Thiotepa clinical trials
Thiotepa is named as an intervention in 17 current clinical trials in our Australia, Israel, Canada, China, France, Poland, Turkey, Mexico, Taiwan, Germany, Spain, Italy, Netherlands, Belgium, Sweden, Denmark, Switzerland, Austria, Czechia, Norway and USA registers. 10 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Children's Oncology Group (3). The most-studied condition is Neuroblastoma. The EU clinical trials register (CTIS) separately lists 2 authorised or ongoing trials.
Where Thiotepa is approved
All regulators →Of the three regulators tracked here, the first to approve Thiotepa was the US, on 9 Mar 1959. It is approved in 3 of the 3 regulators tracked here.
- 1 EU orphan designation, most recently for conditioning treatment prior to haematopoietic-progenitor-cell transplantation (29 Jan 2007, withdrawn)
- 1 EU safety letter (DHPC), latest: quality defect for Tepadina, 1 Jun 2020
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Thiotepa patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Thiotepa, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 1 listed patent; the last listed expires 31 May 2037 (US 9931458).
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Thiotepa
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Thiotepa works
All drug targets →- Acute lymphoblastic leukemiaPhase 3
- Acute myeloid leukemiaPhase 3
- Atypical teratoid rhabdoid tumorPhase 3
- Choroid plexus carcinomaPhase 3
- EpendymomaPhase 3
- Malignant gliomaPhase 3
- MedulloblastomaPhase 3
- Mixed phenotype acute leukemiaPhase 3
- Myelodysplastic syndromePhase 3
- NeuroblastomaPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL671, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 7622, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Thiotepa
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 8 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Tepadina, Thiotepa Riemser (generic)EMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Thiotepa
- ATC code
- L01AC01
- ChEMBL
- CHEMBL671
- DrugBank
- DB04572
- PubChem CID
- 5453
- CAS number
- 52-24-4
- FDA UNII
- 905Z5W3GKH
- Wikidata
- Q416507
- Wikipedia
- Thiotepa
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Thiotepa
17 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Thiotepa in the EU trials register (CTIS)
2 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Thiotepa. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
"EURbG2": A European prospective study of patients with unilateral retinoblastoma requiring enucleation, either first-line or after neoadjuvant chemotherapy, with analysis of histological risk factors and biomarkers at baseline and during follow-up
2024-515962-15-00 · CTIS ↗ · Eye Diseases
|
Phase 2 | Authorised | Institut Curie | France |
|
Framework for Optimizing, Refining, and Unifying Management of HSCT in Pediatric ALL.
2025-522052-13-00 · CTIS ↗ · Hemic and Lymphatic Diseases
|
Phase 3 | Ongoing | Ospedale Pediatrico Bambino Gesu | Germany, Denmark, Finland + 14 more |
Thiotepa across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
8 single-substance products containing Thiotepa on the HPRA medicines list.
- TEPADINA 100 mg powder for concentrate for solution for infusionAdienne S.r.l. · EU/1/10/622/002
- TEPADINA 15 mg powder for concentrate for solution for infusionAdienne S.r.l. · EU/1/10/622/001
- TEPADINA 200 mg powder and solvent for solution for infusionAdienne S.r.l. S.U. · EU/1/10/622/004
- TEPADINA 400 mg powder and solvent for solution for infusionAdienne S.r.l. S.U. · EU/1/10/622/003
- Thiotepa Riemser 100 mg powder for concentrate for solution for infusionEsteve Pharmaceuticals GmbH · EU/1/21/1536/002
Supply shortages
No entry for Thiotepa in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Thiotepa
32 conditionsAll 32 conditions
| Condition (as registered) | Trials |
|---|---|
| Neuroblastoma | 3 |
| Ganglioneuroblastoma, Nodular | 2 |
| Carcinoma, Non-Small-Cell Lung | 1 |
| Carcinoma, Non-Small -Cell Lung | 1 |
| Acute Lymphoblastic Leukaemia | 1 |
| CNS Embryonal Tumor | 1 |
| CNS, Medulloblastoma | 1 |
| Atypical Teratoid Rhabdoid Tumor | 1 |
| Medulloblastoma, Childhood | 1 |
| DLBCL - Diffuse Large B Cell Lymphoma | 1 |
| Acute Myeloid Leukemia (AML) | 1 |
| High Risk Acute Myeloid Leukemia(AML) | 1 |
| Relapsed/Refractory Acute Myeloid Leukemia (AML) | 1 |
| Acute Leukemia, High Risk | 1 |
| Acute Leukemia Refractory | 1 |
| Acute Leukemia, Relapsed | 1 |
| Glioblastoma (GBM) | 1 |
| Leptomeningeal Metastasis | 1 |
| High-Risk Neuroblastoma | 1 |
| Patient With Insufficient Response Chemoimmunotherapy | 1 |
| Retinoblastoma | 1 |
| Graft Versus Host Disease | 1 |
| Hematologic Malignancy | 1 |
| Central Nervous System Nongerminomatous Germ Cell Tumor | 1 |
| Choriocarcinoma | 1 |
| Embryonal Carcinoma | 1 |
| Immature Teratoma | 1 |
| Ganglioneuroblastoma | 1 |
| Acute Lymphoblastic Leukemia | 1 |
| Acute Myeloid Leukemia | 1 |
| Mixed Phenotype Acute Leukemia | 1 |
| Myelodysplastic Syndrome | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Children's Oncology Group | 3 |
| Maia Biotechnology | 2 |
| St. Anna Kinderkrebsforschung | 1 |
| C17 Council | 1 |
| Ou Bai, MD/PHD | 1 |
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | 1 |
| Peking University People's Hospital | 1 |
| Guangdong Second Provincial General Hospital | 1 |
| Second Affiliated Hospital, Zhejiang University, School of Medicine | 1 |
| Tianjin Medical University Cancer Institute and Hospital | 1 |
| Gustave Roussy, Cancer Campus, Grand Paris | 1 |
| Institut Curie | 1 |
| Nantes University Hospital | 1 |
| National Cancer Institute (NCI) | 1 |
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Thiotepa trials
How many clinical trials are testing Thiotepa?
17 current trials in our Australia, Israel, Canada, China, France, Poland, Turkey, Mexico, Taiwan, Germany, Spain, Italy, Netherlands, Belgium, Sweden, Denmark, Switzerland, Austria, Czechia, Norway and USA registers name Thiotepa (also registered as 6-Thio-2'-Deoxyguanosine) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Thiotepa trials recruiting patients?
Yes. 10 of the 17 trials are recruiting: 4 with sites in Australia, 5 with sites in Israel, 5 with sites in Canada, 2 with sites in China, 3 with sites in France, 2 with sites in Poland, 2 with sites in Turkey, 3 with sites in Mexico, 1 with sites in Taiwan, 2 with sites in Germany, 2 with sites in Spain, 2 with sites in Italy, 2 with sites in Netherlands, 2 with sites in Belgium, 2 with sites in Sweden, 2 with sites in Denmark, 2 with sites in Switzerland, 2 with sites in Austria, 2 with sites in Czechia and 2 with sites in Norway. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Thiotepa clinical trials?
Children's Oncology Group (3), Maia Biotechnology (2), St. Anna Kinderkrebsforschung (1) and C17 Council (1), among 14 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Thiotepa licensed in Ireland?
Yes. The HPRA medicines list includes 8 single-substance products containing Thiotepa, for example TEPADINA 100 mg powder for concentrate for solution for infusion (Adienne S.r.l.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Thiotepa shortage?
Not in the lists we track: Thiotepa has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Thiotepa works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Thiotepa works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Thiotepa (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.