as | cytomel (liothyronine) | “cytomel (liothyronine)” NCT00790738 ↗ |
| Known as | L-3,5,3'-triiodothyronine | “Thyroid hormones play multiple roles in lung function, and L-3,5,3'-triiodothyronine (T3) has multiple effects on lung alveolar type II cells.” PMID 33127750 ↗ Oct 2020 |
| Known as | L-T3 | “A recent trial showed that 1:3 μg:μg liothyronine (L-T3) substitution for levothyroxine (L-T4) achieving near-identical TSH levels resulted in a significant decrease in weight...” PMID 23585666 ↗ Apr 20136“Liothyronine (L-T3) is a short-acting thyroid hormone with demonstrated safety and tolerability for short-term and chronic use in euthyroid adults with other health conditions,...” PMID 32120028 ↗ Feb 2020 “The effects of levothyroxine (LT4)/liothyronine (LT3) combination therapy on quality of life (QoL) in hypothyroid patients former on LT4 monotherapy have been disappointing.” PMID 35273566 ↗ Feb 2022 “Participants will either take LT3 with an LT4 dose that is reduced from baseline or they will take liothyronine placebo with their baseline LT4 dose.” NCT07424183 ↗ “Liothyronine (L-triiodothyronine or LT3) in the 5 mcg tablet dose formulation.” NCT04111536 ↗ “Liothyronine/levothyroxine (LT3/LT4) combination therapy.” NCT04782856 ↗ “liothyronine (synthetic T3, LT3)” NCT06731764 ↗ |
| Known as | L-triiodothyronine | “Liothyronine (L-triiodothyronine or LT3) in the 5 mcg tablet dose formulation.” NCT04112316 ↗ |
| Known as | Liothyronine Sodium | “The safety of a commercially available formulation of liothyronine sodium (synthetic T3) administered intratracheally was assessed in an Investigational New Drug...” PMID 33127750 ↗ Oct 2020 |
| Known as | Thyromax | “This preparation of T3 is called Thyromax® or BCT303.” NCT01800617 ↗ |
| Known as | Triostat | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02320669 ↗ |
| Modality | Other / unclassified | “a synthetic thyroid hormone” NCT02320669 ↗ |
| Route | Oral | “oral liothyronine sodium twice daily” NCT00004062 ↗ |