Drugs / Treosulfan
Treosulfan
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed disease related to hematopoietic stem cell transplant 3 milestones | |||||
| Filed | US (FDA) | — | disease related to hematopoietic stem cell transplant | 2022-07-25 | “medac has resubmitted its New Drug Application for treosulfan ( NDA ) with the U.S. Food and Drug Administration ( FDA ).” medexus.com ↗ |
| Filed | US (FDA) | — | disease related to hematopoietic stem cell transplant | 2022-04-22 | “medac received acknowledgement of receipt from the U.S. Food and Drug Administration ( FDA ) of the New Drug Application resubmission for Treosulfan” medexus.com ↗ “medac has resubmitted its New Drug Application for Treosulfan ( NDA ) with the U.S. Food and Drug Administration ( FDA ).” medexus.com ↗ “medac's April 2024 resubmission of the New Drug Application for treosulfan.” medexus.com ↗ |
| Rejected (CRL) | US (FDA) | — | disease related to hematopoietic stem cell transplant | 2021-08-03 | “has received a Complete Response Letter (CRL) from the Food and Drug Administration (FDA) in response to its New Drug Application (NDA) for treosulfan.” medexus.com ↗ “In August, we received notice of a Complete Response Letter (“ CRL ”) from the FDA in regard to treosulfan.” medexus.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | US (FDA) | GRAFAPEX | — | 2025-01-21 | fda.gov ↗ |
| Approved | EU (EMA) | Trecondi | — | 2019-06-20 | europa.eu ↗ |
Trials 38
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2025-08-05 | Medexus Pharma, Inc. | Regulatory GRAFAPEX (treosulfan) for Injection Receives CMS Approval of New Technology Add-On Payment (NTAP) for Eligible Cases in CMS's Fiscal Year 2026 medexus.com ↗
Starting October 1, 2025, eligible procedures involving the use of GRAFAPEX™ will be eligible for additional reimbursement through the NTAP program. |
| 2025-01-22 | Medexus Pharma, Inc. | Regulatory Medexus Announces FDA Approval of GRAFAPEX (treosulfan) for Injection and Provides Business Update medexus.com ↗ |
| 2024-09-16 | Medexus Pharma, Inc. | Regulatory Medexus Provides Update on Treosulfan NDA Review Process and Extended PDUFA Goal Date medexus.com ↗
The FDA has set a new PDUFA target action date of January 30, 2025. |
| 2024-06-25 | Medexus Pharma, Inc. | Regulatory Medexus Generates Record Revenue of US$113.1 Million in Fiscal Year 2024 medexus.com ↗
In addition, we are very pleased that our partner, medac, has done a thorough job collecting information and the FDA has accepted for review the April 2024 resubmission of the New Drug Application, or NDA, for treosulfan. |
| 2024-06-06 | Medexus Pharma, Inc. | Regulatory FDA Accepts for Review Treosulfan NDA Resubmission medexus.com ↗
On Thursday, June 6, 2024, Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) was informed by medac, licensor of Medexus's commercialization rights to treosulfan, that the US Food and Drug Administration has accepted for review medac's April 2024 resubmission of the New Drug Application for treosulfan. |
| 2023-06-13 | Medexus Pharma, Inc. | Results Medexus Highlights Data on Trecondyv (Treosulfan) Presented at MDS 2023 medexus.com ↗
Notably, the study found a 30% improvement (83.2% vs 53.2%) in one-year overall survival for patients treated with treosulfan, among other positive findings. |
| 2022-09-19 | Medexus Pharma, Inc. | Regulatory Medexus Provides Update on Treosulfan NDA Resubmission and Provides Business Update medexus.com ↗
On Friday, September 16, Medexus Pharmaceuticals ( Medexus ) (TSX: MDP) (OTCQX: MEDXF) was informed by medac, licensor of Medexus’s commercialization rights to treosulfan, that the U.S. Food and Drug Administration ( FDA ) has delivered to medac a second notice of incomplete response regarding medac’s new drug application resubmission for treosulfan ( NDA ). |
| 2022-07-25 | Medexus Pharma, Inc. | Regulatory Treosulfan NDA Resubmitted to FDA medexus.com ↗
Medexus Pharmaceuticals ( Medexus ) (TSX: MDP) (OTCQX: MEDXF) and medac, a strategic partner of Medexus, are pleased to announce that medac has resubmitted its New Drug Application for treosulfan ( NDA ) with the U.S. Food and Drug Administration ( FDA ). |
| 2022-06-06 | Medexus Pharma, Inc. | Results Treosulfan Pivotal Study Results Published medexus.com ↗
Study found event-free survival and overall survival superior after treosulfan compared to RIC busulfan, also found non-relapse mortality lower in treosulfan arm than busulfan arm |
| 2022-05-24 | Medexus Pharma, Inc. | Regulatory Medexus Pharmaceuticals Provides Update on Resubmission of Treosulfan NDA medexus.com ↗
The FDA requested certain updates to data files submitted by medac and certain supporting information relating to data provided by medac. |
| 2022-04-22 | Medexus Pharma, Inc. | Regulatory Medexus Pharmaceuticals Announces Resubmission of Treosulfan NDA medexus.com ↗
Medexus Pharmaceuticals ( Medexus ) (TSX: MDP) (OTCQX: MEDXF) and medac, a strategic partner of Medexus, are pleased to announce that medac has resubmitted its New Drug Application for Treosulfan ( NDA ) with the U.S. Food and Drug Administration ( FDA ). |
| 2021-11-01 | Medexus Pharma, Inc. | Regulatory Medexus Pharmaceuticals Announces Type A Meeting with FDA Granted for Treosulfan medexus.com ↗ |
| 2021-08-03 | Medexus Pharma, Inc. | Regulatory Complete Response Letter Received from FDA for Treosulfan medexus.com ↗
Medexus and medac are reviewing the letter to determine the appropriate course of action. |
| 2021-06-28 | Medexus Pharma, Inc. | Regulatory Medexus Receives Notice of Compliance to Commercialize Treosulfan in Canada medexus.com ↗
We are thrilled that Health Canada has approved treosulfan for full scale commercialization under the name Trecondyv ® . |
| 2019-03-06 | Medexus Pharma, Inc. | Regulatory Medexus Granted Authorization by Health Canada to Distribute Treosulfan in Canada medexus.com ↗
today announced that Health Canada has authorized the Company to distribute Treosulfan, a conditioning agent used prior to stem cell transplantation. |
All press releases naming this drug 37 releases
Evidence & citations 20 cited values
Every value below carries the sentence it was read from. 51 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Treosulfan | “Venetoclax (Venclyxto®): 400 mg abs./d day -8 to -2, Fludarabine 30 mg/m2 BSA day -6 to day -2, Treosulfan 10 g/m2 BSA day -4 to day -2” NCT07214064 ↗46“followed by high dose chemotherapy with treosulfan, etoposide and cisplatin (TEC)” NCT00384553 ↗ “Conditioning with treosulfan 14 g/m2 day -6 to -4” NCT01582048 ↗ “* Vecanoid Condition * treosulfan * fludarabine” NCT04000698 ↗ |
| Known as | dihydroxybusulfan | “Treosulfan (L-threitol-1,4-bis-methanesulfonate; dihydroxybusulfan) was initially used in the treatment of certain solid tumors.” PMID 21478921 ↗ Apr 2011 |
| Known as | Grafapex | ChEMBL registry synonym — accepted as the source's own label CHEMBL455186 ↗ |
| Known as | Graftrevo | ChEMBL registry synonym — accepted as the source's own label CHEMBL455186 ↗ |
| Known as | Kepcondi | ChEMBL registry synonym — accepted as the source's own label CHEMBL455186 ↗ |
| Known as | L-threitol 1,4-dimethanesulfonate | ChEMBL registry synonym — accepted as the source's own label CHEMBL455186 ↗ |
| Known as | L-threitol-1,4-bis-methanesulfonate | “Treosulfan (L-threitol-1,4-bis-methanesulfonate; dihydroxybusulfan) was initially used in the treatment of certain solid tumors.” PMID 21478921 ↗ Apr 2011 |
| Known as | L-threitol-1,4-bis-methanesulphonate | “Treosulfan (L-threitol-1,4-bis-methanesulphonate; Ovastat(R)) is a bifunctional alkylating drug indicated for the treatment of advanced ovarian carcinoma.” PMID 12651206 ↗ Apr 2003 |
| Known as | NSC-39069 | ChEMBL registry synonym — accepted as the source's own label CHEMBL455186 ↗ |
| Known as | Ovastat | ChEMBL registry synonym — accepted as the source's own label CHEMBL455186 ↗ |
| Known as | Ovastat(R) | “Treosulfan (L-threitol-1,4-bis-methanesulphonate; Ovastat(R)) is a bifunctional alkylating drug indicated for the treatment of advanced ovarian carcinoma.” PMID 12651206 ↗ Apr 2003 |
| Known as | Threosulphan | ChEMBL registry synonym — accepted as the source's own label CHEMBL455186 ↗ |
| Known as | Trecondi | ChEMBL registry synonym — accepted as the source's own label CHEMBL455186 ↗ |
| Known as | Trecondi Ideogen | “The present study aims to combine high-dose melphalan (Melphalan Ideogen) with treosulfan (Trecondi® Ideogen), a well established bifunctional alkylating agent.” NCT05636787 ↗ |
| Known as | Trecondyv | ChEMBL registry synonym — accepted as the source's own label CHEMBL455186 ↗ |
| Known as | TREO | “Although the use of treosulfan (TREO) in conventional donor hematopoietic cell transplantation (HCT) has been extensively evaluated, its use in cord blood transplantation (CBT)...” PMID 32706891 ↗ Jul 2020 |
| Known as | Treograft | ChEMBL registry synonym — accepted as the source's own label CHEMBL455186 ↗ |
| Known as | Treosulfano | ChEMBL registry synonym — accepted as the source's own label CHEMBL455186 ↗ |
| Modality | Small molecule | “Treosulfan (powder for solution for infusion) is a marketed alkylating medication” NCT07598110 ↗ |
| Route | Oral | “Treosulfan 600 mg/m² p.o. on daý 1-28, 57-84, etc” NCT00170690 ↗ |