Clinical trials
Follow clinical development from study design and recruitment through results.
- Trial phase
- Status
- Readouts
Drug intelligence / Profile preview
Tirosint-SOL is a liquid formulation of levothyroxine sodium, designed for thyroid hormone replacement therapy. It comes in a unique oral solution form that contains only three ingredients: levothyroxine sodium (the active ingredient), glycerol, and water. This makes it particularly suitable for patients with allergies, absorption issues, or those who have difficulty swallowing pills. ## Key Information Tirosint-SOL is FDA-approved for treating hypothyroidism (underactive thyroid) in adults and children, including neonates. It can also be used with surgery and radioiodine therapy to manage thyroid-dependent well-differentiated thyroid cancer. The medication is dispensed in single-dose ampules to protect against moisture and light, preserving its potency. It can be administered either directly into the mouth or mixed with water. ## Administration Tirosint-SOL should be taken: - As a single daily oral dose - On an empty stomach - 15 minutes before breakfast - At least 4 hours before or after drugs known to interfere with its absorption To administer Tirosint-SOL: 1. With water: Squeeze the contents of one ampule into a glass of water, stir, and drink immediately. Rinse the glass with additional water and drink to ensure the total dose is taken. 2. Directly: Either squeeze it into the mouth OR onto a spoon and immediately consume. ## Dosage Information Tirosint-SOL is available in multiple dosage strengths: 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, and 200 mcg/mL. For adults with hypothyroidism, the recommended starting dosage is typically 1.6 mcg/kg/day, though some patients may require a lower starting dose. For elderly patients or those with cardiac conditions, a lower starting dose is recommended to avoid exacerbating cardiac symptoms. Dosage titration is based on serum TSH or free-T4 levels, with adjustments typically made in 12.5 to 25 mcg increments every 4-6 weeks until the patient reaches euthyroid status. ## Advantages Tirosint-SOL offers several advantages over traditional levothyroxine tablets: - Contains only three ingredients (levothyroxine, glycerol, and water) - Free from common allergens like gluten, lactose, dyes, and other inactive ingredients found in tablets - Demonstrates superior absorption - Less affected by food, coffee, or proton pump inhibitors - Suitable for patients with digestive issues - Ideal for those unable to swallow pills or requiring precise dosing Tirosint-SOL was FDA approved on December 15, 2016, and is manufactured by IBSA Pharma Inc.
Beyond the preview
Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.
Follow clinical development from study design and recruitment through results.
Explore development by indication, patient population, and geography.
Trace asset ownership, licensing agreements, and commercial partnerships.
Explore the patent landscape and regulatory exclusivity around an asset.
Compare development programs by target, modality, and indication.
Connect source evidence and development news to your research questions.
See how Gosset can support your research on Tirosint-SOL.