> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/bendamustine-hydrochloride-96c86887-fb47-429c-8d83-f212e0d0fe0b
> Record changed: 2026-11-04

# Bendamustine hydrochloride

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201734)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201734)

First approval year

2008

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201734)

## Development status

**First approval year**

2008

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201734)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201734)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201734)

**Drug name**

Bendamustine hydrochloride

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201734)

**Molecular weight**

394.73

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201734)

**Structure (SMILES)**

Cl.Cn1c(CCCC(=O)O)nc2cc(N(CCCl)CCCl)ccc21

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201734)

### Brand names (12)

- belrapzo
- Belrapzo
- bendamustine hydrochloride
- Bendamustine hydrochloride
- bendeka
- Bendeka
- ribomustine
- Ribomustine
- treanda
- Treanda
- vivimusta
- Vivimusta

### Other names (37)

- 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.

## Identifiers

**CAS registry numbers**

- 3543-75-7

**ChEMBL ID**

CHEMBL1201734

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201734)

**InChIKey**

ZHSKUOZOLHMKEA-UHFFFAOYSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201734)

**RxNorm IDs (RxCUI)**

- 1114693

**FDA ingredient codes (UNII)**

- 981Y8SX18M

### PubChem compound IDs (3)

- 77082
- 46863991
- 168308466

## Regulatory information

### United States

**Applicant**

EAGLE PHARMS

**Approval date**

7 Dec 2015

**Application number**

NDA208194

### Other regulatory facts

**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

## Approval status

**United States (FDA)**

Approved

## Pharmacology

### Drug classification

**Drug name stem**

\-mustine

#### Administration routes

- Parenteral

### Mechanisms of action

- **Mechanism**  
DNA inhibitor

**Action type**  
Inhibitor

**Target**  
DNA

### Investigated indications (20)

- **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

### Open Targets indications (36)

- **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.

### Reported adverse events (33)

- **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.

### Trial references (39)

- NCT00069758  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00069758)
- NCT00389051  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00389051)
- NCT00612183  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00612183)
- NCT01108341  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01108341)
- NCT01596621  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01596621)
- NCT04569838  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04569838)
- NCT00168922  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00168922)
- NCT00274963  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00274963)
- NCT00947388  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00947388)
- NCT01109264  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01109264)
- NCT01369849  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01369849)
- NCT01611090  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01611090)
- NCT01657955  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01657955)
- NCT01886872  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01886872)
- NCT02042911  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02042911)
- NCT00794638  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00794638)
- NCT04115631  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04115631)
- NCT04913103  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04913103)
- NCT01165112  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01165112)
- NCT02420210  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02420210)
- NCT03259529  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03259529)
- NCT01286272  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01286272)
- NCT03269669  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03269669)
- NCT04587687  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04587687)
- NCT00823797  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00823797)

And 14 more, listed on the interactive page.

## Dosing

**Dose**

100 mg/m2

**Route**

Intravenous

**How often**

Days 1 and 2 of a 28-day cycle up to 6 cycles

## Chemical properties

**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

## National Drug Codes

- 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

## Evidence counts

**Recorded assays**

320

**Active assays**

41

### Active assay types (3)

- Confirmatory
- Other
- Screening

## Pharmacologic actions

- Antineoplastic Agents, Alkylating  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D018906.html)

## 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](https://trialight.com/data/trial/a-study-of-surovatamig-azd0486-plus-rituximab-in-previously-44c157a0-9366-48d5-b958-317565b0e0f7.md)
- 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](https://trialight.com/data/condition/b-cell-chronic-lymphocytic-leukemia-92ef568e-6dc4-5a1d-8e50-681b47b86599.md)
- [B-cell non-Hodgkin lymphoma](https://trialight.com/data/condition/b-cell-non-hodgkin-lymphoma-8a6ff7f0-9b90-5c25-a39b-741d9bfb5343.md)
- Childhood leukemia
- Neoplasm of mature B-cells
- [Non-Hodgkin lymphoma](https://trialight.com/data/condition/non-hodgkin-lymphoma-9fc07e31-fd30-5055-991f-04d10cc1f646.md)

### In development for (26)

- [Acute myeloid leukemia](https://trialight.com/data/condition/acute-myeloid-leukemia-b0971a7a-c18d-544e-bd7f-b1a13b9caa30.md) Phase 1
- Adult glioblastoma Phase 2
- [AL amyloidosis](https://trialight.com/data/condition/al-amyloidosis-42ae488b-dbd7-50a6-8ec6-a47098470cd8.md) Phase 2
- Anaplastic astrocytoma Phase 2
- Anaplastic oligodendroglioma Phase 2
- B-cell prolymphocytic leukemia Phase 1
- [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) Phase 1
- Classic Hodgkin lymphoma Phase 2
- [Diffuse large B-cell lymphoma](https://trialight.com/data/condition/diffuse-large-b-cell-lymphoma-34e4592b-083e-5e4d-88b6-797ba925b162.md) Phase 2
- [Fallopian tube cancer](https://trialight.com/data/condition/fallopian-tube-cancer-b95d05ee-41d5-565a-87e1-041170b88760.md) Phase 2
- [Follicular lymphoma](https://trialight.com/data/condition/follicular-lymphoma-88de1ce9-ab0e-5d65-85c4-45a681fa2931.md) Phase 2
- Glioblastoma Phase 2
- Gliosarcoma Phase 2
- Grade III glioma Phase 2
- [Hematopoietic and lymphoid cell neoplasm](https://trialight.com/data/condition/hematopoietic-and-lymphoid-cell-neoplasm-ed3616fa-22fe-5984-94b4-745416e01ef9.md) Phase 1
- Hodgkins lymphoma Phase 2
- Indolent B-cell non-Hodgkin lymphoma Phase 2
- [Leukemia](https://trialight.com/data/condition/leukemia-519aefcd-8521-5941-851b-5b77ca925ca5.md) Phase 2
- [Lung cancer](https://trialight.com/data/condition/lung-cancer-c4ca1fe0-9b3d-5957-a668-2d6cf26bd16a.md) Phase 2
- [Lymphoid leukemia](https://trialight.com/data/condition/lymphoid-leukemia-cfb78df0-6fca-5a14-a697-6a1cb49213fe.md) Phase 1

---

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