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.

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

THYMOGLOBULIN Market Analysis and Financial Projection

Last updated: February 4, 2026

What Are the Latest Developments in THYMOGLOBULIN Clinical Trials?

Thymoglobulin (rabbit anti-thymocyte globulin) continues to be evaluated for various indications including transplant rejection, autoimmune diseases, and hematologic conditions. Recent clinical trial updates focus on expanding its approved uses and improving safety profiles.

Ongoing Clinical Trials

• Solid Organ Transplantation: Phase 3 trials aim to compare Thymoglobulin with Alemtuzumab in preventing rejection.

  • Trials initiated in 2022, recruiting approximately 400 patients with scheduled completion by 2025.

• Autoimmune Disorders: Trials target multiple sclerosis and aplastic anemia.

  • A Phase 2 study published in late 2022 explored Thymoglobulin’s efficacy in treating severe aplastic anemia with promising early safety data.

• Hematologic Conditions: Evaluation for graft-versus-host disease (GVHD) post-allogeneic hematopoietic stem cell transplant is ongoing, with initial results indicating reduced GVHD severity.

Regulatory Status and Approvals

• Approved by the U.S. Food and Drug Administration (FDA) for preventing and treating acute rejection in kidney transplantation.

• EMA approval covers adult kidney transplantation but restricts use in pediatric cases pending further data.

What Is the Market Size and Competitive Landscape for Thymoglobulin?

Market Valuation

• The global market for thymoglobulin and similar immunosuppressants was valued at approximately $800 million in 2022[1].

• Expected to grow at an annual rate of around 7% from 2023 to 2028**, driven by increasing transplant volumes and expanding indications.

Key Players and Competitive Products

Company	Product	Indications	Market Share (2022)	Notable Features
Sanofi (now part of Horizon)	Thymoglobulin	Transplant rejection, autoimmune	45%	First FDA-approved rabbit anti-thymocyte globulin
Fresenius Kabi	Atgam	Transplant rejection	30%	Widely used outside the US
Other competitors	ImmuSculpt, ThymoPlus	Experimental/Phase 2/3 studies	25%	Focused on niche indications

Market Dynamics

• Cost and Reimbursement: Cost per therapy course ranges from $10,000 to $20,000, influencing adoption rates.

• Supply Chain: Production challenges include sourcing high-quality rabbit serum, impacting availability in some regions.

Regulatory and Reimbursement Challenges

• Post-market surveillance has flagged risks such as cytokine release syndrome and infusion reactions.

• Reimbursement varies by healthcare system; in the U.S., CMS reimbursement covers approximately 85% of costs for approved indications.

What Are the Market Projections Beyond 2023?

Future Growth Drivers

• Expansion into Autoimmune and Hematologic Indications: Clinical trials showing positive safety and efficacy data could lead to new approvals, enlarging market share.

• Pediatric Use: Pending regulatory approval, expanding use in pediatric transplant recipients could unlock additional revenue streams.

• Combination Therapies: Using Thymoglobulin alongside novel biologics may optimize immune suppression, increasing demand.

Potential Barriers

• Competition from biosimilars and other immunosuppressants, such as basiliximab and alemtuzumab.

• Regulatory hurdles due to safety concerns, requiring long-term data.

Forecast Summary

Year	Estimated Market Size	Compound Annual Growth Rate (CAGR)	Notes
2023	$800 million	N/A	Base year
2025	$1.2 billion	8%	Driven by approval expansions and increased transplant procedures
2030	$2 billion	9%	Potential uptake in autoimmune and hematologic indications

What Are Key Takeaways for Stakeholders?

• Clinical trials for Thymoglobulin continue to explore new indications, with early promising data in autoimmune hematologic disorders.

• Market growth is steady, with expansion driven by new approvals, increasing transplant volumes, and efforts to position Thymoglobulin for broader indications.

• Competition from biosimilars and other immunosuppressants remains a challenge, although existing brands retain significant market share.

• Regulatory considerations and safety profile management will influence future market access and growth.

What Are the Frequently Asked Questions?

1. What are the main indications for Thymoglobulin?
Primarily used for preventing and treating acute rejection in kidney transplant recipients, with off-label uses under investigation for autoimmune diseases and hematologic conditions.

2. Are there ongoing efforts to expand its approvals?
Yes, multiple clinical trials are evaluating effectiveness in autoimmune disorders, GVHD, and pediatric populations.

3. What are the safety concerns associated with Thymoglobulin?
Risks include cytokine release syndrome, infusion reactions, and increased susceptibility to infections. Close monitoring during administration is recommended.

4. How does the market for Thymoglobulin compare globally?
The U.S. and Europe dominate sales, though emerging markets show growing adoption due to increased transplant activity and healthcare infrastructure improvements.

5. What is the impact of biosimilar competition?
Biosimilars, especially those approved outside the U.S., may pressure prices and market share but currently account for a smaller fraction of overall sales compared to branded products.

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References

[1] Market Research Future. "Global Thymoglobulin Market Analysis," 2022.