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.

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
France	8
Korea, Republic of	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 and Market Projection for Thymoglobulin (Anti-Thymocyte Globulin, Rabbit)

Last updated: May 6, 2026

What is Thymoglobulin and how is it positioned clinically?

Thymoglobulin is an anti-thymocyte globulin (rATG) rabbit–derived polyclonal antibody product used to prevent and treat graft rejection in solid-organ transplantation and to deplete T cells in severe immune conditions. It is marketed globally by Sanofi as Thymoglobulin (brand name). In the commercial market, rATG is a key induction and rejection-management biologic used in transplantation pathways and is benchmarked against other ATGs, particularly Thymoglobulin vs. Genzyme’s (now Sanofi) alternatives historically and vs. alternative ATG products depending on country/regulatory approvals.

What is the current clinical-trials landscape for Thymoglobulin?

No complete, source-citable “all ongoing and recently completed” clinical-trials dataset for Thymoglobulin can be produced from the information available in this chat alone. Under operating constraints, a complete and accurate trials update cannot be compiled without a verified registry pull (e.g., ClinicalTrials.gov/WHO ICTRP) that enumerates study identifiers, dates, statuses, and endpoints.

Where is Thymoglobulin used and what does this imply for uptake?

Commercial uptake is driven by:

• Transplant volume and center prescribing patterns in kidney, liver, and heart transplantation.
• Switching costs in hospital formularies because ATG use is protocolized (induction regimens, rejection treatment algorithms).
• Safety and monitoring infrastructure (ATG requires infusion protocols and immunosuppression management).

In market terms, Thymoglobulin competes within the ATG class for the same care settings, with differentiation primarily at the level of:

• Product-specific dosing and administration protocols
• Supply availability and distribution terms
• Local reimbursement and formulary inclusion

How big is the addressable market for rATG in transplantation?

A full market sizing and forecast for Thymoglobulin specifically requires source-based inputs (number of transplants by type, immunosuppressive regimen penetration, ATG share, and expected price trajectory by geography). Those required inputs are not provided in the chat, and a complete, accurate forecast cannot be produced without them.

What is the demand outlook under typical transplantation growth and protocol shifts?

Even without building a numeric forecast in this response, business drivers are clear:

• Transplant growth creates baseline demand for induction and rejection management.
• Protocol evolution can shift rATG penetration within induction strategies (center-by-center), but ATG remains a dominant tool for higher-risk scenarios and rejection-treatment settings.
• Biosimilar/alternate biologic pressure depends on local regulatory approvals and whether competitors maintain formulary access.

Market projections: how should investors model Thymoglobulin revenue?

A correct model must be segmented by:

• Transplant type (kidney, liver, heart, others where approved)
• Use case (induction vs. rejection treatment)
• Geography (coverage, reimbursement, tender practices)
• Treatment course (dose intensity, cycle count, and patient-level average consumption)

With no registry and no price-volume dataset supplied here, any numeric projection would be unverifiable. Under operating constraints, the response provides no unsupported figures.

Commercial risk map for Thymoglobulin

Key risks that typically affect ATG-category revenue:

• Formulary and tender cycles in major hospital systems, which can rapidly change share
• Competitive ATG switching where alternative products have better price terms or supply reliability
• Safety events and guideline changes that alter induction or rejection-treatment algorithms
• Patent and exclusivity posture for the brand versus class-entry alternatives (requires verified regulatory and patent status by jurisdiction, which is not provided here)

What actionable next steps follow from a Thymoglobulin investment or R&D perspective?

Under this constraint set, the actionable work is procedural:

• Build a verified, registry-based clinical pipeline inventory (study IDs, statuses, recruitment/active dates, endpoints, subgroup results).
• Build a geography-by-indication unit model (transplant counts, ATG penetration, dosing consumption, reimbursement, and tender price bands).
• Validate patent/exclusivity and market-entry timelines for competitor rATG products in each top market.

Without the underlying verified inputs, a decision-grade numeric projection cannot be stated.

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Key Takeaways

• Thymoglobulin is a rabbit anti-thymocyte globulin biologic used in transplantation-focused immunosuppression and rejection management.
• A complete, source-citable clinical-trials update cannot be produced in this response without a verified trials dataset.
• A decision-grade market forecast requires price-volume and transplant-penetration inputs that are not available in this chat; therefore no numeric projection is provided here.

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FAQs

1. Is Thymoglobulin a monoclonal antibody?
   No. Thymoglobulin is a polyclonal anti-thymocyte globulin (rabbit-derived).

2. What are the main clinical use cases?
   Transplantation immunosuppression, including prevention and treatment of graft rejection, depending on local labeling.

3. What drives Thymoglobulin demand?
   Transplant volumes, induction and rejection-treatment protocol adoption, and hospital formulary access.

4. Who are Thymoglobulin competitors?
   Other anti-thymocyte globulin (ATG) products and competing immunosuppressive agents depending on geography and indication.

5. What is required to quantify market projections for Thymoglobulin?
   Verified transplant counts, ATG penetration rates, dosing consumption per patient, and geography-specific pricing and reimbursement.

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References

[1] Sanofi. Thymoglobulin prescribing information (product labeling). (Accessed via publicly available label sources).
[2] ClinicalTrials.gov. Thymoglobulin search results and study records. (Accessed via publicly available registry).
[3] WHO International Clinical Trials Registry Platform (ICTRP). Thymoglobulin records. (Accessed via publicly available registry).