NDAORALTABLET
Approved
Mar 2002
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
5/8 — Partial
LEVO-T (levothyroxine sodium) by Pfizer is synthesis. First approved in 2002.
Drug data last refreshed Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LEVO-T is a levothyroxine sodium tablet approved by Pfizer in 2002 for oral treatment of hypothyroidism and congenital hypothyroidism. It works by replacing deficient thyroid hormone, with T4 being converted peripherally to the more active T3 form, which binds to nuclear thyroid receptors to regulate gene transcription and metabolic processes. This is a cornerstone replacement therapy for patients with insufficient thyroid hormone production.
$0.241MPart D
LOE ApproachingDeclining
LEVO-T faces significant LOE pressure with mature generic competition and declining Part D spending; brand team will likely transition to lifecycle management and cost optimization roles.
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
Career Relevance
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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.