Drug · Small Molecule
Thiotepa
CI-DRUG-00000667Explore in graph →CHEMBL671 Approved
Regulatory
Approvals (17)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
- Source
- EMA — European public assessment reports (centrally authorised medicines)
- Dataset
- EMA medicines data (xlsx)
- Version
- ema-medicines-2026-09-11T06:00
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- EMA copyright — reproduction and distribution permitted for non-commercial and commercial purposes provided EMA is acknowledged as the source (https://www.ema.europa.eu/en/about-us/legal-notice)
- Run
- ING-EMA-20260911-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| EU EMA | — | 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 | approved | Mar 26, 2021 | ema |
| EU EMA | — | 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. | approved | Mar 15, 2010 | ema |
Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.
Data updated 21 hours agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 4 | 37 | 19 | 22 | 181 | 17 | CA, EU, US | Mar 15, 2010 | 1990-02 |
| Malignant Bladder Neoplasm | Approved | — | 0 | 0 | 0 | 0 | 1 | US | Jan 26, 2017 | — |
| Malignant Breast Neoplasm | Approved | Phase 3 | 0 | 0 | 7 | 25 | 2 | US | Jan 26, 2017 | 1991-12 |
| Malignant Gastric Neoplasm | Approved | — | 0 | 0 | 0 | 0 | 1 | US |
Curated evidence
Clinical evidence (0)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
Data not yet available
Clinical trials
Trials with this intervention (182)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT03779854 | Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant | active not recruiting | Phase 2 | 45 | Fred Hutchinson Cancer CenterOTHER | 1 | Sep 25, 2026 | clinicaltrials |
| NCT01511562 | Combination Chemotherapy With or Without Autologous Stem Cell Transplant in Treating Patients With Central Nervous System B-Cell Lymphoma |