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Also known as Levothyroxine sodium new formulation
Levothyroxine new formulation · 1 trial · 1 indication
Dose change was determined by physician according to their clinical judgement.
| Arm | Type | Description |
|---|---|---|
| Levothyroxine sodium new formulation | EXPERIMENTAL | Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level. |
| Name | Type | Description |
|---|---|---|
| Levothyroxine sodium new formulation | DRUG | Levothyroxine tablets |
Inclusion Criteria: 1. (Near) total thyroidectomised patients. 2. Aged 18 years and older. 3. Stabilised on the same daily dose of L-Thyroxine Christiaens® during the last 6 weeks before inclusion in the study. 4. Written informed consent given. 5. Able and willing to comply with protocol requireme...
Levothyroxine new formulation is being developed for the treatment of hypothyroidism, a condition in which the thyroid gland does not produce enough thyroid hormone. It is a reformulated version of levothyroxine sodium, a standard hormone replacement therapy, and is intended to provide an alternative option for patients who require dose adjustment.
Levothyroxine new formulation acts as an agonist at the thyroid hormone receptors THRA and THRB. By binding to and activating these nuclear receptors, it mimics the action of endogenous thyroid hormones, thereby restoring normal metabolic, developmental, and physiological processes in patients with hypothyroidism.
Takeda Pharmaceutical Company Limited (ticker: TAK) is the developer of levothyroxine new formulation. The company is responsible for the clinical development program of this reformulated levothyroxine sodium product.
Levothyroxine new formulation is in Phase 2 clinical development. It is an investigational product and has not been approved by the FDA. The Phase 2 trial has been completed, and no active trials are currently listed.
Levothyroxine new formulation has been studied in one completed Phase 2 trial, NCT01916304, titled "Study of Dose Adjustment From Levothyroxine to a New Levothyroxine Sodium Test Formulation." The trial enrolled 101 participants with hypothyroidism in Belgium and was an uncontrolled study.
Yes, levothyroxine new formulation is also known as levothyroxine sodium new formulation. Both names refer to the same investigational product developed by Takeda for hypothyroidism.