IFOSFAMIDE
Ifosfamide is an alkylating agent indicated for use in combination with other antineoplastic agents for the third-line chemotherapy of germ cell testicular cancer. It must be administered in conjunction with mesna to provide prophylaxis against hemorrhagic cystitis, a dose-limiting urotoxicity.
How IFOSFAMIDE Works
Ifosfamide is a prodrug that requires metabolic activation by hepatic cytochrome P450 isoenzymes. This activation produces an alkylating isophosphoramide mustard and the urotoxic metabolite acrolein. The isophosphoramide mustard exerts cytotoxic effects by forming inter- and intra-strand DNA cross-links, specifically through alkylation at the guanine N-7 positions. These cross-links disrupt DNA replication and transcription, ultimately leading to cell death.
Details
- Status
- Prescription
- First Approved
- 2002-05-28
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
IFOSFAMIDE Approval History
What IFOSFAMIDE Treats
1 indicationsIFOSFAMIDE is approved for 1 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Testicular Cancer
IFOSFAMIDE Boxed Warning
MYELOSUPPRESSION, NEUROTOXICITY, and UROTOXICITY Myelosuppression can be severe and lead to fatal infections. Monitor blood counts prior to and at intervals after each treatment cycle. CNS toxicities can be severe and result in encephalopathy and death. Monitor for CNS toxicity and discontinue treatment for encephalopathy. Nephrotoxicity can be severe and result in renal failure. Hemorrhagic cystitis can be severe and can be reduced by the prophylactic use of mesna. [see Warnings and Precautions...
WARNING: MYELOSUPPRESSION, NEUROTOXICITY, and UROTOXICITY Myelosuppression can be severe and lead to fatal infections. Monitor blood counts prior to and at intervals after each treatment cycle. CNS toxicities can be severe and result in encephalopathy and death. Monitor for CNS toxicity and discontinue treatment for encephalopathy. Nephrotoxicity can be severe and result in renal failure. Hemorrhagic cystitis can be severe and can be reduced by the prophylactic use of mesna. [see Warnings and Precautions ( 5.1 - 5.3 )] WARNING: MYELOSUPPRESSION, NEUROTOXICITY, and UROTOXICITY See full prescribing information for complete boxed warning. Myelosuppression can be severe and lead to fatal infections ( 5.1 ) CNS toxicities can be severe and result in encephalopathy and death ( 5.2 ) Nephrotoxicity can be severe and result in renal failure. Hemorrhagic cystitis can be severe. ( 5.3 )
IFOSFAMIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to IFOSFAMIDE
3 of 6FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
104 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 | active not recruiting | 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, AALL1631 | 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 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 | active not recruiting | 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 | active not recruiting | 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 | active not recruiting | 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 | not yet 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 | 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 | active not recruiting | 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 | 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 104 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
IFOSFAMIDE FDA Label Details
Indications & Usage
FDA Label (PDF)IFOSFAMIDE is indicated for the treatment of Testicular Cancer.
WARNING: MYELOSUPPRESSION, NEUROTOXICITY, and UROTOXICITY Myelosuppression can be severe and lead to fatal infections. Monitor blood counts prior to and at intervals after each treatment cycle. CNS toxicities can be severe and result in encephalopathy and death. Monitor for CNS toxicity and disconti...
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Full clinical data, patents, trials, and competitive landscape for ifosfamide.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.