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Drug ReportsLevothyroxine
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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Events Timeline
Commercial
Clinical
Drug
Target
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Financial
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Safety
Events Timeline
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3M
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2Y
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FDA approval date
EMA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
skin and connective tissue diseasesD017437
endocrine system diseasesD004700
immune system diseasesD007154
Trade Name
FDA
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
SYNTHROIDAbbVieN-021402 RX2002-07-24
12 products, RLD
THYRO-TABSAlvogenN-021116 RX2002-10-24
12 products, RLD
LEVO-TCediprofN-021342 RX2002-03-01
12 products
EUTHYROXEMD SeronoN-021292 RX2002-05-31
11 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
adthyzaunapproved drug other2025-04-11
adthyza thyroidunapproved drug other2025-02-20
ermezaNew Drug Application2022-04-15
euthyroxNew Drug Application2024-10-24
levo-tNew Drug Application2024-07-31
levothroidNew Drug Application2012-03-02
levothyroxineNDA authorized generic2014-09-24
levothyroxine sodiumANDA2025-06-16
levoxylNew Drug Application2020-12-15
np thyroidunapproved drug other2021-05-11
Show 13 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
thyroid neoplasmsEFO_0003841D013964—
autoimmune thyroiditisEFO_0006812D013967E06.3
goiterEFO_0004283D006042E04.9
thyrotoxicosis—D013971E05
myxedemaEFO_1001055D009230E03.9
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Levothyroxine Sodium, Tirosint-Sol, Ibsa
112413822039-09-17U-3757, U-3758
105375382037-02-28DP
110969132037-02-28DP
Levothyroxine Sodium, Levolet, Genus Lifesciences
102319312038-03-23DP
104061082038-03-23DP
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, Ibsa
76914112024-03-14DP
77233902024-03-14DP
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
— H03AA51: Levothyroxine sodium and iodine compounds
HCPCS
No data
Clinical
Clinical Trials
265 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———4————4
Indications Without Phase
No data
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)Loading
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
RxCUI—
ChEMBL IDCHEMBL1624
ChEBI ID18332
PubChem CID5819
DrugBankDB00451
UNII ID054I36CPMN (ChemIDplus, GSRS)
Target
Agency Approved
THRA
THRA
Organism
Homo sapiens
Gene name
THRA
Gene synonyms
EAR7, ERBA1, NR1A1, THRA1, THRA2
NCBI Gene ID
7067
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
Q96H73
Mouse ortholog
Thra (21833)
thyroid hormone receptor alpha (Q99146)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Synthroid – AbbVie
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Levothyroxine – Amneal Pharmaceuticals
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Tabular view
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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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 60,175 documents
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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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68,940 adverse events reported
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