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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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Top 200 Pharmaceuticals by Retail Sales
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
skin and connective tissue diseasesD017437
endocrine system diseasesD004700
immune system diseasesD007154
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
SYNTHROIDAbbVieN-021402 RX2002-07-24
12 products, RLD
THYRO-TABSAlvogenN-021116 RX2002-10-24
12 products, RLD
THYQUIDITYAzurityN-214047 RX2020-11-30
1 products, RLD, RS
LEVO-TCediprofN-021342 RX2002-03-01
12 products
LEVOTHYROXINE SODIUMFresenius KabiN-202231 RX2011-06-24
3 products, RLD, RS
LEVOTHYROXINE SODIUMFresenius KabiN-210632 RX2019-04-11
3 products, RLD, RS
LEVOLETGenus LifesciencesN-021137 RX2003-06-06
12 products
LEVOTHYROXINE SODIUMHikma PharmaceuticalsN-214253 RX2021-05-17
1 products, RLD, RS
TIROSINTIBSA GroupN-021924 RX2006-10-13
15 products, RLD
TIROSINT-SOLIBSA GroupN-206977 RX2016-12-15
15 products, RLD, RS
Show 4 marketed
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
ermezaNew Drug Application2022-04-15
euthyroxNew Drug Application2020-01-08
levo-tNew Drug Application2019-05-02
levoxylNew Drug Application2020-12-15
np thyroid 90unapproved drug other2023-06-07
synthroidNew Drug Application2020-07-22
thyquidityNew Drug Application2023-03-30
tirosintNew Drug Application2023-02-19
unithroidNew Drug Application2019-06-28
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
autoimmune thyroiditisEFO_0006812D013967E06.3
goiterEFO_0004283D006042E04.9
myxedemaEFO_1001055D009230E03.9
thyroid neoplasmsEFO_0003841D013964
thyrotoxicosisD013971E05
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Levothyroxine Sodium, Levolet, Genus Lifesciences
102319312038-03-23DP
104061082038-03-23DP
Levothyroxine Sodium, Tirosint-Sol, Institut Biochimique
105375382037-02-28DP
110969132037-02-28DP
Levothyroxine Sodium, Levothyroxine Sodium, Fresenius Kabi Usa
97823762036-12-01DP
103986692036-12-01DP
111351902036-12-01DP
90062892032-10-03DP
91682382032-08-29DP
91682392032-08-29DP
Levothyroxine Sodium, Levothyroxine Sodium, Hikma
111544982036-07-20DP
Levothyroxine Sodium, Ermeza, Mylan
93457722035-02-27DP
Levothyroxine Sodium, Thyquidity, Azurity
90503072031-08-06DP
Levothyroxine Sodium, Tirosint, Institut Biochimique
76914112024-03-14DP
77233902024-03-14DP
Levothyroxine Sodium, Levoxyl, King Pharms
71015692023-10-02U-759
ATC Codes
H: Systemic hormonal preparations, excl. sex hormones and insulins
H03: Thyroid therapy drugs
H03A: Thyroid preparations
H03AA: Thyroid hormones
H03AA01: Levothyroxine sodium
H03AA03: Combinations of levothyroxine and liothyronine
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
HypothyroidismD007037EFO_0004705E03.9183182553
Healthy volunteers/patients111213
Thyroid diseasesD013959HP_0000820E00-E072237
Thyroid neoplasmsD013964EFO_000384111136
Congenital hypothyroidismD003409E00.1235
Graves diseaseD006111EFO_0004237E05.01224
Heart failureD006333EFO_0003144I50134
Endocrine system diseasesD004700EFO_0001379E34.9123
Down syndromeD004314EFO_0001064Q90112
FatigueD005221HP_0012378R53.83112
Show 17 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PregnancyD011247EFO_0002950Z33.1134
HyperthyroxinemiaD006981EFO_0004127213
Brain deathD001926G93.82112
Chronic renal insufficiencyD051436N18112
DyslipidemiasD050171HP_0003119112
Cerebral intraventricular hemorrhageD00007404211
Postoperative complicationsD011183111
NeoplasmsD009369C80111
Bipolar disorderD001714EFO_0000289F30.9111
ThyrotoxicosisD013971E0511
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Autoimmune thyroiditisD013967EFO_0006812E06.3123
InfertilityD007246EFO_0000545112
Non-alcoholic fatty liver diseaseD065626EFO_0003095K75.8122
Type 2 diabetes mellitusD003924EFO_0001360E1111
Liver cirrhosisD008103EFO_0001422K74.011
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PharmacokineticsD01059922
Drug interactionsD00434711
Iron-deficiency anemiaD018798HP_0001891D5011
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HyperthyroidismD006980E05.922
Diabetes mellitusD003920EFO_0000400E08-E1311
Renal dialysisD006435EFO_0010690Z99.211
ObesityD009765EFO_0001073E66.911
Morbid obesityD009767EFO_000107411
Pregnancy rateD01887311
AgingD000375GO_0007568R41.8111
Food-drug interactionsD01856511
Head and neck neoplasmsD00625811
Laryngeal neoplasmsD007822EFO_0003817C3211
Show 4 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameLEVOTHYROXINE
INNlevothyroxine 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-ID51-48-9
RxCUI10582
ChEMBL IDCHEMBL1624
ChEBI ID18332
PubChem CID5819
DrugBankDB00451
UNII ID054I36CPMN (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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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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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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