Drugs / rhTSH
rhTSH
also known as
recombinant human thyroid stimulating hormone · Recombinant Human TSH (rhTSH) · rTSH · thyrotropin alfa · ZGrhTSH
Trials 4
| 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 21 trial | ||||||
| Phase 2 | NCT00181168 | Mar 2001 → Sep 2003 | thyroid cancer | Johns Hopkins University | Completed | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT04964284 | Oct 2021 → Jan 2026 | differentiated thyroid carcinoma | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Completed | No outcome recorded |
| Phase 3 | NCT04971473 | Sep 2021 → Jul 2023 | differentiated thyroid carcinoma | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Completed | Met primary |
| Comparator or background therapy5 trials | ||||||
| Phase 1 | NCT02278198 Background | Nov 2012 → Sep 2019 | differentiated thyroid carcinoma | University of Colorado, Denver | Completed | 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 | NCT03244956 Background | Dec 2017 → May 2022 | cancer, familial, with in vitro Radioresistance | Gustave Roussy, Cancer Campus, Grand Paris | Completed | No outcome recorded |
| 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 4 | NCT00604318 Comparator | Feb 2008 → Feb 2012 | thyroid cancer | Copenhagen University Hospital at Herlev | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-01-08 | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Regulatory 泽璟制药泽速宁®获批上市！填补中国分化型甲状腺癌术后精准评估市场空白 zelgen.com ↗ |
| 2024-06-03 | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Regulatory 泽璟制药宣布递交注射用重组人促甲状腺激素生物制品上市许可申请 zelgen.com ↗
2024年6月3日，泽璟 制药 宣布 ，公司 自主 研发 的注 射用 重组 人促 甲状 腺激 素（rhTSH）向国 家药 品监 督管 理局 （NMPA）递交 了生 物制 品上 市许 可申 请（BLA），目前 等待 正式 受理 中. |
| 2023-09-18 | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Results 重要进展 I 泽璟制药宣布注射用重组人促甲状腺激素III期临床试验达到预设主要终点 zelgen.com ↗ |
| 2017-05-26 | Genexine, Inc. | Regulatory Genexine Enters into Clinical Trial for Thyroid-Stimulating Hormone (TSH), Orphan Disease Treatment genexine.com ↗
Genexine Inc. (KOSDAQ:095700), a clinical stage biotechnology company developing innovative biologics focused on orphan diseases and immuno-oncology, announced that an IND approval of GX-30, recombinant Thyroid-Stimulating Hormone (TSH), was granted a trial of Phase I & II from the Ministry of Food and Drug Safety (MFDS). |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-01-08 | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | 泽璟制药泽速宁®获批上市！填补中国分化型甲状腺癌术后精准评估市场空白 zelgen.com ↗ |
| 2024-06-03 | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | 泽璟制药宣布递交注射用重组人促甲状腺激素生物制品上市许可申请 zelgen.com ↗ |
| 2023-09-18 | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | 重要进展 I 泽璟制药宣布注射用重组人促甲状腺激素III期临床试验达到预设主要终点 zelgen.com ↗ |
| 2017-05-26 | Genexine, Inc. | Genexine Enters into Clinical Trial for Thyroid-Stimulating Hormone (TSH), Orphan Disease Treatment genexine.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | rhTSH | “Euthyroid Group: Received rhTSH to prepare for radioiodine therapy.” NCT00181168 ↗ |
| 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 TSH (rhTSH) | “Recombinant Human TSH (rhTSH)” NCT00181168 ↗ |
| Known as | rTSH | “recombinant thyroid-stimulating hormone (TSH) (rTSH, thyrotropin alfa for injection)” NCT00181168 ↗ |
| Known as | thyrotropin alfa | “recombinant thyroid-stimulating hormone (TSH) (rTSH, thyrotropin alfa for injection)” NCT00181168 ↗ |
| 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 (rhTSH)” NCT00181168 ↗ |
| Route | Intramuscular | “All doses will be administered via intramuscular (IM) injection” NCT00137891 ↗ |