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
- openFDA — Drugs@FDA applications and drug labels (SPL)
- Dataset
- Drugs@FDA via openFDA
- Version
- drugsfda-2026-09-11
- Retrieved
- Sep 14, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- CC0 1.0 Universal (public domain; https://open.fda.gov/license/)
- Run
- ING-OPENFDA-20260914-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| US FDA | Breast Adenocarcinoma | TEPYLUTE is an alkylating drug indicated for treatment of adenocarcinoma of the breast or ovary. | approved | Jun 25, 2024 | openfda |
| US FDA | Bladder Carcinoma | For treatment of superficial papillary carcinoma of the urinary bladder. | approved | Jan 26, 2017 | openfda |
| US FDA | — | To reduce the risk of graft rejection when used in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) for pediatric patients with class 3 beta-thalassemia. | approved | Jan 26, 2017 | openfda |
| US FDA | Gastric Diffuse Adenocarcinoma | For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. |
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 14 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 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT00002471 | Combination Chemotherapy in Treating Patients With Acute B-Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma | completed | Phase 2 | — | Memorial Sloan Kettering Cancer CenterOTHER | 1 | Jun 20, 2013 | clinicaltrials |
| NCT00004900 | Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Women With Metastatic Breast Cancer | completed |