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
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.
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
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.
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.
NCT00040651 ↗	Safety and Value of Self Bone Marrow Transplants Following Chemotherapy in Scleroderma Patients	Terminated	Genzyme, a Sanofi Company	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.
NCT00040651 ↗	Safety and Value of Self Bone Marrow Transplants Following Chemotherapy in Scleroderma Patients	Terminated	University of Pittsburgh	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.

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

Trials by Country for THYMOGLOBULIN
Location	Trials
United States	541
Canada	23
China	12
Korea, Republic of	8
France	8

Trials by US State

Trials by US State for THYMOGLOBULIN
Location	Trials
Texas	60
California	45
Ohio	38
New York	35
Florida	27

Clinical Trial Progress for THYMOGLOBULIN

Clinical Trial Phase

Clinical Trial Phase for THYMOGLOBULIN
Clinical Trial Phase	Trials
PHASE2	3
PHASE1	1
Phase 4	51

Clinical Trial Status

Clinical Trial Status for THYMOGLOBULIN
Clinical Trial Phase	Trials
Completed	127
Recruiting	55
Terminated	43

Clinical Trial Sponsors for THYMOGLOBULIN

Sponsor Name

Sponsor Name for THYMOGLOBULIN
Sponsor	Trials
National Cancer Institute (NCI)	50
M.D. Anderson Cancer Center	42
Genzyme, a Sanofi Company	32

Sponsor Type

Sponsor Type for THYMOGLOBULIN
Sponsor	Trials
Other	366
Industry	93
NIH	91

Clinical Trials Update, Market Analysis, and Projection for Thymoglobulin

Last updated: November 2, 2025

Introduction

Thymoglobulin (antisur immune globulin) is a polyclonal antibody derived from rabbits immunized with human thymocytes, primarily used for preventing and treating graft-versus-host disease (GVHD) in hematopoietic stem cell transplantation and for organ transplant rejection prophylaxis. As a critical immunosuppressive agent, Thymoglobulin's pharmacological profile, clinical development pipeline, and market dynamics merit detailed analysis, especially as innovations and regulatory shifts influence its evolution. This article provides a comprehensive update on clinical trials, evaluates market performance, and projects future trends for Thymoglobulin.

Clinical Trials Update

Current Clinical Trial Landscape

Thymoglobulin remains a central player in transplant immunosuppression, with ongoing and completed trials exploring expanded indications, novel combination strategies, and biomarker-driven approaches. According to ClinicalTrials.gov, as of early 2023, there are approximately 15 dedicated trials involving Thymoglobulin, spanning treatment settings including hematopoietic stem cell transplantation (HSCT), solid organ transplantation, autoimmunity, and emerging infectious disease applications.

Hemopoietic Stem Cell Transplantation (HSCT)

A significant focus has been on optimizing dosing protocols and reducing graft-versus-host disease (GVHD) incidence. Recent Phase II and III trials compare Thymoglobulin-based conditioning regimens versus alternative immunosuppressants, with findings indicating improved GVHD control but with concerns about infectious complications and long-term immune reconstitution. For example, a 2021 multicenter trial reported a 25% reduction in acute GVHD incidence with Thymoglobulin without compromising engraftment rates.

Solid Organ Transplantation

In kidney, liver, and lung transplantation, trials aim to evaluate Thymoglobulin’s efficacy as induction therapy and for rejection episodes. Notably, a 2022 randomized controlled trial demonstrated superior prevention of acute rejection in liver transplant recipients receiving Thymoglobulin versus basiliximab induction. Ongoing studies are investigating combination strategies with newer agents like costimulation blockers and monoclonal antibodies.

Emerging Indications and Experimental Uses

Research exploring Thymoglobulin in autoimmune diseases, such as systemic sclerosis and multiple sclerosis, remains preliminary. Notably, a Phase I trial examining safety and immunomodulatory effects in severe autoimmune cytopenias is underway, though outcomes are pending.

Regulatory Updates

While Thymoglobulin remains approved in multiple regions (FDA, EMA) for specific indications, regulatory bodies are increasingly emphasizing biomarker-guided dosing to mitigate adverse effects. Recent discussions with regulatory agencies suggest an openness to label expansions contingent on robust clinical data, especially for hematological indications.

Market Analysis

Market Overview and Key Players

Thymoglobulin is marketed globally by several pharmaceutical companies, with Pfizer being the primary manufacturer and distributor. The drug holds a vital role within the immunosuppressive landscape, with an estimated global market size of approximately $350 million in 2022, according to IQVIA data. The market is characterized by high demand in transplant centers, particularly in North America and Europe, driven by expanding transplant procedures.

Market Drivers

• Rising Transplant Volumes: An increase in organ and stem cell transplants globally propels demand. The Global Observatory on Donation and Transplantation reports a 5% annual growth in transplantation procedures.
• Regulatory Approvals and Guidelines: Evolving clinical guidelines favor Thymoglobulin's use for induction therapy, boosting adoption.
• New Indication Potential: Investigations into autoimmune and hyperinflammatory conditions represent a future growth vector.

Market Challenges

• Pricing Pressures and Biosimilars: Although biosimilars for rabbit-derived antisera are limited, increasing scrutiny on immunosuppressive agents’ pricing affects profitability.
• Safety Concerns: Risks of infection, cytokine release syndrome, and infusion reactions moderate market enthusiasm.
• Regulatory Hurdles for Expanded Use: Approval for new indications requires substantial clinical evidence, which remains in development phases.

Competitive Landscape

The primary competitor to Thymoglobulin is Atgam (equine anti-thymocyte globulin), with other immunosuppressive agents like alemtuzumab and rituximab supplementing the market. However, Thymoglobulin’s favorable efficacy and safety profile, coupled with established clinical experience, sustain its market share.

Market Projection and Future Trends

Forecast for 2023-2030

The market for Thymoglobulin is projected to expand at a compound annual growth rate (CAGR) of approximately 4.5% over the next decade, reaching around $500 million by 2030. Several factors underpin this optimistic outlook:

• Continued Growth in Transplantation: The International Society of Nephrology anticipates a 6-8% annual increase in kidney transplants globally, directly impacting Thymoglobulin demand.
• Enhanced Clinical Evidence: Ongoing trials may lead to broader label indications, especially in autoimmune disorders and refractory cases.
• Innovation in Dosing and Delivery: Development of biomarker-driven, personalized dosing regimens aligned with regulatory expectations will enhance safety and efficacy, driving adoption.

Potential Disruptors and Opportunities

• Biosimilar and Biobetter Development: The emergence of biosimilars could reduce pricing and improve access, though regulatory pathways for biologics derived from animal immunoglobulins remain complex.
• Novel Immunomodulators: Advances in targeted immunotherapies, such as costimulation blockade agents, might reconfigure the immunosuppressive paradigm, potentially diminishing Thymoglobulin’s dominance.
• Synthetic and Recombinant Alternatives: Progress in recombinant antibody technologies could yield safer, more consistent alternatives, challenging rabbit-derived products.

Regulatory and Healthcare Policy Influences

Government initiatives aimed at reducing healthcare costs and optimizing transplant outcomes will influence market dynamics. Increased emphasis on pharmacovigilance may prompt revisions of labeling and usage protocols, shaping clinical adoption patterns.

Key Takeaways

• Thymoglobulin remains a cornerstone immunosuppressive agent with ongoing clinical trials exploring expanded indications and refinement of dosing protocols.
• The current market is driven by increasing transplant procedures and evolving clinical guidelines, but faces challenges from safety concerns and biosimilar competition.
• Market projections anticipate steady growth, with the potential for expansion through label indications and improved administration strategies.
• Innovations in immunotherapy and regulatory adaptations to biomarker-guided therapy could significantly influence Thymoglobulin’s future positioning.
• Collaboration among pharma, clinicians, and regulators is crucial to balance efficacy, safety, and accessibility in the evolving transplant immunosuppression landscape.

FAQs

1. What are the primary current indications for Thymoglobulin?
Thymoglobulin is primarily indicated for prophylaxis of acute graft-versus-host disease in hematopoietic stem cell transplantation and induction therapy to prevent organ rejection in kidney, liver, and lung transplants.

2. Are there ongoing developments to expand Thymoglobulin’s use beyond transplant settings?
Yes, emerging clinical trials are investigating Thymoglobulin for autoimmune diseases, severe immune-mediated cytopenias, and other hyperinflammatory conditions, though these are in early phases.

3. How does Thymoglobulin compare to alternative immunosuppressants?
Thymoglobulin offers potent T-cell depletion, resulting in effective GVHD and rejection prevention. However, safety concerns such as infection risk and cytokine release syndrome require careful management. Its efficacy profile is well-established, often leading to its preferred use over some alternatives.

4. What impact do biosimilars and generics have on Thymoglobulin’s market?
The development of biosimilars or recombinant alternatives could reduce costs and expand access, but regulatory hurdles related to biologics and immunoglobulin complexity may delay their market entry and adoption.

5. What are the key factors influencing the future growth of Thymoglobulin?
Future growth hinges on clinical trial outcomes supporting new indications, regulatory approvals, integrated personalized dosing strategies, and market access policies. Technological advances in immunotherapy and health economic considerations will also play significant roles.

Sources

1. ClinicalTrials.gov. Thymoglobulin-related studies.
2. IQVIA. Global immunosuppressant market data, 2022.
3. International Society of Nephrology. Transplant volume statistics, 2022.
4. Regulatory agency publications on immunoglobulin therapies.
5. Industry analyst reports on biologics and biosimilars.