IXEMPRA KIT (ixabepilone)
IXEMPRA KIT is indicated for the treatment of Breast Cancer.
How IXEMPRA KIT Works
Ixabepilone is a semi-synthetic analog of epothilone B that functions as a microtubule inhibitor. It binds directly to $\beta$-tubulin subunits, suppressing microtubule dynamics and inducing cell cycle arrest in the mitotic phase, which leads to apoptosis. Unlike many other chemotherapy agents, ixabepilone has low susceptibility to common multidrug resistance mechanisms, such as P-glycoprotein (P-gp) and MRP-1 efflux transporters, allowing it to remain active in certain taxane-resistant tumors.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2007-10-16
- Routes
- INTRAVENOUS
- Dosage Forms
- INJECTABLE
IXEMPRA KIT Approval History
What IXEMPRA KIT Treats
1 indicationsIXEMPRA KIT is approved for 1 conditions since its original approval in 2007. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Breast Cancer
IXEMPRA KIT Boxed Warning
TOXICITY IN PATIENTS WITH HEPATIC IMPAIRMENT IXEMPRA in combination with capecitabine is contraindicated in patients with AST or ALT >2.5 x ULN or bilirubin >1 x ULN due to increased risk of toxicity and neutropenia-related death [see Contraindications ( 4 ) and Warnings and Precautions ( 5.3 )]. WARNING: TOXICITY IN PATIENTS WITH HEPATIC IMPAIRMENT See full prescribing information for complete boxed warning. IXEMPRA ® in combination with capecitabine is contraindicated in patients with AST or A...
WARNING: TOXICITY IN PATIENTS WITH HEPATIC IMPAIRMENT IXEMPRA in combination with capecitabine is contraindicated in patients with AST or ALT >2.5 x ULN or bilirubin >1 x ULN due to increased risk of toxicity and neutropenia-related death [see Contraindications ( 4 ) and Warnings and Precautions ( 5.3 )]. WARNING: TOXICITY IN PATIENTS WITH HEPATIC IMPAIRMENT See full prescribing information for complete boxed warning. IXEMPRA ® in combination with capecitabine is contraindicated in patients with AST or ALT >2.5 x ULN or bilirubin >1 x ULN due to increased risk of toxicity and neutropenia-related death. ( 4 , 5.3 )
IXEMPRA KIT 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.
What's emerging in IXEMPRA KIT's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications IXEMPRA KIT treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to IXEMPRA KIT
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
44 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00977574 results posted | NCI-2011-01969 NCI-2011-01969, GOG-0086P | Ph 2 | active not recruiting | Paclitaxel, Carboplatin, and Bevacizumab or Paclitaxel, Carboplatin, and Temsirolimus or Ixabepilone, Carboplatin, and Bevacizumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer |
| NCT01375829 | NCI-2012-02907 NCI-2012-02907, NCI-2012-01136 | Ph 1 | active not recruiting | Ixabepilone and Temsirolimus in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery |
| NCT00877500 | 2008-0435 NCI-2018-01849, 2008-0435 | Ph 2 | active not recruiting | Ixabepilone in Treating Participants With Significant Residual Disease of HER2/Neu Negative Invasive Breast Cancer After Systemic Therapy |
| NCT01349088 | 10G.30 2009-34, JT 1502 | Ph 1, Ph 2 | withdrawn | Investigational Drug in Combination With Two Chemotherapy Drugs in Women With Locally Recurrent or Metastatic Breast Cancer |
| NCT03093155 results posted | 2000020232 | Ph 2 | completed | Evaluation of Weekly Ixabepilone With or Without Biweekly Bevacizumab |
| NCT00765765 results posted | CDR0000615000 P30CA072720, CINJ-040804 | Ph 1, Ph 2 | terminated | Ixabepilone and Hydroxychloroquine in Treating Patients With Metastatic Breast Cancer |
| NCT00879086 results posted | E7389-G000-209 | Ph 2 | completed | A Study Comparing Eribulin Mesylate and Ixabepilone in Causing or Exacerbating Neuropathy in Participants With Advanced Breast Cancer |
| NCT02915744 ATTAIN results posted | 15-102-14 | Ph 3 | completed | A Study of Etirinotecan Pegol (NKTR-102) Versus Treatment of Physician's Choice (TPC) in Patients With Metastatic Breast Cancer Who Have Stable Brain Metastases and Have Been Previously Treated With an Anthracycline, a Taxane, and Capecitabine |
| NCT01446016 CAT results posted | Pro00006423 0811-0147 | Ph 2 | completed | Chloroquine With Taxane Chemotherapy for Advanced or Metastatic Breast Cancer After Anthracycline Failure (CAT) |
| NCT00785291 results posted | NCI-2009-00476 NCI-2009-00476, CTSU 40502 | Ph 3 | completed | Paclitaxel, Nab-paclitaxel, or Ixabepilone With or Without Bevacizumab in Treating Patients With Stage IIIC or Stage IV Breast Cancer |
| NCT00828308 results posted | BrUOG-Pros-221 | Ph 2 | completed | Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer |
| NCT00741988 results posted | SCRI LUN 179 | Ph 2 | completed | Ixabepilone and Carboplatin +/- Bevacizumab in Advanced Non-Small-Cell Lung Cancer |
| NCT00866905 results posted | SCRI BRE 133 | Ph 2 | completed | Ixabepilone and Cyclophosphamide as Neoadjuvant Therapy in HER-2 Negative Breast Cancer |
| NCT01097642 ICE results posted | Pro00002243 0908-0265 | Ph 2 | completed | Neo-Adjuvant Study in Triple Negative Breast Cancer Patients |
| NCT00832117 results posted | CA163-177 2008-004909-34 | Ph 1 | completed | Phase I Combination Ixabepilone + Cisplatin |
| NCT00983801 results posted | CA163-200 | Ph 2 | completed | Study of Ixabepilone in Asian Subjects With Unresectable or Metastatic Gastric Cancer |
| NCT01079793 | SCCC-09809 CDR0000666842 | Ph 1, Ph 2 | withdrawn | Radiation Therapy and Ixabepilone in Treating Patients With High-Risk Stage III Prostate Cancer After Surgery |
| NCT01818999 | STU 102012-020 | Ph 2 | withdrawn | Ixabepilone and SBRT For Metastatic Breast Cancer |
| NCT00717704 | WCI-2007-528 | Ph 1 | completed | Solid Tumors Using Ixabepilone and Dasatinib |
| NCT01084057 | 08166 NCI-2010-00306 | Ph 1 | completed | Ixabepilone and Vorinostat in Treating Patients With Metastatic Breast Cancer |
| NCT01416389 results posted | 12847 I1Y-MC-JFBE | Ph 2 | completed | A Study of LY2523355 in Participants With Breast Cancer |
| NCT01168232 results posted | NCI-2011-02056 NCI-2011-02056, GOG-0130F | Ph 2 | completed | Ixabepilone in Treating Patients With Recurrent or Persistent Uterine Cancer |
| NCT01220609 results posted | NCI-2011-02656 NCI-2011-02656, CDR0000686644 | Ph 2 | completed | Ixabepilone in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus Previously Treated With Chemotherapy |
| NCT00672009 | 13963 | Ph 2 | terminated | A Study of Ixabepilone Before Surgery for High-Risk Localized Prostate Cancer |
| NCT00923130 results posted | 090057 09-C-0057 | Ph 2 | completed | Bevacizumab Plus Ixabepilone to Treat Patients With Advanced Kidney Cancer |
| NCT01012362 results posted | 2009LS001 0906M68402, NCI-2009-01444 | Ph 1 | terminated | Study of Pazopanib and Ixabepilone in Patients With Solid Tumors |
| NCT00637897 | CDR0000583652 P30CA012197, CCCWFU-74307 | Ph 1 | completed | Paricalcitol and Chemotherapy in Treating Women With Metastatic Breast Cancer |
| NCT00883116 IXAMPLE2 results posted | CA163-196 2008-007167-16 | Ph 3 | terminated | A Study of Ixabepilone as Second-line Therapy for Locally Advanced, Recurrent, or Metastatic Endometrial Cancer |
| NCT01075100 results posted | 08007 | Ph 2 | completed | Ixabepilone + Carboplatin Metastatic Breast Cancer |
| NCT00568022 results posted | CA163-117 | Ph 1 | completed | A Phase I Study of Ixabepilone in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer |
| NCT00633464 results posted | CA163-139 | Ph 2 | completed | Randomized Phase II Study of Ixabepilone Alone and Ixabepilone Plus Cetuximab as First-Line Treatment for Female Subjects With Triple Negative Locally Advanced Non-resectable and/or Metastatic Breast Cancer |
| NCT00593827 results posted | CA163-132 USOR 06-106 | Ph 2 | completed | Phase II Trial of Weekly or Every 3-week Ixabepilone for Patients With Metastatic Breast Cancer |
| NCT00490646 results posted | CA163-140 Eudract No: 2007-000721-21 | Ph 2 | completed | A Phase II Combination of Trastuzumab and Ixabepilone Versus Trastuzumab and Docetaxel in Patients With Advanced and/or Metastatic Breast Cancer |
| NCT00998738 results posted | RC08CC NCI-2009-01229, RC08CC | Ph 3 | terminated | Calcium and Magnesium in Preventing Peripheral Neuropathy Caused by Ixabepilone in Patients With Breast Cancer |
| NCT00884676 | 20080376 GA6181ZB, CA163159 | Ph 1 | completed | Ixabepilone and Sunitinib Malate in Treating Patients With Progressive Advanced Solid Tumors |
| NCT01057212 | 09-97B | Ph 2 | terminated | Trial of Bevacizumab and Ixabepilone for Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) |
| NCT00798252 | CA182-030 2007-005097-31 | Ph 1 | completed | Ascending Multiple-Dose Study of Brivanib Alaninate in Combination With Chemotherapeutic Agents in Subjects With Advanced Cancers |
| NCT00821886 results posted | SCRI BRE 139 | Ph 2 | completed | Neoadjuvant Ixabepilone/Carboplatin/Trastuzumab in HER2-Positive Locally Advanced Breast Cancer |
| NCT00825734 results posted | SCRI BRE 138 | Ph 1, Ph 2 | completed | Phase I/II Trial of Sorafenib Plus Ixabepilone in HER2-Negative Metastatic Breast Cancer |
| NCT00751868 GIM9 | GIM9-NEO-ADIXERN | Ph 2 | completed | FEC With G-CSF Support Followed by Ixabepilone With G-CSF Support as Neoadjuvant Chemotherapy in BC |
| NCT00924352 results posted | ALSSMBC0804 | Ph 1, Ph 2 | completed | Trial of Dasatinib Plus Ixabepilone in 2nd or 3rd Line Metastatic Breast Cancer |
| NCT00804310 UCDCC#207 | CDR0000626165 P30CA093373 | Ph 1 | terminated | Lapatinib and Ixabepilone in Treating Patients With Advanced Solid Tumors |
| NCT00998101 | LCCC 0816 P30CA016086, CDR0000656960 | Ph 2 | withdrawn | Carboplatin, Ixabepilone, and Cetuximab in Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Previously Untreated With Chemotherapy |
| NCT00790894 HIT | HE 11A08 | Ph 2 | terminated | Trial of Ixabepilone in Patients With HER-2 Negative Metastatic Breast Cancer (HIT) |
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.
IXEMPRA KIT FDA Label Details
Indications & Usage
FDA Label (PDF)IXEMPRA KIT is indicated for the treatment of Breast Cancer.
WARNING: TOXICITY IN PATIENTS WITH HEPATIC IMPAIRMENT IXEMPRA in combination with capecitabine is contraindicated in patients with AST or ALT >2.5 x ULN or bilirubin >1 x ULN due to increased risk of toxicity and neutropenia-related death [see Contraindications ( 4 ) and Warnings and Precautions ( 5...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment