CLINICAL TRIALS PROFILE FOR THYMOGLOBULIN

Biosimilar Clinical Trials for THYMOGLOBULIN

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01624805 ↗	Methylprednisolone, Horse Anti-Thymocyte Globulin, Cyclosporine, Filgrastim, and/or Pegfilgrastim or Pegfilgrastim Biosimilar in Treating Patients With Aplastic Anemia or Low or Intermediate-Risk Myelodysplastic Syndrome	Recruiting	National Cancer Institute (NCI)	Phase 2	2012-06-25	This phase II trial studies methylprednisolone, horse anti-thymocyte globulin, cyclosporine, filgrastim, and/or pegfilgrastim or pegfilgrastim biosimilar in treating patients with aplastic anemia or low or intermediate-risk myelodysplastic syndrome. Horse anti-thymocyte globulin is made from horse blood and targets immune cells known as T-lymphocytes. Since T-lymphocytes are believed to be involved in causing low blood counts in aplastic anemia and in some cases of myelodysplastic syndromes, killing these cells may help treat the disease. Methylprednisolone and cyclosporine work to suppress immune cells called lymphocytes. This may help to improve low blood counts in aplastic anemia and myelodysplastic syndromes. Filgrastim and pegfilgrastim are designed to cause white blood cells to grow. This may help to fight infections and help improve the white blood cell count. Giving methylprednisolone and horse anti-thymocyte globulin together with cyclosporine, filgrastim, and/or pegfilgrastim may be an effective treatment for patients with aplastic anemia or myelodysplastic syndrome.
NCT01624805 ↗	Methylprednisolone, Horse Anti-Thymocyte Globulin, Cyclosporine, Filgrastim, and/or Pegfilgrastim or Pegfilgrastim Biosimilar in Treating Patients With Aplastic Anemia or Low or Intermediate-Risk Myelodysplastic Syndrome	Recruiting	M.D. Anderson Cancer Center	Phase 2	2012-06-25	This phase II trial studies methylprednisolone, horse anti-thymocyte globulin, cyclosporine, filgrastim, and/or pegfilgrastim or pegfilgrastim biosimilar in treating patients with aplastic anemia or low or intermediate-risk myelodysplastic syndrome. Horse anti-thymocyte globulin is made from horse blood and targets immune cells known as T-lymphocytes. Since T-lymphocytes are believed to be involved in causing low blood counts in aplastic anemia and in some cases of myelodysplastic syndromes, killing these cells may help treat the disease. Methylprednisolone and cyclosporine work to suppress immune cells called lymphocytes. This may help to improve low blood counts in aplastic anemia and myelodysplastic syndromes. Filgrastim and pegfilgrastim are designed to cause white blood cells to grow. This may help to fight infections and help improve the white blood cell count. Giving methylprednisolone and horse anti-thymocyte globulin together with cyclosporine, filgrastim, and/or pegfilgrastim may be an effective treatment for patients with aplastic anemia or myelodysplastic syndrome.

All Clinical Trials for THYMOGLOBULIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00040651 ↗	Safety and Value of Self Bone Marrow Transplants Following Chemotherapy in Scleroderma Patients	Terminated	Amgen	Phase 1	2002-07-01	Scleroderma, or systemic sclerosis (SSc), is a diffuse connective tissue disease characterized by changes in the skin, blood vessels, skeletal muscles, and internal organs. The purpose of this study is to determine the safety and value of self bone marrow transplants after chemotherapy in patients with severe SSc.
NCT00038857 ↗	Megadose CD34 Selected Progenitor Cells for Transplantation in Patients With Advanced Hematological Malignant Diseases	Completed	M.D. Anderson Cancer Center	Phase 2	2001-09-01	Donor: This clinical study will evaluate the feasibility of a purified CD34 peripheral blood progenitor cell (PBPC) transplants in patients with hematological malignancies. The primary objectives of the study are to evaluate the recipient obtaining donor derived neutrophil engraftment and the incidence of acute graft versus host disease [GvHD] (grade III-IV). Secondary objectives include assessments of recipient having donor derived platelet engraftment, incidence of graft failure and chronic GvHD, overall and disease free survival, clinical safety and device performance of the CliniMACS CD34 selection device.
NCT00025038 ↗	Combination Chemotherapy Followed By Donor Bone Marrow or Umbilical Cord Blood Transplant in Treating Children With Newly Diagnosed Juvenile Myelomonocytic Leukemia	Completed	National Cancer Institute (NCI)	Phase 2	2001-06-01	Giving chemotherapy drugs, such as R115777, isotretinoin, cytarabine, and fludarabine, before a donor bone marrow transplant or an umbilical cord transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. This phase II trial is studying how well giving combination chemotherapy together with donor bone marrow or umbilical cord blood transplant works in treating children with newly diagnosed juvenile myelomonocytic leukemia
NCT00006178 ↗	Sirolimus and Thymoglobulin to Prevent Kidney Transplant Rejection	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2	2000-08-01	This study will test the safety and effectiveness of two drugs, Sirolimus and Thymoglobulin, for preventing rejection of transplanted kidneys. Standard anti-rejection therapy uses a combination of drugs, such as cyclosporine, tacrolimus, azathioprine, steroids, and others, that are taken daily for life. However, even with this daily therapy, more than half of kidney recipients slowly reject their transplant within 10 years. Both Thymoglobulin, an antibody, and Sirolimus, an anti-rejection drug, prevent rejection by lowering the response of the immune system to the transplanted organ. Thymoglobulin is given in the pre- and postoperative period, and Sirolimus is taken long term. Patients who receive a kidney transplant at the National Institutes of Health Clinical Center are eligible for this study. Candidates will be screened with a medical history, physical examination, and blood and urine tests. Participants will undergo a kidney transplant. Before the surgery, a central line (intravenous catheter), through which blood and medicine can be given, is placed in the neck or chest. Patients may also undergo leukapheresis, a procedure for collecting white blood cells. The cells can be stored for transfusion later if white cell counts drop following Thymoglobulin treatment. For this procedure, blood is drawn from a needle placed in the arm and flows into a machine that separates the blood components by spinning. The white cells are collected in a bag and the red cells and plasma are returned through a second needle in the other arm. Thymoglobulin will be given intravenously the day before the transplant and days 1 through 9 after the operation. Sirolimus will be taken by mouth, mixed with water or orange juice. Sirolimus therapy starts the day of the transplant and continues for life. Follow-up study visits will be scheduled weekly for the first month after the transplant, then every 6 months for 1 year and then once a year for 4 years. Procedures during these visits may include blood and urine tests, physical examination, and check of vital signs (i.e., blood pressure, heart rate, breathing rate, temperature). Kidney biopsies (removal of a small piece of tissue for examination under the microscope) will be done at 2 weeks, 1 month and 6 months after surgery and then yearly for 4 years to check for any damage to the kidney. In addition, a local doctor will do routine laboratory tests 2 to 3 times a week for the first 2 to 3 months aft...
NCT00007787 ↗	Antibody and Delayed Cyclosporine Versus Initial Cyclosporine Alone in Patients Receiving Kidney Transplants	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	2000-04-01	The purpose of this study is to see if kidney function can be improved during transplants by giving the drug Thymoglobulin with delayed cyclosporine treatment instead of initial cyclosporine treatment. There have been improvements for patients receiving kidney transplants, yet acute rejection is still a problem. This can lead to kidney failure over time. Patients whose graft fails to function properly in the first week after transplant do not do as well after 5 years as compared to patients without early problems. This study will see if Thymoglobulin, a drug that suppresses the immune system, will improve early graft function.

Clinical Trial Conditions for THYMOGLOBULIN

Condition Name

Condition Name for THYMOGLOBULIN
Intervention	Trials
Leukemia	39
Lymphoma	21
Myelodysplastic Syndrome	21
Kidney Transplantation	20

Condition MeSH

Condition MeSH for THYMOGLOBULIN
Intervention	Trials
Leukemia	68
Myelodysplastic Syndromes	51
Preleukemia	50
Leukemia, Myeloid	44

Clinical Trial Locations for THYMOGLOBULIN

Trials by Country

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Trials by Country for THYMOGLOBULIN
Location	Trials
United States	520
Canada	23
China	11
Korea, Republic of	8
France	8

Trials by US State

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−

Trials by US State for THYMOGLOBULIN
Location	Trials
Texas	60
California	44
Ohio	37
New York	34
Florida	26

Clinical Trial Progress for THYMOGLOBULIN

Clinical Trial Phase

Clinical Trial Phase for THYMOGLOBULIN
Clinical Trial Phase	Trials
Phase 4	51
Phase 3	20
Phase 2/Phase 3	11

Clinical Trial Status

Clinical Trial Status for THYMOGLOBULIN
Clinical Trial Phase	Trials
Completed	127
Recruiting	51
Terminated	43

Clinical Trial Sponsors for THYMOGLOBULIN

Sponsor Name

Sponsor Name for THYMOGLOBULIN
Sponsor	Trials
National Cancer Institute (NCI)	49
M.D. Anderson Cancer Center	42
Genzyme, a Sanofi Company	32

Sponsor Type

Sponsor Type for THYMOGLOBULIN
Sponsor	Trials
Other	362
Industry	92
NIH	89

Thymoglobulin: Clinical Trials, Market Analysis, and Projections

Introduction to Thymoglobulin

Thymoglobulin, also known as anti-thymocyte globulin (ATG), is a polyclonal antibody preparation derived from rabbits, used primarily to prevent and treat acute rejection in organ transplant patients, particularly in kidney transplants. Here, we will delve into the current clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

FDA Approval and Clinical Studies

Thymoglobulin received FDA approval in 2017 for the prophylaxis and treatment of acute rejection in patients receiving a kidney transplant. The approval was based on two randomized multicenter studies that compared Thymoglobulin to interleukin-2 receptor antagonists (IL2RA) in deceased donor kidney transplant recipients. These studies demonstrated a significantly lower incidence of treatment failure, including biopsy-proven acute rejection, graft loss, death, or lost to follow-up, in the Thymoglobulin group compared to the IL2RA group[3].

Adverse Reactions and Safety

The most frequent adverse reactions associated with Thymoglobulin include leukopenia, hyperkalemia, urinary tract infections, and pyrexia. These side effects highlight the need for careful monitoring and management during treatment[3].

Market Analysis

Current Market Performance

As of the second quarter of 2024, Thymoglobulin sales were €129 million, which represents a slight decrease of 0.7% primarily due to lower sales in China. Despite this, Thymoglobulin remains a significant player in the organ transplant rejection medications market[2].

Global Market Projections

The global organ transplant rejection medications market, which includes Thymoglobulin, is projected to grow at a CAGR of 3.9% from 2023 to 2031, reaching a value of over US$ 7.0 billion by 2031. This growth is driven by increasing demand for effective immunosuppressive therapies and advancements in transplant procedures[5].

Regional Market Analysis

The market for organ transplant rejection medications, including Thymoglobulin, varies by region. North America and Europe are key markets, with significant contributions from drug classes such as antibodies, antimetabolites, and calcineurin inhibitors. The Asia Pacific region is also expected to show substantial growth due to increasing healthcare infrastructure and rising transplant rates[5].

Competitive Landscape

Other Immunotherapies

Thymoglobulin competes with other immunotherapies such as alemtuzumab, belatacept, and muromonab-CD3. Each of these drugs has its own set of indications and side effect profiles, contributing to a diverse market landscape. For instance, alemtuzumab is used in the treatment of multiple sclerosis and certain types of leukemia, while belatacept is specifically used in kidney transplant patients[5].

Emerging Alternatives

The development of fully-human anti-thymocyte immunoglobulins, such as SAB-142 by SAB Biotherapeutics, could potentially disrupt the market. SAB-142 is being investigated as a disease-modifying treatment for Type 1 Diabetes and has shown promise in early clinical trials, offering a safer and more precise immunomodulation compared to rabbit-derived ATG[1].

Future Projections

Market Growth Drivers

The growth of the Thymoglobulin market will be driven by several factors, including an increase in organ transplant procedures, advancements in immunosuppressive therapies, and expanding healthcare infrastructure in emerging markets. Additionally, ongoing research and development in the field of immunotherapy will continue to shape the market landscape[5].

Challenges and Opportunities

Despite the positive outlook, the market faces challenges such as the emergence of biosimilars and generic competitors, which could impact sales. However, the ongoing need for effective and safe immunosuppressive treatments presents opportunities for Thymoglobulin and other similar drugs to maintain their market presence.

Key Takeaways

• Clinical Efficacy: Thymoglobulin has demonstrated significant efficacy in preventing and treating acute rejection in kidney transplant patients.
• Market Performance: Despite a slight decline in recent sales, Thymoglobulin remains a key player in the organ transplant rejection medications market.
• Future Projections: The market is expected to grow at a CAGR of 3.9% from 2023 to 2031, driven by increasing demand and advancements in immunosuppressive therapies.
• Competitive Landscape: Thymoglobulin faces competition from other immunotherapies but remains a vital option due to its established efficacy and safety profile.

FAQs

What is Thymoglobulin used for?

Thymoglobulin is used for the prophylaxis and treatment of acute rejection in patients receiving a kidney transplant.

What are the common side effects of Thymoglobulin?

Common side effects include leukopenia, hyperkalemia, urinary tract infections, and pyrexia.

How does Thymoglobulin compare to other immunotherapies?

Thymoglobulin competes with other immunotherapies like alemtuzumab and belatacept but has a distinct safety and efficacy profile, particularly in kidney transplant patients.

What are the future projections for the Thymoglobulin market?

The market is projected to grow at a CAGR of 3.9% from 2023 to 2031, reaching over US$ 7.0 billion by 2031.

Are there any emerging alternatives to Thymoglobulin?

Yes, fully-human anti-thymocyte immunoglobulins like SAB-142 are being developed and could potentially offer safer and more precise immunomodulation.

Sources

1. SAB Biotherapeutics Announces Commencement of the HUMAN Phase 1 Clinical Trial with SAB-142 - Biospace
2. Sanofi Q2: strong performance with 10% sales growth; 2024 - Sanofi
3. Sanofi Receives FDA Approval of Thymoglobulin® for the Prevention of Acute Kidney Transplant Rejection - Sanofi
4. Expired RFA-DK-25-004: Coordinating Center for Type 1 Diabetes - NIH
5. Organ Transplant Rejection Medications Market Insights 2031 - Transparency Market Research