Levothyroxine
Ermeza, Euthyrox, Levo-t, Levolet, 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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Commercial
Trade Name
FDA
EMA
Ermeza, Euthyrox, Levolet, Levoxyl, Levo-t, Synthroid, Thyquidity, Thyro-tabs, Tirosint, Tirosint-sol, Unithroid (generic drugs available since 2002-06-05)
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 |
|---|---|---|
| ermeza | New Drug Application | 2022-04-15 |
| euthyrox | New Drug Application | 2020-01-08 |
| levo-t | New Drug Application | 2019-05-02 |
| levoxyl | New Drug Application | 2020-12-15 |
| np thyroid 90 | unapproved drug other | 2023-06-07 |
| synthroid | New Drug Application | 2020-07-22 |
| thyquidity | New Drug Application | 2023-03-30 |
| tirosint | New Drug Application | 2023-02-19 |
| unithroid | New Drug Application | 2019-06-28 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| autoimmune thyroiditis | EFO_0006812 | D013967 | E06.3 |
| goiter | EFO_0004283 | D006042 | E04.9 |
| myxedema | EFO_1001055 | D009230 | E03.9 |
| thyroid neoplasms | EFO_0003841 | D013964 | — |
| thyrotoxicosis | — | D013971 | E05 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Levothyroxine Sodium, Levolet, Genus Lifesciences | |||
| 10231931 | 2038-03-23 | DP | |
| 10406108 | 2038-03-23 | DP | |
| Levothyroxine Sodium, Tirosint-Sol, Institut Biochimique | |||
| 10537538 | 2037-02-28 | DP | |
| 11096913 | 2037-02-28 | 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, Institut Biochimique | |||
| 7691411 | 2024-03-14 | DP | |
| 7723390 | 2024-03-14 | DP | |
| Levothyroxine Sodium, Levoxyl, King Pharms | |||
| 7101569 | 2023-10-02 | U-759 | |
HCPCS
No data
Clinical
Clinical Trials
137 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 | 1 | 8 | 3 | 18 | 25 | 53 |
| Healthy volunteers/patients | — | 11 | 1 | — | 2 | — | 13 | ||
| Thyroid diseases | D013959 | HP_0000820 | E00-E07 | — | 2 | — | 2 | 3 | 7 |
| Thyroid neoplasms | D013964 | EFO_0003841 | 1 | 1 | — | 1 | 3 | 6 | |
| Congenital hypothyroidism | D003409 | E00.1 | — | — | — | 2 | 3 | 5 | |
| Graves disease | D006111 | EFO_0004237 | E05.0 | — | 1 | 2 | 2 | — | 4 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | 1 | 3 | — | 4 |
| Endocrine system diseases | D004700 | EFO_0001379 | E34.9 | — | 1 | — | 2 | — | 3 |
| Down syndrome | D004314 | EFO_0001064 | Q90 | — | — | — | 1 | 1 | 2 |
| Fatigue | D005221 | HP_0012378 | R53.83 | — | — | — | 1 | 1 | 2 |
Show 17 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | 1 | — | 3 | 4 |
| Hyperthyroxinemia | D006981 | EFO_0004127 | — | — | 2 | — | 1 | 3 | |
| Brain death | D001926 | G93.82 | — | — | 1 | — | 1 | 2 | |
| Chronic renal insufficiency | D051436 | N18 | — | — | 1 | — | 1 | 2 | |
| Dyslipidemias | D050171 | HP_0003119 | — | — | 1 | — | 1 | 2 | |
| Cerebral intraventricular hemorrhage | D000074042 | — | — | 1 | — | — | 1 | ||
| Postoperative complications | D011183 | — | 1 | 1 | — | — | 1 | ||
| Neoplasms | D009369 | C80 | — | 1 | 1 | — | — | 1 | |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | 1 | 1 | — | — | 1 |
| Thyrotoxicosis | D013971 | E05 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Autoimmune thyroiditis | D013967 | EFO_0006812 | E06.3 | — | 1 | — | — | 2 | 3 |
| Infertility | D007246 | EFO_0000545 | — | 1 | — | — | 1 | 2 | |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | 2 | — | — | — | 2 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | — | — | — | 1 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics | D010599 | 2 | — | — | — | — | 2 | ||
| Drug interactions | D004347 | 1 | — | — | — | — | 1 | ||
| Iron-deficiency anemia | D018798 | HP_0001891 | D50 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hyperthyroidism | D006980 | E05.9 | — | — | — | — | 2 | 2 | |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | — | — | 1 | 1 |
| Renal dialysis | D006435 | EFO_0010690 | Z99.2 | — | — | — | — | 1 | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
| Morbid obesity | D009767 | EFO_0001074 | — | — | — | — | 1 | 1 | |
| Pregnancy rate | D018873 | — | — | — | — | 1 | 1 | ||
| Aging | D000375 | GO_0007568 | R41.81 | — | — | — | — | 1 | 1 |
| Food-drug interactions | D018565 | — | — | — | — | 1 | 1 | ||
| Head and neck neoplasms | D006258 | — | — | — | — | 1 | 1 | ||
| Laryngeal neoplasms | D007822 | EFO_0003817 | C32 | — | — | — | — | 1 | 1 |
Show 4 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 | 10582 |
| 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
Clinical Variant
No data
Financial
Synthroid - AbbVie
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Levothyroxine - Amneal Pharmaceuticals
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Trends
PubMed Central
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Additional graphs summarizing 14,753 documents
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Safety
Black-box Warning
Black-box warning for: Ermeza, Euthyrox, Levo-t, Levoxyl, Np thyroid 90, Synthroid, Thyquidity, Tirosint, Unithroid
Adverse Events
Top Adverse Reactions
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93,891 adverse events reported
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