CLINICAL TRIALS PROFILE FOR ANTI-THYMOCYTE GLOBULIN (RABBIT)

All Clinical Trials for anti-thymocyte globulin (rabbit)

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00016458 ↗	Phase II Pilot Study of Cyclophosphamide and Rabbit Anti-Thymocyte Globulin as Salvage Therapy in Patients With Diffuse Systemic Sclerosis	Completed	Fred Hutchinson Cancer Research Center	Phase 2	2000-06-01	OBJECTIVES: I. Determine the toxicity of cyclophosphamide and rabbit anti-thymocyte globulin in patients with diffuse systemic sclerosis. II. Determine the efficacy of this regimen in terms of controlling disease in these patients.
NCT00029380 ↗	Cord Blood Transplantation for Sickle Cell Anemia and Thalassemia	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	1999-01-01	This study will develop a national cord blood bank for siblings of patients with hemoglobinopathies and thalassemia.
NCT00053196 ↗	Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2002-12-01	RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving immunosuppressive therapy after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well donor bone marrow or peripheral stem cell transplant works in treating patients with relapsed hematologic cancer after treatment with chemotherapy and autologous stem cell transplant.
NCT00053196 ↗	Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Cancer	Completed	Alliance for Clinical Trials in Oncology	Phase 2	2002-12-01	RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving immunosuppressive therapy after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well donor bone marrow or peripheral stem cell transplant works in treating patients with relapsed hematologic cancer after treatment with chemotherapy and autologous stem cell transplant.
NCT00076570 ↗	Combination Drug Therapy Followed by Single Drug Steroid Free Therapy to Prevent Organ Rejection in Kidney Transplantation	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2	2004-01-01	This study will test the safety and effectiveness of a combination of three drugs followed by long-term treatment with just one drug in preventing organ rejection in kidney transplant patients. Current anti-rejection medicines are not completely effective in preventing rejection. This trial will test how well Thymoglobulin, Tacrolimus, and Sirolimus work together post-transplant and if the treatment can be reduced over time to control rejection with either Tacrolimus or Sirolimus alone. Candidates for kidney transplantation at the National Institutes of Health Clinical Center may participate in this 5-year study. Patients will be screened for eligibility with a medical history, physical examination, and blood tests. Participants will undergo the following tests and procedures: - Central line placement: A large intravenous catheter (plastic tube, or IV line) is placed in a vein in the chest or neck under local anesthesia before the transplant surgery. The line remains in place for some time during the hospitalization to administer Thymoglobulin, antibiotics, and blood, if needed. The line is also used to collect blood samples. - Leukapheresis: This procedure for collecting white blood cells is done before the transplant. The cells are studied to evaluate the patient's immune system. Whole blood is withdrawn through a catheter in an arm vein or through the central line and directed into a machine that separates the blood components by spinning. The white cells are removed and the red cells and plasma are returned to the body. - Kidney transplant: Patients undergo kidney transplant surgery under general anesthesia. - Immunosuppressive therapy: Patients receive thymoglobulin by vein for 4 days starting 1 day before the transplant. They also take Tylenol, Benadryl and a steroid (methylprednisolone) to help reduce the side effects of the Thymoglobulin. After the transplant, patients receive Tacrolimus and Sirolimus by mouth once a day for 6 months and then either Tacrolimus or Sirolimus alone indefinitely. In addition, they take medicines to help prevent viral and fungal infections for 6 months because the immunosuppressive therapy leaves them vulnerable to infection. - Follow-up visits: After hospital discharge, patients return to the Clinical Center twice a week for 4 weeks, then every 6 months for 1 year, and then yearly for another 4 years. At each visit, the patient's vital signs are checked and blood and urine samples are collected. Periodically, patients are also questioned about how they feel and how the transplant has affected their quality of life. Kidney biopsies (removal of a small amount of kidney tissue through a thin needle) are done when the patient begins single-drug immunosuppression (generally 6 months after transplantation) and 1 year after that. The biopsied tissue is examined to evaluate how well the kidney is responding to the treatment and to determine how to proceed with therapy. - Routine laboratory tests: Routine tests, coordinated by the patient's local physician, are done 2 to 3 times a week for the first 2 to 3 months after transplantation, then weekly for several more months, and at least monthly for life.

Clinical Trial Conditions for anti-thymocyte globulin (rabbit)

Condition Name

Condition Name for anti-thymocyte globulin (rabbit)
Intervention	Trials
Kidney Transplantation	5
Aplastic Anemia	4
Kidney Failure	3
Leukemia	3

Condition MeSH

Condition MeSH for anti-thymocyte globulin (rabbit)
Intervention	Trials
Anemia	10
Anemia, Aplastic	9
Leukemia	7
Neoplasms	7

Clinical Trial Locations for anti-thymocyte globulin (rabbit)

Trials by Country

Trials by Country for anti-thymocyte globulin (rabbit)
Location	Trials
United States	89
China	13
Japan	5
Italy	2
Pakistan	1

Trials by US State

Trials by US State for anti-thymocyte globulin (rabbit)
Location	Trials
New York	9
California	8
Illinois	7
North Carolina	7
Texas	7

Clinical Trial Progress for anti-thymocyte globulin (rabbit)

Clinical Trial Phase

Clinical Trial Phase for anti-thymocyte globulin (rabbit)
Clinical Trial Phase	Trials
PHASE2	3
PHASE1	1
Phase 4	11

Clinical Trial Status

Clinical Trial Status for anti-thymocyte globulin (rabbit)
Clinical Trial Phase	Trials
Completed	23
Recruiting	20
Terminated	5

Clinical Trial Sponsors for anti-thymocyte globulin (rabbit)

Sponsor Name

Sponsor Name for anti-thymocyte globulin (rabbit)
Sponsor	Trials
Genzyme, a Sanofi Company	6
M.D. Anderson Cancer Center	5
National Cancer Institute (NCI)	4

Sponsor Type

Sponsor Type for anti-thymocyte globulin (rabbit)
Sponsor	Trials
Other	62
Industry	13
NIH	10

Clinical Trials Update, Market Analysis, and Projection for Anti-Thymocyte Globulin (Rabbit)

Last updated: October 31, 2025

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Introduction

Anti-thymocyte globulin (rabbit), commonly known as rATG, is an immunosuppressive agent used primarily in transplantation medicine, autoimmune diseases, and hematologic disorders. Derived from rabbit serum antibodies targeting human T lymphocytes, rATG modulates immune responses, thereby reducing graft rejection and managing severe autoimmune conditions. As clinical research advances and healthcare frameworks evolve, understanding the latest developments and market trajectories of rATG becomes crucial for stakeholders. This analysis provides an in-depth update on clinical trial activity, evaluates current market dynamics, and projects future trends for this biologic agent.

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Clinical Trial Landscape for Anti-Thymocyte Globulin (Rabbit)

Current Clinical Trial Overview

Recent years have witnessed a steady increase in clinical investigations exploring rATG's efficacy across diverse indications. According to ClinicalTrials.gov, as of Q4 2023, over 50 trials are actively recruiting or ongoing globally, primarily focusing on:

• Solid organ transplantation: Renal, bone marrow, and liver transplantation are predominant areas, with trials evaluating optimized dosing protocols and combination therapies.
• Autoimmune diseases: Trials assessing rATG's role in treating severe aplastic anemia, multiple sclerosis, and Crohn’s disease are emerging.
• Hematologic conditions: Use in graft-versus-host disease (GVHD) prophylaxis and hematological malignancies.

Notably, several pivotal studies aim to compare rATG with other induction agents like basiliximab and alemtuzumab, seeking to clarify its relative efficacy and safety profile.

Innovative Trial Developments

• Personalized dosing protocols: Investigations into pharmacogenomics aim to tailor rATG dosing based on patient-specific immune response, potentially improving outcomes and reducing adverse effects.

• Combination therapy assessments: Trials integrating rATG with novel immunosuppressants or biologics provide insights into synergistic effects, especially in high-risk transplant recipients.

• Biomarker-driven studies: Several studies focus on identifying biomarkers predictive of response to rATG, enhancing patient selection accuracy.

Safety and Efficacy Findings

Early trial results reinforce rATG's efficacy in decreasing rejection episodes and maintaining graft function. However, concerns over adverse effects like cytokine release syndrome, infections, and hematological toxicity persist. Ongoing trials are crucial to refine dosing strategies and mitigate risks.

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Market Analysis

Market Size and Growth Drivers

The global rATG market was valued at approximately $350 million in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 7-9% through 2030. Key drivers include:

• Expanding indications: Growing use in stem cell transplantation and autoimmune disorders broadens the therapeutic landscape.
• Rising transplantation procedures: The global increase in organ transplants, driven by technological advances and improved donor management, fuels demand.
• Regulatory approvals: Recent and pending approvals in emerging markets enhance market penetration and access.
• Genericization: Patent expiry and availability of biosimilars have increased affordability and competition, influencing market dynamics.

Competitive Landscape

Major players include:

• Horizon Therapeutics: Provider of Thymoglobulin, a leading rATG formulation.
• Fresenius Kabi: Offers biosimilar versions with cost advantages.
• Chinese manufacturers: Increasing regional presence driven by rising transplant activity.

Market differentiation hinges on factors like product efficacy, safety profiles, manufacturing scale, and pricing strategies. The biosimilar segment is particularly competitive, pressuring originator companies to innovate and optimize formulations.

Regulatory and Reimbursement Environment

Regulatory landscapes differ globally, with FDA and EMA approvals establishing market credibility. Reimbursement policies increasingly favor biologics but demand substantial evidence of cost-effectiveness, especially for biosimilars. This environment incentivizes cost-efficient manufacturing and value-based modeling.

Challenges

• Safety concerns: Managing adverse effects remains a significant hurdle.
• Pricing pressures: Biosimilar competition and healthcare cost containment policies pressurize pricing strategies.
• Supply chain complexities: Ensuring consistent quality and supply amidst complex biologic production processes.

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Market Projections (2024–2030)

The future of the rATG market hinges on several factors:

• Indication expansion: Ongoing clinical trials may unlock new therapeutic uses, such as in autoimmune neuroinflammatory diseases.
• Technological innovations: Improved manufacturing processes will reduce costs and enhance product stability.
• Global healthcare trends: Increased transplant rates in emerging markets are poised to drive regional growth.
• Regulatory approval pathways: Streamlined processes for biosimilars could accelerate market entry and competition.

By 2030, the market is expected to surpass $600 million, with biosimilar uptake and novel indications contributing significantly to growth. The balanced interplay of innovation, regulation, and market penetration will dictate the trajectory.

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Conclusion

Anti-thymocyte globulin (rabbit) remains a cornerstone immunosuppressant with a robust clinical trial pipeline and expanding global utilization. Its market outlook appears optimistic, driven by increasing transplant volumes, emerging indications, and biosimilar competition. Nonetheless, safety management and cost considerations will continue to influence adoption rates.

Key Takeaways

• Clinical trials are actively evolving, with advances in personalized dosing, combination therapies, and biomarker research promising to optimize efficacy and safety.
• Market valuation is poised for growth, fueled by heightened transplant activity, indication expansion, and biosimilar proliferation.
• Regulatory and reimbursement landscapes are challenging but present opportunities for innovation and market penetration, especially in emerging regions.
• Safety profiles and cost-effectiveness remain critical, necessitating ongoing research and strategic positioning.
• Stakeholders must monitor clinical trial outcomes, regulatory developments, and competitive strategies to capitalize on growth opportunities.

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FAQs

1. What are the primary indications for anti-thymocyte globulin (rabbit)?
   rATG is primarily used in solid organ transplantation (especially kidney), hematopoietic stem cell transplantation, and severe autoimmune diseases like aplastic anemia. It is employed to prevent graft rejection and manage autoimmune responses.

2. Are biosimilars impacting the rATG market?
   Yes. The introduction of biosimilars has increased market competition, lowered prices, and improved access, especially in regions where cost constraints previously limited usage.

3. What are the main safety concerns associated with rATG?
   Adverse effects include cytokine release syndrome, infections due to immunosuppression, hematological toxicity, and hypersensitivity reactions. Optimizing dosing and monitoring are critical to mitigate these risks.

4. What advancements are being explored in current clinical trials?
   Trials focus on personalized dosing guided by pharmacogenomics, combination therapies with other biologics, and biomarker-driven patient selection to improve outcomes and safety.

5. How does the regulatory environment influence the rATG market?
   Regulatory approvals, particularly from the FDA and EMA, validate product safety and efficacy, facilitating market entry. Streamlined pathways for biosimilars may accelerate competition and access but require robust evidence for approval.

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Sources

1. ClinicalTrials.gov. (2023). Search results for "anti-thymocyte globulin rabbit".
2. Grand View Research. (2023). Biologics Market Size, Share & Trends Analysis.
3. FiercePharma. (2023). Biosimilars reshape the hematology landscape.
4. U.S. Food and Drug Administration (FDA). Drug approvals and labeling information.
5. Pharma Intelligence. Market forecasts for biologics and immunosuppressants.