Drug · Small Molecule
Treosulfan
CI-DRUG-00000747Explore in graph →CHEMBL455186 Approved
Regulatory
Approvals (6)
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 | Acute Myeloid Leukemia | Use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML). | approved | Jan 21, 2025 | openfda |
| US FDA | Myelodysplastic Syndrome | . Use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with myelodysplastic syndrome (MDS). | approved | Jan 21, 2025 | openfda |
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 11 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 3 | 5 | 5 | 4 | 28 | 6 | CA, EU, US | Jun 20, 2019 | 2001-11 |
| Leukemia | Approved | Phase 3 | 4 | 4 | 2 | 17 | 1 | US | Jan 21, 2025 | 2004-03 |
| Malignant Ovarian Neoplasm | Phase3 | Phase 3 | 0 | 0 | 1 | 1 | 0 | — | — | 2004-08 |
| Non-Hodgkin Lymphoma | Phase2 | Phase 2 | 2 | 2 | 0 | 4 | 0 | — |
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 (28)
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 |
|---|---|---|---|---|---|---|---|---|
| NCT01949129 | Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia | recruiting | Phase 2 / Phase 3 | 1,800 | St. Anna KinderkrebsforschungOTHER | 31 | Sep 4, 2026 | clinicaltrials |
| NCT07025824 | Evaluation of Treosulfan Versus Melphalan Conditioning Followed by PTCy in Patients With AML and MDS Undergoing Allogeneic Transplantation(RELEVANT) |