ERMEZA (levothyroxine sodium)
ERMEZA is a thyroid hormone replacement indicated for adult and pediatric patients, including neonates, with primary (thyroidal), secondary (pituitary), or tertiary (hypothalamic) congenital or acquired hypothyroidism. It is also indicated as an adjunct to surgery and radioiodine therapy for the management of thyrotropin-dependent well-differentiated thyroid cancer. **Limitations of Use:** ERMEZA 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. IMPROVED_HOW_IT_WORKS: Levothyroxine (T4) exerts its effects by diffusing into the cell nucleus and binding to thyroid receptor proteins attached to DNA. This hormone-nuclear receptor complex activates gene transcription and the synthesis of messenger RNA and cytoplasmic proteins. While ERMEZA provides T4, the drug's physiological actions are predominantly mediated by T3, which is largely derived from T4 through deiodination in peripheral tissues.
How ERMEZA Works
This medication works by entering the cell nucleus and binding to specific thyroid receptor proteins attached to DNA. This interaction triggers the transcription of genes and the synthesis of proteins necessary for various physiological functions. While the drug provides T4, most of its effects come from its conversion into T3 within the body's peripheral tissues.
Details
- Status
- Prescription
- First Approved
- 2022-04-29
- Patent Cliff
- 2035
- Routes
- ORAL
- Dosage Forms
- SOLUTION
ERMEZA Approval History
What ERMEZA Treats
2 indicationsERMEZA is approved for 2 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypothyroidism
- Thyroid Cancer
ERMEZA Boxed Warning
NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS Thyroid hormones, including ERMEZA, 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 anor...
WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS Thyroid hormones, including ERMEZA, 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 ERMEZA, 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 ).
ERMEZA 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 ERMEZA
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.
ERMEZA FDA Label Details
Indications & Usage
FDA Label (PDF)ERMEZA is indicated for the treatment of Hypothyroidism; Thyroid Cancer.
WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS Thyroid hormones, including ERMEZA, 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...
ERMEZA Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for ERMEZA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2035
- • 1 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.