NDAORALTABLET
Approved
Jul 2002
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
4/8 — Partial
SYNTHROID (levothyroxine sodium) by AbbVie is synthesis. First approved in 2002.
Drug data last refreshed 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SYNTHROID (levothyroxine sodium) is an oral tablet thyroid hormone replacement therapy manufactured by AbbVie, approved by the FDA on July 24, 2002. It is indicated for treatment of hypothyroidism across multiple etiologies including primary, secondary (pituitary), and tertiary (hypothalamic) forms, as well as adjunctive therapy in thyroid cancer management. The drug works by replacing or supplementing endogenous thyroid hormones; levothyroxine (T4) is peripherally converted to the active form triiodothyronine (T3), which binds to thyroid receptors in cell nuclei to modulate gene transcription and protein synthesis. SYNTHROID remains the standard-of-care thyroid replacement therapy and is among the most prescribed medications in the United States.
$0.4BPart D
Mechanism of Action
synthesis. Triiodothyronine (T3) and L-thyroxine (T4) diffuse into the cell nucleus and bind to thyroid receptor proteins attached to DNA. This hormone nuclear receptor complex activates gene transcription and synthesis of messenger RNA and cytoplasmic proteins. The physiological actions of thyroid…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
Bioequivalence of Two Formulations of Levothyroxine Sodium 200 Micrograms (mcg) Under Tablet Form
Started Jun 2019
72 enrolled
Healthy
Levothyroxine Sodium in Thyroidectomized Patients Taking Proton Pump Inhibitors
Started Jul 2018
66 enrolled
Hypothyroidism;Postablative
Study of Dose Adjustment From Levothyroxine to a New Levothyroxine Sodium Test Formulation
Started Jul 2013
101 enrolled
Hypothyroidism
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.