Levothyroxine
Ermeza, Euthyrox, Levo-t, Levolet, Levothyroxine, Levoxyl, Synthroid, Thyquidity, Thyro-tabs, Tirosint, Tirosint-sol, Unithroid (levothyroxine) is a small molecule pharmaceutical. Levothyroxine was first approved as Unithroid on 2000-08-21. It is used to treat autoimmune thyroiditis, goiter, myxedema, thyroid neoplasms, and thyrotoxicosis in the USA. The pharmaceutical is active against thyroid hormone receptor beta and thyroid hormone receptor alpha.
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Trade Name
FDA
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Ermeza, Euthyrox, Levo-t, Levolet, Levothyroxine, Levoxyl, Synthroid, Thyquidity, Thyro-tabs, Tirosint, Tirosint-sol, Unithroid (discontinued: Euthyrox, Levothyroxine, Levoxyl)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Levothyroxine sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SYNTHROID | AbbVie | N-021402 RX | 2002-07-24 | 12 products, RLD |
| THYRO-TABS | Alvogen | N-021116 RX | 2002-10-24 | 12 products, RLD |
| THYQUIDITY | Azurity | N-214047 RX | 2020-11-30 | 1 products, RLD, RS |
| LEVO-T | Cediprof | N-021342 RX | 2002-03-01 | 12 products |
| LEVOTHYROXINE SODIUM | Fresenius Kabi | N-202231 RX | 2011-06-24 | 3 products, RLD, RS |
| LEVOTHYROXINE SODIUM | Fresenius Kabi | N-210632 RX | 2019-04-11 | 3 products, RLD, RS |
| LEVOLET | Genus Lifesciences | N-021137 RX | 2003-06-06 | 12 products |
| LEVOTHYROXINE SODIUM | Hikma Pharmaceuticals | N-214253 RX | 2021-05-17 | 1 products, RLD, RS |
| TIROSINT | IBSA Group | N-021924 RX | 2006-10-13 | 15 products, RLD |
| TIROSINT-SOL | IBSA Group | N-206977 RX | 2016-12-15 | 15 products, RLD, RS |
Show 4 marketed
Show 2 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| adthyza | unapproved drug other | 2023-02-23 |
| adthyza thyroid | unapproved drug other | 2023-12-08 |
| ermeza | New Drug Application | 2022-04-15 |
| euthyrox | New Drug Application | 2023-11-06 |
| levo-t | New Drug Application | 2024-07-31 |
| levothroid | New Drug Application | 2012-03-02 |
| levothyroxine | NDA authorized generic | 2014-09-24 |
| levothyroxine sodium | ANDA | 2024-11-06 |
| levoxyl | New Drug Application | 2020-12-15 |
| np thyroid | unapproved drug other | 2021-05-11 |
Show 12 more
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Levothyroxine Sodium, Tirosint-Sol, Ibsa | |||
| 11241382 | 2039-09-17 | U-3757, U-3758 | |
| 10537538 | 2037-02-28 | DP | |
| 11096913 | 2037-02-28 | DP | |
| Levothyroxine Sodium, Levolet, Genus Lifesciences | |||
| 10231931 | 2038-03-23 | DP | |
| 10406108 | 2038-03-23 | DP | |
| Levothyroxine Sodium, Levothyroxine Sodium, Fresenius Kabi Usa | |||
| 9782376 | 2036-12-01 | DP | |
| 10398669 | 2036-12-01 | DP | |
| 11135190 | 2036-12-01 | DP | |
| 9006289 | 2032-10-03 | DP | |
| 9168238 | 2032-08-29 | DP | |
| 9168239 | 2032-08-29 | DP | |
| Levothyroxine Sodium, Levothyroxine Sodium, Hikma | |||
| 11154498 | 2036-07-20 | DP | |
| Levothyroxine Sodium, Ermeza, Mylan | |||
| 9345772 | 2035-02-27 | DP | |
| Levothyroxine Sodium, Thyquidity, Azurity | |||
| 9050307 | 2031-08-06 | DP | |
| Levothyroxine Sodium, Tirosint, Ibsa | |||
| 7691411 | 2024-03-14 | DP | |
| 7723390 | 2024-03-14 | DP | |
ATC Codes
HCPCS
No data
Clinical
Clinical Trials
392 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypothyroidism | D007037 | EFO_0004705 | E03.9 | 5 | 15 | 11 | 32 | 58 | 115 |
| Thyroid diseases | D013959 | HP_0000820 | E00-E07 | 2 | 9 | 4 | 8 | 31 | 52 |
| Thyroid neoplasms | D013964 | EFO_0003841 | — | 2 | 5 | 3 | 2 | 15 | 26 |
| Healthy volunteers/patients | — | — | — | 13 | 1 | — | 2 | 2 | 17 |
| Heart failure | D006333 | HP_0001635 | I50 | — | 3 | 1 | 4 | 6 | 14 |
| Syndrome | D013577 | — | — | — | 1 | 1 | 1 | 8 | 11 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | — | 4 | 5 | 9 |
| Infarction | D007238 | EFO_0009463 | — | — | — | — | 4 | 4 | 8 |
| Graves disease | D006111 | EFO_0004237 | E05.0 | — | 1 | 3 | 3 | 2 | 8 |
| Depression | D003863 | — | F33.9 | — | 1 | 1 | 1 | 5 | 7 |
Show 55 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hashimoto disease | D050031 | EFO_0003779 | E06.3 | — | 1 | 1 | — | 8 | 10 |
| Neoplasms | D009369 | — | C80 | 4 | 5 | 1 | — | 4 | 10 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | 1 | — | 4 | 5 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | — | — | 1 | — | 4 | 5 |
| Chronic renal insufficiency | D051436 | — | N18 | — | — | 1 | — | 3 | 4 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | 1 | — | 3 | 4 |
| Dyslipidemias | D050171 | HP_0003119 | — | — | — | 2 | — | 2 | 4 |
| Premature birth | D047928 | EFO_0003917 | O60 | — | — | 2 | — | 2 | 4 |
| Ventricular dysfunction | D018754 | — | — | — | 1 | 2 | — | — | 3 |
| Hypersensitivity | D006967 | HP_0012393 | T78.40 | — | — | 1 | — | 2 | 3 |
Show 26 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Thyroiditis | D013966 | — | E06 | — | 1 | — | — | 7 | 8 |
| Leukemia | D007938 | — | C95 | 6 | 7 | — | — | — | 8 |
| Lymphoma | D008223 | — | C85.9 | 6 | 7 | — | — | — | 8 |
| Autoimmune thyroiditis | D013967 | EFO_0006812 | E06.3 | — | 1 | — | — | 6 | 7 |
| Infertility | D007246 | HP_0000789 | — | — | 2 | — | — | 3 | 5 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 3 | — | — | 2 | 5 |
| Ischemia | D007511 | EFO_0000556 | — | — | 2 | — | — | 2 | 4 |
| Myeloid leukemia | D007951 | — | C92 | 2 | 3 | — | — | — | 3 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | 3 | — | — | — | 3 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | 1 | 2 | — | — | — | 3 |
Show 36 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Coronary artery disease | D003324 | — | I25.1 | 1 | — | — | — | 9 | 10 |
| Coronary disease | D003327 | — | — | 1 | — | — | — | 5 | 6 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | 1 | — | — | — | 5 | 6 |
| Hyperthyroidism | D006980 | — | E05.9 | 1 | — | — | — | 5 | 6 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | 1 | — | — | — | 1 | 2 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | 2 | — | — | — | — | 2 |
| Residual neoplasm | D018365 | — | — | 2 | — | — | — | — | 2 |
| Philadelphia chromosome | D010677 | — | — | 2 | — | — | — | — | 2 |
| Melanosis | D008548 | HP_0001480 | L81.1 | 1 | — | — | — | 1 | 2 |
| Pharmacokinetics | D010599 | — | — | 2 | — | — | — | — | 2 |
Show 13 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | — | — | 5 | 5 |
| Covid-19 | D000086382 | — | — | — | — | — | — | 5 | 5 |
| Wounds and injuries | D014947 | — | T14.8 | — | — | — | — | 5 | 5 |
| Pregnancy rate | D018873 | — | — | — | — | — | — | 4 | 4 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | — | 4 | 4 |
| Epilepsy | D004827 | EFO_0000474 | G40.9 | — | — | — | — | 3 | 3 |
| Carcinoma | D002277 | — | C80.0 | — | — | — | — | 3 | 3 |
| Tachycardia | D013610 | HP_0001649 | R00.0 | — | — | — | — | 3 | 3 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | — | 3 | 3 |
| Prolapse | D011391 | — | — | — | — | — | — | 3 | 3 |
Show 183 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Levothyroxine |
| INN | levothyroxine sodium |
| Description | L-thyroxine is the L-enantiomer of thyroxine. It has a role as a thyroid hormone, an antithyroid drug, a human metabolite and a mouse metabolite. It is a thyroxine, an iodophenol, a 2-halophenol, a L-phenylalanine derivative and a non-proteinogenic L-alpha-amino acid. It is a conjugate acid of a L-thyroxine(1-). It is an enantiomer of a D-thyroxine. It is a tautomer of a L-thyroxine zwitterion. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | N[C@@H](Cc1cc(I)c(Oc2cc(I)c(O)c(I)c2)c(I)c1)C(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 51-48-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1624 |
| ChEBI ID | 18332 |
| PubChem CID | 5819 |
| DrugBank | DB00451 |
| UNII ID | 054I36CPMN (ChemIDplus, GSRS) |
Target
Agency Approved
THRB
THRB
THRA
THRA
Organism
Homo sapiens
Gene name
THRB
Gene synonyms
ERBA2, NR1A2, THR1
NCBI Gene ID
Protein name
thyroid hormone receptor beta
Protein synonyms
c-erbA-2, c-erbA-beta, Nuclear receptor subfamily 1 group A member 2, oncogene ERBA2, thyroid hormone receptor, beta (erythroblastic leukemia viral (v-erb-a) oncogene homolog 2, avian)
Uniprot ID
Mouse ortholog
Thrb (21834)
thyroid hormone receptor beta (Q3TY80)
Alternate
No data
Variants
No data
Financial
Revenue by drug
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Levothyroxine – Amneal Pharmaceuticals
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Synthroid – AbbVie
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Estimated US medical usage
Levothyroxine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Adthyza, Adthyza thyroid, Ermeza, Euthyrox, Levo-t, Levothyroxine sodium, Levoxyl, Np thyroid 60, Np thyroid 90, Sertraline hydrochloride, Synthroid, Thyquidity, Tirosint, Tirosint tirosint, Unithroid
Adverse Events
Top Adverse Reactions
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72,196 adverse events reported
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