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Drug

Thiotepa

Approved · EMA
Late-stage development
Also known as Phosphorothioic acid triethylenetriamide, Tepadina, Tepylute, Thiophosphamide+11 more

Phosphorothioic acid triethylenetriamide, Tepadina, Tepylute, Thiophosphamide, Thiophosphoramide, Thioplex, Thiotriethylenephosphoramide, Tri-1-aziridinylphosphine sulfide, Triethylene thiophosphoramide, Triethylenethiophosphoramide, Triethylenethiophosphorotriamide, Tris(1-aziridinyl)phosphine sulfide, Tris(aziridinyl)phosphine sulfide, N,N',N''-tri-1,2-ethanediyl-, Phosphorothioic triamide, N,N',N''-tri-1,2-ethanediyl-.

RxNorm10473ChEMBLCHEMBL671UNII905Z5W3GKH
49
Active clinical trials
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Autologous Stem Cell Transplantation With CD34-Selected Peripheral Blood Stem Cells (PBSC) in Patients With Treatment Resistant Systemic Sclerosis (SSc)

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

T-Cell Depleted, Alternative Donor Transplant in Pediatric and Adult Patients With Severe Sickle Cell Disease (SCD) and Other Transfusion-Dependent Anemias

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

Reduced Intensity Conditioning With Thiotepa Combined With Busulfan, Fludarabine and Cytarabine in Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma.

Clinical trial2026-07-15Primary completion · ClinicalTrials.gov

Pilot Study: Infusion of Off-the-Shelf Ex Vivo Expanded Cryopreserved Progenitor Cells (Dilanubicel) in the Setting of Single Cord Blood Transplantation for Patients With Hematologic Malignancies

Clinical trial2026-07-10Results posted · ClinicalTrials.gov

A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma

Clinical trial2026-07-09Results expected Q4 2029 · ClinicalTrials.gov

Reduced Intensity Conditioning for Haploidentical Bone Marrow Transplantation in Patients With Symptomatic Sickle Cell Disease. (BMTCTN1507)

Clinical trial2026-07-08Results posted · ClinicalTrials.gov

CD34+ Stem Cell Selection for Patients Receiving a Matched or Partially Matched Family or Unrelated Adult Donor Allogeneic Stem Cell Transplant for Malignant Disease

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

Phase 1 Trial of Thiotepa-based Conditioning Regimen With De-escalated Post-graft Cyclophosphamide for Allogeneic Stem Cell Transplantation in Hematologic Malignancies

Clinical trial2026-07-01Results expected Q2 2029 · ClinicalTrials.gov

A Multi-Center, Phase 3, Randomized Trial of Matched Unrelated Donor (MUD) Versus HLA-Haploidentical Related (Haplo) Myeloablative Hematopoietic Cell Transplantation for Children, Adolescents, and Young Adults (AYA) With Acute Leukemia or Myelodysplastic Syndrome (MDS)

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

A Pilot Study of Intrathecal Topotecan and Maintenance Chemotherapy in the Post-consolidation Setting for the Treatment of High-risk Embryonal Central Nervous System Tumours in Children Less Than 6 Years of Age

Clinical trial2026-06-08Results expected Q4 2030 · ClinicalTrials.gov

Approval: Thiotepa Riemser (EMA)

Regulatory2021-03-26EMA

Approval: Tepadina (EMA)

Regulatory2010-03-15EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Thiotepa
Aliases & brands
Phosphorothioic acid triethylenetriamideTepadinaTepyluteThiophosphamideThiophosphoramideThioplexThiotriethylenephosphoramideTri-1-aziridinylphosphine sulfideTriethylene thiophosphoramideTriethylenethiophosphoramideTriethylenethiophosphorotriamideTris(1-aziridinyl)phosphine sulfideTris(aziridinyl)phosphine sulfideN,N',N''-tri-1,2-ethanediyl-Phosphorothioic triamide, N,N',N''-tri-1,2-ethanediyl-
RxNorm CUI
10473
ChEMBL ID
CHEMBL671
UNII
905Z5W3GKH
Regulatory jurisdictions
ema

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2010-03-15
Latest approval
2021-03-26
Authorities
EMA
Total events
2
emaEuropean Medicines Agency· 2 events
2021-03-26Approval
Approval: Thiotepa Riemser (EMA)
Indication: Thiotepa Riemser is indicated, in combination with other chemotherapy medicinal products: with or without total body irradiation (TBI), as conditioning treatment prior to… Show full indication

Thiotepa Riemser is indicated, in combination with other chemotherapy medicinal products: with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients; when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients. Thiotepa Riemser is indicated, in combination with other chemotherapy medicinal products: with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients; when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients

Evidence ↗
2010-03-15Approval
Approval: Tepadina (EMA)
Indication: TEPADINA is indicated, in combination with other chemotherapy medicinal products:- with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or… Show full indication

TEPADINA is indicated, in combination with other chemotherapy medicinal products:- with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients;- when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

196 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
196
registered trials across all phases
LATEST COMPLETION 2026
49
Active studies
35
Recruiting
33
Late-stage (III+)
93
Completed
54
Discontinued
PHASE DISTRIBUTIONn = 196
Early Phase 13Phase 129Phase 1 / 221Phase 2110Phase 2 / 35Phase 319Phase 41Phase N / A8

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Evaluation of Allogeneic Marrow Transplants Depleted of T-Cells by CD34+ Selection in Patients Undergoing Transplantation With an Unrelated Matched or 1 Antigen Mismatched Donor or a 1 Antigen Mismatched Related Donor

CompletedPH IVUniversity of Maryland, Baltimoren=452000

High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)

RecruitingPH IIIGustave Roussy, Cancer Campus, Grand Parisn=8002032

A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or ALK Inhibitor Therapy Added to Intensive Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma (NBL)

RecruitingPH IIIChildren's Oncology Groupn=7502030

Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia

RecruitingPH II/IIIKey trialSt. Anna Kinderkrebsforschungn=1,8002030

A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma

RecruitingPH IIINational Cancer Institute (NCI)n=4782029

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Pilot Induction Regimen Incorporating Chimeric 14.18 Antibody (ch14.18, Dinutuximab) (NSC# 764038) and Sargramostim (GM-CSF) for the Treatment of Newly Diagnosed High-Risk Neuroblastoma

CompletedPH IINational Cancer Institute (NCI)n=422026

A Phase III Randomized Trial for the Treatment of Newly Diagnosed Supratentorial PNET and High Risk Medulloblastoma in Children < 36 Months Old With Intensive Induction Chemotherapy With Methotrexate Followed by Consolidation With Stem Cell Rescue vs. the Same Therapy Without Methotrexate

CompletedPH IIIChildren's Oncology Groupn=912025

A Phase II Study Evaluating Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts From HLA-Matched Related and Unrelated Donors for Prevention of GVHD

CompletedPH IIFred Hutchinson Cancer Centern=842025

Reduced Intensity Conditioning for Haploidentical Bone Marrow Transplantation in Patients With Symptomatic Sickle Cell Disease. (BMTCTN1507)

CompletedPH IIMedical College of Wisconsinn=952025

A Trial of Intensive Multi-Modality Therapy for Extra-Ocular Retinoblastoma

CompletedPH IIIChildren's Oncology Groupn=602024

Randomized Phase II Trial On Primary Chemotherapy With High-Dose Methotrexate And High-Dose Cytarabine With Or Without Thiotepa, And With Or Without Rituximab, Followed By Brain Irradiation Vs. High-Dose Chemotherapy Supported By Autologous Stem Cells Transplantation For Immunocompetent Patients With Newly Diagnosed Primary CNS Lymphoma

CompletedPH IIInternational Extranodal Lymphoma Study Group (IELSG)n=2272024
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.