Synthroid

(Levothyroxine)

ApprovedSmall molecule

Levothyroxine is used to treat an underactive thyroid (hypothyroidism) by replacing the thyroid hormone that your body isn't making enough of. It helps restore normal metabolism and energy levels.[2] Synthroid is currently approved and in use across 22 indications[4].[1]

Synthroid is one of 352 small molecule programs targeting Insulin resistance. It is currently in Approved.

Indications

Total Trials

Active Trials

351

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Insulin ResistanceActive, not recruiting

Disorder of Lipid MetabolismApproved

Transient Congenital HypothyroidismActive, not recruiting

HypothyroidismActive, not recruiting

Congenital HypothyroidismActive, not recruiting

Euthyroid Sick SyndromeApproved

Central Congenital HypothyroidismActive, not recruiting

Acute Myocardial InfarctionActive, not recruiting

Graves DiseaseApproved

Pituitary HypothyroidismActive, not recruiting

Insulin ResistancePreclinical

Active, not recruiting

Disorder of Lipid MetabolismApproved

Approved

Transient Congenital HypothyroidismPreclinical

Active, not recruiting

HypothyroidismApproved

Active, not recruiting

Congenital HypothyroidismPreclinical

Active, not recruiting

Euthyroid Sick SyndromeApproved

Approved

Central Congenital HypothyroidismPreclinical

Active, not recruiting

Acute Myocardial InfarctionApproved

Active, not recruiting

Graves DiseaseApproved

Approved

Pituitary HypothyroidismPreclinical

Active, not recruiting

Showing 10 of 21 indications

Competition

Competitive Landscape

540 competitors in Chronic Kidney Disease

#DrugCompanyPhaseTrials

Synthroid

IInstitut Jerome Lejeune

Approved

1 2

Aranesp

Amgen

Preclinical

40 3

Uloric

Takeda

Preclinical

3 4

Sovaldi

Gilead

Preclinical

1 5

Glucotrol

Pfizer

Preclinical

1 6

Vemlidy

Gilead

Preclinical

1 7

Lorelco

Sanofi

Preclinical

1 8

Flomax

Sanofi

Preclinical

—9

Miochol

BBausch Health Americas, Inc.

Preclinical

2 10

Genotropin

EMD Serono

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 1Recruiting

Transplant Recipient

NCT06428097

Q2 2027

Phase 3Recruiting

Obesity

NCT07332273

Q2 2028

Phase 2/3Recruiting

Hypothyroidism

NCT06345339

Phase 2/3Recruiting

Hypothyroidism

NCT06731764

Q3 2029

Phase 3Recruiting

Hypothyroidism

NCT05316922

Clinical

Trials by Indication[1]

Hypothyroidism22 trials

Thyroid Hormone Replacement for Subclinical Hypothyroidism

Completed·NNHS Greater Glasgow and Clyde·Phase 4·NCT01660126·737 enrolled

Mechanistic Study of Subclinical Hypothyroidism In the Elderly

Completed·UUniversity of Pennsylvania·N/A·NCT02399475·14 enrolled

A Study Evaluating the Safety and Efficacy of Hormone Replacement Therapy With ST-1891 Compared to Levothyroxine in Patients With Primary Hypothyroidism

Completed·SSention Therapeutics, LLC·Phase 2·NCT05412979·490 enrolled

Show 19 more trials

Recovery Rate in Secondary Hypothyroidism

Recruiting·NNova Scotia Health Authority··NCT05276856·90 enrolled

Novel Approaches to the Treatment of Hypothyroidism

Recruiting·UUConn Health·Phase 2/3·NCT06731764·90 enrolled

Treatment Trial of Subclinical Hypothyroidism in Down Syndrome

Completed·—·N/A·NCT01832753·12 enrolled

Desiccated Thyroid Extract and Levothyroxine for Hypothyroidism Treatment

Unknown status·WWalter Reed National Military Medical Center·N/A·NCT01739972·180 enrolled

A Study Evaluation the Safety and Efficacy of Hormone Replacement Therapy With North Star Compared to Levothyroxine in Patients With Primary Hypothyroidism

Completed·NNeuvosyn Laboratories, LLC·Phase 2·NCT05712421·303 enrolled

Thyroxin Treatment in Sub Clinical Hypothyroidism, on the Apnea Hypopnea Index Score, Lipids and Highly Sensitive CRP

Unknown status·KKing Saud University·Phase 3·NCT01486667·200 enrolled

Effects of Levothyroxine on Endothelial Function of Patients With Subclinical Hypothyroidism

Completed·IIsfahan University of Medical Sciences·Phase 2/3·NCT02090907·50 enrolled

Hypothyroidism, Metabolism and Food Intake

Completed·HHerlev Hospital··NCT02993562·18 enrolled

Thyroid Hormone Replacement for Subclinical Hypothyroidism and Chronic Heart Failure (ThyroHeart-CHF)

Unknown status·—·Phase 4·NCT03096613·124 enrolled

Desiccated Thyroid Extract Versus Synthetic T3/T4 Combination (ThyrolarTM) Versus L-T4 Alone in the Therapy of Primary Hypothyroidism With Special Attention to the Gene Polymorphism

Unknown status·WWalter Reed National Military Medical Center·N/A·NCT02317926·81 enrolled

Discontinuation of Levothyroxine Therapy for Patients With Subclinical Hypothyroidism

Completed·VVA Office of Research and Development·Phase 4·NCT04288115·52 enrolled

The Effect of Levothyroxine on Arterial Stiffness and Lipid Profile in Patients With Subclinical Hypothyroidism

Completed·—·N/A·NCT00498238·34 enrolled

Levothyroxine Treatment for Subclinical Hypothyroidism After Head and Neck Surgery

Withdrawn·UUniversity of Alberta·Phase 2/3·NCT02548715

Effect of Thyroid Hormone Replacement on Fatigability in Untreated Older Adults With Subclinical Hypothyroidism

Completed·IInsel Gruppe AG, University Hospital Bern·Phase 4·NCT02500342·276 enrolled

A Study to Assess the Safety and Efficacy of Oral Armour Thyroid Compared to Synthetic T4 for the Treatment of Primary Hypothyroidism in Adult Participants

Recruiting· AbbVie logo

AbbVie·Phase 2/3·NCT06345339·2,800 enrolled

TSH Suppression During Radiotherapy on Thyroid Site to Prevent Iatrogenic Hypothyroidism in Pediatric Cancer Patients

Recruiting·FFondazione IRCCS Istituto Nazionale dei Tumori, Milano·Phase 3·NCT05316922·68 enrolled

Mean Percentage of Levothyroxine Dosage Increase in Patients With Hypothyroidism Started on Enteral Feeding

Withdrawn·JJocelyne Karam·Phase 4·NCT02577367

Can Levothyroxine Treatment Reduce the Development of Cardio-metabolic Disorder in Subclinical Hypothyroidism?

Unknown status·—·Phase 1/2·NCT04178928·40 enrolled

Effects of Levothyroxine Treatment on Hemodynamic and Renal Functions in Subclinical Hypothyroidism

Withdrawn·—·Phase 4·NCT02186405

Thyroid6 trials

Levothyroxine Replacement With Liquid Gel Capsules vs Tablets Post-thyroidectomy

Terminated·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT02946918·14 enrolled

A Study of Armour® Thyroid Compared to Synthetic T4 (Levothyroxine) in Previously Hypothyroid Participants

Completed· AbbVie logo

AbbVie·Phase 2·NCT04124705·284 enrolled

Improving White Matter Integrity With Thyroid Hormone

Completed·UUniversity of Illinois at Chicago··NCT04098991·5 enrolled

Show 3 more trials

Effect of HCQ Combined With LT4 on LBR in Euthyroid Women With URPL and TPO-Ab

Recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·N/A·NCT06652113·796 enrolled

Comparison of Levothyroxine Formulation in Hypothyroid Patients With Enteral Feeding

Terminated·UUniversity of California, Los Angeles·Phase 4·NCT04878614·3 enrolled

Thyroid and Adrenocortical Hormone Replacement in Organ Donors

Completed·MMedical University of South Carolina·N/A·NCT04528797·199 enrolled

Pregnancy3 trials

Thyroid Hormone Dose Adjustment in Pregnancy

Completed·—·N/A·NCT00230802·48 enrolled

Safety and Efficacy of Empiric Levothyroxine (LT4) Dose Increase Versus Individualized LT4 Dose Increase in Hypothyroid Women During Pregnancy

Completed·MMedstar Health Research Institute·N/A·NCT03115515·60 enrolled

Thyroid Therapy for Mild Thyroid Deficiency in Pregnancy

Completed·TThe George Washington University Biostatistics Center·Phase 3·NCT00388297·1,203 enrolled

Cardiovascular2 trials

The TRUST Trial - CardioVascular Imaging ECHO

Completed·IInsel Gruppe AG, University Hospital Bern·Phase 4·NCT02832960·185 enrolled

The TRUST Study - CardioVascular Imaging IMT

Completed·IInsel Gruppe AG, University Hospital Bern·Phase 4·NCT02832934·184 enrolled

Adult2 trials

A Study of Levothyroxine and Enlicitide Decanoate (MK-0616) in Healthy Adult Participants (MK-0616-028)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT06625814·28 enrolled

Study to Evaluate the Effect of IW-3718 on the Pharmacokinetics of Oral Contraceptive, Levothyroxine, Glyburide, and Digoxin in Healthy Adult Volunteers

Completed·IIronwood Pharmaceuticals, Inc.·Phase 1·NCT03856970·87 enrolled

28 more indications

ALS2 trials

Bioavailability Investigations of Thyronajod Mite Tablets of Dosage Strengths 50 μg Levothyrox-ine/75 μg Iodine, and 100 μg Levothyroxine/75 μg Iodine vs. a Levothyroxine Drinking-Solution: A Randomised Cross Over Study in Healthy Male Individuals. Currently: 100 μg/ 75 μg Tablets

Completed·HHeidelberg University·Phase 1·NCT01465646·24 enrolled

Completed·HHeidelberg University·Phase 1·NCT01465633·24 enrolled

Thyroid Cancer2 trials

Study of Resistance to Thyroid Hormone After Long-term Exposure in People With Thyroid Cancer

Withdrawn·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT04868045

COACH - Comparing Two Different Methods to Suppress Thyrotropin in Patients With Advanced Thyroid Cancer

Not yet recruiting·AAHS Cancer Control Alberta·Phase 2·NCT06790589·70 enrolled

Congenital Hypothyroidism1 trial

Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism

Completed·EErica Eugster·N/A·NCT02374593·24 enrolled

Transplant Recipient1 trial

Levothyroxine Supplementation for Heart Transplant Recipients

Recruiting·UUniversity of California, San Francisco·Phase 1·NCT06428097·97 enrolled

Acute Myocardial Infarction1 trial

Thyroid Hormone Replacement for Hypothyroidism and Acute Myocardial Infarction(ThyroHeart-AMI)

Unknown status·—·Phase 4·NCT02512978·160 enrolled

Interaction1 trial

Sorafenib Drug Drug Interaction Study in Healthy Male Subjects

Completed· Bayer logo

Bayer·Phase 1·NCT02332031·25 enrolled

Bariatric Surgery1 trial

Levothyroxine (L-T4) Absorption After Bariatric Surgery

Completed·UUniversity of Sao Paulo·N/A·NCT01189344·30 enrolled

Complication1 trial

Wound Complications in Head and Neck Surgery

Completed·UUniversity of Michigan··NCT03134976·51 enrolled

Thyroid Dysfunction1 trial

Novel Biomarkers and Skeletal Outcomes Associated With Subclinical Thyroid Dysfunction

Completed·IInsel Gruppe AG, University Hospital Bern·Phase 4·NCT02491008·145 enrolled

Insulin resistance1 trial

Effect of Levothyroxine on Serum Adiponectin, Insulin Resistance and Cardiovascular Risk in Patients With Hypothyroidism

Completed·—··NCT02467244·120 enrolled

Brain Tumors1 trial

Combined Levothyroxine/Liothyronine Supplementation in Hypothyroid Patients With Brain Tumors

Terminated·MM.D. Anderson Cancer Center·N/A·NCT00488644·12 enrolled

Elderly1 trial

Study of Optimal Replacement of Thyroxine in the Elderly

Completed·NNewcastle-upon-Tyne Hospitals NHS Trust·Phase 4·NCT01647750·48 enrolled

Obesity1 trial

Levothyroxine as Adjuvant to a Hypocaloric Diet for the Treatment of Obesity.

Recruiting·FFundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud·Phase 3·NCT07332273·286 enrolled

Alveolar Soft Part Sarcoma1 trial

Sunitinib or Cediranib for Alveolar Soft Part Sarcoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01391962·34 enrolled

Depression1 trial

The TRUST Study - Depression Substudy

Completed·IInsel Gruppe AG, University Hospital Bern·Phase 4·NCT01853579·426 enrolled

Thyroid Disease1 trial

Recurrent Pregnancy Loss and Thyroid Disease

Unknown status·SSecond Affiliated Hospital of Soochow University·Phase 1·NCT03106935·300 enrolled

Polycystic Ovary Syndrome1 trial

Best Treatment for Women With Both (Polycystic Ovary Syndrome) PCOS and Subclinical Hypothyroidism

Recruiting·MMuhamed Ahmed Abdelmoaty Muhamed Alhagrasy·N/A·NCT06041204·200 enrolled

Pediatric Patients1 trial

Use of Liquid Stable Levothyroxine in Trisomy 21 Pediatric Patients

Terminated·—·Phase 4·NCT04747275·6 enrolled

Efficacy and Safety1 trial

Evaluation of the Efficacy and Safety of Levothyroxine in Brain Death Organ Donors: a Randomized Controled Trial

Terminated·CCentre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal·Phase 4·NCT02211053·15 enrolled

Metabolism1 trial

Energy Metabolism in Thyroidectomized Patients

Completed·VVirginia Commonwealth University·Phase 2·NCT04782856·13 enrolled

Chronic Kidney Disease1 trial

Supplementation of Thyroid Hormone for TSH Control in Patients With Chronic Kidney Disease Without TRR.

Completed·HHospital Civil de Guadalajara·Phase 3·NCT03898622·32 enrolled

Treatment1 trial

Thyroid Lobectomy With or Without Levothyroxine Treatment Postoperatively

Completed·JJagiellonian University··NCT00941551·150 enrolled

Euthyroid Sick Syndrome1 trial

Levothyroxine for Children With Euthyroid Sick Syndrome

Completed·—·Phase 4·NCT01631305·80 enrolled

Semaglutide1 trial

A Trial Investigating the Influence of Oral Semaglutide on the Pharmacokinetics of Levothyroxine and the Influence of Co-administered Tablets on the Pharmacokinetics of Semaglutide Administered Orally in Healthy Subjects.

Completed· Novo Nordisk logo

Novo Nordisk·Phase 1·NCT02920385·45 enrolled

Coronary Artery Bypass1 trial

Thyroid Hormone Replacement After Coronary Artery Bypass Grafting for Patients With Subclinical Hypothyroidism

Recruiting·SSeoul National University Bundang Hospital·N/A·NCT07380854·338 enrolled

Cardiovascular Function1 trial

Effects of Liothyronine on Energy Expenditure and Cardiovascular Function

Completed·VVirginia Commonwealth University·Phase 1/2·NCT03098433·22 enrolled

SLE1 trial

Levothyroxine in Pregnant SLE Patients

Withdrawn·JJohns Hopkins University·Phase 4·NCT01276782

Unspecified3 trials

Early Levothyroxine Post Radioactive Iodine

Completed·MMayo Clinic·Phase 2/3·NCT01950260·61 enrolled

The Role of Levothyroxine on Goiter With Atypia of Undetermined Significance

Withdrawn·SSheng-Chiang Su·Phase 4·NCT02329379

Bioequivalence of Two Levothyroxine Tablet Formulations in Healthy Indian Volunteers

Completed· GSK logo

GSK·Phase 4·NCT01536678·26 enrolled

Regulatory

FDA Approval Timeline[5]

Aug 21, 2000

UNITHROID

NDA NDA021210

May 25, 2001

LEVOXYL

NDA NDA021301

Mar 1, 2002

LEVO-T

NDA NDA021342

May 31, 2002

EUTHYROX

NDA NDA021292

Jul 24, 2002

SYNTHROID

NDA NDA021402

Oct 24, 2002

THYRO-TABS

NDA NDA021116

Jun 6, 2003

LEVOLET

NDA NDA021137

Aug 1, 2007

TIROSINT

NDA NDA021924

Jun 24, 2011

LEVOTHYROXINE SODIUM

NDA NDA202231

Dec 15, 2016

TIROSINT-SOL

NDA NDA206977

Apr 11, 2019

LEVOTHYROXINE SODIUM

NDA NDA210632

Nov 30, 2020

THYQUIDITY

NDA NDA214047

May 17, 2021

LEVOTHYROXINE SODIUM

NDA NDA214253

Apr 29, 2022

ERMEZA

NDA NDA215809

Sources

References

[1]
ClinicalTrials.gov — 67 trial records for Levothyroxine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Synthroid drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Levothyroxine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Levothyroxine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA215809). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Synthroid. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Institut Jerome Lejeune company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Thyroid Hormone Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: IInstitut Jerome Lejeune

Patent Landscape[6]

Patent Cliff

Aug 6, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9050307Aug 6, 2031

9168238Aug 29, 2032

9168239Aug 29, 2032

9006289Oct 3, 2032

9345772Feb 27, 2035

10 more patents

11154498Jul 20, 2036

10398669Dec 1, 2036

9782376Dec 1, 2036

11135190Dec 1, 2036

11096913Feb 28, 2037

10537538Feb 28, 2037

10406108Mar 23, 2038

10231931Mar 23, 2038

11241382Sep 17, 2039

12564565Sep 26, 2044

Synthroid

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Q2 2028

Q3 2029

Trials by Indication[1]

Hypothyroidism22 trials

Thyroid6 trials

Pregnancy3 trials

Cardiovascular2 trials

Adult2 trials

ALS2 trials

Thyroid Cancer2 trials

Congenital Hypothyroidism1 trial

Transplant Recipient1 trial

Acute Myocardial Infarction1 trial

Interaction1 trial

Bariatric Surgery1 trial

Complication1 trial

Thyroid Dysfunction1 trial

Insulin resistance1 trial

Brain Tumors1 trial

Elderly1 trial

Obesity1 trial

Alveolar Soft Part Sarcoma1 trial

Depression1 trial

Thyroid Disease1 trial

Polycystic Ovary Syndrome1 trial

Pediatric Patients1 trial

Efficacy and Safety1 trial

Metabolism1 trial

Chronic Kidney Disease1 trial

Treatment1 trial

Euthyroid Sick Syndrome1 trial

Semaglutide1 trial

Coronary Artery Bypass1 trial

Cardiovascular Function1 trial

SLE1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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