Data updated: May 26, 2026
BENDAMUSTINE HYDROCHLORIDE
Trial Activity: Stable 60 active trials
Oncology
Approved 2022-12-07
Development Insights
Hoffmann-La Roche conducting 15 trials (7%)
213 indications explored (Broad Platform)
→ chronic lymphocytic leukemia (32 trials)
→ multiple myeloma (23 trials)
→ lymphoma (21 trials)
7
Indications
--
Phase 3 Trials
3
Years on Market
Details
- Status
- None (Tentative Approval)
- First Approved
- 2022-12-07
- Routes
- INTRAVENOUS, IV (INFUSION)
- Dosage Forms
- SOLUTION, POWDER
Companies
Dr. Reddy's PHARMOBEDIENT Apotex AVYXA HOLDINGS GLENMARK PHARMS LTD NANG KUANG PHARM CO MEITHEAL ACCORD HLTHCARE CELERITY PHARMS Fresenius Kabi EUGIA PHARMA Pfizer Baxter BRECKENRIDGE
Active Ingredient: BENDAMUSTINE HYDROCHLORIDE
Website: ↗
BENDAMUSTINE HYDROCHLORIDE Approval History
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
27 FDA actions from 2022 to 2025
Jun 2023 ORIGINAL
Update
Apr 2023 ORIGINAL
Update
Feb 2023 ORIGINAL
Update
What BENDAMUSTINE HYDROCHLORIDE Treats
7 FDA approvalsOriginally approved for its first indication in 2022 . Covers 7 distinct patient populations.
- Other (7)
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Clinical Trial Registry
247 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03269669 | NCI-2017-00009 NCI-2017-00009, S1608 | Ph 2 | active not recruiting | Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma |
| NCT02970318 results posted | ACE-CL-309 2015-004454-17 | Ph 3 | active not recruiting | A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL |
| NCT06846671 CaDAnCe-302 | BGB-16673-302 2024-518893-15-00 | Ph 3 | recruiting | A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors |
| NCT06970743 CaDAnCe-303 | BGB-16673-303 | Ph 3 | recruiting | A Study of BGB-16673 Compared to Investigator's Choice in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Covalent Bruton Tyrosine Kinase (BTK) Inhibitors |
| NCT07225985 | RG1125830 NCI-2025-07661, FHIRB0021079 | Ph 1, Ph 2 | recruiting | Pralatrexate With Bendamustine and Total-Body Irradiation Followed by Donor Stem Cell Transplant for the Treatment of Relapsed or Refractory T-Cell Non-Hodgkin Lymphoma |
| NCT05139017 | 2140-003 VLS-101, MK-2140-003 | Ph 2, Ph 3 | recruiting | A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003) |
| NCT06191744 EPCORE™FL-2 | M22-003 2023-506906-38-00 | Ph 3 | recruiting | Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma |
| NCT04115631 | EA4181 NCI-2019-05536, EA4181 | Ph 2 | active not recruiting | A Comparison of Three Chemotherapy Regimens for the Treatment of Patients With Newly Diagnosed Mantle Cell Lymphoma |
| NCT05848765 REFRACT | RG_22-020 | Ph 2 | recruiting | Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy |
| NCT06084936 GLOBRYTE | GO43878 | Ph 3 | recruiting | A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma |
| NCT01886872 results posted | NCI-2013-01220 NCI-2013-01220, ALLIANCE A041202 | Ph 3 | active not recruiting | Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia |
| NCT06308978 | FT819-102 | Ph 1 | recruiting | A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease |
| NCT04666038 BRUIN CLL-321 results posted | 18073 J2N-OX-JZNN, LOXO-BTK-20020 | Ph 3 | active not recruiting | Study of LOXO-305 (Pirtobrutinib) Versus Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) |
| NCT03593018 | ORACLE | Ph 3 | completed | Efficacy and Safety of Oral Azacitidine Compared to Investigator's Choice Therapy in Patients With Relapsed or Refractory AITL |
| NCT03755804 | cHOD17 NCI-2018-02924 | Ph 2 | active not recruiting | Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17 |
| NCT03623373 results posted | 201809111 | Ph 2 | completed | Acalabrutinib With Bendamustine / Rituximab Followed by Cytarabine / Rituximab for Untreated Mantle Cell Lymphoma |
| NCT03856216 results posted | 2018-0860 NCI-2019-00531, 2018-0860 | Ph 2 | terminated | Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Leukemia or Lymphoma Undergoing Stem Cell Transplantation |
| NCT01661881 results posted | 12-168 | Ph 2 | active not recruiting | Rituximab/Bendamustine + Rituximab/Cytarabine for Mantle Cell Lymphoma |
| NCT06522737 TERZO | SBI-0145-304 2024-516605-23-00 | Ph 3 | recruiting | A Study of Duvelisib Versus Gemcitabine or Bendamustine in Participants With Relapsed/Refractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype |
| NCT04673617 | AB-101-01 | Ph 1, Ph 2 | completed | AB-101 as Monotherapy and With Immunotherapy in Patients With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma |
| NCT06561347 ZEBRA | 24-294 | Ph 2 | recruiting | Zanubrutinib, Bendamustine, Rituximab Prev. Untreated WM |
| NCT07139873 | DZ2024B0002 | Ph 3 | recruiting | A Study of DZD8586 Versus Investigator's Choice in r/r CLL/SLL (TAI-SHAN6) |
| NCT01479842 | OSU-10052 NCI-2011-03293 | Ph 1 | active not recruiting | Rituxan/Bendamustine/PCI-32765 in Relapsed DLBCL, MCL, or Indolent Non-Hodgkin's Lymphoma |
| NCT04629729 | FT819-101 | Ph 1 | active not recruiting | FT819 in Subjects With B-cell Malignancies |
| NCT07477639 IMPACT-MS | TRX319-01 | Ph 1, Ph 2 | recruiting | Treatment of Participants With Primary or Secondary Progressive Multiple Sclerosis |
| NCT06313996 | CA082-011 2023-507477-18 | Ph 3 | withdrawn | A Study to Evaluate the Efficacy and Safety of Liso-cel Compared to Standard of Care in Adults With Relapsed or Refractory Follicular Lymphoma |
| NCT06483048 | MC220602 HT9425-24-1-0232, CDMRP-OC230401 | Ph 1 | recruiting | MUC1-Activated T Cells for the Treatment of Relapsed and Resistant Ovarian Cancer |
| NCT05624554 | 1026-008 2022-501481-21-00, MK-1026-008 | Ph 3 | active not recruiting | A Study of Nemtabrutinib vs Chemoimmunotherapy for Participants With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Without TP53 Aberrations (MK-1026-008, BELLWAVE-008) |
| NCT06091254 OLYMPIA-1 | R1979-HM-2298 2022-502660-20-00 | Ph 3 | recruiting | A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Adult Participants With Previously Untreated Follicular Lymphoma |
| NCT03336333 SEQUOIA results posted | BGB-3111-304 2017-001551-31, CTR20190416 | Ph 3 | active not recruiting | A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL |
| NCT04285567 CRISTALLO results posted | CO41685 2019-003327-37, 2023-504036-17-00 | Ph 3 | completed | A Study to Compare the Efficacy and Safety of a Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/ Bendamustine And Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL (17P) or TP53 Mutation |
| NCT03609593 | AAAR6357 | Ph 2 | completed | Bendamustine/Rituximab Followed by Venetoclax and Rituximab for Treatment of Chronic Lymphocytic Leukemia |
| NCT06854003 BRAZAN | 24-654 | Ph 2 | recruiting | BRAZAN: A Randomized Phase 2 Study of Bendamustine, Rituximab, Cytarabine (AraC) Induction With Zanubrutinib (BRAZAN) Followed by Zanubrutinib/Rituximab +/- Sonrotoclax Maintenance in Treatment-Naïve Mantle Cell Lymphoma |
| NCT02972840 | ACE-LY-308 2023-509354-58-00, 2015-005220-26 | Ph 3 | active not recruiting | A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL |
| NCT05551936 | BTCRC LYM20-463 | Ph 1, Ph 2 | active not recruiting | A Study of Tazemetostat With Rituximab and Abbreviated Bendamustine in the Frontline Treatment of High Tumor Burden Follicular Lymphoma |
| NCT06191887 | MC230807 NCI-2023-10077, 23-004166 | Ph 1 | recruiting | B-Cell Activating Factor Receptor (BAFFR)-Based Chimeric Antigen Receptor T-Cells With Fludarabine and Cyclophosphamide Lymphodepletion for the Treatment of Relapsed or Refractory B-cell Hematologic Malignancies |
| NCT04674813 | CC-95266-MM-001 U1111-1260-4921 | Ph 1 | completed | A Study of CC-95266 in Participants With Relapsed and/or Refractory Multiple Myeloma |
| NCT04624906 BRAWM | 3242 | Ph 2 | active not recruiting | Bendamustine, Rituximab and Acalabrutinib in Waldenstrom's Macroglobulinemia |
| NCT05023980 BRUIN CLL-313 | 18088 J2N-OX-JZNP, LOXO-BTK-20023 | Ph 3 | active not recruiting | A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) |
| NCT05508867 | 4280A-008 MK-4280A-008, 2023-503615-14-00 | Ph 2 | completed | A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Physician's Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (MK-4280A-008) |
| NCT04223765 | LCCC 1811-ATL R01CA193140-01 | Ph 1 | recruiting | Study of Kappa Chimeric Antigen Receptor (CAR) T Lymphocytes Co-Expressing the Kappa and CD28 CARs for Relapsed/Refractory Kappa+ Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. |
| NCT04022239 | 2018-0972 NCI-2019-03900, 2018-0972 | Ph 1, Ph 2 | recruiting | Bendamustine With or Without Cyclophosphamide in Preventing GVHD in Patients Undergoing Stem Cell Transplant |
| NCT06425302 GOLSEEK-2 | CA073-1022 U1111-1303-4594, 2024-511304-16 | Ph 2 | active not recruiting | A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma |
| NCT03602157 | LCCC 1606-ATL R01CA247497 | Ph 1 | active not recruiting | Study of CAR-T Cells Expressing CD30 and CCR4 for r/r CD30+ HL and CTCL |
| NCT06043713 | RG1123135 NCI-2023-06287, 20048 | Ph 1 | recruiting | Autologous CD8+ and CD4+ Transgenic T Cells Expressing High Affinity KRASG12V Mutation-Specific T Cell Receptors (FH-A11KRASG12V-TCR) in Treating Patients With Metastatic Solid Tumor Cancers With KRAS G12V Mutations |
| NCT06006117 | MARSUN | Ph 3 | recruiting | Mosunetuzumab-Lenalidomide Versus Investigator Choices in Patients With Relapsed or Refractory Marginal Zone Lymphoma |
| NCT07189065 | LP-168-CN203 | Ph 2 | recruiting | A Study of Rocbrutinib in Participants With Relapse or Refractory Non-GCB Diffuse Large B-Cell Lymphoma |
| NCT05182073 | FT576-101 | Ph 1 | completed | FT576 in Subjects With Multiple Myeloma |
| NCT06241456 | FT825-101 | Ph 1 | recruiting | FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in Advanced Solid Tumors |
| NCT03696784 | LCCC 1813-ATL K12CA120780 | Ph 1 | active not recruiting | Anti-CD19 CAR-T Cells With Inducible Caspase 9 Safety Switch for B-cell Lymphoma |
Showing 50 of 247 trials
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BENDAMUSTINE HYDROCHLORIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment