CLINICAL TRIALS PROFILE FOR THYROTROPIN ALFA

505(b)(2) Clinical Trials for Thyrotropin Alfa

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT00054756 ↗	Study of Thyrotropin-Releasing Hormone in Normal Volunteers and in Patients With Thyroid or Pituitary Abnormalities	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2	2003-02-07	This study will determine the safety and activity of a new formulation of thyrotropin-releasing hormone (TRH), a drug used for diagnosing and evaluating patients with certain thyroid gland abnormalities. Normal thyroid gland function depends on proper chemical signaling between the thyroid gland, the hypothalamus (the part of the brain where TRH is made), and the pituitary (another part of the brain). The TRH test helps assess this interaction. Production of the only FDA-approved preparation of TRH was stopped in July 2002. As a result, to have a continuous source of TRH available for NIH clinical and research purposes, the NIH Clinical Center (CC) Pharmacy Department produced a pharmaceutical grade formulation of TRH for patient use. This study will test the CC formulation in healthy volunteers to show that its activity and side effects are similar to those of the previously available commercial test preparation. It will then be studied in CC patients for whom the diagnostic test is recommended. Healthy volunteers between 18 and 65 years of age and all patients requiring TRH evaluation of hypothalamic-pituitary-thyroid gland interaction may be eligible for this study. Patients include those with pituitary reserve, inconsistent thyroid function test, inappropriate TSH secretion, or pre- and post-operative evaluation of pituitary tumors. Normal volunteers will be screened with a medical history, physical examination, and blood tests. Women of child-bearing potential will be given a pregnancy test; pregnant and breast-feeding women may not participate. The TRH test procedure will be the same for healthy volunteers and patients. All participants fast from midnight before the morning of the test. In the morning, a catheter (flexible plastic tube) is inserted into an arm vein for easy injection of the TRH and collection of blood samples. Blood pressure is monitored before and during the test. A blood sample is drawn, and then TRH is given through the catheter over a 1-minute period. Another nine blood samples are collected over a 3-hour period from the time of the TRH injection for measuring levels of various hormones. A total of less than 4 tablespoons of blood is taken for the test.

All Clinical Trials for Thyrotropin Alfa

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004778 ↗	Phase III Randomized, Double-Blind, Placebo-Controlled Study of Antenatal Thyrotropin-Releasing Hormone in Pregnant Women With Threatened Premature Delivery	Completed	Children's Hospital of Philadelphia	Phase 3	1993-08-01	OBJECTIVES: I. Evaluate the effect of thyrotropin-releasing hormone (TRH) on the severity of initial lung disease and occurrence of chronic lung disease when given antenatally to women with threatened premature delivery. II. Evaluate possible mechanisms for the effects of TRH on the severity and incidence of chronic lung disease. III. Investigate whether a deficiency in endogenous cortisol and/or thyroid hormones after birth influences the severity of lung disease and the development of chronic lung disease.
NCT00004778 ↗	Phase III Randomized, Double-Blind, Placebo-Controlled Study of Antenatal Thyrotropin-Releasing Hormone in Pregnant Women With Threatened Premature Delivery	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 3	1993-08-01	OBJECTIVES: I. Evaluate the effect of thyrotropin-releasing hormone (TRH) on the severity of initial lung disease and occurrence of chronic lung disease when given antenatally to women with threatened premature delivery. II. Evaluate possible mechanisms for the effects of TRH on the severity and incidence of chronic lung disease. III. Investigate whether a deficiency in endogenous cortisol and/or thyroid hormones after birth influences the severity of lung disease and the development of chronic lung disease.
NCT00004778 ↗	Phase III Randomized, Double-Blind, Placebo-Controlled Study of Antenatal Thyrotropin-Releasing Hormone in Pregnant Women With Threatened Premature Delivery	Completed	National Center for Research Resources (NCRR)	Phase 3	1993-08-01	OBJECTIVES: I. Evaluate the effect of thyrotropin-releasing hormone (TRH) on the severity of initial lung disease and occurrence of chronic lung disease when given antenatally to women with threatened premature delivery. II. Evaluate possible mechanisms for the effects of TRH on the severity and incidence of chronic lung disease. III. Investigate whether a deficiency in endogenous cortisol and/or thyroid hormones after birth influences the severity of lung disease and the development of chronic lung disease.
NCT00004840 ↗	Study of Antenatal Thyrotropin-Releasing Hormone in Women in Premature Labor to Prevent Lung Disease in Preterm Infants	Completed	Children's Hospital of Philadelphia	N/A	1998-05-01	OBJECTIVES: I. Assess the efficacy and safety of antenatal administration of thyrotropin-releasing hormone to women in premature labor to improve pulmonary outcomes in preterm infants.
NCT00004840 ↗	Study of Antenatal Thyrotropin-Releasing Hormone in Women in Premature Labor to Prevent Lung Disease in Preterm Infants	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	N/A	1998-05-01	OBJECTIVES: I. Assess the efficacy and safety of antenatal administration of thyrotropin-releasing hormone to women in premature labor to improve pulmonary outcomes in preterm infants.

Clinical Trial Conditions for Thyrotropin Alfa

Condition Name

Condition Name for Thyrotropin Alfa
Intervention	Trials
Thyroid Cancer	3
Subclinical Hypothyroidism	2
Hypothyroidism	2
Respiratory Distress Syndrome	2

Condition MeSH

Condition MeSH for Thyrotropin Alfa
Intervention	Trials
Thyroid Diseases	10
Thyroid Neoplasms	5
Graves Ophthalmopathy	4
Eye Diseases	4

Clinical Trial Locations for Thyrotropin Alfa

Trials by Country

Trials by Country for Thyrotropin Alfa
Location	Trials
United States	17
Denmark	4
China	2
France	2
Taiwan	1

Trials by US State

Trials by US State for Thyrotropin Alfa
Location	Trials
Maryland	5
California	2
Texas	2
Massachusetts	1
Pennsylvania	1

Clinical Trial Progress for Thyrotropin Alfa

Clinical Trial Phase

Clinical Trial Phase for Thyrotropin Alfa
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Thyrotropin Alfa
Clinical Trial Phase	Trials
Completed	18
Unknown status	3
Recruiting	3

Clinical Trial Sponsors for Thyrotropin Alfa

Sponsor Name

Sponsor Name for Thyrotropin Alfa
Sponsor	Trials
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	7
National Cancer Institute (NCI)	2
Odense University Hospital	2

Sponsor Type

Sponsor Type for Thyrotropin Alfa
Sponsor	Trials
Other	29
NIH	14
Industry	4

Thyrotropin Alfa: Clinical Trials, Market Analysis, and Projections

Introduction to Thyrotropin Alfa

Thyrotropin alfa, marketed under the brand name Thyrogen, is a recombinant form of human thyroid-stimulating hormone (TSH) used primarily in the management of well-differentiated thyroid cancer. Here, we will delve into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Phase III Clinical Trials

Thyrotropin alfa has been extensively studied in phase III clinical trials to evaluate its efficacy and safety in patients with well-differentiated thyroid cancer. Two key trials compared the use of Thyrogen with thyroid hormone withdrawal for preparing patients for radioiodine whole body scans and thyroglobulin testing.

• These trials involved 358 patients and demonstrated that Thyrogen significantly enhanced the sensitivity of thyroglobulin testing in patients maintained on thyroid hormone therapy. The combination of a Thyrogen-stimulated scan and a serum thyroglobulin test detected all patients with metastatic disease, although it was not as sensitive as combination testing performed after thyroid hormone withdrawal[1][4].

Comparative Studies

A randomized non-inferiority trial conducted in the UK compared low-dose and high-dose radioiodine, each in combination with either thyrotropin alfa or thyroid hormone withdrawal. This study involved 438 patients and found that low-dose radioiodine plus thyrotropin alfa was as effective as high-dose radioiodine, with a lower rate of adverse events. The ablation success rates were similar across all groups, with lower hospitalization rates and fewer adverse events in the low-dose group[1].

Safety and Tolerability

Thyrotropin alfa has been shown to have a favorable safety profile in clinical trials. Studies have indicated that it is not mutagenic and does not have significant toxic effects in animal models. Toxicology studies in rodents and primates have not revealed any adverse or toxic responses to thyrotropin alfa, even at doses several times higher than the expected human dose[4].

Market Analysis

Global Market Size and Growth

The global market for thyroid cancer drugs, which includes thyrotropin alfa, is projected to grow significantly. The market size was valued at USD 1.2 billion in 2022 and is expected to reach USD 4.3 billion by 2031, growing at a CAGR of 14.6% during the forecast period[2].

Thyrogen Market Specifics

The Thyrogen market itself was valued at USD 689 million in 2023 and is anticipated to reach USD 852.7 million by 2030, growing at a CAGR of 3.1% during the forecast period 2024-2030. The main player in the Thyrogen market is Sanofi Genzyme[5].

Regional Market Dynamics

• North America: This region is the largest market shareholder for thyroid cancer drugs, driven by improved payment policies, modern healthcare facilities, and an aging population. The market here is expected to grow at a CAGR of 14.5% during the forecast period[2].
• Europe: Europe is the second-largest market and is anticipated to exhibit a CAGR of 14.8%. The European regulatory framework, particularly the European Medicines Agency (EMA), plays a crucial role in approving and controlling thyroid cancer therapies[2].
• Asia-Pacific: This region has seen robust growth and is expected to continue growing due to the expanding elderly population and the scale of hospitals[2].

Future Projections and Trends

Advancements in Treatment Options

The thyroid cancer drugs market, including thyrotropin alfa, is expected to benefit from advancements in precision medicine and targeted therapies. Increased investment in research and clinical trials is driving the development of new and more effective treatment options. For instance, the medullary thyroid cancer market is seeing significant progress with targeted radiation therapies and personalized medicine strategies[3].

Regulatory Environment

The regulatory environment, particularly in regions like Europe and North America, is supportive of the development and approval of new thyroid cancer therapies. Rigorous clinical trials and collaborations between pharmaceutical companies, academic institutions, and healthcare organizations are key factors in this growth[2].

Patient Needs and Market Drivers

The growing incidence of thyroid cancer and the need for treatments with fewer adverse effects are major drivers of the market. The rise in neuroendocrine tumor cases and the aging population also contribute to the increasing demand for thyroid cancer drugs, including thyrotropin alfa[2].

Key Takeaways

• Thyrotropin alfa has been proven effective in clinical trials for preparing patients with well-differentiated thyroid cancer for radioiodine scans and thyroglobulin testing.
• The drug has a favorable safety profile and is non-inferior to thyroid hormone withdrawal in terms of efficacy.
• The global thyroid cancer drugs market, including the Thyrogen market, is expected to grow significantly over the next decade.
• Regional markets, particularly North America and Europe, are driving this growth due to advanced healthcare infrastructure and regulatory support.
• Advancements in precision medicine and targeted therapies are expected to further enhance the market.

FAQs

What is thyrotropin alfa used for?

Thyrotropin alfa is used primarily in the management of well-differentiated thyroid cancer to prepare patients for radioiodine whole body scans and thyroglobulin testing.

How effective is thyrotropin alfa compared to thyroid hormone withdrawal?

Thyrotropin alfa has been shown to be non-inferior to thyroid hormone withdrawal in terms of efficacy for preparing patients for radioiodine scans and thyroglobulin testing, with the added benefit of fewer adverse events.

What is the projected growth rate of the Thyrogen market?

The Thyrogen market is expected to grow at a CAGR of 3.1% from 2024 to 2030.

Which regions are driving the growth of the thyroid cancer drugs market?

North America and Europe are the primary regions driving the growth of the thyroid cancer drugs market, followed by the Asia-Pacific region.

What are the key drivers of the thyroid cancer drugs market?

The key drivers include the growing incidence of thyroid cancer, the need for treatments with fewer adverse effects, and the rise in neuroendocrine tumor cases.

Sources

1. Aetna: Thyrogen (Thyrotropin Alfa) - Medical Clinical Policy Bulletins.
2. StraitsResearch: Thyroid Cancer Drugs Market Size to Jump at US$4.3 billion by 2031.
3. BioSpace: Medullary Thyroid Cancer Market to Reach USD 405.1 Million by 2034.
4. Sanofi: Thyrotropin alfa Lyophilized powder for solution for injection.
5. Valuates Reports: Global Thyrogen Market Research Report 2024.