LEVOLET (levothyroxine sodium)
Levolet is indicated as replacement therapy in adult and pediatric patients, including neonates, for primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. It is also used as an adjunct to surgery and radioiodine therapy for the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of use: Levolet is not indicated for the suppression of benign thyroid nodules or nontoxic diffuse goiter in iodine-sufficient patients, nor is it indicated for hypothyroidism during the recovery phase of subacute thyroiditis.
How LEVOLET Works
Levothyroxine (T4) exerts its physiological effects primarily through its conversion to triiodothyronine (T3). Both T4 and T3 diffuse into the cell nucleus and bind to thyroid receptor proteins attached to DNA. This hormone-nuclear receptor complex activates gene transcription and the synthesis of messenger RNA and cytoplasmic proteins, thereby regulating metabolic processes. While the medication provides exogenous T4, the majority of its physiological activity is derived from T3, which is produced via the peripheral deiodination of T4.
Details
- Status
- Prescription
- First Approved
- 2003-06-06
- Patent Cliff
- 2038
- Routes
- ORAL
- Dosage Forms
- TABLET
LEVOLET Approval History
What LEVOLET Treats
2 indicationsLEVOLET is approved for 2 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypothyroidism
- Thyroid Cancer
LEVOLET Boxed Warning
NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS Thyroid hormones, including levothyroxine sodium, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used ...
WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS Thyroid hormones, including levothyroxine sodium, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects [see Adverse Reactions (6) , Drug Interactions (7.7) , and Overdosage (10) ]. WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS See full prescribing information for complete boxed warning Thyroid hormones, including levothyroxine sodium, should not be used for the treatment of obesity or for weight loss. Doses beyond the range of daily hormonal requirements may produce serious or even life-threatening manifestations of toxicity (6 , 10) .
LEVOLET Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to LEVOLET
3 of 14FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06073665 DOT4 | 1R01AG081698-01, #853300 R01AG081698 | Ph 4 | recruiting | Dosing of LT4 in Older Individuals |
| NCT05228184 | 20US-T414 | Ph 4 | terminated | Use of Tirosint®-SOL or Tablet Formulations of Levothyroxine in Pediatric Patients With Congenital Hypothyroidism (CH) |
| NCT05823012 results posted | XP-8121-120 | Ph 2 | completed | Study of XP-8121 For the Treatment of Adult Subjects With Hypothyroidism |
| NCT04878614 | IRB#20-002097 | Ph 4 | terminated | Comparison of Levothyroxine Formulation in Hypothyroid Patients With Enteral Feeding |
| NCT03281083 | MRN-01-NAFLD-01 | Ph 2 | terminated | Levothyroxine for Non-Alcoholic Fatty Liver Disease (NAFLD) |
| NCT00921050 | EN_LC_P136 | Ph 2, Ph 3 | completed | Subclinical Hypothyroidism and Mind in the Elderly |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LEVOLET FDA Label Details
Indications & Usage
FDA Label (PDF)LEVOLET is indicated for the treatment of Hypothyroidism; Thyroid Cancer.
WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS Thyroid hormones, including levothyroxine sodium, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. In euthyroid patients, doses within the range of daily hormonal requirements a...
LEVOLET Patents & Exclusivity
Patents (2 active)
Pro Intelligence Preview
Deep insights for LEVOLET
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2038
- • 240 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 14 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.