{"entity":{"id":"thyrotropin-alfa","kind":"drug","name":"Thyrotropin alfa","aka":["Recombinant human TSH","rhTSH"],"tldr":"Thyrogen is an injected version of thyroid-stimulating hormone that lets people with thyroid cancer have radioiodine treatment and follow-up blood tests without stopping their thyroid hormone tablets and suffering weeks of hypothyroidism.","summary":"Thyrotropin alfa was approved by the FDA in November 1998 as an adjunctive diagnostic tool for serum thyroglobulin testing with or without radioiodine imaging in the follow-up of well-differentiated thyroid cancer, and in 2007 for pre-therapeutic stimulation before radioiodine remnant ablation after thyroidectomy in patients without distant metastases; the EU authorised Thyrogen in 2000 with the same uses. The HiLo and ESTIMABL trials showed that rhTSH-stimulated low-dose (1.1 GBq) radioiodine ablation is as effective as high-dose ablation after thyroid hormone withdrawal, sparing patients hypothyroid symptoms and reducing radiation exposure. Nausea and headache are the main adverse effects; transient tumour swelling can occur with CNS or spinal metastases. Marketed by Sanofi (Genzyme).","status":"approved","asOf":"2026-09-10","wikipedia":"https://en.wikipedia.org/wiki/Thyrotropin_alfa","links":[{"label":"EPAR (EMA)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/thyrogen"},{"label":"US label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=thyrotropin%20alfa"}],"tags":["ema-list","supportive"],"related":[],"cancers":["thyroid"],"sections":[],"technologies":["radioiodine-therapy"],"targets":[],"drugs":[],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":["radioiodine-term"],"trials":["nct04964284","nct04971473","nct00295763"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Thyrogen","modality":"Recombinant human thyroid-stimulating hormone","mechanism":"Recombinant TSH stimulates iodine uptake and thyroglobulin release from thyroid remnants and differentiated thyroid cancer cells, allowing radioiodine ablation and thyroglobulin testing without stopping levothyroxine.","approvals":[{"region":"US","year":1998,"indication":"Adjunctive diagnostic tool for thyroglobulin testing in well-differentiated thyroid cancer; pre-therapeutic stimulation for radioiodine remnant ablation added 2007"},{"region":"EU","year":2000,"indication":"Thyroglobulin testing and radioiodine imaging in thyroid cancer follow-up; pre-therapeutic stimulation for radioiodine ablation"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/thyrotropin-alfa/","neighbours":{"cancer":[{"id":"thyroid","kind":"cancer","name":"Thyroid cancer","route":"/cancers/thyroid/"}],"technology":[{"id":"radioiodine-therapy","kind":"technology","name":"Radioiodine therapy and whole-body iodine scanning","route":"/technologies/radioiodine-therapy/"}],"company":[{"id":"sanofi","kind":"company","name":"Sanofi","route":"/companies/sanofi/"}],"term":[{"id":"radioiodine-term","kind":"term","name":"Radioiodine therapy (I-131)","route":"/terms/radioiodine-term/"}],"trial":[{"id":"nct00295763","kind":"trial","name":"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","route":"/trials/nct00295763/"},{"id":"nct04971473","kind":"trial","name":"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","route":"/trials/nct04971473/"},{"id":"nct04964284","kind":"trial","name":"rhTSH for Radioactive Iodine Remnant Ablation in Participants With Differentiated Thyroid Cancer (DTC)","route":"/trials/nct04964284/"}],"target":[{"id":"tshr","kind":"target","name":"TSH receptor (TSHR)","route":"/targets/tshr/"}]}}