TheraRadar
Data updated: May 26, 2026

TEPADINA AND SODIUM CHLORIDE (thiotepa)

Alkylating Activity
Oncology Approved 2017-01-26

TEPADINA AND SODIUM CHLORIDE is indicated for the treatment of Breast Adenocarcinoma; Ovarian Adenocarcinoma; Urinary Bladder Carcinoma; Lymphoma; Hodgkin's Lymphoma.

Source: FDA Label • ADIENNE SA
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
9
Years on Market

Details

Status
Prescription
First Approved
2017-01-26
Patent Cliff
2037

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Routes
INTRAVENOUS
Dosage Forms
POWDER

Companies

ADIENNE SA
Active Ingredient: THIOTEPA

TEPADINA AND SODIUM CHLORIDE Approval History

2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
12 FDA actions from 2017 to 2026
Jan 2026 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label
Oct 2025 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label
Apr 2025 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label

What TEPADINA AND SODIUM CHLORIDE Treats

5 indications

TEPADINA AND SODIUM CHLORIDE is approved for 5 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Breast Adenocarcinoma
  • Ovarian Adenocarcinoma
  • Urinary Bladder Carcinoma
  • Lymphoma
  • Hodgkin's Lymphoma
Source: FDA Label

TEPADINA AND SODIUM CHLORIDE Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

LOMUSTINE
CARNEGIE
2025 2 indic.
PLERIXAFOR
GLAND
2023 2 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in TEPADINA AND SODIUM CHLORIDE's indications

See all emerging drugs →

Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TEPADINA AND SODIUM CHLORIDE treats. First-in-class if their pivotal trials read out positive.

Ceralasertib AZD6738 ~ Mixed — Ph3 readout
AstraZeneca
ATR · small-molecule ATR kinase inhibitor · 2 Phase 3 trials
Tiragolumab MTIG7192A / RG6058 ~ Mixed — Ph3 readout
Hoffmann-La Roche
TIGIT · monoclonal antibody (anti-TIGIT) · 10 Phase 3 trials

Drugs Similar to TEPADINA AND SODIUM CHLORIDE

3 of 11

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

THIOTEPA
THIOTEPA
5 shared
Fresenius Kabi
Shared indications:
Breast AdenocarcinomaOvarian AdenocarcinomaUrinary Bladder Carcinoma +2 more
TEPADINA
THIOTEPA
2 shared
ADIENNE SA
Shared indications:
Breast AdenocarcinomaUrinary Bladder Carcinoma
ALLOPURINOL SODIUM
ALLOPURINOL SODIUM
1 shared
GLAND
Shared indications:
Lymphoma
View all 11 similar drugs Pro
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Clinical Trial Registry

89 trials
Trial Sponsor ID Phase Status Title
NCT06172296 NCI-2023-08530 NCI-2023-08530, ANBL2131 Ph 3 recruiting Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
NCT05088356 IRB-60439 NCI-2021-12228 Ph 1 active not recruiting Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft
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
NCT04872595 21-193 Ph 2 active not recruiting A Modified Dose of Rabbit Anti-thymocyte Globulin (rATG) in Children and Adults Receiving Treatment to Help Prepare Their Bodies for a Bone Marrow Transplant
NCT07566377 26-168 Ph 2 recruiting Cord Blood Transplantation in Children and Young Adults With Blood Cancer
NCT04217278 COSI RG_17-234 Ph 2, Ph 3 active not recruiting A Trial of Treatments to Assess the Effects on Outcome of Adults With AML and MDS Undergoing Allogeneic SCT
NCT06158828 ABCD-NK 202401147 Ph 1, Ph 2 recruiting Pilot Study of Memory-like Natural Killer (ML NK) Cells After TCRαβ T Cell Depleted Haploidentical Transplant in AML
NCT04684368 ACNS2021 NCI-2020-13175, ACNS2021 Ph 2 recruiting A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT
NCT07565220 HCC 26-008 Ph 1 not yet recruiting Thiotepa-based Conditioning Regimen With De-escalated Post-graft Cyclophosphamide for Allogeneic Stem Cell Transplantation in Hematologic Malignancies
NCT03263559 results posted BMTCTN1507 2U10HL069294-11, 5U24CA076518 Ph 2 completed Haploidentical Bone Marrow Transplantation in Sickle Cell Patients (BMTCTN1507)
NCT06195891 23343 NCI-2023-08816, 23343 Ph 1 recruiting Orca-T Following Chemotherapy and Total Marrow and Lymphoid Irradiation for the Treatment of Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia or Myelodysplastic Syndrome
NCT06807606 2024-1605 NCI-2025-00794 Ph 2 recruiting Optimized Cord Blood Transplantation for the Treatment of Patients With High-risk Hematologic Malignancies Who Have Relapsed After First Allogeneic Stem Cell Transplantation
NCT04859946 2020-0971 NCI-2021-02784, 2020-0971 Ph 2 active not recruiting Itacitinib for the Prevention of Graft Versus Host Disease
NCT03786783 results posted NCI-2018-03732 NCI-2018-03732, ANBL17P1 Ph 2 active not recruiting Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma
NCT03849651 results posted HAP2HCT NCI-2019-00338 Ph 2 active not recruiting TCRαβ-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-cell Depleted Haploidentical Donor Hematopoietc Cell Transplantation for Hematologic Malignancies
NCT06687772 CNS-PHLAT 202411136 Ph 2 recruiting CNS-Relapse Prevention in High-Risk Diffuse Large B-cell Lymphoma With Thiotepa-based Autologous Stem Cell Transplant
NCT01011920 results posted IELSG32 2009-012432-32 Ph 2 completed Trial for Patients With Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma
NCT03970096 RG1005364 9749, NCI-2019-03188 Ph 2 recruiting Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)
NCT03980769 RG1005072 NCI-2019-03243, 9621 Ph 2 recruiting Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Thiotepa in Treating Patients With Non-malignant Disorders
NCT06872333 2024LS140 Ph 2 recruiting Allo HSCT for High Risk Hemoglobinopathies
NCT05565105 2021-KOE-001 Ph 2 not yet recruiting CD34+ Transplants for Leukemia and Lymphoma
NCT07441967 IIT2025140 Ph 2 not yet recruiting The Safety and Efficacy of the Regimen of Thiotepa + Fludarabine +Granulocyte Colony-Stimulating Factor+ Cytarabine + Busulfan in Single Unrelated Umbilical Cord Blood Transplantation
NCT03126916 ANBL1531 NCI-2016-01734, ANBL1531 Ph 3 recruiting Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)
NCT04708054 2020-0790 NCI-2020-13919, 2020-0790 Ph 2, Ph 3 recruiting Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients With High-Risk AML and MDS
NCT02861417 2016-0137 NCI-2017-00614, 2016-0137 Ph 2 active not recruiting Busulfan, Fludarabine Phosphate, and Post-Transplant Cyclophosphamide in Treating Patients With Blood Cancer Undergoing Donor Stem Cell Transplant
NCT01511562 results posted CALGB-51101 CALGB-51101, CDR0000721927 Ph 2 active not recruiting Combination Chemotherapy With or Without Autologous Stem Cell Transplant in Treating Patients With Central Nervous System B-Cell Lymphoma
NCT06252870 CY-MET-RIC RC23_0286 Ph 2 recruiting Study Testing Two Conditioning Regimen With a Single Prophylaxis of GVHD by Cyclophosphamide and Methotrexate Post-transplant in Patients Eligible for Matched-donor Allograft Transplantation
NCT06013423 RG1123652 NCI-2023-05598, FHIRB0020219 Ph 2 recruiting Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases
NCT03500731 STUDY19110120 Ph 1, Ph 2 recruiting Lung and Bone Marrow Transplantation for Lung and Bone Marrow Failure
NCT01746849 12-077 Ph 2 active not recruiting Palifermin With Leuprolide Acetate for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation
NCT02870907 RB SFCE 09 IC 2009-04 Ph 2 active not recruiting Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated (RB SFCE 2009)
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
NCT05457556 ASCT2031 NCI-2022-07080, ASCT2031 Ph 3 active not recruiting Mismatched Related Donor Versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents, and Young Adults With Acute Leukemia or Myelodysplastic Syndrome
NCT00692939 STUDY19100005 Ph 1, Ph 2 recruiting Autologous Stem Cell Transplantation for Crohn's Disease
NCT01962415 HSCT+RIC STUDY19060337 Ph 2 recruiting Reduced Intensity Conditioning for Non-Malignant Disorders Undergoing UCBT, BMT or PBSCT
NCT07276737 SHSYXY-NT/T-TCB-2025 Ph 2 not yet recruiting Preconditioning With a Combination of Thiotepa, Cyclophosphamide, and Busulfan for Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of NK/T-Cell Lymphoma
NCT03342196 results posted CASE10Z17 Ph 2 completed Thiotepa Plus Fludarabine+ Melphalan as the Preparative Regime for Alternative Donor Transplantation
NCT02605421 2015LS108 Ph 2 recruiting Myeloablative Consolidation Therapy and Tandem Autologous Stem Cell Rescue in Patients With High-Risk Neuroblastoma
NCT04678401 20-336 Ph 1 recruiting IS-free Treg HaploHCT
NCT03779854 RG1003345 9880, NCI-2018-01752 Ph 2 recruiting Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant
NCT03630211 SSc STUDY19050297 Ph 2 recruiting Autologous Stem Cell Transplantation in Patients With Systemic Sclerosis
NCT05579769 results posted CNI60 Ph 2 terminated Pediatric Study of GVHD Ppx w/o Calcineurin Inhibitors After Day60 Post First Allo HSCT for Hematological Malignancies.
NCT03165292 VERITAS 2015-003130-27 2015/2294 Ph 2 terminated Evaluation of 2 Intensification Treatment Strategies for Neuroblastoma Patients With a Poor Response to Induction
NCT03399773 9910 NCI-2017-02205, 9910 Ph 2 active not recruiting Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes
NCT03653338 STUDY19050050 Ph 1, Ph 2 recruiting T-Cell Depleted Alternative Donor Bone Marrow Transplant for Sickle Cell Disease (SCD) and Other Anemias
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
NCT02329080 results posted IELSG42 Ph 2 completed New Combination of Chemoimmunotherapy for Systemic B-cell Lymphoma With Central Nervous System Involvement
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)
NCT04530487 results posted 2020-0496 NCI-2020-05879, 2020-0496 Ph 2 terminated Donor Stem Cell Transplant After Chemotherapy for the Treatment of Recurrent or Refractory High-Risk Solid Tumors in Pediatric and Adolescent-Young Adults
NCT04221035 HR-NBL2 2019-001068-31 2019/2894, 2024-514917-36-00 Ph 3 recruiting High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)

Showing 50 of 89 trials

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Active Pipeline

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Key Completed Trials

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

TEPADINA AND SODIUM CHLORIDE FDA Label Details

Indications & Usage

FDA Label (PDF)

TEPADINA AND SODIUM CHLORIDE is indicated for the treatment of Breast Adenocarcinoma; Ovarian Adenocarcinoma; Urinary Bladder Carcinoma; Lymphoma; Hodgkin's Lymphoma.

View full patent landscape →
1 OB patents · 1 families · 83 international docs across 36 countries

TEPADINA AND SODIUM CHLORIDE Patents & Exclusivity

Latest Patent: May 2037

Patents (1 active)

US9931458 Expires May 31, 2037
Source: FDA Orange Book

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Revenue Insights

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Patent Timeline

  • • Cliff: 2037
  • • 4 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • 11 similar drugs
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA208264 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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