Drugs / Thyrogen
Thyrogen
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | THYROGEN | — | 2006-01-24 – 2020-03-12 | fda.gov ↗ |
| Approved | EU (EMA) | Thyrogen | — | 2000-03-09 | europa.eu ↗ |
| Approved | US (FDA) | THYROGEN | — | 1998-11-30 | fda.gov ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03276988 | Sep 2017 → Jan 2020 | postsurgical hypothyroidism | Genexine, Inc. | Completed | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT00435851 | Feb 2007 → ? | thyroid cancer | Gustave Roussy, Cancer Campus, Grand Paris | Unknown | Met primary |
| Phase 3 | NCT00196729 | Dec 2001 → Sep 2003 | thyroid tumor | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT00001730 | Dec 1997 → Apr 2000 | hypothyroidism, thyroid cancer | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT03841617 Comparator | Jul 2019 → Nov 2035 expected | thyroid cancer | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Recruiting | No outcome recorded |
| Phase 3 | NCT00295763 Background | May → Jul 2006 | differentiated thyroid carcinoma | Genzyme, a Sanofi Company | Completed | No outcome recorded |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Thyrogen | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03841617 ↗ |
| Known as | human recombinant TSH | “injection of human recombinant TSH (rhTSH Thyrogen)” NCT03841617 ↗ |
| Known as | rhTSH | “the recombinant human TSH (rhTSH, Thyrogen®, Genzyme Therapeutics, Cambridge, USA) was approved in Europe in 2005 as an alternative stimulation procedure” NCT00435851 ↗1“injection of human recombinant TSH (rhTSH Thyrogen)” NCT03841617 ↗ |
| Known as | thyrotropin alfa | “Thyrogen (thyrotropin alfa for injection)” NCT00295763 ↗ |
| Modality | Protein / enzyme biologic | “recombinant human TSH (Thyrogen® (Registered Trademark))” NCT00001730 ↗ |
| Route | Intramuscular | “Thyrogen (0.9 mg) was administered intramuscularly (IM)” NCT00196729 ↗ |