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Trecondi (TREOSULFAN)
Trecondi (treosulfan) is a marketed drug by Medexus used primarily for allogeneic HSCT in AML patients, with a key composition patent expiring in 2028. Its mechanism of crosslinking DNA to inhibit replication and cell division provides a strong therapeutic profile, distinguishing it from off-patent competitors like busulfan, which has 15 generics available. The primary risk is the potential erosion of market share due to the availability of multiple generic alternatives.
At a glance
| Generic name | TREOSULFAN |
|---|---|
| Sponsor | Medexus |
| Drug class | treosulfan |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2019 |
Approved indications
- Allogeneic HSCT in AML
- Allogeneic HSCT in MDS
Boxed warnings
- WARNING: MYELOSUPPRESSION GRAFAPEX causes severe and prolonged myelosuppression at the recommended dosage. Hematopoietic stem cell transplantation is required to prevent potentially fatal complications of the prolonged myelosuppression. Monitor hematologic laboratory parameters [see Warnings and Precautions ( 5.1 )] . WARNING: MYELOSUPPRESSION See full prescribing information for complete boxed warning. GRAFAPEX causes severe and prolonged myelosuppression. Hematopoietic stem cell transplantation is required to prevent potentially fatal complications of the prolonged myelosuppression. Monitor hematologic laboratory parameters. ( 5.1 )
Common side effects
- musculoskeletal pain
- stomatitis
- pyrexia
- nausea
- edema
- infection
- vomiting
- rash
- diarrhea
- headache
- febrile neutropenia
- abdominal pain
Drug interactions
- CYP2C19 and CYP3A4 substrates
Key clinical trials
- MT2025-35 Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning Treosulfan and Fludarabine, With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases (PHASE2)
- Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Thiotepa in Treating Patients With Non-malignant Disorders (PHASE2)
- Treosulfan-Based Conditioning Regimen Before a Blood or Bone Marrow Transplant for the Treatment of Bone Marrow Failure Diseases (BMT CTN 1904) (PHASE2)
- Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies (PHASE2)
- Treosulfan-Based Versus Clofarabine-Based Conditioning Before Donor Hematopoietic Stem Cell Transplant for the Treatment of Myelodysplastic Syndromes or Acute Myeloid Leukemia (PHASE2)
- Study of Treosulfan-Based Conditioning for HSCT in Nijmegen Breakage Syndrome (PHASE2)
- Treosulfan-based Versus Busulfan-based Conditioning in Paediatric Patients With Non-malignant Diseases (PHASE2)
- Effect of Moderate Renal Impairment and Race/Ethnicity on Treosulfan Pharmacokinetics (PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Trecondi CI brief — competitive landscape report
- Trecondi updates RSS · CI watch RSS
- Medexus portfolio CI