NDAORALCAPSULE
Approved
Oct 2006
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
4
Data completeness
5/8 — Partial
TIROSINT (levothyroxine sodium) by Pfizer is synthesis. First approved in 2006.
Drug data last refreshed 12h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TIROSINT is a branded oral capsule formulation of levothyroxine sodium, a synthetic thyroid hormone replacement therapy. It treats hypothyroidism by replacing deficient thyroid hormones and restoring metabolic function. The drug works by diffusing into cell nuclei where it binds thyroid receptor proteins, activating gene transcription and synthesis of metabolic proteins.
$15MPart D
Peak18.1 years to LOEPeak lifecycle positioning with minimal competitive pressure suggests a stable, mature brand with modest team size and maintenance-focused commercial strategies.
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)
Use of Tirosint®-SOL or Tablet Formulations of Levothyroxine in Pediatric Patients With Congenital Hypothyroidism (CH)
Started Jan 2022
34 enrolled
Congenital Hypothyroidism
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.