Treosulfan

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Low Dose Treosulfan Based Conditioning Regimen and PTCy in HSCT for Nijmegen Breakage Syndrome	2024/01/10	NCT06198842	Phase 2	Recruiting	Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Clinical Trial Investigating the Chemotherapeutic Compound Treosulfan (Trecondi® Ideogen) in Myeloma Patients	2022/12/05	NCT05636787	Phase 2	Recruiting	Insel Gruppe AG, University Hospital Bern
Effect of Moderate Renal Impairment and Race/Ethnicity on Treosulfan Pharmacokinetics	2022/09/09	NCT05534620	Phase 1	Recruiting	medac GmbH
Treosulfan-Based Versus Clofarabine-Based Conditioning Before Donor Hematopoietic Stem Cell Transplant for the Treatment of Myelodysplastic Syndromes or Acute Myeloid Leukemia	2021/08/06	NCT04994808	Phase 2	Recruiting	Fred Hutchinson Cancer Center
Treosulfan-Based Conditioning Regimen Before a Blood or Bone Marrow Transplant for the Treatment of Bone Marrow Failure Diseases (BMT CTN 1904)	2021/07/16	NCT04965597	Phase 2	Active, not recruiting	Fred Hutchinson Cancer Center
Low Dose Treosulfan Based Conditioning Regimen in HSCT for Nijmegen Breakage Syndrome	2020/05/22	NCT04400045	Phase 2	UNKNOWN	Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies	2019/12/12	NCT04195633	Phase 2	Recruiting	Fred Hutchinson Cancer Center
Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Thiotepa in Treating Patients With Non-malignant Disorders	2019/06/10	NCT03980769	Phase 2	Recruiting	Fred Hutchinson Cancer Center
Phase II Trial in Elderly Patients With AML or MDS in Complete Remission Not Eligible for Allogenic Transplant	2019/05/23	NCT03961919	Phase 2	Completed	Ciceri Fabio
A Trial With Metronomic Low-dose Treosulfan, Pioglitazone and Clarithromycin Versus Standard Treatment in NSCLC	2016/08/02	NCT02852083	Phase 2	UNKNOWN	University Hospital Regensburg

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Trecondi	medac Gesellschaft für klinische Spezialpräparate mbH,Theaterstrasse 6,22880 Wedel,Germany	Authorised	6/20/2019

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
TRECONDI POWDER FOR SOLUTION FOR INFUSION 1 G PER VIAL	Oncotec Pharma Produktion GmbH	SIN16923P	INJECTION, POWDER, FOR SOLUTION	1 g / vial	12/26/2023
TRECONDI POWDER FOR SOLUTION FOR INFUSION 5 G PER VIAL	Oncotec Pharma Produktion GmbH	SIN16922P	INJECTION, POWDER, FOR SOLUTION	5 g / vial	12/26/2023

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
TRECONDI treosulfan 1 g powder for injection for intravenous infusion vial	369770	Link Medical Products Pty Ltd T/A Link Pharmaceuticals	Medicine	A	9/23/2022
TRECONDI treosulfan 5 g powder for injection for intravenous infusion vial	369771	Link Medical Products Pty Ltd T/A Link Pharmaceuticals	Medicine	A	9/23/2022

Related News

FDA Approves Treosulfan Plus Fludarabine for Allo-HSCT Conditioning in AML and MDS

6 months ago

The FDA approved treosulfan with fludarabine as a conditioning regimen for allogeneic hematopoietic stem cell transplantation (allo-HSCT) in AML and MDS patients.

FDA Approves GRAFAPEX (Treosulfan) for Injection in AlloHSCT Conditioning Regimen

7 months ago

The FDA has approved GRAFAPEX (treosulfan) in combination with fludarabine for allogeneic hematopoietic stem cell transplantation (alloHSCT) conditioning.

Key Oncology Updates: Approvals, Designations, and Trial Results

8 months ago

Treosulfan gains FDA approval for allogeneic hematopoietic stem cell transplantation conditioning in AML and MDS, offering a new option for adult and pediatric patients.

FDA Extends Review of Treosulfan NDA for AML and MDS Treatment

10 months ago

The FDA has extended the review period for the New Drug Application (NDA) of treosulfan by three months, setting a new PDUFA target action date of January 30, 2025.

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