Cerubidine
(Daunorubicin Hydrochloride)Phase 3Small molecule
Daunorubicin is used to treat certain types of cancer, particularly leukemia and lymphoma, by killing cancer cells. It works by damaging cancer cell DNA so the cells cannot survive and spread.[1] Cerubidine is currently being investigated across 6 indications[3], with its most advanced program in Phase 3.[1]
Cerubidine is one of 105 small molecule programs targeting T lymphoblastic leukemia/lymphoma. It is currently in Phase 3.
6
Indications
126
Total Trials
21
Active Trials
104
Competitors
3
FDA Applications
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[3][1]
Indication
Competition
Competitive Landscape
235 competitors in Acute Myeloid Leukemia
#DrugCompanyPhaseTrials
1Idamycin
PfizerPhase 3
Novantrone
PfizerPhase 3
Xospata
AstellasPhase 3
Fludara
SanofiPhase 3
Cerubidine
HHikma Pharmaceuticals LLC
Phase 3
Vepesid
AAvyxa
Phase 3
Vanflyta
Daiichi SankyoPhase 3
Mylotarg
WWyeth-Lederle Vaccines
Phase 3
Cerubidine
HHikma Pharmaceuticals LLC
Phase 3
Neupogen
EEastern Cooperative Oncology Group
Phase 3
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Acute Lymphoblastic Leukemia42 trials
Show 39 more trials
Venetoclax and a Pediatric-Inspired Regimen for the Treatment of Newly Diagnosed B Cell Acute Lymphoblastic Leukemia
Recruiting·—·Phase 1·NCT05157971·24 enrolled
Imatinib Mesylate and Combination Chemotherapy With or Without a Donor Stem Cell Transplant in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Completed·—·Phase 2·NCT00618501·50 enrolled
Risk-Adjusted Combination Chemotherapy in Treating Young Patients With Acute Lymphoblastic Leukemia
Unknown status·—·Phase 3·NCT00764907·4,000 enrolled
Acute Myeloid Leukemia42 trials
Show 39 more trials
Everolimus, Cytarabine, and Daunorubicin in Treating Patients With Relapsed Acute Myeloid Leukemia
Unknown status·IInstitut de Recherche Clinique sur les Cancers et le Sang·Phase 1·NCT00544999·21 enrolled
Combination Chemotherapy, Interleukin-2, and Peripheral Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia
Unknown status·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00004128·2,000 enrolled
Leukemia10 trials
Show 7 more trials
Bone Marrow Transplantation4 trials
17 more indications
Myelodysplastic Syndromes3 trials
Myelodysplastic Syndrome3 trials
Acute Promyelocytic Leukemia2 trials
Lymphoblastic Lymphoma2 trials
B Acute Lymphoblastic Leukemia2 trials
Chronic Myelogenous Leukemia1 trial
Myeloproliferative Disorder1 trial
Core Binding Factor Acute Myeloid Leukemia1 trial
Acute Leukemia of Ambiguous Lineage1 trial
Untreated Adult Acute Myeloid Leukemia1 trial
T lymphoblastic leukemia/lymphoma1 trial
Regulatory
FDA Approval Timeline[4]
Jan 1, 1982
CERUBIDINE
NDA NDA050484
Apr 8, 1996
DAUNOXOME
NDA NDA050704
Jan 30, 1998
DAUNORUBICIN HYDROCHLORIDE
NDA NDA050731
Sources
References
- [1]
- [2]
- [3]Open Targets Platform — Drug–disease associations for Daunorubicin Hydrochloride. EMBL-EBI & Wellcome Sanger Institute.
- [4]
- [5]
Details
Drug Info
Quick Facts
- Mechanism of Action
- DNA Topoisomerase II Alpha Inhibitor[2]
- Modality
- Small molecule[2]
- Highest Phase
- Phase 3[1]
- Company
- HHikma Pharmaceuticals LLC