Drugs / GX-30
GX-30
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 2
| 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 31 trial · 1 met primary | ||||||
| Phase 3 | NCT00415233 | Nov 2006 → Jun 2011 | head and neck cancer | University College, London | Unknown | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 0 | NCT02145143 Background | May 2014 → Nov 2024 | thyroid gland carcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GX-30 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03276988 ↗ |
| Known as | thyrotropin alfa | “recombinant human thyrotropin (thyrotropin alfa)” PMID 22551128 ↗ May 2012 |
| Known as | thyrotropin alpha | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02145143 ↗ |
| Modality | Protein / enzyme biologic | “recombinant human thyrotropin (thyrotropin alfa)” PMID 22551128 ↗ May 2012 |
| Route | Intramuscular | “by intramuscular injection” NCT00415233 ↗ |