Drugs / rhTSH
rhTSH
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 13 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00137891 | Jun → Aug 2005 | — | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT04137185 | Jun 2019 → Dec 2020 | differentiated thyroid carcinoma | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Completed | No outcome recorded |
| Phase 1/2 | NCT03276988 | Sep 2017 → Jan 2020 | postsurgical hypothyroidism | Genexine, Inc. | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT04447183 | Nov 2020 → Aug 2024 | differentiated thyroid carcinoma | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Unknown | No outcome recorded |
| Phase 2 | NCT00181168 | Mar 2001 → Sep 2003 | thyroid cancer | Johns Hopkins University | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT04964284 | Oct 2021 → Sep 2024 | differentiated thyroid carcinoma | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Unknown | No outcome recorded |
| Phase 3 | NCT04971473 | Sep 2021 → Jul 2023 | differentiated thyroid carcinoma | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Completed | No outcome recorded |
| Phase 3 | NCT00435851 | Feb 2007 → ? | thyroid cancer | Gustave Roussy, Cancer Campus, Grand Paris | Unknown | No outcome recorded |
| Phase 3 | NCT00415233 | Nov 2006 → Jun 2011 | head and neck cancer | University College, London | Unknown | No outcome recorded |
| 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 |
| Phase not applicable2 trials | ||||||
| — | NCT06431620 | Jun 2024 → May 2026 overdue | — | Nanjing First Hospital, Nanjing Medical University | Recruiting | No outcome recorded |
| — | NCT06405217 | Apr 2024 → Mar 2026 overdue | differentiated thyroid carcinoma | Nanjing First Hospital, Nanjing Medical University | Recruiting | No outcome recorded |
Also used as a comparator or background therapy in 10 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02145143 Background | May 2014 → Nov 2024 | thyroid gland carcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT02278198 Background | Nov 2012 → Sep 2019 | differentiated thyroid carcinoma | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT06440850 Background | Jul 2024 → Nov 2026 expected | thyroid gland follicular carcinoma, thyroid gland papillary carcinoma | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05668962 Background | Mar 2023 → Mar 2025 overdue | thyroid gland follicular carcinoma, thyroid gland papillary carcinoma | Massachusetts General Hospital | Recruiting | No outcome recorded |
| 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 2 | NCT03244956 Background | Dec 2017 → May 2022 | cancer, familial, with in vitro Radioresistance | Gustave Roussy, Cancer Campus, Grand Paris | Completed | No outcome recorded |
| Phase 2 | NCT00085293 Background | May 2004 → Jan 2014 | thyroid gland follicular carcinoma, thyroid gland papillary carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT01837745 Comparator | May 2013 → Apr 2022 overdue | differentiated thyroid carcinoma | Gustave Roussy, Cancer Campus, Grand Paris | Active not recruiting | No outcome recorded |
| Phase 3 | NCT00295763 Background | May → Jul 2006 | differentiated thyroid carcinoma | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT00604318 Comparator | Feb 2008 → Feb 2012 | thyroid cancer | Copenhagen University Hospital at Herlev | Completed | No outcome recorded |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| 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 ↗12“Euthyroid Group: Received rhTSH to prepare for radioiodine therapy.” NCT00181168 ↗ “Recombinant Human Thyroid Stimulating Hormone for Injection(rhTSH)” NCT04447183 ↗ “injection of human recombinant TSH (rhTSH Thyrogen)” NCT03841617 ↗ “recombinant human thyrotropin (rhTSH) injection” NCT06431620 ↗ |
| Known as | GX-30 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03276988 ↗ |
| Known as | human recombinant TSH | “injection of human recombinant TSH (rhTSH Thyrogen)” NCT03841617 ↗ |
| Known as | recombinant human thyroid stimulating hormone | “modified release formulation of recombinant human thyroid stimulating hormone (rhTSH) dosed at 0.1 mg” NCT00137891 ↗ |
| Known as | recombinant human thyrotropin | “recombinant human thyrotropin (rhTSH) injection” NCT06431620 ↗ |
| Known as | Recombinant Human TSH (rhTSH) | “Recombinant Human TSH (rhTSH)” NCT00181168 ↗ |
| Known as | Recombinant thyrotropin alfa | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00085293 ↗ |
| Known as | rTSH | “recombinant thyroid-stimulating hormone (TSH) (rTSH, thyrotropin alfa for injection)” NCT00181168 ↗ |
| Known as | Thyrogen | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00295763 ↗ |
| Known as | thyrotropin alfa | “recombinant thyroid-stimulating hormone (TSH) (rTSH, thyrotropin alfa for injection)” NCT00181168 ↗2“recombinant human thyrotropin (thyrotropin alfa)” PMID 22551128 ↗ May 2012 “Thyrogen (thyrotropin alfa for injection)” NCT00295763 ↗ |
| Known as | thyrotropin alpha | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02145143 ↗ |
| Known as | ZGrhTSH | “PURPOSE: To evaluate the efficacy of a novel recombinant human thyroid-stimulating hormone (ZGrhTSH) as an alternative to thyroid hormone withdrawal (THW) in dynamic assessment...” PMID 40488858 ↗ Jun 2025 |
| Modality | Protein / enzyme biologic | “recombinant human TSH (Thyrogen® (Registered Trademark))” NCT00001730 ↗ |
| Route | Intramuscular | “All doses will be administered via intramuscular (IM) injection” NCT00137891 ↗ |