Levothyroxine
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
- Molecular weight
- 776.87
- Structure (SMILES)
- N[C@@H](Cc1cc(I)c(Oc2cc(I)c(O)c(I)c2)c(I)c1)C(=O)O
- l thyroxine
- l thyroxine l t4
- L-thyroxine
- L-Thyroxine
- L-thyroxine (L-T4)
- levothyroxin
- Levothyroxin
- levothyroxine
- Levothyroxine
- LEVOTHYROXINE [HSDB]
- LEVOTHYROXINE [USP-RS]
- LEVOTHYROXINE [VANDF]
- Levothyroxine [WHO-DD]
- levothyroxine hsdb
- levothyroxine usp rs
- levothyroxine vandf
- levothyroxine who dd
- LIOTHYRONINE SODIUM IMPURITY A [EP IMPURITY]
- liothyronine sodium impurity a ep impurity
- nsc 36397
- NSC-36397
- sk f 1 6528
- SK&F 1-6528
- synthetic levothyroxine
- Synthetic levothyroxine
And 8 more, listed on the interactive page.
- CAS registry numbers
- 51-48-9
- ChEMBL ID
- CHEMBL1624
- InChIKey
- XUIIKFGFIJCVMT-LBPRGKRZSA-N
- RxNorm IDs (RxCUI)
- 10582
- FDA ingredient codes (UNII)
- Q51BO43MG4
- 5819
- 25201348
- Applicant
- STEVENS J
- Approval date
- 21 Aug 2000
- Application number
- NDA021210
- First in class
- No
- Orphan designation
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- United States (FDA)
- Approved
- 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
Open Targets mechanisms
- Mechanism
- Thyroid hormone receptor agonist
- Action type
- Agonist
- Target
- Thyroid hormone receptor
- Action type
- Agonist
- Gene symbol
- THRA
- Protein identifier
- P10827
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- Agonist
- Gene symbol
- THRB
- Protein identifier
- P10828
- Organism
- Homo sapiens
- Target development level
- Clinical
- Condition
- Diabetes Mellitus
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000400
- Subject identifier
- D003920
- Condition
- Infections
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000544
- Subject identifier
- D007239
- Condition
- Pregnancy
- Highest recorded phase
- 0.5
- Condition identifier
- EFO:0002950
- Subject identifier
- D011247
- Condition
- Graves Disease
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004237
- Subject identifier
- D006111
- Condition
- Hypothyroidism
- Highest recorded phase
- 3
- Condition identifier
- EFO:0004705
- Subject identifier
- D007037
- Condition
- Bipolar Disorder
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0004985
- Subject identifier
- D001714
- Condition
- Congenital Hypothyroidism
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0018612
- Subject identifier
- D003409
- Condition
- Lipid Metabolism Disorders
- Highest recorded phase
- 3
- Condition identifier
- Orphanet:309005
- Subject identifier
- D052439
- Condition identifier
- EFO_0000400
- Highest recorded phase
- 1
- Condition identifier
- EFO_0001063
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001074
- Condition identifier
- EFO_0002950
- Condition identifier
- EFO_0002950
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004237
- Condition identifier
- EFO_0004705
- Condition identifier
- EFO_0006890
- Highest recorded phase
- 2
- Condition identifier
- EFO_0007634
- Highest recorded phase
- 2
- Condition identifier
- EFO_1000627
- Highest recorded phase
- 3
- Condition identifier
- EFO_1000931
- Highest recorded phase
- 3
- Condition identifier
- EFO_1000954
- Highest recorded phase
- 3
- Condition identifier
- EFO_1001436
- Condition identifier
- EFO_1001491
- Highest recorded phase
- 3
- Condition identifier
- HP_0000093
- Highest recorded phase
- 3
- Condition identifier
- HP_0000739
- Condition identifier
- HP_0000832
- Highest recorded phase
- 2
- Condition identifier
- HP_0001397
- Highest recorded phase
- 1
- Condition identifier
- HP_0001513
- Highest recorded phase
- 3
- Condition identifier
- HP_0001643
- Highest recorded phase
- 3
- Condition identifier
- HP_0008245
- Condition identifier
- HP_0012378
- Condition identifier
- HP_0030746
- Highest recorded phase
- 3
- Condition identifier
- HP_0031273
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0002009
And 32 more, listed on the interactive page.
Open Targets warnings
- Warning
- Black Box Warning
- Country
- United States
- Event
- abortion spontaneous
- Reports
- 57
- Reporting signal score
- 88.0716
- Event
- asthma
- Reports
- 31
- Reporting signal score
- 23.306
- Event
- atrial fibrillation
- Reports
- 39
- Reporting signal score
- 27.9594
- Event
- blood thyroid stimulating hormone abnormal
- Reports
- 17
- Reporting signal score
- 70.9782
- Event
- blood thyroid stimulating hormone decreased
- Reports
- 19
- Reporting signal score
- 57.8573
- Event
- blood thyroid stimulating hormone increased
- Reports
- 35
- Reporting signal score
- 103.853
- Event
- breath sounds abnormal
- Reports
- 10
- Reporting signal score
- 22.3214
- Event
- drug abuse
- Reports
- 44
- Reporting signal score
- 50.2499
- Event
- drug interaction
- Reports
- 50
- Reporting signal score
- 22.8111
- Event
- foetal growth restriction
- Reports
- 18
- Reporting signal score
- 39.4701
- Event
- full blood count abnormal
- Reports
- 14
- Reporting signal score
- 39.0982
- Event
- hypercapnia
- Reports
- 9
- Reporting signal score
- 22.8217
- Event
- hyperlactacidaemia
- Reports
- 9
- Reporting signal score
- 22.9569
- Event
- hypertension
- Reports
- 55
- Reporting signal score
- 24.2636
- Event
- hyperthyroidism
- Reports
- 75
- Reporting signal score
- 221.402
- Event
- hypothyroidism
- Reports
- 44
- Reporting signal score
- 82.8523
- Event
- intracranial pressure increased
- Reports
- 11
- Reporting signal score
- 22.8465
- Event
- live birth
- Reports
- 17
- Reporting signal score
- 40.0455
- Event
- low birth weight baby
- Reports
- 17
- Reporting signal score
- 32.0385
- Event
- milk-alkali syndrome
- Reports
- 8
- Reporting signal score
- 29.1521
- Event
- nasal obstruction
- Reports
- 8
- Reporting signal score
- 26.1044
- Event
- obstructive airways disorder
- Reports
- 15
- Reporting signal score
- 26.5767
- Event
- osteoporosis
- Reports
- 19
- Reporting signal score
- 24.5184
- Event
- palpitations
- Reports
- 46
- Reporting signal score
- 41.0949
- Event
- pneumothorax spontaneous
- Reports
- 7
- Reporting signal score
- 24.6581
And 10 more, listed on the interactive page.
- NCT00403390
- NCT02090907
- NCT03053115
- NCT03102177
- NCT03627611
- NCT05316922
- NCT05412979
- NCT05712421
- NCT06345339
- NCT01486667
- NCT01528839
- NCT01950260
- NCT02920385
- NCT03106935
- NCT06428097
- Route
- Oral
- How often
- Once daily
- Avoid foods that decrease absorption such as soybean-based infant formula
- Do not store suspension
- Preferably on an empty stomach
- Stop biotin and biotin-containing supplements at least 2 days before assessing TSH and/or T4 levels
- Take at least 4 hours before or after drugs that interfere with absorption
- Hydrogen bond acceptors
- 4
- Hydrogen bond donors
- 3
- Polar surface area
- 92.78
- Calculated partition coefficient (ALogP)
- 4.56
- Calculated partition coefficient (XLogP)
- 2.4
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Rule-of-five violations
- 1
- Rotatable bonds
- 5
- Heavy atoms
- 24
- Molecular formula
- C15H11I4NO4
- Monoisotopic mass
- 776.6867
- Natural product
- Yes
- 42192-327
- 42192-328
- 42192-329
- 42192-330
- 42192-331
- 51655-132
- 64950-170
- 64950-171
- 64950-172
- 64950-173
- 64950-174
- 64950-175
- 64950-179
- 64950-180
- 72189-202
- 72189-218
- 73352-693
- 73352-694
- 73352-695
- 73352-696
- 73352-697
- 73352-698
- 73352-699
- 73352-700
- 76420-566
And 13 more, listed on the interactive page.
- Recorded assays
- 2,713
- Active assays
- 152
- Confirmatory
- Other
- Screening
- Summary
Related records
Trials (135)
- 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.
- Adjuvant Treatment of Graves´ Ophthalmopathy With NSAID (aGO Study)
- Antithyroid Drug Treatment of Thyrotoxicosis in Young People
- Assessing the Impact of the Early and Systematic Hormonal Replacement After Radio-isotopic Ablation of Graves'hyperthyroïdism on Quality of Life, Efficiency and Tolerance
- 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?
- COACH - Comparing Two Different Methods to Suppress Thyrotropin in Patients With Advanced Thyroid Cancer
- Cognitive Functions During Thyrotropin Suppressive Therapy in Patients With Differentiated Thyroid Carcinoma
In development for (20)
- Bipolar disorder Phase 2
- Bronchopulmonary dysplasia Phase 3
- Chronic kidney disease Phase 3
- Congenital hypothyroidism Phase 3
- Diabetes mellitus Phase 1
- Differentiated thyroid carcinoma Phase 3
- Down syndrome Phase 3
- Enterocolitis Phase 3
- Euthyroid sick syndrome Phase 3
- Fatty liver disease Phase 1
- Graves disease Phase 2
- Habitual spontaneous abortion Phase 3
- Hypothyroidism Phase 3
- Inherited lipid metabolism disorder Phase 3
- Metabolic dysfunction-associated steatohepatitis Phase 2
- Obesity disorder Phase 3
- Obstructive sleep apnea syndrome Phase 3
- Retinopathy of prematurity Phase 3
- Thyroid cancer Phase 2
- Transient congenital hypothyroidism Phase 3
Other linked conditions (15)
- Anxiety
- Autoimmune thyroid disease
- Benign thyroid gland neoplasm
- Cardiovascular disorder
- Central congenital hypothyroidism
- Depressive disorder
- Hashimoto thyroiditis
- Hyperthyroidism
- Intracerebral hemorrhage
- Major depressive disorder
- Morbid obesity
- Polycystic ovary syndrome
- Thyroid gland disorder
- Thyroid gland papillary carcinoma
- Thyroiditis