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Drug

Thyrotropin alfa

Established medicine
ResearchOngoing clinical research
Also known as Thyrogen, rTSH, rhTSH, Thyrotropin alpha+3 more

Thyrogen, rTSH, rhTSH, Thyrotropin alpha, Recombinant Human Thyroid Stimulating Hormone, Recombinant thyrotropin, Recombinant thyrotropin alfa.

RxNorm4952UNIIAVX3D5A4LM
5
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

The Use of 124-I-PET/CT Whole Body and Lesional Dosimetry in Differentiated Thyroid Cancer

Clinical trial2026-07-02Results expected Q4 2035 · ClinicalTrials.gov

Safety and Efficacy of Recombinant Human Thyroid Stimulating Hormone for Adjuvant Diagnosis in Patients With Locally Advanced/Metastatic Differentiated Thyroid Cancer

Clinical trial2026-05-31Primary completion · ClinicalTrials.gov

Safety and Efficacy of Recombinant Human Thyroid Stimulating Hormone for Radioiodine 131I Treatment in Patients With Locally Advanced/Metastatic Differentiated Thyroid Cancer

Clinical trial2026-03-31Primary completion · ClinicalTrials.gov

A Pilot Clinical Trial of Vemurafenib and Cobimetinib as a Redifferentiation Strategy in High-Risk, Radioactive Iodine (RAI) Naïve, BRAFV600E Mutated Differentiated Thyroid Carcinoma Patients Undergoing Initial RAI Therapy

Clinical trial2026-02-02Results expected Q4 2026 · ClinicalTrials.gov

Efficacy of a Selective MEK (Trametinib) and BRAFV600E (Dabrafenib) Inhibitors Associated With Radioactive Iodine (RAI) for the Treatment of Refractory Metastatic Differentiated Thyroid Cancer With RAS or BRAFV600E Mutation

Clinical trial2026-01-15Completed · ClinicalTrials.gov

Restoration of Radioiodine Uptake with Selpercatinib in RET Fusion-Positive Radioiodine-Refractory Thyroid Cancer: a Phase 2 Study Performed in Collaboration with the International Thyroid Oncology Group (ITOG)

Clinical trial2025-03-01Primary completion · ClinicalTrials.gov

Enhancing Radioiodine (RAI) Incorporation Into BRAF Mutant, RAI-Refractory Thyroid Cancers With the BRAF Inhibitor Vemurafenib: A Pilot Study

Clinical trial2024-11-21Completed · ClinicalTrials.gov

A Randomized, Open-label, Multi-center, Controlled Phase Ⅲ Study to Evaluate the Safety and Efficacy of Recombinant Human Thryoid Stimulating Hormone（rhTSH） for Adjuvant Radioiodine Ablation Therapy in Postoperative Patients With Differentiated Thyroid Cancer

Clinical trial2024-09-01Primary completion · ClinicalTrials.gov

An Open, Single-arm, Self-controlled, Multi-center Phase 3 Study to Compare 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

Clinical trial2023-07-05Completed · ClinicalTrials.gov

Evaluation of Thyroid Stunning From a Diagnostic Dose of I-123

Clinical trial2019-09-20Completed · ClinicalTrials.gov

Phase II Study of Decitabine in Patients With Metastatic Papillary Thyroid Cancer or Follicular Thyroid Cancer Unresponsive to Radioiodine

Clinical trial2018-11-29Results posted · ClinicalTrials.gov

Approval: Thyrogen (EMA)

Regulatory2000-03-09EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Thyrotropin alfa
Aliases & brands
ThyrogenrTSHrhTSHThyrotropin alphaRecombinant Human Thyroid Stimulating HormoneRecombinant thyrotropinRecombinant thyrotropin alfa
RxNorm CUI
4952
UNII
AVX3D5A4LM
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2000-03-09
Latest approval
2000-03-09
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2000-03-09Approval
Approval: Thyrogen (EMA)
Indication: Thyrogen is indicated for use with serum thyroglobulin (Tg) testing with or without radioiodine imaging for the detection of thyroid remnants and well-differentiated thyroid… Show full indication

Thyrogen is indicated for use with serum thyroglobulin (Tg) testing with or without radioiodine imaging for the detection of thyroid remnants and well-differentiated thyroid cancer in post thyroidectomy patients maintained on hormone suppression therapy (THST).   Low risk patients with well-differentiated thyroid carcinoma who have undetectable serum Tg levels on THST and no rh (recombinant human) TSH-stimulated increase of Tg levels may be followed-up by assaying rh TSH-stimulated Tg levels.  Thyrogen is indicated for pre-therapeutic stimulation in combination with a range of 30 mCi (1.1 GBq) to 100 mCi (3.7 GBq) radioiodine for ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer (see section 4.4).

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

14 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
14
registered trials across all phases
LATEST COMPLETION 2026
5
Active studies
5
Recruiting
7
Late-stage (III+)
8
Completed
1
Discontinued
PHASE DISTRIBUTIONn = 14
Early Phase 11Phase 11Phase 25Phase 33Phase 42Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Is it Possible to Increase Quality of Life, Using Recombinant TSH Instead of Withdrawal of Thyroid Hormone Treatment, Before Iodine Uptake in Patients With Thyroid Cancer?

CompletedPH IVCopenhagen University Hospital at Herlevn=562012

A Dosimetry Study of Radioiodine (131-I) Uptake Following the Administration of Thyrogen and Hypothyroid States During Thyroid Hormone Withdrawal

CompletedPH IVNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)n=202000

A Randomized, Open-label, Multi-center, Controlled Phase Ⅲ Study to Evaluate the Safety and Efficacy of Recombinant Human Thryoid Stimulating Hormone（rhTSH） for Adjuvant Radioiodine Ablation Therapy in Postoperative Patients With Differentiated Thyroid Cancer

Unknown statusPH IIISuzhou Zelgen Biopharmaceuticals Co.,Ltdn=3282024

An Open, Single-arm, Self-controlled, Multi-center Phase 3 Study to Compare 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

CompletedPH IIISuzhou Zelgen Biopharmaceuticals Co.,Ltdn=2012023

Follow-up of Thyroid Cancer Patients From Study THYR-008-00 Who Received Thyroid Remnant Ablation Using Either the Hypothyroid or the Thyrogen Method.

CompletedPH IIIGenzyme, a Sanofi Companyn=612006

Recent completions

Trials that read out recently, adding to the completed evidence base.

Efficacy of a Selective MEK (Trametinib) and BRAFV600E (Dabrafenib) Inhibitors Associated With Radioactive Iodine (RAI) for the Treatment of Refractory Metastatic Differentiated Thyroid Cancer With RAS or BRAFV600E Mutation

CompletedPH IIGustave Roussy, Cancer Campus, Grand Parisn=402026

Enhancing Radioiodine (RAI) Incorporation Into BRAF Mutant, RAI-Refractory Thyroid Cancers With the BRAF Inhibitor Vemurafenib: A Pilot Study

CompletedPH IMemorial Sloan Kettering Cancer Centern=122024

An Open, Single-arm, Self-controlled, Multi-center Phase 3 Study to Compare 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

CompletedPH IIISuzhou Zelgen Biopharmaceuticals Co.,Ltdn=2012023

Evaluation of Thyroid Stunning From a Diagnostic Dose of I-123

CompletedPH IUniversity of Colorado, Denvern=52019

Phase II Study of Decitabine in Patients With Metastatic Papillary Thyroid Cancer or Follicular Thyroid Cancer Unresponsive to Radioiodine

CompletedPH IINational Cancer Institute (NCI)n=122014

Is it Possible to Increase Quality of Life, Using Recombinant TSH Instead of Withdrawal of Thyroid Hormone Treatment, Before Iodine Uptake in Patients With Thyroid Cancer?

CompletedPH IVCopenhagen University Hospital at Herlevn=562012
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.