Drugs / Levothyroxine
last change Sep 2026 re-read 9 days ago

Levothyroxine

Other / unclassified

Developed for
hypothyroidism · thyroid gland disorder · congenital hypothyroidism · heart failure · atherosclerosis · differentiated thyroid carcinoma · goiter · Graves disease
+32 more · postsurgical hypothyroidism · systolic heart failure · thyroid cancer · thyroid hormone metabolism, abnormal · type 2 diabetes mellitus · bipolar disorder · chronic kidney disease · depressive disorder · disease related to solid organ transplantation · Down syndrome · euthyroid sick syndrome · fetal growth restriction · habitual spontaneous abortion · hyperlipidemia · muscular atrophy · myocardial infarction · NAFLD1 · neurodevelopmental disorder · nodular goiter · obesity disorder · paraquat poisoning · pregnancy loss, recurrent, 4 · schizophrenia · thyroid gland papillary carcinoma · toxic multinodular goitre · anxiety · fibrotic liver disease · intracerebral hemorrhage · metabolic dysfunction-associated steatohepatitis · peripheral hypothyroidism · pregnancy disorder with abortive outcome · systemic lupus erythematosus
Investigated by
Insel Gruppe AG, University Hospital Bern · University of Lausanne Hospitals · Mylan Pharmaceuticals Inc · Beijing Chao Yang Hospital · Chinese Academy of Medical Sciences, Fuwai Hospital · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
+124 more · Seoul National University Bundang Hospital · Beijing Friendship Hospital · Heidelberg University · IBSA Institut Biochimique SA · Leiden University Medical Center · National Institute on Aging (NIA) · Peking University Third Hospital · Sanofi-Synthelabo · Second Affiliated Hospital, School of Medicine, Zhejiang University · The Luhe Teaching Hospital of the Capital Medical University · University Hospital, Geneva · University of Aarhus · University of California, Irvine · University of Pennsylvania · AHS Cancer Control Alberta · AbbVie · Akrimax Pharmaceuticals · Assaf-Harofeh Medical Center · Autonomous University of Nuevo León · Azienda USL Modena · Bayer · Beijing Anzhen Hospital · Beijing Municipal Science & Technology Commission · Boston Children's Hospital · Celerion · Central Hospital, Nancy, France · Centre Hospitalier Universitaire de Nice · Centre Hospitalier Universitaire, Amiens · Changi General Hospital · Charite University, Berlin, Germany · Children's Mercy Hospital Kansas City · Cromsource · Duke-NUS Graduate Medical School · Emirates Health Services (EHS) · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · First Affiliated Hospital of Chongqing Medical University · First Affiliated Hospital of Guangxi Medical University · First Affiliated Hospital of Kunming Medical University · First People's Hospital of Hangzhou · Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · General Hospital of Ningxia Medical University · Georgetown University · Henan Provincial People's Hospital · Hôpital Cochin · Indiana University · Institute for Human Development and Potential (IHDP), Singapore · Institute of Bioengineering and Bioimaging (IBB) · Ironwood Pharmaceuticals, Inc. · Isfahan University of Medical Sciences · Jerome Lejeune Institute · Jocelyne Karam · Khoo Teck Puat Hospital · M.D. Anderson Cancer Center · MR Research Center, Skejby Sygehus, Brendstrupgaardsvej 100, 8200 Aarhus N · Maastricht University Medical Center · Maimonides Medical Center · Mayo Clinic · Medical University of South Carolina · Medstar Health Research Institute · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Merck Sharp & Dohme LLC · Meyer Children's Hospital IRCCS · Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy · National Cancer Center, Korea · National Institute for Health Research, United Kingdom · National Institute of Neurological Disorders and Stroke (NINDS) · National Taiwan University Hospital · National University Health System, Singapore · Newcastle-upon-Tyne Hospitals NHS Trust · Ng Teng Fong General Hospital · Novo Nordisk A/S · Oregon Health and Science University · Peking Union Medical College Hospital · all 130 on the full record

Regulatory milestones approvals, filings & regulatory actions · 9 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) LEVOLET — 2022-08-05 fda.gov ↗
Label expansions (3) US (FDA) THYRO-TABS — 2016-05-19 – 2022-04-14 fda.gov ↗
Label expansion US (FDA) EUTHYROX — 2018-09-14 fda.gov ↗
Label expansions (2) US (FDA) LEVO-T — 2004-06-23 – 2011-03-09 fda.gov ↗
Label expansion US (FDA) UNITHROID — 2004-12-13 fda.gov ↗
Approved US (FDA) UNITHROID — 2000-08-21 fda.gov ↗

Trials 84 · started per year

today
US approved 2000
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20002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 02 trials
Phase 0 NCT07011953 Jul 2025 → Jul 2027 expected schizophrenia Peking University Not yet recruiting No outcome recorded
Phase 0 NCT03102177 May 2011 → Nov 2013 hypothyroidism Georgetown University Completed No outcome recorded
Phase 112 trials · 1 met primary
Phase 1 NCT06625814 Jul → Aug 2024 — Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT06428097 Mar 2024 → Mar 2027 expected disease related to solid organ transplantation, heart failure University of California, San Francisco Recruiting No outcome recorded
Phase 1 NCT03979274 Dec 2019 → Jan 2020 — Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany Completed Met primary
Phase 1 NCT03856970 Mar → Jun 2019 — Ironwood Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1 NCT02920385 Oct 2016 → Apr 2017 diabetes mellitus Novo Nordisk A/S Completed No outcome recorded
Phase 1 NCT02332031 Feb → Jun 2015 — Bayer Completed No outcome recorded
Phase 1 NCT00648882 Mar → Apr 2007 — Mylan Pharmaceuticals Inc Completed No outcome recorded
Phase 1 NCT00648700 Aug → Sep 2005 — Mylan Pharmaceuticals Inc Completed No outcome recorded
Phase 1 NCT01465633 Aug → Nov 2003 — Heidelberg University Completed No outcome recorded
Phase 1 NCT01465646 Jun → Dec 2003 — Heidelberg University Completed No outcome recorded
Phase 25 trials
Phase 2 NCT06790589 Dec 2026 → Dec 2027 expected differentiated thyroid carcinoma AHS Cancer Control Alberta Not yet recruiting No outcome recorded
Phase 2 NCT05823012 May 2023 → Feb 2024 hypothyroidism Xeris Pharmaceuticals Completed No outcome recorded
Phase 2 NCT04782856 Oct 2020 → Apr 2023 goiter, hypothyroidism, thyroid cancer Virginia Commonwealth University Completed No outcome recorded
Phase 2 NCT03281083 Mar 2014 → Jul 2016 NAFLD1, type 2 diabetes mellitus Duke-NUS Graduate Medical School Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT01916304 Jul 2013 → Jun 2014 hypothyroidism Takeda Completed No outcome recorded
Phase 2/38 trials · 2 missed
Phase 2/3 NCT06731764 Dec 2024 → Dec 2027 expected hypothyroidism UConn Health Recruiting No outcome recorded
Phase 2/3 NCT06345339 Apr 2024 → Sep 2027 expected hypothyroidism AbbVie Recruiting No outcome recorded
Phase 2/3 NCT03053115 Mar 2017 → Sep 2021 hypothyroidism Azienda USL Modena Completed No outcome recorded
Phase 2/3 NCT02548715 Jul 2015 → Jul 2017 hypothyroidism, neoplasm University of Alberta Withdrawn No outcome recorded
Phase 2/3 NCT01950260 Sep 2013 → Apr 2017 Graves disease Mayo Clinic Completed Missed primary
Phase 2/3 NCT02090907 May 2013 → Feb 2014 hypothyroidism Isfahan University of Medical Sciences Completed No outcome recorded
Phase 2/3 NCT00921050 Jun 2009 → Mar 2012 hypothyroidism Autonomous University of Nuevo León Completed No outcome recorded
Phase 2/3 NCT01528839 Mar 2004 → May 2008 bipolar disorder Charite University, Berlin, Germany Completed Missed primary
Phase 37 trials · 2 missed
Phase 3 NCT07239674 Nov 2025 → Nov 2027 expected differentiated thyroid carcinoma West China Hospital Not yet recruiting No outcome recorded
Phase 3 NCT07332273 Nov 2025 → Nov 2026 expected obesity disorder Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud Recruiting No outcome recorded
Phase 3 NCT06999278 Jun 2025 → Apr 2027 expected habitual spontaneous abortion Women's Hospital School Of Medicine Zhejiang University Not yet recruiting No outcome recorded
Phase 3 NCT05316922 Dec 2021 → Sep 2029 expected hypothyroidism Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Recruiting No outcome recorded
Phase 3 NCT01576705 Apr 2012 → Dec 2017 Down syndrome Jerome Lejeune Institute Completed Missed primary
Phase 3 NCT00388297 Oct 2006 → Aug 2015 hypothyroidism, pregnancy disorder The George Washington University Biostatistics Center Completed Missed primary
Phase 3 NCT01306227 Sep 2006 → Dec 2014 thyroid gland disorder Centre Hospitalier Universitaire, Amiens Completed No outcome recorded
Phase 427 trials · 2 met primary · 4 missed
Phase 4 NCT06073665 Jan 2024 → Apr 2028 expected hypothyroidism University of Pennsylvania Recruiting No outcome recorded
Phase 4 NCT06135948 Mar → Jun 2022 thyroid hormone metabolism, abnormal Emirates Health Services (EHS) Completed No outcome recorded
Phase 4 NCT05228184 Jan 2022 → Mar 2025 congenital hypothyroidism IBSA Institut Biochimique SA Terminated Met primary Stop: Enrollment
Phase 4 NCT04878614 May 2021 → Feb 2022 hypothyroidism University of California, Los Angeles Terminated No outcome recorded Stop: Enrollment
Phase 4 NCT04747275 Jan → Nov 2021 hypothyroidism, trisomy 21 Children's Mercy Hospital Kansas City Terminated No outcome recorded
Phase 4 NCT04132622 Jan 2020 → Dec 2022 paraquat poisoning Second Affiliated Hospital, School of Medicine, Zhejiang University Unknown No outcome recorded
Phase 4 NCT04953195 Jan 2019 → Sep 2021 hypothyroidism Beijing Chao Yang Hospital Unknown No outcome recorded
Phase 4 NCT03094416 Jul 2018 → Jun 2020 postsurgical hypothyroidism IBSA Institut Biochimique SA Completed No outcome recorded
Phase 4 NCT03096613 Apr 2017 → Feb 2019 hypothyroidism, systolic heart failure Chinese Academy of Medical Sciences, Fuwai Hospital Unknown Met primary
Phase 4 NCT02946918 Feb 2017 → Nov 2019 postsurgical hypothyroidism, thyroid cancer University of Texas Southwestern Medical Center Terminated No outcome recorded
Phase not applicable23 trials · 1 missed
— NCT07625722 Jun 2026 → Jun 2027 expected fetal growth restriction, neurodevelopmental disorder, thyroid hormone metabolism, abnormal Shandong Provincial Hospital Not yet recruiting No outcome recorded
— NCT06971965 Jun 2025 → Dec 2027 expected thyroid gland papillary carcinoma National Cancer Center, Korea Not yet recruiting No outcome recorded
— NCT07393165 May 2025 → May 2026 overdue hypothyroidism Tanta University Recruiting No outcome recorded
— NCT06652113 Nov 2024 → Mar 2035 expected autoimmune thyroid disease, pregnancy loss, recurrent, 4 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Recruiting No outcome recorded
— NCT07421869 Jun 2024 → Mar 2029 expected hypothyroidism Seoul National University Bundang Hospital Recruiting No outcome recorded
— NCT05240911 Jun 2022 → Feb 2023 hypothyroidism, thyroid tumor Second Affiliated Hospital, School of Medicine, Zhejiang University Unknown No outcome recorded
— NCT07380854 Feb 2022 → Feb 2032 expected hypothyroidism Seoul National University Bundang Hospital Recruiting No outcome recorded
— NCT06041204 May 2021 → May 2026 overdue female infertility, hypothyroidism, polycystic ovary syndrome Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy Recruiting No outcome recorded
— NCT03977207 Jul 2020 → Nov 2025 overdue hypothyroidism University of California, Irvine Recruiting No outcome recorded
— NCT03606824 Mar 2019 → Feb 2020 atherosclerotic cardiovascular disease, hyperlipidemia, hypothyroidism Shaochun.Li Unknown No outcome recorded
Comparator or background therapy43 trials
Phase 0 NCT06373523 Background Sep 2024 → Jun 2025 overdue NAFLD1, fibrotic liver disease Post Graduate Institute of Medical Education and Research, Chandigarh Not yet recruiting No outcome recorded
Phase 0 NCT03106935 Comparator Jul 2015 → Dec 2017 pregnancy loss, recurrent, 4 Second Affiliated Hospital of Soochow University Unknown No outcome recorded
Phase 1 NCT04868045 Background Apr 2021 → Feb 2023 thyroid cancer Memorial Sloan Kettering Cancer Center Withdrawn No outcome recorded Stop: Enrollment
Phase 1 NCT01557504 Background Jul 2012 → Apr 2014 type 2 diabetes mellitus Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT00535561 Comparator Jun → Sep 2007 hypothyroidism, iron deficiency anemia Duzce University Completed No outcome recorded

News releases announcing trial results or a regulatory action · 7

DateIssuerRelease
2026-05-01 Alembic Pharmaceuticals Ltd. Regulatory 22nd May, 2026 Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited announces USFDA Final Approval for Levothyroxine Sodium Tablets USP, 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg and 300 mcg.
2024-05-30 Xeris Pharmaceuticals Results Xeris Biopharma Announces Positive Topline Phase 2 Clinical Data of Its Investigational XeriSol™-Formulated Once-Weekly Subcutaneous (SC) Levothyroxine (XP-8121) xerispharma.com ↗
Participants who completed the study rated higher treatment satisfaction with XP-8121 compared to oral and a majority (72%) indicated a strong preference for the SC route of administration
2022-10-20 Xeris Pharmaceuticals Results Xeris Biopharma Announces Positive Topline Phase 1 Clinical Data of Its Investigational Subcutaneous (SC) Levothyroxine (XP-8121); Hosts Conference Call and Webcast xerispharma.com ↗
today announced topline results from its Phase 1 study of subcutaneous (SC) levothyroxine (XP-8121) in healthy adult volunteers.
2021-08-11 Xeris Pharmaceuticals Regulatory Xeris Pharmaceuticals Announces FDA Acceptance of its IND Application for XeriSol™ Levothyroxine (XP-8121) for the Treatment of Hypothyroidism xerispharma.com ↗
2019-11-01 Lupin Limited Regulatory Lupin receives sANDA approval from US FDA for Levothyroxine Sodium Tablets USP AB rating to Reference Listed Drug, LEVOXYL® lupin.com ↗
2019-09-20 Lupin Limited Regulatory Lupin receives sANDA approval from U.S. FDA for Levothyroxine Sodium Tablets USP to be considered AB rated to Reference Listed Drug, UNITHROID® lupin.com ↗
2019-01-21 Lupin Limited Regulatory Lupin receives FDA approval for Levothyroxine Sodium Tablets USP lupin.com ↗

All press releases naming this drug 16 releases

DateIssuerRelease

Evidence & citations 55 cited values

Every value below carries the sentence it was read from. 133 sources stand behind the page.

FieldValueCited text
Known as levothyroxine “Concomitant use of thyroid hormone (eg, levothyroxine) is permitted during the study provided the participant has been receiving a stable dose for at least 12 weeks prior to...” NCT01557504 ↗
96

“Prospective, Single Dose, Randomized, Open Label, Comparative, Cross-study to Establish Bioequivalence Between the New Formulation and the Approved Formulation for...” NCT03979274 ↗

“Atrophic subtype support may include: estradiol, progesterone, testosterone, DHEA, pregnenolone, levothyroxine, liothyronine, hydrocortisone.” NCT05894954 ↗

“the study aim to detect the effect of low dose levothyroxine 50 ug on pregnant females and compare it with others receiving placebo” NCT03391154 ↗

“The participants randomised in this group will continue taking the classical treatment prescribed for Hashimoto (Levothyroxine)” NCT04600349 ↗

“The participants randomised in this group will continue taking the classical treatment prescribed for Hashimoto (Levothyroxine)” NCT04472988 ↗

“while on a continuous block-replacement regimen (+BRT, n = 48, median dose 15 mg methimazole and 100 μg levothyroxine)” PMID 21175612 ↗ Dec 2010

“The relationship between probiotics and levothyroxine (LT4) requirement has not yet been investigated.” PMID 29184537 ↗ Nov 2017

“The intervention will start with Levothyroxine 50 mcg daily with regular blinded dosis titration.” NCT04354896 ↗

“despite adequate levels of TSH after starting levothyroxine (LT4) therapy” PMID 35572853 ↗ May 2022

“75 micrograms of levothyroxine only daily for three months” NCT06641440 ↗

Show 86 more sources

Known as Eferox ChEMBL registry synonym — accepted as the source's own label CHEMBL1624 ↗
Known as Eltroxin “The patients were treated with levothyroxine (Eltroxin, Glaxo) at a starting dose of 50 mcg per day.” NCT00498238 ↗
1

NCT01280292 ↗

Known as Eltroxin (Levothyroxin, GlaxoSmithKline Pharma) “Eltroxin (Levothyroxin, GlaxoSmithKline Pharma)” NCT00770016 ↗
Known as eltroxin 50 “will receive 50 ug of levothyroxine (eltroxin 50) aspen,Egypt throughout the pregnancy” NCT03391154 ↗
Known as Ermeza ChEMBL registry synonym — accepted as the source's own label CHEMBL1624 ↗
Known as Euthyrox “Levothyroxine sodium tablets (Euthyrox, 50 μg) will be given 12.5μg \~50 μg daily based on patients' TSH levels and weights as described above.” NCT06652113 ↗
3

“Maintain the original antipsychotic regimen combined with levothyroxine sodium tablets (Euthyrox), 50 μg/day for 8 weeks.” NCT07011953 ↗

NCT01379170 ↗

NCT06353555 ↗

Known as Euthyrox/levothyroxine “Euthyrox/levothyroxine” NCT01379170 ↗
Known as Eutirox “Prospective, Single Dose, Randomized, Open Label, Comparative, Cross-study to Establish Bioequivalence Between the New Formulation and the Approved Formulation for...” NCT03979274 ↗
Known as Evotrox ChEMBL registry synonym — accepted as the source's own label CHEMBL1624 ↗
Known as L-thyroxine “Patients were randomly assigned to one of four treatments: placebo, folinic acid (FA), L-thyroxine, or FA+L-thyroxine, administered for 12 months.” PMID 31281181 ↗ Jul 2019
10

“patients who received an increased dose of L-thyroxine, 25 mcg, n = 50” NCT06135948 ↗

NCT00565864 ↗

NCT01306227 ↗

NCT01528839 ↗

NCT00524238 ↗

NCT07393165 ↗

NCT06660823 ↗

NCT01848171 ↗

NCT02917863 ↗

NCT01831869 ↗

Known as L-Thyroxine Christiaens “Levothyroxine (L-Thyroxine Christiaens®) is used in the treatment of hypothyroidism.” NCT01916304 ↗
Known as L-thyroxine henning ChEMBL registry synonym — accepted as the source's own label CHEMBL1624 ↗
Known as Levaxin ChEMBL registry synonym — accepted as the source's own label CHEMBL1624 ↗
Known as Levo-t ChEMBL registry synonym — accepted as the source's own label CHEMBL1624 ↗
Known as Levolet ChEMBL registry synonym — accepted as the source's own label CHEMBL1624 ↗
Known as Levothroid “Levothroid® Tablets 300 μg” NCT00648700 ↗
Known as Levothyrox ChEMBL registry synonym — accepted as the source's own label CHEMBL1624 ↗
Known as levothyroxin “Drug: levothyroxin” NCT03391154 ↗
6

NCT03053115 ↗

NCT05371262 ↗

NCT00552253 ↗

NCT06971965 ↗

NCT00770016 ↗

NCT06276205 ↗

Known as Levothyroxine sodique ChEMBL registry synonym — accepted as the source's own label CHEMBL1624 ↗
Known as Levothyroxine Sodium “Levothyroxine sodium tablets (Euthyrox, 50 μg) will be given 12.5μg \~50 μg daily based on patients' TSH levels and weights as described above.” NCT06652113 ↗
17

“Maintain the original antipsychotic regimen combined with levothyroxine sodium tablets (Euthyrox), 50 μg/day for 8 weeks.” NCT07011953 ↗

“Levothyroxine sodium new formulation” NCT01916304 ↗

“Levothyroxine Sodium Tablets 300 μg” NCT00648700 ↗

“Levothyroxine Sodium (LT4) Tablets” NCT07424183 ↗

“Levothyroxine Sodium (LT4) Tablets” NCT06653907 ↗

“Drug: Levothyroxine Sodium” NCT03977207 ↗

“Drug: Levothyroxine Sodium” NCT03281083 ↗

“Drug: levothyroxine sodium” NCT00921050 ↗

“Drug: Levothyroxine Sodium” NCT03191188 ↗

“Drug: Levothyroxine Sodium” NCT05228184 ↗

Show 7 more sources

Known as Levothyroxine sodium anhydrous ChEMBL registry synonym — accepted as the source's own label CHEMBL1624 ↗
Known as Levothyroxine sodium hydrate ChEMBL registry synonym — accepted as the source's own label CHEMBL1624 ↗
Known as Levothyroxine sodium pentahydrate ChEMBL registry synonym — accepted as the source's own label CHEMBL1624 ↗
Known as Levothyroxine Sodium Tablets “Drug: Levothyroxine Sodium Tablets” NCT04953195 ↗