Data updated: May 26, 2026
NOVANTRONE (mitoxantrone hydrochloride)
Trial Activity: Declining 6 active trials
CNS
Approved 1987-12-23
Development Insights
National Cancer Institute (NCI) conducting 9 trials (27%)
79 indications explored (Broad Platform)
→ recurrent adult acute myeloid leukemia (16 trials)
→ adult acute myeloid leukemia with 11q23 (mll) abnormalities (11 trials)
→ adult acute myeloid leukemia with inv(16)(p13;q22) (11 trials)
3
Indications
--
Phase 3 Trials
1
Priority Reviews
38
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1987-12-23
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
NOVANTRONE Approval History
1988
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Original
New Indication
New Form
Label Update
94 FDA actions from 1987 to 2012 · 1 indication expansions
Feb 2001 SUPPL
Mfg
Jan 2001 SUPPL
Label
Oct 2000 SUPPL
Mfg
Feb 2000 SUPPL
Label
Aug 1998 SUPPL
Mfg
May 1998 SUPPL
Label
Sep 1997 SUPPL
Label
May 1997 SUPPL
Label
May 1997 SUPPL
Mfg
Nov 1996 SUPPL
Efficacy
Oct 1996 SUPPL
Label
Apr 1995 SUPPL
Mfg
Sep 1994 SUPPL
Label
Apr 1994 SUPPL
Mfg
Feb 1992 SUPPL
Mfg
Nov 1990 SUPPL
Mfg
Jul 1990 SUPPL
Mfg
Feb 1990 SUPPL
Mfg
Mar 1988 SUPPL
Mfg
Dec 1987 ORIGINAL
New Drug
What NOVANTRONE Treats
3 FDA approvalsOriginally approved for its first indication in 1987 . Covers 3 distinct patient populations.
- Other (3)
📋
Clinical Trial Registry
33 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03983824 | NCI-2019-03607 NCI-2019-03607, PHI-103 | Ph 1 | active not recruiting | Testing the Addition of an Anti-cancer Drug, M3814, to the Usual Treatment (Mitoxantrone, Etoposide, and Cytarabine) for Relapsed or Refractory Acute Myeloid Leukemia |
| NCT04293562 | AAML1831 NCI-2020-00546, AAML1831 | Ph 3 | recruiting | A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations |
| NCT02101853 results posted | NCI-2014-00631 NCI-2014-00631, s15-00970 | Ph 3 | active not recruiting | Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia |
| NCT05955261 | AML23 NCI-2023-04138 | Ph 2 | suspended | A Study of Venetoclax in Combination With Conventional Chemotherapy in Pediatric Patients With Acute Myeloid Leukemia |
| NCT02339740 results posted | AAML1331 NCI-2014-02266, PAAML1331_A01PAMDREVW0 | Ph 3 | active not recruiting | Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia |
| NCT01371981 results posted | NCI-2011-02670 NCI-2011-02670, CDR0000701850 | Ph 3 | active not recruiting | Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia |
| NCT02521493 results posted | AAML1531 NCI-2015-00324, AAML1531 | Ph 3 | active not recruiting | Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome |
| NCT02484391 results posted | IRB00033779 NCI-2015-01002, IRB00033779 | Ph 1 | completed | CPI-613, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Granulocytic Sarcoma |
| NCT03531918 results posted | 10000 NCI-2018-00776, 10000 | Ph 1, Ph 2 | completed | Gemtuzumab Ozogamicin With G-CSF, Cladribine, Cytarabine & Mitoxantrone for Untreated AML & High-Grade Myeloid Neoplasm |
| NCT02299518 | OSU 14089 NCI-2014-02229 | Ph 1 | completed | Selinexor and Chemotherapy in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia |
| NCT01154439 AML1208 | AML1208 GIMEMA-AML1208, 2008-007666-28 | Ph 1 | completed | Everolimus MICE-regimen in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia |
| NCT00866918 results posted | AAML0631 NCI-2011-01904, CDR0000637184 | Ph 3 | completed | Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia |
| NCT03012672 results posted | 9759 NCI-2016-02051, 9759 | Ph 2 | completed | Higher or Lower Dose Cladribine, Cytarabine, and Mitoxantrone in Treating Medically Less Fit Patients With Newly Diagnosed Acute Myeloid Leukemia or Myeloid Neoplasm |
| NCT02756572 results posted | 9567 NCI-2016-00477, 9567 | Ph 2 | completed | Early Allogeneic Hematopoietic Cell Transplantation in Treating Patients With Relapsed or Refractory High-Grade Myeloid Neoplasms |
| NCT01839240 | 12-0111 NCI-2012-02028 | Ph 1 | completed | Azacitidine, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With High-Risk Acute Myeloid Leukemia |
| NCT02573363 | IRB15-0412 NCI-2015-01647, IRB15-0412 | Ph 1 | completed | Selinexor With Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia |
| NCT02921061 results posted | 9713 NCI-2016-01401, 9713 | Ph 1, Ph 2 | completed | Decitabine With GCLAM for Adults With Newly Diagnosed, Relapsed, or Refractory AML or High-Risk MDS |
| NCT02044796 results posted | 2734.00 NCI-2013-02465, 2734.00 | Ph 1, Ph 2 | completed | Filgrastim, Cladribine, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Newly Diagnosed or Relapsed/Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes |
| NCT01729845 results posted | 2652.00 NCI-2012-02224, 2652 | Ph 1, Ph 2 | completed | Decitabine Followed by Mitoxantrone Hydrochloride, Etoposide, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes |
| NCT02070458 | CASE7913 NCI-2014-00371, X16014_MLN9708 | Ph 1 | completed | Ixazomib, Mitoxantrone Hydrochloride, Etoposide, and Intermediate-Dose Cytarabine in Relapsed or Refractory Acute Myeloid Leukemia |
| NCT01904643 | IRB-27313 NCI-2013-01349, IRB-27313 | Ph 1 | terminated | Lenalidomide and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia |
| NCT00795002 results posted | NCI-2009-00298 NCI-2009-00298, CDR0000625222 | Ph 2 | completed | Alvocidib, Cytarabine, and Mitoxantrone in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia |
| NCT01768897 | IRB00022138 NCI-2012-02768, P30CA012197 | Ph 1 | completed | CPI-613, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia |
| NCT01801046 | 9L-11-8 NCI-2013-00447 | Ph 1 | terminated | Donor Stem Cell Transplant in Treating Patients With High Risk Acute Myeloid Leukemia |
| NCT01249430 | NCI-2011-02554 NCI-2011-02554, CDR0000689575 | Ph 1 | completed | Azacitidine in Combination With Mitoxantrone, Etoposide Phosphate, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia |
| NCT01349972 results posted | NCI-2011-02587 NCI-2011-02587, JHOC-J1101 | Ph 2 | completed | Alvocidib, Cytarabine, and Mitoxantrone Hydrochloride or Cytarabine and Daunorubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia |
| NCT01342887 results posted | 2409.00 NCI-2011-00657 | Ph 1, Ph 2 | terminated | Cyclosporine, Pravastatin Sodium, Etoposide, and Mitoxantrone Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia |
| NCT01174888 | OSU-09111 NCI-2010-01335 | Ph 1 | completed | Phase I Combination of Midostaurin, Bortezomib, and Chemo in Relapsed/Refractory Acute Myeloid Leukemia |
| NCT01260714 | NCI-2011-02559 NCI-2011-02559, CDR0000690647 | Ph 1 | terminated | Azacitidine, Mitoxantrone Hydrochloride, and Etoposide in Treating Older Patients With Poor-Prognosis Acute Myeloid Leukemia |
| NCT01127009 | CASE4909 NCI-2010-01203, CASE4909 | Ph 1 | completed | Bortezomib, Mitoxantrone, Etoposide, and Cytarabine in Relapsed or Refractory Acute Myeloid Leukemia |
| NCT01403415 | NCI-2011-02679 NCI-2011-02679, COG-ADVL1114 | Ph 1 | completed | Temsirolimus, Dexamethasone, Mitoxantrone Hydrochloride, Vincristine Sulfate, and Pegaspargase in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma |
| NCT00634244 results posted | NCI-2009-00520 NCI-2009-00520, E1906 | Ph 2 | completed | Comparing Three Different Combination Chemotherapy Regimens in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia |
| NCT00840684 | CDR0000634230 IPC-LAM-HR, IPC-2006-007 | Ph 1, Ph 2 | completed | Laromustine, Daunorubicin, and Cytarabine in Treating Patients With Acute Myeloid Leukemia |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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.
NOVANTRONE FDA Label Details
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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