Bendamustine hydrochloride
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2008
- First approval year
- 2008
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Bendamustine hydrochloride
- Molecular weight
- 394.73
- Structure (SMILES)
- Cl.Cn1c(CCCC(=O)O)nc2cc(N(CCCl)CCCl)ccc21
- belrapzo
- Belrapzo
- bendamustine hydrochloride
- Bendamustine hydrochloride
- bendeka
- Bendeka
- ribomustine
- Ribomustine
- treanda
- Treanda
- vivimusta
- Vivimusta
- 1h benzimidazole 2 butanoic acid 5 bis 2 chloroethyl amino 1 methyl monohydrochloride
- 1H-BENZIMIDAZOLE-2-BUTANOIC ACID, 5-(BIS(2-CHLOROETHYL)AMINO)-1-METHYL-, MONOHYDROCHLORIDE
- bendamustin ribomustin
- bendamustine hcl
- Bendamustine hcl
- bendamustine hydrochloride
- Bendamustine hydrochloride
- BENDAMUSTINE HYDROCHLORIDE [JAN]
- BENDAMUSTINE HYDROCHLORIDE [MART.]
- BENDAMUSTINE HYDROCHLORIDE [MI]
- BENDAMUSTINE HYDROCHLORIDE [ORANGE BOOK]
- BENDAMUSTINE HYDROCHLORIDE [USAN]
- BENDAMUSTINE HYDROCHLORIDE [USP MONOGRAPH]
- BENDAMUSTINE HYDROCHLORIDE [USP-RS]
- Bendamustine hydrochloride [WHO-DD]
- bendamustine hydrochloride jan
- bendamustine hydrochloride mart
- bendamustine hydrochloride mi
- bendamustine hydrochloride orange book
- bendamustine hydrochloride usan
- bendamustine hydrochloride usp monograph
- bendamustine hydrochloride usp rs
- bendamustine hydrochloride who dd
- nsc 138783
- NSC-138783
And 12 more, listed on the interactive page.
- CAS registry numbers
- 3543-75-7
- ChEMBL ID
- CHEMBL1201734
- InChIKey
- ZHSKUOZOLHMKEA-UHFFFAOYSA-N
- RxNorm IDs (RxCUI)
- 1114693
- FDA ingredient codes (UNII)
- 981Y8SX18M
- 77082
- 46863991
- 168308466
- Applicant
- EAGLE PHARMS
- Approval date
- 7 Dec 2015
- Application number
- NDA208194
- Patents
- 53
- Designations
- 3
- Earliest recorded loss of exclusivity
- 29 Jul 2042
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- United States (FDA)
- Approved
- Drug name stem
- -mustine
Administration routes
- Parenteral
Mechanisms of action
- Mechanism
- DNA inhibitor
- Action type
- Inhibitor
- Target
- DNA
- Condition
- Leukemia, Lymphocytic, Chronic, B-Cell
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000095
- Subject identifier
- D015451
- Condition
- Lymphoma, Non-Hodgkin
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000096
- Subject identifier
- D008228
- Condition
- Hodgkin Disease
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000183
- Subject identifier
- D006689
- Condition
- Lymphoma, Large B-Cell, Diffuse
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000403
- Subject identifier
- D016403
- Condition
- Leukemia
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000565
- Subject identifier
- D007938
- Condition
- Lymphoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000574
- Subject identifier
- D008223
- Condition
- Small Cell Lung Carcinoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000702
- Subject identifier
- D055752
- Condition
- Multiple Myeloma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001378
- Subject identifier
- D009101
- Condition
- Astrocytoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0002499
- Subject identifier
- D001254
- Condition
- Oligodendroglioma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0002501
- Subject identifier
- D009837
- Condition
- Leukemia, Lymphoid
- Highest recorded phase
- 1
- Condition identifier
- EFO:0004289
- Subject identifier
- D007945
- Condition
- Lymphoma, Non-Hodgkin
- Highest recorded phase
- 4
- Condition identifier
- EFO:0005952
- Subject identifier
- D008228
- Condition
- Gliosarcoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:1001465
- Subject identifier
- D018316
- Condition
- Lymphoma, Mantle-Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:1001469
- Subject identifier
- D020522
- Condition
- Lung Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0008903
- Subject identifier
- D008175
- Condition
- Hodgkin Disease
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0009348
- Subject identifier
- D006689
- Condition
- Lymphoma, Follicular
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0018906
- Subject identifier
- D008224
- Condition
- Amyloidosis, Familial
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0019438
- Subject identifier
- D028226
- Condition
- Glioblastoma
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0020690
- Subject identifier
- D005909
- Condition
- Hematologic Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- MONDO:0044881
- Subject identifier
- D019337
- Condition identifier
- EFO_0000095
- Condition identifier
- EFO_0000096
- Condition identifier
- EFO_0000183
- Condition identifier
- EFO_0000702
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001378
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002499
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002501
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004952
- Highest recorded phase
- 2
- Condition identifier
- EFO_0005952
- Condition identifier
- EFO_1001465
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001469
- Condition identifier
- EFO_1001938
- Condition identifier
- MONDO_0002158
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004355
- Condition identifier
- MONDO_0004355
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0004948
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0004949
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0004952
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0004992
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005062
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0008170
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0008433
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0008903
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0009693
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0015759
- Highest recorded phase
- 4
And 11 more, listed on the interactive page.
- Event
- b-cell lymphoma recurrent
- Reports
- 42
- Reporting signal score
- 147.818
- Event
- blood lactate dehydrogenase increased
- Reports
- 114
- Reporting signal score
- 141.655
- Event
- cd4 lymphocytes decreased
- Reports
- 63
- Reporting signal score
- 157.287
- Event
- chronic lymphocytic leukaemia
- Reports
- 70
- Reporting signal score
- 155.406
- Event
- covid-19
- Reports
- 162
- Reporting signal score
- 127.431
- Event
- cytomegalovirus chorioretinitis
- Reports
- 72
- Reporting signal score
- 202.847
- Event
- cytomegalovirus infection
- Reports
- 237
- Reporting signal score
- 465.899
- Event
- cytomegalovirus infection reactivation
- Reports
- 52
- Reporting signal score
- 122.505
- Event
- cytopenia
- Reports
- 134
- Reporting signal score
- 251.088
- Event
- diffuse large b-cell lymphoma
- Reports
- 135
- Reporting signal score
- 334.02
- Event
- diffuse large b-cell lymphoma recurrent
- Reports
- 71
- Reporting signal score
- 207.437
- Event
- disease progression
- Reports
- 328
- Reporting signal score
- 263.159
- Event
- end stage renal disease
- Reports
- 85
- Reporting signal score
- 176.215
- Event
- extravasation
- Reports
- 87
- Reporting signal score
- 162.697
- Event
- febrile neutropenia
- Reports
- 683
- Reporting signal score
- 1,131.91
- Event
- headache
- Reports
- 78
- Reporting signal score
- 133.99
- Event
- hypogammaglobulinaemia
- Reports
- 73
- Reporting signal score
- 135.19
- Event
- infusion related reaction
- Reports
- 231
- Reporting signal score
- 183.98
- Event
- lymphocyte count decreased
- Reports
- 204
- Reporting signal score
- 324.784
- Event
- lymphopenia
- Reports
- 114
- Reporting signal score
- 137.905
- Event
- malignant neoplasm progression
- Reports
- 208
- Reporting signal score
- 153.707
- Event
- myelodysplastic syndrome
- Reports
- 138
- Reporting signal score
- 230.237
- Event
- myelosuppression
- Reports
- 105
- Reporting signal score
- 157.375
- Event
- neutropenia
- Reports
- 635
- Reporting signal score
- 579.643
- Event
- neutrophil count decreased
- Reports
- 279
- Reporting signal score
- 356.962
And 8 more, listed on the interactive page.
- NCT00069758
- NCT00389051
- NCT00612183
- NCT01108341
- NCT01596621
- NCT04569838
- NCT00168922
- NCT00274963
- NCT00947388
- NCT01109264
- NCT01369849
- NCT01611090
- NCT01657955
- NCT01886872
- NCT02042911
- NCT00794638
- NCT04115631
- NCT04913103
- NCT01165112
- NCT02420210
- NCT03259529
- NCT01286272
- NCT03269669
- NCT04587687
- NCT00823797
And 14 more, listed on the interactive page.
- Dose
- 100 mg/m2
- Route
- Intravenous
- How often
- Days 1 and 2 of a 28-day cycle up to 6 cycles
- Hydrogen bond acceptors
- 4
- Hydrogen bond donors
- 1
- Polar surface area
- 58.36
- Calculated partition coefficient (ALogP)
- 3.26
- Prodrug
- No
- Chirality
- Achiral
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 9
- Heavy atoms
- 24
- Molecular formula
- C16H22Cl3N3O2
- Monoisotopic mass
- 393.077760
- Natural product
- No
- 10019-079
- 16729-250
- 16729-251
- 24338-270
- 42367-521
- 55150-391
- 55150-392
- 63459-348
- 63459-390
- 63459-391
- 68001-572
- 71225-120
- 71288-102
- 71288-103
- 83831-183
- 60505-6228
- Recorded assays
- 320
- Active assays
- 41
- Confirmatory
- Other
- Screening
- Antineoplastic Agents, Alkylating
Related records
Trials (75)
- A Comparison of Three Chemotherapy Regimens for the Treatment of Patients With Newly Diagnosed Mantle Cell Lymphoma
- A Phase I Clinical Trial of SyB L-0501 in Combination With Rituximab to Patients With Aggressive B-cell Non-Hodgkin's Lymphoma
- A Phase I Study of Bendamustine Hydrochloride in Patients With Indolent B-cell Non-Hodgkin's Lymphoma
- A Practical Clinical Study Comparing the Fixed-cycle Regimen Containing Orelabrutinib With BTKi Monotherapy
- A Prospective Multicenter Phase 2 Study of FCR/BR Alternating With Ibrutinib in Treatment-naive Patients With CLL
- A Study of Acalabrutinib in Combination With Rituximab + (Bendamustine or Venetoclax) in Subjects With MCL
- A Study of Bendamustine in the Treatment of Chinese Participants With Indolent Non-Hodgkin Lymphoma Refractory to Rituximab Treatment
- A Study of Ibrutinib in Combination With Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
- A Study of Safety and Efficacy of Nivolumab and Bendamustine (NB) in Patients With Relapsed/Refractory Hodgkin's Lymphoma
- A Study of Surovatamig (AZD0486) Plus Rituximab in Previously Untreated Follicular Lymphoma Patients
- A Study to Evaluate the Efficacy and Safety of Bendamustine Hydrochloride Injection
- Akt Inhibitor MK2206, Bendamustine Hydrochloride, and Rituximab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
- BeFluBu vs FluBuRux Conditioning in Haploidentical HCT
- Benadamustine, Fludarabine and Busulfan Conditioning in Recipients of Haploidentical Stem Cell Transplantation (FluBuBe)
- Bendamustine and Idarubicin in Treating Older Patients With Previously Untreated AML or MDS
- Bendamustine and Mitoxantrone in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
- Bendamustine and Rituximab As Salvage Therapy In Patients With Chronic Lymphoproliferative Disorders
- Bendamustine and Rituximab Combination Therapy for Cold Agglutinin Disease
- Bendamustine as Second-Line Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer
- Bendamustine HCL in Relapsed and Primary Refractory Hodgkin Lymphoma
Approved for (5)
- B-cell chronic lymphocytic leukemia
- B-cell non-Hodgkin lymphoma
- Childhood leukemia
- Neoplasm of mature B-cells
- Non-Hodgkin lymphoma
In development for (26)
- Acute myeloid leukemia Phase 1
- Adult glioblastoma Phase 2
- AL amyloidosis Phase 2
- Anaplastic astrocytoma Phase 2
- Anaplastic oligodendroglioma Phase 2
- B-cell prolymphocytic leukemia Phase 1
- Cancer Phase 1
- Classic Hodgkin lymphoma Phase 2
- Diffuse large B-cell lymphoma Phase 2
- Fallopian tube cancer Phase 2
- Follicular lymphoma Phase 2
- Glioblastoma Phase 2
- Gliosarcoma Phase 2
- Grade III glioma Phase 2
- Hematopoietic and lymphoid cell neoplasm Phase 1
- Hodgkins lymphoma Phase 2
- Indolent B-cell non-Hodgkin lymphoma Phase 2
- Leukemia Phase 2
- Lung cancer Phase 2
- Lymphoid leukemia Phase 1