TheraRadar
Data updated: Nov 8, 2026

IFEX/MESNEX KIT (ifosfamide) · Baxter

Oncology Approved 1987-08-14
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
1
Priority Reviews
39
Years on Market

Details

Status
Discontinued
First Approved
1987-08-14
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Baxter
Active Ingredient: IFOSFAMIDE , MESNA

IFEX/MESNEX KIT Approval History

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Original
New Indication
New Form
Label Update
34 FDA actions from 1987 to 2026
Oct 2026 SUPPL
Label · Labeling
FDA Letter Label
Dec 2024 SUPPL
Label · Labeling
FDA Letter Label
Jul 2018 SUPPL
Label · Labeling
FDA Letter Label

What IFEX/MESNEX KIT Treats

1 FDA approvals

Originally approved for its first indication in 1987 .

  • Other (1)
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Clinical Trial Registry

107 trials
Trial Sponsor ID Phase Status Title
NCT06230224 OLYMPIA-4 R1979-HM-2299 2022-502783-21-00 Ph 3 active not recruiting A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell Non-Hodgkin Lymphoma
NCT04043494 LBL 2018 UKM17_0023 2017-001691-39 Ph 3 recruiting International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma
NCT06647953 ARAR2331 NCI-2024-08232, ARAR2331 Ph 3 recruiting Testing a Standardized Approach to Surgery and Chemotherapy for Type I Pleuropulmonary Blastoma or the Addition of an Anti-cancer Drug, Topotecan, to the Usual Treatment for Types II and III Pleuropulmonary Blastoma
NCT04322318 AREN1921 NCI-2020-01561, AREN1921 Ph 2 recruiting A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT
NCT04684368 ACNS2021 NCI-2020-13175, ACNS2021 Ph 2 recruiting A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT
NCT05533775 iMATRIX GLO CO43810 Ph 1, Ph 2 recruiting A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma
NCT02112916 results posted NCI-2014-00712 NCI-2014-00712, s14-01925 Ph 3 active not recruiting Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma
NCT02180867 results posted NCI-2014-01340 NCI-2014-01340, ARST1321 Ph 2, Ph 3 completed Radiation Therapy With or Without Combination Chemotherapy or Pazopanib Before Surgery in Treating Patients With Newly Diagnosed Non-rhabdomyosarcoma Soft Tissue Sarcomas That Can Be Removed by Surgery
NCT03007147 AALL1631 NCI-2016-01588, 2024-515499-12-00 Ph 3 active not recruiting Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
NCT03206671 B-NHL 2013 UKM12_0020 2013-003253-21 Ph 3 active not recruiting Treatment Protocol of the NHL-BFM and the NOPHO Study Groups for Mature Aggressive B-cell Lymphoma and Leukemia in Children and Adolescents
NCT01871766 RMS13 NCI-2013-00913 Ph 2 active not recruiting Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Patients With Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy
NCT04968106 TORNADO IB 2021-01 2023-509498-21-00, 2021-001085-37 Ph 2 active not recruiting Neoadjuvant Chemotherapy and Retifanlimab in Patients With Selected Sarcomas (TORNADO)
NCT06239272 NRSTS2021 NCI-2024-02554 Ph 1, Ph 2 recruiting NRSTS2021, A Risk Adapted Study Evaluating Maintenance Pazopanib, Limited Margin, Dose-Escalated Radiation Therapy and Selinexor in Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)
NCT05813327 202305073 Ph 1 terminated Neoadjuvant ADI-PEG 20 + Ifosfamide + Radiotherapy in Soft Tissue Sarcoma
NCT01864109 13-068 Ph 2 active not recruiting Irinotecan and Temozolomide in Combination With Existing High Dose Alkylator Based Chemotherapy for Treatment of Patients With Newly Diagnosed Ewing Sarcoma
NCT03418038 LS1781 P50CA097274, NCI-2018-00057 Ph 2 recruiting Ascorbic Acid and Chemotherapy for the Treatment of Relapsed or Refractory Lymphoma, CCUS, and Chronic Myelomonocytic Leukemia
NCT02106988 2013-0367 NCI-2014-01356 Ph 2 active not recruiting Concurrent Chemotherapy and Radiation Therapy for Newly Diagnosed Nasal NK Cell Lymphoma
NCT00864318 TICE 08 GENH 06 Ph 2 completed Dose Intensification Study in Refractory Germ Cell Tumors With Relapse and Bad Prognosis
NCT02306161 results posted NCI-2014-02380 NCI-2014-02380, AEWS1221 Ph 3 active not recruiting Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma
NCT07477457 25-257 Ph 2 recruiting A Study of Gefitinib, Trametinib, Disulfiram, and Sunitinib in Addition to Standard Chemotherapy in People With Osteosarcoma
NCT07194044 METTSEO MCC-23281 Ph 1 recruiting Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes
NCT01946529 results posted ESFT13 NCI-2013-01657 Ph 2 completed Therapeutic Trial for Patients With Ewing Sarcoma Family of Tumor and Desmoplastic Small Round Cell Tumors
NCT05991388 Glo-BNHL RG_21-124 ITCC-100, 1004701 Ph 2, Ph 3 recruiting A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell Non-Hodgkin Lymphoma
NCT06820957 AEWS2431 NCI-2025-00801, AEWS2431 Ph 2, Ph 3 terminated Testing a New Combination of Anti-cancer Drugs in Patients Newly Diagnosed With Ewing Sarcoma Who Have Cancer That Has Spread to Other Parts of the Body
NCT06528496 24-144 Ph 2 recruiting N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma
NCT01959698 results posted I 240813 NCI-2013-01784, I 240813 Ph 1 active not recruiting Carfilzomib, Rituximab, Ifosfamide, Carboplatin, and Etoposide in Treating Patients With Relapsed or Refractory Stage I-IV Diffuse Large B-cell Lymphoma
NCT01231906 results posted AEWS1031 NCI-2011-02611, S12-01231 Ph 3 completed Combination Chemotherapy in Treating Patients With Non-Metastatic Extracranial Ewing Sarcoma
NCT07321912 BCC023 Ph 2 recruiting Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma
NCT06835049 TNT-HYPE SAKK 57/24 Ph 2 recruiting Feasibility of Total Neoadjuvant Treatment With HYPErthermia in Patients With High-risk Extremity and Trunk Soft Tissue Sarcoma (TNT-HYPE)
NCT05364424 GO43693 Ph 1 completed A Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Glofitamab in Combination With Rituximab Plus Ifosfamide, Carboplatin Etoposide Phosphate in Participants With Relapsed/Refractory Transplant or CAR-T Therapy Eligible Diffuse B-Cell Lymphoma
NCT01602666 results posted ACNS1123 NCI-2012-01967, CDR0000734032 Ph 2 completed Chemotherapy Followed by Radiation Therapy in Treating Younger Patients With Newly Diagnosed Localized Central Nervous System Germ Cell Tumors
NCT05821088 OSU-22140 NCI-2023-02612 Ph 2 active not recruiting Tafasitamab and Lenalidomide Followed by Tafasitamab and ICE as Salvage Therapy for Transplant Eligible Patients With Relapsed/ Refractory Large B-Cell Lymphoma
NCT02227199 BV-ICE results posted 9111 NCI-2014-01782, 9111 Ph 1, Ph 2 completed Brentuximab Vedotin, Ifosfamide, Carboplatin, and Etoposide in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma
NCT03016871 results posted 16403 NCI-2016-02038, 16403 Ph 2 active not recruiting Nivolumab, Ifosfamide, Carboplatin, and Etoposide as Second-Line Therapy in Treating Patients With Refractory or Relapsed HL
NCT04833114 Pola-R-ICE Pola-R-ICE MO40599 / GLA 2017-R2 Ph 3 completed Polatuzumab Vedotin Plus Rituximab, Ifosfamide, Carboplatin and Etoposide (Pola-R-ICE) Versus R-ICE Alone in Second Line Treatment of Diffuse Large B-cell Lymphoma (DLBCL)
NCT06905509 UCDCC316 NCI-2025-01557, UCDCC316 Ph 2 recruiting Epcoritamab Plus Standard of Care Platinum-Based Chemotherapy and Autologous Hematopoietic Cell Transplant for the Treatment of Relapsed or Refractory Large B-cell Lymphoma
NCT04665765 results posted 20148 NCI-2020-08524, 20148 Ph 2 active not recruiting Polatuzumab Vedotin, Rituximab, Ifosfamide, Carboplatin, and Etoposide (PolaR-ICE) as Initial Salvage Therapy for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
NCT04776525 44-2020 Ph 2 recruiting Sequential Neoadjuvant Chemotherapy in Soft Tissue Sarcoma
NCT02393157 O-ICE L-11,392 Ph 2 recruiting Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature NHL
NCT06277154 MASCT-I-2004 Ph 2 recruiting MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment of Advanced Soft Tissue Sarcoma
NCT03034304 HRYZ MASCT-I-1001 Ph 1 terminated A Phase I Clinical Study for Evaluating the Safety and Efficacy of MASCT-I in Patients With Advanced Solid Tumors
NCT00878254 results posted 20080803 SCCC-2008043 Ph 2 completed Rituximab and Combination Chemotherapy in Treating Patients With Previously Untreated Mantle Cell Lymphoma
NCT02329080 results posted IELSG42 Ph 2 completed New Combination of Chemoimmunotherapy for Systemic B-cell Lymphoma With Central Nervous System Involvement
NCT01873326 13-074 Ph 2 active not recruiting Paclitaxel, Ifosfamide and Cisplatin (TIP) Versus Bleomycin, Etoposide and Cisplatin (BEP) for Patients With Previously Untreated Intermediate- and Poor-risk Germ Cell Tumors
NCT04221035 HR-NBL2 2019-001068-31 2019/2894, 2024-514917-36-00 Ph 3 recruiting High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)
NCT04189952 results posted 20190706 Ph 2 terminated Acalabrutinib in Combination With R-ICE For Relapsed or Refractory Lymphoma
NCT03643276 AIEOP-BFM ALL 2017 Ph 3 recruiting Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017
NCT02305654 InPACT ICR CTSU/2014/10048 CRUK/13/005, 13580965 Ph 3 active not recruiting International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)
NCT03440567 17428 NCI-2018-00098, 17428 Ph 1 completed Avelumab, Utomilumab, Rituximab, Ibrutinib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma
NCT02375204 A031102 U10CA180821, NCI-2014-01696 Ph 3 active not recruiting Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell Tumors

Showing 50 of 107 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

IFEX/MESNEX KIT FDA Label Details

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Data Sources

FDA Approval: NDA019763 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.