NDAORALTABLET
Approved
May 2002
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
5/8 — Partial
EUTHYROX (levothyroxine sodium) by Pfizer is synthesis. First approved in 2002.
Drug data last refreshed 8h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EUTHYROX (levothyroxine sodium) is an oral tablet containing synthetic thyroid hormone used to treat hypothyroidism and congenital hypothyroidism. It works by diffusing into cell nuclei and binding to thyroid receptors on DNA, activating gene transcription and protein synthesis to restore normal metabolic function. Approximately 80% of T3 production derives from peripheral T4 deiodination.
$0.001BPart D
LOE ApproachingEUTHYROX faces significant competitive pressure in a crowded levothyroxine market with LOE approaching, suggesting smaller team and focus on defensive positioning rather than growth initiatives.
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 (4)
BE of Euthyrox® Tablets (Merck Nantong Versus Merck Darmstadt Sites)
Started Jan 2022
56 enrolled
Healthy
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.