Levothyroxine sodium
Highest phase reached
Approved
Drug type
Small molecule
First approval year
1982
- First approval year
- 1982
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Levothyroxine sodium
- Molecular weight
- 816.87
- Structure (SMILES)
- N[C@@H](Cc1cc(I)c(Oc2cc(I)c(O)c(I)c2)c(I)c1)C(=O)[O-].O.[Na+]
- eltroxin
- Eltroxin
- ermeza
- Ermeza
- euthyrox
- Euthyrox
- evotrox
- Evotrox
- l thyroxine henning
- L-thyroxine henning
- levo t
- Levo-t
- levolet
- Levolet
- levothroid
- Levothroid
- levothyroxine sodium
- Levothyroxine sodium
- levoxyl
- Levoxyl
- novothyrox
- Novothyrox
- synthroid
- Synthroid
- thyquidity
And 9 more, listed on the interactive page.
- Brand Name Levothyroxine (Synthroid)
- brand name levothyroxine synthroid
- eferox
- Eferox
- Eltroxin
- Euthyrox
- levaxin
- Levaxin
- Levothroid® Tablets 300 μg
- levothyrox
- Levothyrox
- levothyroxine sodique
- Levothyroxine sodique
- levothyroxine sodium
- Levothyroxine sodium
- levothyroxine sodium anhydrous
- Levothyroxine sodium anhydrous
- levothyroxine sodium hydrate
- Levothyroxine sodium hydrate
- levothyroxine sodium monohydrate
- LEVOTHYROXINE SODIUM MONOHYDRATE
- LEVOTHYROXINE SODIUM MONOHYDRATE [WHO-IP]
- levothyroxine sodium monohydrate who ip
- levothyroxine sodium pentahydrate
- Levothyroxine sodium pentahydrate
And 29 more, listed on the interactive page.
- ATC classification codes
- H03AA01
Sources for recorded values
- CAS registry numbers
- 31178-59-3
- ChEMBL ID
- CHEMBL2103741
- InChIKey
- ANMYAHDLKVNJJO-LTCKWSDVSA-M
- RxNorm IDs (RxCUI)
- 40144
- FDA ingredient codes (UNII)
- B82379R9W0
- 23667619
- 131664344
- Applicant
- STEVENS J
- Approval date
- 21 Aug 2000
- Application number
- NDA021210
- Patents
- 16
- Designations
- 1
- Earliest recorded loss of exclusivity
- 26 Sept 2044
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- T4
- Type
- Metabolite
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- Parenteral
- Action
- Agonist
- Action type
- Agonist
- Target
- Thyroid hormone receptor-α
- Gene symbol
- THRA
- Protein identifier
- P10827
- Affinity units
- pIC50
- Primary target
- Yes
- Action
- Agonist
- Action type
- Agonist
- Target
- Thyroid hormone receptor-β
- Gene symbol
- THRB
- Protein identifier
- P10828
- Median affinity
- 8.52
- Affinity units
- pIC50
- Primary target
- Yes
- Mechanism
- Thyroid hormone receptor agonist
- Action type
- Agonist
- Target
- Thyroid hormone receptor
- Protein identifier
- P10827
- Mechanism
- Thyroid hormone receptor agonist
- Action type
- Agonist
- Target
- Thyroid hormone receptor
- Protein identifier
- P10828
Open Targets mechanisms
- Mechanism
- Thyroid hormone receptor agonist
- Action type
- Agonist
- Target
- Thyroid hormone receptor
- Condition
- Thyroid Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0002892
- Subject identifier
- D013964
- Condition
- Pain
- Highest recorded phase
- 1
- Condition identifier
- EFO:0003843
- Subject identifier
- D010146
- Condition
- Hypothyroidism
- Highest recorded phase
- 4
- Condition identifier
- EFO:0004705
- Subject identifier
- D007037
- Condition
- Thyroid Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:1002017
- Subject identifier
- D013964
- Condition
- Thyroid Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0002108
- Subject identifier
- D013964
- Condition
- Bipolar Disorder
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0004985
- Subject identifier
- D001714
- Condition
- Congenital Hypothyroidism
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0018612
- Subject identifier
- D003409
- Condition identifier
- EFO_0002892
- Condition identifier
- EFO_0004705
- Condition identifier
- EFO_1002017
- Condition identifier
- MONDO_0002108
- Condition identifier
- MONDO_0002108
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0004985
- Condition identifier
- MONDO_0005148
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005420
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0013209
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0015075
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0015447
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0018612
- Condition identifier
- MONDO_0018612
- Highest recorded phase
- 4
Warnings
- Warning
- Black Box Warning
Open Targets warnings
- Warning
- Black Box Warning
- Country
- United States
- Event
- alopecia
- Reports
- 298
- Reporting signal score
- 234.976
- Event
- asthma
- Reports
- 185
- Reporting signal score
- 129.122
- Event
- balance disorder
- Reports
- 201
- Reporting signal score
- 183.382
- Event
- blood calcium decreased
- Reports
- 154
- Reporting signal score
- 320.714
- Event
- blood thyroid stimulating hormone abnormal
- Reports
- 149
- Reporting signal score
- 670.605
- Event
- blood thyroid stimulating hormone decreased
- Reports
- 143
- Reporting signal score
- 459.055
- Event
- blood thyroid stimulating hormone increased
- Reports
- 447
- Reporting signal score
- 1,640.02
- Event
- blood thyroid stimulating hormone normal
- Reports
- 72
- Reporting signal score
- 375.255
- Event
- cognitive disorder
- Reports
- 223
- Reporting signal score
- 300.037
- Event
- constipation
- Reports
- 307
- Reporting signal score
- 143.58
- Event
- creatinine renal clearance decreased
- Reports
- 149
- Reporting signal score
- 396.749
- Event
- depressed level of consciousness
- Reports
- 207
- Reporting signal score
- 228.852
- Event
- fatigue
- Reports
- 826
- Reporting signal score
- 250.726
- Event
- feeling abnormal
- Reports
- 267
- Reporting signal score
- 139.188
- Event
- hyperthyroidism
- Reports
- 219
- Reporting signal score
- 477.714
- Event
- hypothyroidism
- Reports
- 295
- Reporting signal score
- 568.31
- Event
- insomnia
- Reports
- 316
- Reporting signal score
- 139.092
- Event
- mobility decreased
- Reports
- 204
- Reporting signal score
- 234.743
- Event
- orthostatic hypotension
- Reports
- 186
- Reporting signal score
- 285.549
- Event
- palpitations
- Reports
- 390
- Reporting signal score
- 442.783
- Event
- pharmaceutical product complaint
- Reports
- 106
- Reporting signal score
- 125.87
- Event
- sedation
- Reports
- 185
- Reporting signal score
- 288.219
- Event
- sedation complication
- Reports
- 154
- Reporting signal score
- 555.395
- Event
- therapeutic response unexpected with drug substitution
- Reports
- 68
- Reporting signal score
- 123.577
- Event
- thyroid function test abnormal
- Reports
- 113
- Reporting signal score
- 347.056
And 3 more, listed on the interactive page.
- NCT00921050
- NCT01831869
- NCT01848171
- NCT01916304
- NCT02917863
- NCT03094416
- NCT04878614
- NCT05823012
- NCT06073665
- NCT01528839
- NCT02004301
- NCT05228184
- Dose
- 1.6 mcg/kg/day
- Route
- Oral
- How often
- Once daily
Conditions of use
- Take on an empty stomach, one-half to one hour before breakfast with a full glass of water
- Hydrogen bond acceptors
- 4
- Hydrogen bond donors
- 3
- Polar surface area
- 92.78
- Calculated partition coefficient (ALogP)
- 4.56
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Rule-of-five violations
- 1
- Rotatable bonds
- 5
- Heavy atoms
- 26
- Molecular formula
- C15H12I4NNaO5
- Monoisotopic mass
- 816.6792
- Natural product
- Yes
Related records
Trials (127)
- A Clinical Trial of Adjunctive Thyroxine for Avolition in Schizophrenia
- A Pilot Feasibility Trial of Thyroid Hormone Replacement in Dialysis Patients
- A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients
- A Study Evaluating the Safety and Efficacy of Hormone Replacement Therapy With ST-1891 Compared to Levothyroxine in Patients With Primary Hypothyroidism
- A Study Evaluation the Safety and Efficacy of Hormone Replacement Therapy With North Star Compared to Levothyroxine in Patients With Primary Hypothyroidism
- A Study in Healthy Male Volunteers to Investigate the Safety and Tolerability of a Single Dose of Neosaxitoxin Alone and in Combination With Bupivacaine (With and Without Epinephrine) for Brachial Plexus Blockade
- A Study of Armour® Thyroid Compared to Synthetic T4 (Levothyroxine) in Previously Hypothyroid Participants
- A Study of Levothyroxine and Enlicitide Decanoate (MK-0616) in Healthy Adult Participants (MK-0616-028)
- A Study to Assess the Safety and Efficacy of Oral Armour Thyroid Compared to Synthetic T4 for the Treatment of Primary Hypothyroidism in Adult Participants
- A Trial Investigating the Influence of Oral Semaglutide on the Pharmacokinetics of Levothyroxine and the Influence of Co-administered Tablets on the Pharmacokinetics of Semaglutide Administered Orally in Healthy Subjects.
- Antithyroid Drug Treatment of Thyrotoxicosis in Young People
- BE of Euthyrox® Tablets (Merck Nantong Versus Merck Darmstadt Sites)
- Best Treatment for Women With Both (Polycystic Ovary Syndrome) PCOS and Subclinical Hypothyroidism
- Bioavailability Investigations of Thyronajod Mite Tablets of Dosage Strengths 50 μg Levothyrox-ine/75 μg Iodine, and 100 μg Levothyroxine/75 μg Iodine vs. a Levothyroxine Drinking-Solution: A Randomised Cross Over Study in Healthy Male Individuals. Currently: 100 μg/ 75 μg Tablets
- Bioavailability Investigations of Thyronajod Mite Tablets of Dosage Strengths 50 μg Levothyrox-ine/75 μg Iodine, and 100 μg Levothyroxine/75 μg Iodine vs. a Levothyroxine Drinking-Solution: A Randomised Cross Over Study in Healthy Male Individuals. Currently: 50 μg/ 75 μg Tablets
- Bioequivalence of Two Levothyroxine Tablet Formulations in Healthy Indian Volunteers
- Bioequivalence Study of Levothyroxine Sodium Tablets 100 mcg
- Bioequivalence Study of Levothyroxine Sodium Tablets 150 mcg
- Can Levothyroxine Treatment Reduce the Development of Cardio-metabolic Disorder in Subclinical Hypothyroidism?
- Central Hypothyroidism, a Novel Laboratory Measurement
Approved for (5)
- Congenital hypothyroidism
- Differentiated thyroid carcinoma
- Hypothyroidism
- Thyroid cancer
- Thyroid gland carcinoma
In development for (1)
- Bipolar disorder Phase 2