TheraRadar
Data updated: May 26, 2026

Thymoglobulin (anti-thymocyte globulin (rabbit))

Approved 1999-05-18
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
27
Years on Market

Details

Status
Prescription
First Approved
1999-05-18
Revenue
$137M (Q4-2025)

Pro Metrics

Patent cliff and revenue data

Unlock with Pro
Routes
Intravenous
Dosage Forms
For Injection

Companies

Sanofi
Active Ingredient: Anti-thymocyte Globulin (Rabbit)

Thymoglobulin Approval History

2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 1999 to 1999
May 1999 ORIGINAL
Update · CBER biologic (Purple Book)

What Thymoglobulin Treats

1 FDA approvals

Originally approved for its first indication in 1999 .

  • Other (1)
📋

Clinical Trial Registry

50 trials
Trial Sponsor ID Phase Status Title
NCT07257419 HAPALL NCI-2025-08364 Ph 1 recruiting CD45RA-depleted CD19-CAR T Cell Consolidation After TCRαβ+/CD19 B Cell-depleted Haploidentical Hematopoietic Cell Transplantation for Relapsed/Refractory CD19+ ALL and Lymphoma
NCT04888741 MoTD RG_19-116 Ph 2 recruiting Methods of T Cell Depletion Trial (MoTD)
NCT06083129 OPTISAGE APHP230276 Ph 3 recruiting Phase III Study Comparing GVHD Prophylaxis With ATG-thymoglobulin to ATLG-grafalon in Elderly Patients With Acute Myeloid Leukemia or Myelodysplasic Syndrome and Receiving an Allogeneic Hematopoietic Stem Cell Transplantation With a 10/10 HLA Matched Unrelated Donor
NCT05735717 2021LS061 Ph 2 recruiting MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies
NCT06872333 2024LS140 Ph 2 recruiting Allo HSCT for High Risk Hemoglobinopathies
NCT04224558 Pro00051458 Ph 1, Ph 2 recruiting Stem Cell Transplantation in Crohn's Disease
NCT03292861 ATG Pilot Study Ph 2 enrolling by invitation The Effect and Safety Profile of Thymoglobulin® in Primary Cardiac Transplant Recipients
NCT04395222 results posted 19-08020738 Ph 2 active not recruiting Tocilizumab for the Prevention of Graft Failure and GVHD in Haplo-Cord Transplantation
NCT07052370 HAP3HCT NCI-2025-04293 Ph 1 recruiting TCRαβ-depleted Progenitor Cell Graft With Early Memory T-cell DLI, Plus Selected Use of Blinatumomab, in naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies
NCT03219359 GCO 17-0378 Ph 2 recruiting Autologous Stem Cell Transplant for Crohn's Disease
NCT02512497 OSU-16242 NCI-2015-01555 Ph 1 completed Romidepsin Maintenance After Allogeneic Stem Cell Transplantation
NCT01810588 results posted 1205012383 Ph 2 active not recruiting Targeting the IPA and Matching for the Non-Inherited Maternal Antigen for Haplo-Cord Transplantation
NCT02790515 REF2HCT NCI-2016-00812 Ph 2 active not recruiting Provision of TCRγδ T Cells and Memory T Cells Plus Selected Use of Blinatumomab in Naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies Relapsed or Refractory Despite Prior Transplantation
NCT04558736 HAPSAA Ph 2 recruiting Haploidentical HCT for Severe Aplastic Anemia
NCT03597594 SCIDBMT Ph 1, Ph 2 active not recruiting Haplocompatible Transplant Using TCRα/β Depletion Followed by CD45RA-Depleted Donor Lymphocyte Infusions for Severe Combined Immunodeficiency (SCID)
NCT04202835 CTTC1901 OZM-099 Ph 2 active not recruiting ATG Plus PTCy vs ATG for CGVHD Prophylaxis
NCT04046549 results posted VIB4920.P2.S1 Ph 2 completed A Study to Evaluate the Safety and Efficacy of Dual Costimulation Blockade With VIB4920 and Belatacept for Prophylaxis of Allograft Rejection in Adults Receiving a Kidney Transplant
NCT02582775 results posted 2015LS076 Ph 2 completed MT2015-20: Biochemical Correction of Severe EB by Allo HSCT and Serial Donor MSCs
NCT04302805 INHIBIT Eudra CT: 2019-003723-37 Ph 3 completed rATG Versus rATG Combined With Intravenous Immunoglobulin (IVIG) Induction Immunosuppression in HLA Incompatible Transplantation (INHIBIT)
NCT04009525 GX-HSCT-MT 2019 Ph 4 completed Hematopoietic Stem Cell Transplantation for Patients With Thalassemia Major: A Multicenter, Prospective Clinical Study
NCT02867800 AAAQ2350 Ph 1 completed Abatacept for GVHD Prophylaxis After Hematopoietic Stem Cell Transplantation for Pediatric Sickle Cell Disease
NCT02441803 results posted 2014-0358 NCI-2015-00849 Ph 2 completed Allogeneic Hematopoietic Stem Cell Transplantation (AlloSCT) Initial Salvage Therapy for Induction Failure Acute Myeloid Leukemia (AML)
NCT02464878 results posted Islet after Kidney - AAT Ph 2 completed Multicenter Trial of the Effect of AAT on Islet Transplant Engraftment and Durability After Renal Transplant
NCT02745717 Shanghai1st-48 Ph 4 completed The Efficacy of Immunosuppressive Therapy Combined With Cord Blood Transfusion in Treatment of Severe Aplastic Anemia
NCT02224872 results posted J1424 IRB00031590 Ph 2 completed Transplantation of Partially Mismatched Related or Matched Unrelated Bone Marrow for Patients With Refractory Severe Aplastic Anemia
NCT03852407 HLA BHS-TC14 2017-000824-91 Ph 2 recruiting Allogeneic Hematopoietic Cell Transplantation From HLA-matched Donor After Flu-Mel-PTCy Versus Flu-Mel-ATG Reduced-intensity Conditioning
NCT02833805 results posted J1688 IRB00107139 Ph 2 completed NMA Haplo or MUD BMT for Newly Diagnosed Severe Aplastic Anemia
NCT03600909 results posted 17-498 Ph 2 terminated A Study of the Effect of Blood Stem Cell Transplant After Chemotherapy Alone in Patients With Fanconi Anemia
NCT01471444 results posted 2011-0628 NCI-2012-00038 Ph 3 completed Fludarabine-IV Busulfan ± Clofarabine and Allogeneic Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
NCT01790594 results posted DAIT CTOT-15 U01AI084150, NIAID CRMS ID#: 20117 Ph 2 terminated Optimization of NULOJIX® Usage Towards Minimizing CNI Exposure in Simultaneous Pancreas and Kidney Transplantation
NCT02137239 results posted IM103-177 2013-002090-21 Ph 2 completed Regimen Optimization Study
NCT02544113 results posted 15-943 Ph 2 completed A Randomized Controlled Clinical Trial of Thymoglobulin® After Liver Transplantation
NCT00813124 results posted 2008-0087 NCI-2012-02122 Ph 2 completed Azacitidine After Allo Blood And Marrow Transplantation (BMT) for Chronic Myelogenous Leukemia (CML)
NCT01856257 results posted DAIT CTOT-16 Ph 2 terminated Open-Label Phase 2 Trial of a Steroid-Free, CNI-Free, Belatacept-Based Immunosuppressive Regimen
NCT01490723 results posted 2011-0393 NCI-2016-00250 Ph 2 completed Zevalin-Containing Nonmyeloablative Conditioning for Stem Cell Transplantation (SCT)
NCT00899431 results posted 2007-0871 NCI-2012-01620 Ph 2 terminated Nonmyeloablative Stem Cell Transplantation for Chronic Lymphocytic Leukemia (CLL)
NCT03006419 R-2016-3001-61 Ph 4 completed Basiliximab vs Low-dose Thymoglobulin Induction Therapy in Low Risk Kidney Transplant Patients
NCT01392989 results posted IRB-18127 SU-04202010-5724, BMT217 Ph 2 completed Post T-plant Infusion of Allogeneic Cytokine Induced Killer (CIK) Cells as Consolidative Therapy in Myelodysplastic Syndromes/Myeloproliferative Disorders
NCT02627573 06/15-n Ph 2 terminated Trial of GVHD Prophylasxis With PTCy or Thymoglobulin in Unrelated SCT
NCT01157949 MA-1007-1 Ph 3 withdrawn A Study to Compare the Effectiveness of a Drug That Suppresses the Immune System Called Thymoglobulin® in Preventing the Development of a Disease That Affects the Majority of Heart Transplant Recipients Called Cardiac Allograft Vasculopathy (CAV)
NCT02084446 CRAD001ABR25T Ph 4 completed Everolimus + Very Low Tacrolimus vs Enteric-coated Mycophenolate Sodium + Low Tacrolimus in de Novo Renal Transplant
NCT00709592 results posted MCC-11561 NCI-2011-01698 Ph 2 completed Reduced Intensity Total Body Irradiation + Thymoglobulin Followed by Allogeneic PBSCT
NCT00990249 results posted 2009-0209 NCI-2012-01270 Ph 2 completed Busulfan Plus Clofarabine Followed by Allogeneic Hematopoietic Stem Cell Transplantation
NCT02877082 results posted IRB00082499 NCI-2016-01035, Winship3258-16 Ph 2 terminated Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients
NCT02683291 16966913.6.0000.5411 Ph 4 completed Sirolimus Associated With Tacrolimus at Low Doses in Elderly Kidney Transplant Patients
NCT00771745 results posted Pre-Tx Thymo Ph 4 completed Prospective Pilot Study of Pre-Transplant Thymoglobulin Administration in Living Donor Renal Transplant Recipients
NCT01354301 CRAD001ABR18T Ph 4 completed Efficacy and Safety of Induction Strategies Combined With Low Tacrolimus Exposure in Kidney Transplant Recipients Receiving Everolimus or Sodium Mycophenolate
NCT00916045 07CC12 REC - 07/H0808/193, EudraCT - 2007-001657-26 Ph 2 terminated Pilot Study of Unrelated Cord Blood Transplantation
NCT01622556 15954 UCB-2011 Ph 2 terminated Conditioning Treatment With Umbilical Cord Blood Transplant for Hematologic Malignancies
NCT01939171 HULP- Nefro 001 2009-013398-16 Ph 2 completed Thymoglobulin in Cadaver Donor
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

Thymoglobulin FDA Label Details

Pro Intelligence Preview

Deep insights for Thymoglobulin

Revenue Insights

  • • Q4-2025: $137M
  • • Historical trend analysis

Patent Timeline

  • • Patent expiration dates
  • • Generic/biosimilar risk

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
Unlock Full Intelligence

Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: BLA103869 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.