Sold as Novantrone. Every FDA application for this active ingredient: 2 branded and 7 generic.
As of Nov 15, 2026, FDA lists 9 applications for Mitoxantrone Hydrochloride (sold as Novantrone), first approved Dec 23, 1987, with 1 new use approved and 0 published complete response letters.
| Mitoxantrone HCL | Part B | $40K | -24% | 70 |
| Mitoxantrone HCl | Part D | $4K | New | 0 |
| Mitoxantrone Hydrochloride Liposome Combined With Cladribine And Sotorasib For Relapsed Refractory Acute Myeloid LeukemiaRelapsed and Refractory Acute Myeloid Leukemia (RR-AML) · The Affiliated People's Hospital of Ningbo University | Phase 2 | Not yet recruiting | Oct 15, 2026 |
| Rituximab, Pirtobrutinib, Lisaftoclax and Liposomal Mitoxantrone for for Richter Syndrome Transformed From CLLRichter Syndrome · Institute of Hematology & Blood Diseases Hospital, China | Phase 2 | Not yet recruiting | Sep 21, 2026 |
| Liposomal Mitoxantrone Plus Azacitidine and Venetoclax in Newly Diagnosed Elderly or Unfit AMLAcute Myeloid Leukemia (AML) · Institute of Hematology & Blood Diseases Hospital, China | Phase 1 | Not yet recruiting | Sep 18, 2026 |
| A Randomized Trial of Venetoclax-Based Induction Intensity in Newly Diagnosed Acute Myeloid LeukemiaAcute Myeloid Leukemia (AML) · Institute of Hematology & Blood Diseases Hospital, China | Phase 2 | Not yet recruiting | Aug 10, 2026 |
| Mitoxantrone Hydrochloride Liposome, Cytarabine, G-CSF Plus Venetoclax vs. Azacitidine Plus Venetoclax for MDS-IB2 and Secondary/Elderly AMLAcute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS) · Ruijin Hospital | Phase 3 | Not yet recruiting | Jul 29, 2026 |
| SHR2554 Plus Liposomal Mitoxantrone as First-line Treatment for Peripheral T-cell Lymphoma (PTCL)PTCL, First Line Treatment · Institute of Hematology & Blood Diseases Hospital, China | Phase 1 / Phase 2 | Not yet recruiting | Jul 24, 2026 |
| TR115 VS Investigator's Choice in Relapsed/Refractory Peripheral T/NK Cell LymphomaPTCL, NK T-Cell Lymphoma · Tarapeutics Science Inc. | Phase 3 | Not yet recruiting | Jun 10, 2026 |
| Combination of Mitoxantrone Liposome and Etoposide, Dexamethasone, Pegaspargase and Golidocitinib (MEPL-G) in the Treatment of NK/T-cell Lymphoma Associated Hemophagocytic Lymphohistiocytosis (NKTCL-HLH)Extranodal NK T Cell Lymphoma, Hemophagocytic Lymphohistiocytosis (HLH) · Beijing Tongren Hospital | Phase 1 / Phase 2 | Recruiting | Apr 13, 2026 |
| Dec 23, 1987 | NovantroneNDA 19297 · New molecular entity | Emd Serono | 30 | Discontinued |
| Oct 13, 2000 | NovantroneNDA 21120 · TYPE 6 | Serono Inc | 0 | Discontinued |
| Apr 11, 2006 | Mitoxantrone HydrochlorideANDA 76611 | Hikma | 1 | Marketed |
| Apr 11, 2006 | Mitoxantrone HydrochlorideANDA 76871 | Hospira | 6 | Marketed |
| Apr 11, 2006 | Mitoxantrone HydrochlorideANDA 77356 | Meitheal | 3 | Marketed |
| Apr 11, 2006 | Mitoxantrone HydrochlorideANDA 77496 | Fresenius Kabi USA | 2 | Marketed |
| May 14, 2008 | Mitoxantrone HydrochlorideANDA 78606 | Fresenius Kabi Oncol | 0 | Discontinued |
| Apr 13, 2009 | Mitoxantrone HydrochlorideANDA 78980 | Rising | 1 | Discontinued |
| Dec 11, 2012 | Mitoxantrone HydrochlorideANDA 201014 | Rising | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Hikma
Fresenius Kabi USA