NDAORALSOLUTION
Approved
Dec 2016
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
7
Data completeness
5/8 — Partial
TIROSINT-SOL (levothyroxine sodium) by Pfizer is synthesis. First approved in 2016.
Drug data last refreshed 12h ago · AI intelligence enriched 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TIROSINT-SOL is an oral liquid formulation of levothyroxine sodium, a synthetic thyroid hormone replacement used to treat hypothyroidism and other thyroid disorders. The drug works by diffusing into cell nuclei and binding to thyroid receptors, activating gene transcription and protein synthesis; approximately 80% of therapeutic T3 is derived from peripheral deiodination of T4. It represents a differentiated delivery platform for a well-established active pharmaceutical ingredient.
$0.002BPart D
Peak17.9 years to LOEProduct is in peak commercial phase with established market presence and modest Part D volume; team size and hiring activity likely stable but specialized.
Mechanism of Action
synthesis. Triiodothyronine (T 3 ) and levothyroxine (T 4 ) 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…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
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
Fasting Study of Levothyroxine Sodium Tablets 300 mcg to Synthroid® Tablets 300 mcg
Started Mar 2007
33 enrolled
Healthy
Fasting Study of Levothyroxine Sodium Tablets 300 μg to Levothroid® Tablets 300 μg
Started Aug 2005
32 enrolled
Healthy
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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.