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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EMA
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 |
| LEVO-T | Cediprof | N-021342 RX | 2002-03-01 | 12 products |
| EUTHYROX | EMD Serono | N-021292 RX | 2002-05-31 | 11 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 | 2025-04-11 |
| adthyza thyroid | unapproved drug other | 2025-02-20 |
| ermeza | New Drug Application | 2022-04-15 |
| euthyrox | New Drug Application | 2024-10-24 |
| 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 | 2025-05-22 |
| levoxyl | New Drug Application | 2020-12-15 |
| np thyroid | unapproved drug other | 2021-05-11 |
Show 13 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
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Clinical
Clinical Trials
264 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 | 16 | 13 | 32 | 60 | 119 |
| Thyroid diseases | D013959 | — | E00-E07 | 2 | 10 | 4 | 8 | 35 | 57 |
| Thyroid neoplasms | D013964 | EFO_0003841 | — | 2 | 6 | 3 | 2 | 17 | 29 |
| Healthy volunteers/patients | — | — | — | 13 | 1 | — | 2 | 1 | 16 |
| Graves disease | D006111 | EFO_0004237 | E05.0 | — | 1 | 3 | 3 | 3 | 9 |
| Congenital hypothyroidism | D003409 | — | E00.1 | — | — | — | 2 | 7 | 9 |
| Syndrome | D013577 | — | — | — | — | 1 | 1 | 5 | 7 |
| Goiter | D006042 | EFO_0004283 | E04.9 | — | 1 | — | 3 | 2 | 6 |
| Recurrence | D012008 | — | — | 1 | 1 | 1 | 2 | 1 | 6 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 2 | 1 | — | 1 | 1 | 5 |
Show 47 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 | — | 10 | 12 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | 1 | — | 4 | 5 |
| Habitual abortion | D000026 | EFO_1000954 | N96 | 1 | — | 2 | — | 1 | 4 |
| Dyslipidemias | D050171 | — | — | — | — | 2 | — | 2 | 4 |
| Premature birth | D047928 | EFO_0003917 | O60 | — | — | 2 | — | 2 | 4 |
| Neoplasms | D009369 | — | C80 | — | 1 | 1 | — | 2 | 3 |
| Chronic renal insufficiency | D051436 | — | N18 | — | — | 1 | — | 2 | 3 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | 1 | — | 2 | 3 |
| Thyrotoxicosis | D013971 | — | E05 | — | 1 | 1 | — | 1 | 3 |
| Spontaneous abortion | D000022 | EFO_1001255 | O00.1 | 1 | — | 1 | — | 1 | 3 |
Show 12 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Thyroiditis | D013966 | — | E06 | — | 1 | — | — | 10 | 11 |
| Autoimmune thyroiditis | D013967 | EFO_0006812 | E06.3 | — | 1 | — | — | 8 | 9 |
| Infertility | D007246 | EFO_0000545 | — | — | 2 | — | — | 3 | 5 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | 1 | 2 | — | — | — | 3 |
| Fatty liver | D005234 | EFO_0003934 | — | 1 | 2 | — | — | — | 3 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | 1 | 2 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | 1 | — | — | — | 2 |
| Sarcoma | D012509 | — | — | — | 1 | — | — | — | 1 |
| Alveolar soft part sarcoma | D018234 | — | — | — | 1 | — | — | — | 1 |
| Environmental biomarkers | D000074062 | — | — | — | 1 | — | — | — | 1 |
Show 7 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hyperthyroidism | D006980 | — | E05.9 | 1 | — | — | — | 5 | 6 |
| Melanosis | D008548 | EFO_0003963 | L81.1 | 1 | — | — | — | 1 | 2 |
| Pharmacokinetics | D010599 | — | — | 2 | — | — | — | — | 2 |
| Crush injuries | D000071576 | — | T14.8 | 1 | — | — | — | — | 1 |
| Drug interactions | D004347 | — | — | 1 | — | — | — | — | 1 |
| Anemia | D000740 | EFO_0004272 | D64.9 | 1 | — | — | — | — | 1 |
| Iron-deficiency anemia | D018798 | — | D50 | 1 | — | — | — | — | 1 |
| Deficiency diseases | D003677 | EFO_1001067 | E63 | 1 | — | — | — | — | 1 |
| Iron deficiencies | D000090463 | — | E61.1 | 1 | — | — | — | — | 1 |
| Heart transplantation | D016027 | EFO_0010673 | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy rate | D018873 | — | — | — | — | — | — | 4 | 4 |
| Covid-19 | D000086382 | — | U07.1 | — | — | — | — | 4 | 4 |
| Carcinoma | D002277 | — | C80.0 | — | — | — | — | 3 | 3 |
| Hyperprolactinemia | D006966 | — | E22.1 | — | — | — | — | 2 | 2 |
| Epilepsy | D004827 | EFO_0000474 | G40.9 | — | — | — | — | 2 | 2 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | — | — | — | — | 2 | 2 |
| Autoimmune diseases | D001327 | EFO_0000540 | M30-M36 | — | — | — | — | 2 | 2 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 2 | 2 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | — | — | 2 | 2 |
| Thyroidectomy | D013965 | — | — | — | — | — | — | 2 | 2 |
Show 68 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
THRA
THRA
Organism
Homo sapiens
Gene name
THRA
Gene synonyms
EAR7, ERBA1, NR1A1, THRA1, THRA2
NCBI Gene ID
Protein name
thyroid hormone receptor alpha
Protein synonyms
c-erbA protooncogene, c-erbA-1, c-erbA-alpha, EAR-7, ERBA-related 7, Nuclear receptor subfamily 1 group A member 1, thyroid hormone receptor alpha 1, thyroid hormone receptor, alpha (erythroblastic leukemia viral (v-erb-a) oncogene homolog, avian), triiodothyronine receptor, V-erbA-related protein 7
Uniprot ID
Mouse ortholog
Thra (21833)
thyroid hormone receptor alpha (Q99146)
Alternate
No data
Variants
No data
Financial
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Synthroid – AbbVie
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Levothyroxine – Amneal Pharmaceuticals
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Estimated US medical usage
Levothyroxine
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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
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67,195 adverse events reported
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