> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/bendamustine-07f7a21f-820a-4423-a534-0d6d0380b382
> Record changed: 2026-10-13

# Bendamustine

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL487253)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL487253)

First approval year

2008

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL487253)

## Development status

**First approval year**

2008

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL487253)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL487253)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL487253)

**Drug name**

Bendamustine

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL487253)

**Molecular weight**

358.27

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL487253)

**Structure (SMILES)**

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

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL487253)

### Other names (16)

- 1h benzimidazole 2 butanoic acid 5 bis 2 chloroethyl amino 1 methyl
- 1H-BENZIMIDAZOLE-2-BUTANOIC ACID, 5-(BIS(2-CHLOROETHYL)AMINO)-1-METHYL-
- bendamustina
- Bendamustina
- bendamustine
- Bendamustine
- BENDAMUSTINE \[HSDB\]
- bendamustine \[INN\]
- BENDAMUSTINE \[MI\]
- BENDAMUSTINE \[VANDF\]
- Bendamustine \[WHO-DD\]
- bendamustine hsdb
- bendamustine inn
- bendamustine mi
- bendamustine vandf
- bendamustine who dd

## Identifiers

**ATC classification codes**

- L01AA09

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL487253)

**CAS registry numbers**

- 16506-27-7

**ChEMBL ID**

CHEMBL487253

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL487253)

**InChIKey**

YTKUWDBFDASYHO-UHFFFAOYSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL487253)

**PubChem compound IDs**

- 65628

**FDA ingredient codes (UNII)**

- 9266D9P3PQ

### RxNorm IDs (RxCUI) (2)

- 134547
- 1114693

## Regulatory information

### United States

**Applicant**

CEPHALON

**Approval date**

20 Mar 2008

**Application number**

NDA022249

### Other regulatory facts

**Patents**

0

**Designations**

1

**First in class**

No

**Fast track**

No

**Breakthrough designation**

No

**Orphan designation**

No

**Priority review**

No

**Orphan exclusivity**

No

**Accelerated approval**

No

**Availability**

Prescription only

## Pharmacology

### Drug classification

**Pharmacology name**

bendamustine

**Type**

Synthetic organic

**Drug name stem**

\-mustine

**Approval recorded by Guide to Pharmacology**

Yes

#### Administration routes

- Parenteral

### Investigated indications (34)

- **Condition**  
Leukemia, Biphenotypic, Acute

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000094

**Subject identifier**  
D015456
- **Condition**  
Leukemia, Lymphocytic, Chronic, B-Cell

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000095

**Subject identifier**  
D015451
- **Condition**  
Lymphoma, Follicular

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000096

**Subject identifier**  
D008224
- **Condition**  
Hodgkin Disease

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000183

**Subject identifier**  
D006689
- **Condition**  
Lymphoma, B-Cell, Marginal Zone

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000191

**Subject identifier**  
D018442
- **Condition**  
Myelodysplastic Syndromes

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000198

**Subject identifier**  
D009190
- **Condition**  
Lymphoma, T-Cell, Peripheral

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000211

**Subject identifier**  
D016411
- **Condition**  
Precursor Cell Lymphoblastic Leukemia-Lymphoma

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000220

**Subject identifier**  
D054198
- **Condition**  
Leukemia, Myeloid, Acute

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000222

**Subject identifier**  
D015470
- **Condition**  
Immunoblastic Lymphadenopathy

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000255

**Subject identifier**  
D007119
- **Condition**  
Leukemia, Myelogenous, Chronic, BCR-ABL Positive

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000339

**Subject identifier**  
D015464
- **Condition**  
Lymphoma, Large B-Cell, Diffuse

**Highest recorded phase**  
3

**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**  
3

**Condition identifier**  
EFO:0000574

**Subject identifier**  
D008223
- **Condition**  
Neoplasms

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0000616

**Subject identifier**  
D009369
- **Condition**  
Small Cell Lung Carcinoma

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000702

**Subject identifier**  
D055752
- **Condition**  
Multiple Myeloma

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0001378

**Subject identifier**  
D009101
- **Condition**  
Hematologic Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0001642

**Subject identifier**  
D019337
- **Condition**  
Prostatic Neoplasms

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0001663

**Subject identifier**  
D011471
- **Condition**  
Lymphoma, Non-Hodgkin

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0005952

**Subject identifier**  
D008228
- **Condition**  
Leukemia, Plasma Cell

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0006475

**Subject identifier**  
D007952
- **Condition**  
Waldenstrom Macroglobulinemia

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0009441

**Subject identifier**  
D008258
- **Condition**  
Lymphoma, B-Cell, Marginal Zone

**Highest recorded phase**  
3

**Condition identifier**  
EFO:1000630

**Subject identifier**  
D018442
- **Condition**  
Leukemia, Hairy Cell

**Highest recorded phase**  
2

**Condition identifier**  
EFO:1000956

**Subject identifier**  
D007943
- **Condition**  
Lymphoma, Mantle-Cell

**Highest recorded phase**  
3

**Condition identifier**  
EFO:1001469

**Subject identifier**  
D020522

And 9 more, listed on the interactive page.

### Open Targets indications (70)

- **Condition identifier**  
EFO\_0000095

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000096
- **Condition identifier**  
EFO\_0000183

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000191

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000255

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000403

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000565

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000574

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000616
- **Condition identifier**  
EFO\_0000702

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0001378

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0005952

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0009441

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_1000630

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_1001469

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_1001938

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_1001968

**Highest recorded phase**  
2
- **Condition identifier**  
HP\_0000083

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0000430

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0000432

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0000607

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0001106

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0002083

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0002571

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0004948

**Highest recorded phase**  
3

And 45 more, listed on the interactive page.

### Reported adverse events (37)

- **Event**  
anaemia

**Reports**  
249

**Reporting signal score**

134.772
- **Event**  
b-cell lymphoma recurrent

**Reports**  
36

**Reporting signal score**

148.329
- **Event**  
basal cell carcinoma

**Reports**  
57

**Reporting signal score**

73.7201
- **Event**  
chronic lymphocytic leukaemia

**Reports**  
35

**Reporting signal score**

79.63
- **Event**  
chronic lymphocytic leukaemia recurrent

**Reports**  
24

**Reporting signal score**

77.8509
- **Event**  
covid-19

**Reports**  
94

**Reporting signal score**

90.1226
- **Event**  
cytokine release syndrome

**Reports**  
56

**Reporting signal score**

104.774
- **Event**  
cytomegalovirus chorioretinitis

**Reports**  
31

**Reporting signal score**

84.6379
- **Event**  
cytomegalovirus infection

**Reports**  
123

**Reporting signal score**

252.239
- **Event**  
cytomegalovirus infection reactivation

**Reports**  
30

**Reporting signal score**

76.6057
- **Event**  
cytopenia

**Reports**  
59

**Reporting signal score**

106.711
- **Event**  
diffuse large b-cell lymphoma

**Reports**  
91

**Reporting signal score**

257.232
- **Event**  
diffuse large b-cell lymphoma recurrent

**Reports**  
62

**Reporting signal score**

219.077
- **Event**  
diffuse large b-cell lymphoma refractory

**Reports**  
21

**Reporting signal score**

76.8979
- **Event**  
disease progression

**Reports**  
245

**Reporting signal score**

293.226
- **Event**  
febrile neutropenia

**Reports**  
397

**Reporting signal score**

739.606
- **Event**  
hypogammaglobulinaemia

**Reports**  
39

**Reporting signal score**

76.7221
- **Event**  
infection

**Reports**  
150

**Reporting signal score**

97.8294
- **Event**  
infusion related reaction

**Reports**  
109

**Reporting signal score**

87.8043
- **Event**  
leukopenia

**Reports**  
118

**Reporting signal score**

103.978
- **Event**  
lymphocyte count decreased

**Reports**  
85

**Reporting signal score**

125.895
- **Event**  
lymphopenia

**Reports**  
71

**Reporting signal score**

103.322
- **Event**  
mantle cell lymphoma

**Reports**  
19

**Reporting signal score**

59.1493
- **Event**  
myelodysplastic syndrome

**Reports**  
78

**Reporting signal score**

143.435
- **Event**  
neutropenia

**Reports**  
421

**Reporting signal score**

510.87

And 12 more, listed on the interactive page.

### Trial references (250)

- NCT00076349  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00076349)
- NCT00139841  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00139841)
- NCT00426855  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00426855)
- NCT00547534  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00547534)
- NCT00825149  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00825149)
- NCT00877006  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00877006)
- NCT01059630  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01059630)
- NCT01133158  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01133158)
- NCT01232556  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01232556)
- NCT01294579  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01294579)
- NCT01332968  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01332968)
- NCT01456351  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01456351)
- NCT01458366  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01458366)
- NCT01491841  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01491841)
- NCT01570049  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01570049)
- NCT01594229  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01594229)
- NCT01724021  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01724021)
- NCT01900509  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01900509)
- NCT01929265  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01929265)
- NCT02006485  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02006485)
- NCT02187133  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02187133)
- NCT02626455  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02626455)
- NCT02836639  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02836639)
- NCT02954406  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02954406)
- NCT03311126  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03311126)

And 225 more, listed on the interactive page.

## Dosing

**Dose**

100 mg/m2 for CLL; 120 mg/m2 for NHL

**Route**

Intravenous

**How often**

On Days 1 and 2 of a 28-day cycle for CLL; on Days 1 and 2 of a 21-day cycle for NHL

## Chemical properties

**Hydrogen bond acceptors**

4

**Hydrogen bond donors**

1

**Polar surface area**

58.36

**Calculated partition coefficient (ALogP)**

3.26

**Calculated partition coefficient (XLogP)**

2.9

**Prodrug**

No

**Chirality**

Achiral

**Inorganic**

No

**Rule-of-five violations**

0

**Rotatable bonds**

9

**Heavy atoms**

23

**Molecular formula**

C16H21Cl2N3O2

**Monoisotopic mass**

357.1010823

**Natural product**

Yes

## Evidence counts

**Recorded assays**

912

**Active assays**

72

### Active assay types (4)

- Confirmatory
- Other
- Screening
- Summary

## Pharmacologic actions

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

## Related records

### Trials (301)

- [A Clinical Trial of MK-1045 and Rituximab in People With Follicular Lymphoma (MK-1045-007)](https://trialight.com/data/trial/a-clinical-trial-of-mk-1045-and-rituximab-in-people-with-3c20ff0c-d021-4948-bdbc-f32491858aae.md)
- A Clinical Trial to Evaluate the Efficacy and Safety of TQB3909 Tablets Versus Investigator's Choice in the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
- A Comparison of Three Chemotherapy Regimens for the Treatment of Patients With Newly Diagnosed Mantle Cell Lymphoma
- A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL
- A Multicenter, Prospective, Open-Label, Randomized Controlled Clinical Study of Orelabrutinib Combined With Obinutuzumab and Lenalidomide Versus Obinutuzumab Plus Chemotherapy for Treatment-Naive Follicular Lymphoma
- A Multicentre Phase I-II Study to Investigate the Combination of Bendamustine With Weekly Paclitaxel as First or Second Line Therapy in Patients With Metastatic Breast Cancer
- [A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease](https://trialight.com/data/trial/a-phase-1-study-of-ft819-in-b-cell-mediated-autoimmune-6b8b0d2c-15f0-4af3-a304-bbce1760f628.md)
- A Phase 1/2 Study of CYT-0851 in B-Cell Malignancies and Advanced Solid Tumors
- A Phase 1/2 Study of Lenalidomide in Combination With Bendamustine in Relapsed and Primary Refractory Hodgkin Lymphoma
- A Phase 2 Clinical Trial to Evaluate Zanubrutinib Combined With BR (Bendamustine/Rituximab) Regimen in Subjects With Newly-diagnosed Waldenström's Macroglobulinemia
- A Phase 2, Multicenter, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
- A Phase I Study of Bendamustine and Melphalan Conditioning and Autologous Stem Cell Transplantation for Treatment of Multiple Myeloma and Relapsed/Refractory B-cell Lymphoma in Elderly Patients
- A Phase II Clinical Study of Zanubrutinib Combined With Four Cycles of CD20 Monoclonal Antibody and Reduced-Dose Bendamustine in the Treatment of Untreated Waldenström Macroglobulinemia
- A Phase II Study for Patients With Indolent Non-follicular Non-Hodgkin's Lymphoma
- A Phase II Study of VELCADE (Bortezomib) in Combination With Bendamustine and Rituximab in Subjects With Relapsed or Refractory Follicular Lymphoma
- A Phase III Clinical Study Comparing JS004 Plus Toripalimab With Investigator-Selected Chemotherapy in Patients With PD-(L)1monoclonal Antibody Refractory Classic Hodgkin Lymphoma (cHL)
- A Pilot Study of Immunotherapy Including Haploidentical NK Cell Infusion Following CD133+ Positively-Selected Autologous Hematopoietic Stem Cells in Children With High Risk Solid Tumors or Lymphomas
- A Real-world Study of Obinutuzumab-based Therapy for Previously Untreated FL
- A Risk Stratified Sequential Treatment With Rituximab, Brentuximab Vedotin and Bendamustine (RBvB)
- A Safety and Efficacy Study of Obinutuzumab Alone or in Combination With Chemotherapy in Participants With Chronic Lymphocytic Leukemia

### Approved for (2)

- [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md)
- Neoplasm

### In development for (33)

- Acute lymphoblastic leukemia Phase 2
- [Acute myeloid leukemia](https://trialight.com/data/condition/acute-myeloid-leukemia-b0971a7a-c18d-544e-bd7f-b1a13b9caa30.md) Phase 1
- AL amyloidosis Phase 2
- [Angioimmunoblastic T-cell lymphoma](https://trialight.com/data/condition/angioimmunoblastic-t-cell-lymphoma-5b697108-b9cf-53e9-afde-71a36bf55d6b.md) Phase 3
- B-cell acute lymphoblastic leukemia Phase 1
- [B-cell chronic lymphocytic leukemia](https://trialight.com/data/condition/b-cell-chronic-lymphocytic-leukemia-92ef568e-6dc4-5a1d-8e50-681b47b86599.md) Phase 3
- [B-cell non-Hodgkin lymphoma](https://trialight.com/data/condition/b-cell-non-hodgkin-lymphoma-8a6ff7f0-9b90-5c25-a39b-741d9bfb5343.md) Phase 1
- [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Phase 2
- Chronic myeloid leukemia Phase 1
- Classic Hodgkin lymphoma Phase 3
- Cold agglutinin disease Phase 2
- [Diffuse large B-cell lymphoma](https://trialight.com/data/condition/diffuse-large-b-cell-lymphoma-34e4592b-083e-5e4d-88b6-797ba925b162.md) Phase 3
- [Follicular lymphoma](https://trialight.com/data/condition/follicular-lymphoma-88de1ce9-ab0e-5d65-85c4-45a681fa2931.md) Phase 3
- Hairy cell leukemia Phase 2
- [Hematopoietic and lymphoid system neoplasm](https://trialight.com/data/condition/hematopoietic-and-lymphoid-system-neoplasm-510101ac-7ce5-5dd1-8980-f2f110effdf0.md) Phase 2
- Hodgkins lymphoma Phase 3
- [Leukemia](https://trialight.com/data/condition/leukemia-519aefcd-8521-5941-851b-5b77ca925ca5.md) Phase 2
- Lymphoid neoplasm Phase 2
- [Lymphoma](https://trialight.com/data/condition/lymphoma-de4db685-7419-5e0e-b958-4591ffd69d43.md) Phase 3
- MALT lymphoma Phase 3

---

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