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Thyrogen (THYROTROPIN ALFA)
Thyrotropin alfa (Thyrogen), marketed by Sanofi, is a recombinant human thyrotropin used primarily for meal timing, with a key composition patent expiring in 2028. Its mechanism of action, which involves binding to the thyrotropin receptor on the thyroid gland to stimulate thyroglobulin production, provides a targeted approach for its indication. The primary risk is the lack of revenue data and key trial results, which may limit its market visibility and competitive positioning.
At a glance
| Generic name | THYROTROPIN ALFA |
|---|---|
| Sponsor | Sanofi |
| Drug class | Adrenocorticotropic Hormone [EPC] |
| Target | Thyrotropin receptor |
| Modality | Recombinant protein |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1953 |
Approved indications
- Meal timing
Common side effects
- Nausea
- Headache
- Fatigue
- Vomiting
- Dizziness
- Asthenia
- Influenza-like symptoms
- Fever
- Chills/Shivering
- Myalgia/Arthralgia
- Malaise
- Urticaria
Serious adverse events
- Nausea (severe)
- Fatigue (severe)
- Asthenia (severe)
Key clinical trials
- The Use of 124-I-PET/CT Whole Body and Lesional Dosimetry in Differentiated Thyroid Cancer (PHASE2)
- Efficacy of MEK (Trametinib) and BRAFV600E (Dabrafenib) Inhibitors With Radioactive Iodine (RAI) for the Treatment of Refractory Metastatic Differentiated Thyroid Cancer (PHASE2)
- Vemurafenib and Cobimetinib for the Treatment of Patients With High Risk Differentiated Thyroid Carcinoma With BRAFV600E Mutation (PHASE2)
- CASE 1320: RAI Uptake and Serum Prolactin in Thyroid Cancer
- Study to Evaluate NBI-921352 as Adjunctive Therapy in Subjects With SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE) (PHASE2)
- Study of CM310 in Patients With Uncontrolled Seasonal Allergic Rhinitis (PHASE2)
- Study to Assess Efficacy and Safety of Dupilumab in the Treatment of Keloids (PHASE2)
- Extra Luteinizing Hormone Improve Embryo Quality in IVF Patients With Low LH During Long GnRH-Agonist Treatment (NA)
Patents
| Patent | Expiry | Type |
|---|---|---|
| Biologic Exclusivity |
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:
- Thyrogen CI brief — competitive landscape report
- Thyrogen updates RSS · CI watch RSS
- Sanofi portfolio CI