bendamustine hydrochloride

Phase 2Small molecule

bendamustine hydrochloride is one of 105 small molecule programs targeting Non-Hodgkins Lymphoma. It is currently in Phase 2.

Indications

Total Trials

Active Trials

104

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Non-Hodgkins LymphomaUnknown

B-Cell Non-Hodgkins LymphomaUnknown

Childhood LeukemiaUnknown

Mantle Cell LymphomaCompleted

Recurrent Follicular LymphomaRecruiting

Classical Hodgkin LymphomaRecruiting

Extranodal Marginal Zone B-Cell Lymphoma of Mucosa-Associated Lymphoid TissueActive, not recruiting

ConditioningRecruiting

Neoplasm of Mature B-CellsUnknown

Non-Hodgkins LymphomaPreclinical

Unknown

B-Cell Non-Hodgkins LymphomaPreclinical

Unknown

Childhood LeukemiaPreclinical

Unknown

Mantle Cell LymphomaPhase 2

Completed

Recurrent Follicular LymphomaPhase 2

Recruiting

Classical Hodgkin LymphomaPhase 2

Recruiting

Extranodal Marginal Zone B-Cell Lymphoma of Mucosa-Associated Lymphoid TissuePhase 1

Active, not recruiting

ConditioningPhase 2

Recruiting

Neoplasm of Mature B-CellsPreclinical

Unknown

Competition

Competitive Landscape

60 competitors in Non-Hodgkins Lymphoma

#DrugCompanyPhaseTrials

Aliqopa

Bayer

Approved

1 2

Calquence

AstraZeneca

Approved

1 3

Fludara

Sanofi

Approved

1 4

Adriamycin

Oncovin

Trexall

Venclexta

Dacogen

Sun Pharmaceutical Industries, Inc.

Eloxatin

Jaypirca

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Active, not recruiting

Extranodal Marginal Zone B-Cell Lymphoma of Mucosa-Associated Lymphoid Tissue

NCT01479842

Phase 2Active, not recruiting

Liver Lymphoma

NCT04115631

Q1 2027

Phase 2Active, not recruiting

Grade 1 Follicular Lymphoma

NCT03269669

Q2 2027

Phase 3Active, not recruiting

Stage I Chronic Lymphocytic Leukemia

NCT01886872

Q3 2027

Phase 1Active, not recruiting

B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma

NCT02153580

Phase 2Not yet recruiting

Mantle Cell Lymphoma

NCT04913103

Clinical

Trials by Indication[1]

Lymphoma9 trials

Study to Evaluate the Efficacy and Safety of Treatment With Bendamustine in Combination With Ofatumumab in Previously Untreated Patients With Indolent B-Cell Non-Hodgkin's Lymphoma (NHL)

Completed·CCephalon·Phase 2·NCT01108341·50 enrolled

A Phase I Study of Bendamustine Hydrochloride in Patients With Indolent B-cell Non-Hodgkin's Lymphoma

Completed·SSymBio Pharmaceuticals·Phase 1·NCT00389051·9 enrolled

A Study of Safety and Efficacy of Nivolumab and Bendamustine (NB) in Patients With Relapsed/Refractory Hodgkin's Lymphoma

Completed·SSt. Petersburg State Pavlov Medical University·Phase 1/2·NCT03343652·30 enrolled

Show 6 more trials

Ofatumumab and Bendamustine Hydrochloride With or Without Bortezomib in Treating Patients With Untreated Follicular Non-Hodgkin Lymphoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01286272·135 enrolled

A Study of Bendamustine in the Treatment of Chinese Participants With Indolent Non-Hodgkin Lymphoma Refractory to Rituximab Treatment

Completed· Teva logo

Teva·Phase 3·NCT01596621·102 enrolled

Gemcitabine and Bendamustine in Patients With Relapsed or Refractory Hodgkin's Lymphoma

Completed·BBeth Christian·Phase 1/2·NCT01535924·26 enrolled

Rituximab, Bendamustine Hydrochloride, and Lenalidomide in Treating Patients With Aggressive B-Cell Lymphoma

Completed·SSwiss Cancer Institute·Phase 1/2·NCT00987493·49 enrolled

Obatoclax Mesylate, Rituximab, and Bendamustine Hydrochloride in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma

Withdrawn·NNational Cancer Institute (NCI)·Phase 1/2·NCT01238146

CPI-613, Bendamustine Hydrochloride, and Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

Terminated·WWake Forest University Health Sciences·Phase 1·NCT02168907·1 enrolled

Chronic Lymphocytic Leukemia7 trials

Akt Inhibitor MK2206, Bendamustine Hydrochloride, and Rituximab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT01369849·15 enrolled

Bendamustine and Mitoxantrone in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Completed·GGerman CLL Study Group·Phase 2·NCT00274963·60 enrolled

S0902 Bendamustine and Rituximab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia That Has Not Responded to Previous Treatment

Withdrawn·SSWOG Cancer Research Network·Phase 2·NCT00939328

Show 4 more trials

Bendamustine Plus Alemtuzumab for Refractory Chronic Lymphocytic Leukemia (CLL)

Terminated·—·Phase 1·NCT00947388·9 enrolled

A Study of Ibrutinib in Combination With Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01611090·578 enrolled

Bendamustine Hydrochloride Injection for Previously Untreated Chronic Lymphocytic Leukemia

Unknown status·SShandong Lanjin Pharmaceuticals Co.,Ltd·Phase 3·NCT01657955·96 enrolled

Bendamustine Hydrochloride Injection for Initial Treatment of Chronic Lymphocytic Leukemia

Completed· Jiangsu Simcere Pharmaceutical Co., Ltd. logo

Jiangsu Simcere Pharmaceutical Co., Ltd.·Phase 2·NCT01109264·147 enrolled

Multiple Myeloma5 trials

Carfilzomib, Bendamustine Hydrochloride, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT02095834·18 enrolled

Bendamustine Hydrochloride, Etoposide, Dexamethasone, and Filgrastim For Peripheral Blood Stem Cell Mobilization in Treating Patients With Refractory or Recurrent Lymphoma or Multiple Myeloma

Completed·UUniversity of Washington·Phase 2·NCT01110135·43 enrolled

Bendamustine Hydrochloride, Lenalidomide, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma

Completed·MMayo Clinic·Phase 1/2·NCT01049945·70 enrolled

Show 2 more trials

Veliparib, Bendamustine Hydrochloride, and Rituximab in Treating Patients With Relapsed or Refractory Lymphoma, Multiple Myeloma, or Solid Tumors

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT01326702·43 enrolled

Bendamustine Hydrochloride, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

Completed·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 2·NCT02224729·24 enrolled

Mantle Cell Lymphoma3 trials

Study of PV in Combination With Bendamustine and Rituximab for Patients With R/R MCL

Not yet recruiting·CCzech Lymphoma Study Group·Phase 2·NCT04913103·21 enrolled

Clinical Study on SyB L-0501 in Patients With Indolent B-cell Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma

Completed·SSymBio Pharmaceuticals·Phase 2·NCT00612183·56 enrolled

S1106 Rituximab With Combination Chemotherapy or Bendamustine Hydrochloride Followed by Consolidation Chemotherapy and Stem Cell Transplantation in Older Patients With Previously Untreated Mantle Cell Lymphoma

Completed·SSWOG Cancer Research Network·Phase 2·NCT01412879·53 enrolled

Diffuse Large B-Cell Lymphoma2 trials

Bendamustine, Obinutuzumab, and Dexamethasone in Older Patients With Diffuse Large B-cell Lymphoma

Terminated·UUniversity of Chicago·Phase 2·NCT02420210·2 enrolled

Bendamustine Hydrochloride, Rituximab, Etoposide, and Carboplatin in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma or Hodgkin Lymphoma

Completed·UUniversity of Washington·Phase 1/2·NCT01165112·48 enrolled

20 more indications

Haploidentical Stem Cell Transplantation1 trial

Benadamustine, Fludarabine and Busulfan Conditioning in Recipients of Haploidentical Stem Cell Transplantation (FluBuBe)

Completed·SSt. Petersburg State Pavlov Medical University·Phase 2·NCT04942730·50 enrolled

Glioma1 trial

Bendamustine Hydrochloride in Treating Patients With Recurrent or Progressive Anaplastic Glioma

Completed·UUniversity of Washington·Phase 2·NCT00823797·45 enrolled

Conditioning1 trial

BeFluBu vs FluBuRux Conditioning in Haploidentical HCT

Recruiting·SSt. Petersburg State Pavlov Medical University·Phase 2·NCT06477549·220 enrolled

Lymphoid Malignancies1 trial

CMC-544 and Allogeneic Transplantation for CD22 Positive-Lymphoid Malignancies

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT01664910·27 enrolled

Relapsed or Refractory1 trial

Everolimus and Bendamustine Hydrochloride in Treating Patients With Relapsed or Refractory Hematologic Cancer

Completed·UUniversity of California, Davis·Phase 1·NCT02240719·20 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of Bendamustine, Gemcitabine, Rituximab, Nivolumab (BeGeRN) in Patients With r/r DLBCL

Completed·SSt. Petersburg State Pavlov Medical University·Phase 1/2·NCT03259529·30 enrolled

Myeloid Malignancies1 trial

Post-transplantation Benadamustine and Cyclophosphamide in Patients With Refractory Myeloid Malignancies

Completed·SSt. Petersburg State Pavlov Medical University·Phase 2·NCT04943757·50 enrolled

Amyloidosis1 trial

Isatuximab and Bendamustine in Systemic Light Chain Amyloidosis

Withdrawn·TTufts Medical Center·Phase 2·NCT04943302

Small Cell Lung Cancer1 trial

Bendamustine as Second-Line Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer

Completed·VVanderbilt-Ingram Cancer Center·Phase 2·NCT00984542·50 enrolled

Older Patients1 trial

Bendamustine and Idarubicin in Treating Older Patients With Previously Untreated AML or MDS

Completed·FFred Hutchinson Cancer Center·Phase 1/2·NCT01141725·39 enrolled

Efficacy and Safety1 trial

A Study to Evaluate the Efficacy and Safety of Bendamustine Hydrochloride Injection

Completed· Chia Tai Tianqing Pharmaceutical Group Co., Ltd. logo

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Phase 2·NCT04569838·91 enrolled

T-cell non-Hodgkin lymphoma1 trial

CPI-613 and Bendamustine Hydrochloride in Treating Patients With Relapsed or Refractory T-Cell Non-Hodgkin Lymphoma or Hodgkin Lymphoma

Completed·WWake Forest University Health Sciences·Phase 1·NCT02168140·16 enrolled

B-cell Lymphoma1 trial

Bendamustine Versus Fludarabine/Cyclophosphamide for Lymphodepletion in CAR-T Therapy: a Randomized Trial

Recruiting·SSwiss Cancer Institute·Phase 2·NCT07593482·92 enrolled

B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma1 trial

Phase I Study to Evaluate Cellular Immunotherapy Using Memory-Enriched T Cells Lentivirally Transduced to Express a CD19-Specific, Hinge-Optimized, CD28-Costimulatory Chimeric Receptor and a Truncated EGFR Following Lymphodepleting Chemotherapy in Adult Patients With CD19+ B-Cell Lymphoproliferative Neoplasms

Active, not recruiting·CCity of Hope Medical Center·Phase 1·NCT02153580·37 enrolled

Stage I Chronic Lymphocytic Leukemia1 trial

A Randomized Phase III Study of Bendamustine Plus Rituximab Versus Ibrutinib Plus Rituximab Versus Ibrutinib Alone in Untreated Older Patients (≥ 65 Years of Age) With Chronic Lymphocytic Leukemia (CLL)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT01886872·547 enrolled

Liver Lymphoma1 trial

A Randomized 3-Arm Phase II Study Comparing 1.) Bendamustine, Rituximab and High Dose Cytarabine (BR/CR) 2.) Bendamustine, Rituximab, High Dose Cytarabine and Acalabrutinib (BR/CR-A), and 3.) Bendamustine, Rituximab and Acalabrutinib (BR-A) in Patients </= 70 Years Old With Untreated Mantle Cell Lymphoma

Active, not recruiting·EECOG-ACRIN Cancer Research Group·Phase 2·NCT04115631·360 enrolled

Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue1 trial

A Phase I, Dose-escalation Trial of Rituxan and Bendamustine in Combination With Bruton's Tyrosine Kinase Inhibitor, PCI-32765, in Patients With Relapsed Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, or Indolent Non-Hodgkin's Lymphoma

Active, not recruiting·KKami Maddocks, MD·Phase 1·NCT01479842·48 enrolled

Grade 1 Follicular Lymphoma1 trial

Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03269669·73 enrolled

Recurrent Follicular Lymphoma1 trial

A Phase II Study of Brentuximab Vedotin Plus Bendamustine for Relapsed/Refractory Follicular Lymphoma

Recruiting·JJoseph Tuscano·Phase 2·NCT04587687·23 enrolled

Classical Hodgkin Lymphoma1 trial

Phase 2 Study Evaluating the Safety and Efficacy of Pembrolizumab (KEytruda) in Combination With Bendamustine (TREanda) in Relapsed/Refractory Hodgkin Lymphoma

Recruiting·UUniversity Health Network, Toronto·Phase 2·NCT04510636·40 enrolled

Regulatory

FDA Approval Timeline[4]

Jun 23, 2016

BENDEKA

NDA NDA208194

Jun 23, 2016

BENDEKA

NDA NDA208194

Sep 23, 2016

BENDEKA

NDA NDA208194

Feb 6, 2017

BENDEKA

NDA NDA208194

Feb 9, 2017

BENDEKA

NDA NDA208194

May 15, 2018

BELRAPZO

NDA NDA205580

Jul 30, 2018

BENDEKA

NDA NDA208194

Aug 31, 2018

BELRAPZO

NDA NDA205580

Oct 8, 2019

BENDEKA

NDA NDA208194

Oct 30, 2019

BELRAPZO

NDA NDA205580

Nov 8, 2019

BENDEKA

NDA NDA208194

Oct 14, 2021

BENDEKA

NDA NDA208194

Oct 14, 2021

BELRAPZO

NDA NDA205580

Jun 2, 2022

BELRAPZO

NDA NDA205580

Dec 7, 2022

VIVIMUSTA

NDA NDA212209

Dec 7, 2022

BENDAMUSTINE HYDROCHLORIDE

NDA NDA215033

Dec 7, 2022

BENDAMUSTINE HYDROCHLORIDE

NDA ANDA205574

Dec 15, 2022

BENDAMUSTINE HYDROCHLORIDE

NDA NDA216078

May 15, 2023

VIVIMUSTA

NDA NDA212209

Jun 5, 2023

BENDAMUSTINE HYDROCHLORIDE

NDA ANDA214739

Jan 11, 2024

BENDEKA

NDA NDA208194

Jan 11, 2024

BELRAPZO

NDA NDA205580

Feb 8, 2024

VIVIMUSTA

NDA NDA212209

Feb 26, 2024

BENDAMUSTINE HYDROCHLORIDE

NDA NDA216078

Feb 27, 2024

VIVIMUSTA

NDA NDA212209

Apr 15, 2024

BENDAMUSTINE HYDROCHLORIDE

NDA NDA215033

Jul 3, 2025

GOBARDEN

NDA NDA219014

Sep 25, 2026

GOBARDEN

NDA NDA219014

Sources

References

[1]
ClinicalTrials.gov — 46 trial records for bendamustine hydrochloride. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — bendamustine hydrochloride compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for bendamustine hydrochloride. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA219014). U.S. Food & Drug Administration.
[5]
SEC EDGAR — SymBio Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: SSymBio Pharmaceuticals

bendamustine hydrochloride

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q3 2027

Trials by Indication[1]

Lymphoma9 trials

Chronic Lymphocytic Leukemia7 trials

Multiple Myeloma5 trials

Mantle Cell Lymphoma3 trials

Diffuse Large B-Cell Lymphoma2 trials

Haploidentical Stem Cell Transplantation1 trial

Glioma1 trial

Conditioning1 trial

Lymphoid Malignancies1 trial

Relapsed or Refractory1 trial

Safety and Efficacy1 trial

Myeloid Malignancies1 trial

Amyloidosis1 trial

Small Cell Lung Cancer1 trial

Older Patients1 trial

Efficacy and Safety1 trial

T-cell non-Hodgkin lymphoma1 trial

B-cell Lymphoma1 trial

B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma1 trial

Stage I Chronic Lymphocytic Leukemia1 trial

Liver Lymphoma1 trial

Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue1 trial

Grade 1 Follicular Lymphoma1 trial

Recurrent Follicular Lymphoma1 trial

Classical Hodgkin Lymphoma1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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