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Unithroid (LEVOTHYROXINE SODIUM)
Unithroid (generic name: LEVOTHYROXINE SODIUM) is a l-Thyroxine Small molecule drug developed by Fresenius Kabi. It is currently FDA-approved (first approved 2000) for Congenital hypothyroidism, Diagnostic Test for Thyroid Dysfunction, Goiter.
Unithroid works by replacing or supplementing the thyroid hormone thyroxine, which is produced by the thyroid gland.
Unithroid is a brand name for levothyroxine sodium tablets, which are used to treat various conditions including hypothyroidism, as indicated by ClinicalTrials.gov. Levothyroxine sodium tablets, including Unithroid, work by replacing thyroid hormones in the body, as per ChEMBL's information on the mechanism of levothyroxine.
At a glance
| Generic name | LEVOTHYROXINE SODIUM |
|---|---|
| Sponsor | Fresenius Kabi |
| Drug class | l-Thyroxine |
| Target | Thyroid hormone receptor beta |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2000 |
Mechanism of action
Thyroid hormones exert their physiologic actions through control of DNA transcription and protein synthesis. Triiodothyronine (T3) and L-thyroxine (T4) 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 thyroid hormones are produced predominantly by T3, the majority of which (approximately 80%) is derived from T4 by deiodination in peripheral tissues.
Approved indications
- Congenital hypothyroidism
- Diagnostic Test for Thyroid Dysfunction
- Goiter
- Hashimoto thyroiditis
- Hyperlipidemia
- Hypothyroidism
- Malignant tumor of thyroid gland
- Myxedema
Boxed warnings
- WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS Thyroid hormones, including UNITHROID, 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 UNITHROID, 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 ).
Common side effects
- Weight loss
- Hair loss
- Diarrhea
- Vomiting
- Abdominal cramps
- Palpitations
- Tachycardia
- Arrhythmias
- Increased pulse and blood pressure
- Heart failure
- Angina
- Myocardial infarction
Drug interactions
- ferric sulfate
- phenprocoumon
- sucralfate
- warfarin
Key clinical trials
- Novel Approaches to the Treatment of Hypothyroidism (PHASE2,PHASE3)
- Comparison of Levothyroxine Formulations in the Treatment of Congenital Hypothyroidism
- T4/T3 Therapy in Hypothyroidism (PHASE2)
- SNUH Immune Checkpoint Inhibitor-induced Hypothyroidism Recovery Trial (NA)
- Thyroid Hormone for Treatment of Nonalcoholic Steatohepatitis in Veterans (PHASE2)
- Dosing of LT4 in Older Individuals (PHASE4)
- A Study Evaluation the Safety and Efficacy of Hormone Replacement Therapy With North Star Compared to Levothyroxine in Patients With Primary Hypothyroidism (PHASE2)
- Precision Medicine Approach for Early Dementia & Mild Cognitive Impairment (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 11241382 | 2039-09-17 | Method of Use |
| 10231931 | 2038-03-23 | Formulation |
| 9168238 | 2032-08-29 | Formulation |
| 10406108 | 2038-03-23 | Formulation |
| 9168239 | 2032-08-29 | Formulation |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Unithroid CI brief — competitive landscape report
- Unithroid updates RSS · CI watch RSS
- Fresenius Kabi portfolio CI
Frequently asked questions about Unithroid
What is Unithroid?
How does Unithroid work?
What is Unithroid used for?
Who makes Unithroid?
What is the generic name of Unithroid?
What drug class is Unithroid in?
When was Unithroid approved?
What development phase is Unithroid in?
What are the side effects of Unithroid?
What does Unithroid target?
Related
- Drug class: All l-Thyroxine drugs
- Target: All drugs targeting Thyroid hormone receptor beta
- Manufacturer: Fresenius Kabi — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Congenital hypothyroidism
- Indication: Drugs for Diagnostic Test for Thyroid Dysfunction
- Indication: Drugs for Goiter
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing