{"id":"thyrogen-radioiodine-131i","safety":{"commonSideEffects":[{"rate":null,"effect":"Hypothyroidism"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Radiation-related effects (salivary gland dysfunction, bone marrow suppression)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"Thyrogen is a recombinant form of thyroid-stimulating hormone (TSH) that binds to TSH receptors on thyroid follicular cells, stimulating them to produce thyroglobulin and increase iodine uptake. When combined with radioactive iodine-131, this enhanced uptake allows the radioactive isotope to concentrate in thyroid tissue and metastases, delivering targeted radiation to destroy thyroid cancer cells while minimizing systemic exposure.","oneSentence":"Thyrogen (recombinant human TSH) stimulates thyroid tissue to take up radioiodine (131I), enabling targeted destruction of thyroid cancer cells and metastases.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:38:35.243Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Thyroid cancer (differentiated thyroid cancer with radioiodine-avid metastases)"},{"name":"Thyroid remnant ablation in thyroid cancer patients"}]},"trialDetails":[{"nctId":"NCT03215095","phase":"EARLY_PHASE1","title":"RAI Plus Immunotherapy for Recurrent/Metastatic Thyroid Cancers","status":"ACTIVE_NOT_RECRUITING","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2017-07-10","conditions":"Thyroid Cancer","enrollment":11},{"nctId":"NCT02145143","phase":"EARLY_PHASE1","title":"Enhancing Radioiodine (RAI) Incorporation Into BRAF Mutant, RAI-Refractory Thyroid Cancers With the BRAF Inhibitor Vemurafenib: A Pilot Study","status":"COMPLETED","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2014-05-20","conditions":"Thyroid Carcinoma","enrollment":12},{"nctId":"NCT06405217","phase":"NA","title":"Recombinant Human Thyroid Stimulating Hormone for Radioiodine 131I Treatment","status":"RECRUITING","sponsor":"Nanjing First Hospital, Nanjing Medical University","startDate":"2024-04-20","conditions":"DTC - Differentiated Thyroid Cancer, Thyroid Stimulating; Hormone, C, Radiotherapy; Complications","enrollment":30},{"nctId":"NCT04971473","phase":"PHASE3","title":"Comparison of the Efficacy and Safety of rhTSH as An Adjunctive Diagnostic Tool in Differentiated Thyroid Cancer Patients Who Had Been Thyroidectomized Vs. Patients Who After Thyroid Hormone Withdrawal","status":"COMPLETED","sponsor":"Suzhou Zelgen Biopharmaceuticals Co.,Ltd","startDate":"2021-09-10","conditions":"Differentiated Thyroid Cancer","enrollment":201},{"nctId":"NCT04447183","phase":"PHASE2","title":"The Safety and Effectiveness of rhTSH in Radioiodine Treatment for Patients With Differentiated Thyroid Cancer.","status":"UNKNOWN","sponsor":"Suzhou Zelgen Biopharmaceuticals Co.,Ltd","startDate":"2020-11-23","conditions":"Differentiated Thyroid Cancer","enrollment":120},{"nctId":"NCT04964284","phase":"PHASE3","title":"Efficacy and Safety Study of rhTSH for Adjuvant Radioiodine Ablation Therapy in Patients With Differentiated Thyroid Cancer","status":"UNKNOWN","sponsor":"Suzhou Zelgen Biopharmaceuticals Co.,Ltd","startDate":"2021-10-06","conditions":"Differentiated Thyroid Cancer","enrollment":328},{"nctId":"NCT01837745","phase":"PHASE3","title":"Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients?","status":"ACTIVE_NOT_RECRUITING","sponsor":"Gustave Roussy, Cancer Campus, Grand Paris","startDate":"2013-05-13","conditions":"Low Risk Differentiated Thyroid Cancer","enrollment":776},{"nctId":"NCT00085293","phase":"PHASE2","title":"Decitabine in Treating Patients With Metastatic Papillary Thyroid Cancer or Follicular Thyroid Cancer Unresponsive to Iodine I 131","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"2004-05","conditions":"Recurrent Thyroid Cancer, Stage IVA Follicular Thyroid Cancer, Stage IVA Papillary Thyroid Cancer","enrollment":12},{"nctId":"NCT00196729","phase":"PHASE3","title":"Comparison of the Safety and Successful Ablation of Thyroid Remnant in Post-thyroidectomized Euthyroid Patients (i.e. Patients Administered Thyrogen) Versus Hypothyroid Patients (no Thyrogen) Following 131I Administration","status":"COMPLETED","sponsor":"Genzyme, a Sanofi Company","startDate":"2001-12","conditions":"Thyroid Neoplasms","enrollment":63},{"nctId":"NCT00295763","phase":"PHASE3","title":"A New Study to Follow-up Thyroid Cancer Patients Who Participated in a Previous Study, Which Compared the Success of Destruction of the Thyroid Remnant Using Standard Treatment or Thyrogen.","status":"COMPLETED","sponsor":"Genzyme, a Sanofi Company","startDate":"2006-05","conditions":"Differentiated Thyroid Cancer","enrollment":61},{"nctId":"NCT00275171","phase":"PHASE2","title":"rhTSH, Radioiodine Uptake and Goiter Reduction Following 131I Therapy in Patients With Benign Nontoxic Nodular Goiter","status":"COMPLETED","sponsor":"Steen Bonnema","startDate":"2006-02","conditions":"Nodular Goiter","enrollment":90},{"nctId":"NCT00145366","phase":"PHASE2","title":"rhTSH, Thyroid Size, and Radioiodine Therapy in Benign Goiter","status":"COMPLETED","sponsor":"Odense University Hospital","startDate":"2002-04","conditions":"Benign Nontoxic and Toxic Goiter, Graves' Disease","enrollment":110},{"nctId":"NCT00454077","phase":"","title":"rhTSH-Thyroid Ablation With 1850 MBq of 131I","status":"COMPLETED","sponsor":"University of Siena","startDate":"2004-12","conditions":"Thyroid Cancer","enrollment":72}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":8,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Thyrogen + Radioiodine (131I)","genericName":"Thyrogen + Radioiodine (131I)","companyName":"Genzyme, a Sanofi Company","companyId":"genzyme-a-sanofi-company","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Thyrogen (recombinant human TSH) stimulates thyroid tissue to take up radioiodine (131I), enabling targeted destruction of thyroid cancer cells and metastases. Used for Thyroid cancer (differentiated thyroid cancer with radioiodine-avid metastases), Thyroid remnant ablation in thyroid cancer patients.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}