Data updated: Nov 8, 2026
GOBARDEN (bendamustine hydrochloride) · AVYXA HOLDINGS
Approved 2025-07-03
GOBARDEN is FDA-approved to treat 2 conditions (same as BELRAPZO).
1
Indication
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Phase 3 Trials
1
Years on Market
Details
- Status
- Prescription
- First Approved
- 2025-07-03
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
GOBARDEN Approval History
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2025 to 2026
What GOBARDEN Treats
2 indicationsGOBARDEN is approved for 2 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
Same approved indications as BELRAPZO (same active ingredient).
Source: FDA Label
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Clinical Trial Registry
40 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 |
| 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 |
| 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 |
| 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 |
| NCT01286272 results posted | NCI-2011-02625 NCI-2011-02625, CALGB-50904 | Ph 2 | completed | Ofatumumab and Bendamustine Hydrochloride With or Without Bortezomib in Treating Patients With Untreated Follicular Non-Hodgkin Lymphoma |
| NCT02153580 | 13351 NCI-2014-01168, 114025 | Ph 1 | active not recruiting | Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia |
| NCT02224729 results posted | 14D.300 2014-025, JT 6192 | Ph 2 | completed | Bendamustine Hydrochloride, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma |
| NCT04587687 | UCDCC#284 NCI-2020-06645, UCDCC#284 | Ph 2 | recruiting | Brentuximab Vedotin and Bendamustine for the Treatment of Relapsed or Refractory Follicular Lymphoma |
| NCT04943302 | 00001665 | Ph 2 | withdrawn | Isatuximab and Bendamustine in Systemic Light Chain Amyloidosis |
| NCT04943757 PTBCy | 05/21-n | Ph 2 | completed | Post-transplantation Benadamustine and Cyclophosphamide in Patients With Refractory Myeloid Malignancies |
| NCT01664910 results posted | 2012-0265 NCI-2012-02072, 2012-0265 | Ph 1, Ph 2 | completed | CMC-544 and Allogeneic Transplantation for CD22 Positive-Lymphoid Malignancies |
| NCT06477549 | 14/24-n | Ph 2 | recruiting | BeFluBu vs FluBuRux Conditioning in Haploidentical HCT |
| NCT04942730 FluBuBe | 06/21-n | Ph 2 | completed | Benadamustine, Fludarabine and Busulfan Conditioning in Recipients of Haploidentical Stem Cell Transplantation (FluBuBe) |
| NCT04510636 | KEsTREL-01 CAPCR 20-5231 | Ph 2 | recruiting | Study of Pembrolizumab With Bendamustine in Hodgkin Lymphoma |
| NCT02168140 | IRB00028206 NCI-2014-01281, CCCWFU 28314 | Ph 1 | completed | CPI-613 and Bendamustine Hydrochloride in Treating Patients With Relapsed or Refractory T-Cell Non-Hodgkin Lymphoma or Hodgkin Lymphoma |
| NCT01596621 results posted | C18083/3076 | Ph 3 | completed | A Study of Bendamustine in the Treatment of Chinese Participants With Indolent Non-Hodgkin Lymphoma Refractory to Rituximab Treatment |
| NCT01535924 results posted | OSU-11015 NCI-2012-00022 | Ph 1, Ph 2 | completed | Gemcitabine and Bendamustine in Patients With Relapsed or Refractory Hodgkin's Lymphoma |
| NCT01412879 results posted | CDR0000707601 S1106, U10CA032102 | Ph 2 | completed | 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 |
| NCT03259529 BeGeRN | DLBCL BeGeRN 1/2 | Ph 1, Ph 2 | completed | Safety and Efficacy of Bendamustine, Gemcitabine, Rituximab, Nivolumab (BeGeRN) in Patients With r/r DLBCL |
| NCT04913103 CLSGMCLPOLA | CLSG-MCL-POLA | Ph 2 | not yet recruiting | Study of PV in Combination With Bendamustine and Rituximab for Patients With R/R MCL |
| NCT02095834 | 2012-0162 NCI-2014-00884, 2012-0162 | Ph 1 | completed | Carfilzomib, Bendamustine Hydrochloride, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma |
| NCT03343652 NB001 | 10/17-n | Ph 1, Ph 2 | completed | A Study of Safety and Efficacy of Nivolumab and Bendamustine (NB) in Patients With Relapsed/Refractory Hodgkin's Lymphoma |
| NCT01611090 results posted | CR100840 PCI-32765CLL3001, 2012-000600-15 | Ph 3 | completed | A Study of Ibrutinib in Combination With Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma |
| NCT01049945 results posted | MMRC-020-021 NCI-2009-01535, MMRC-020-021 | Ph 1, Ph 2 | completed | Bendamustine Hydrochloride, Lenalidomide, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma |
| NCT01326702 results posted | NCI-2011-02583 NCI-2011-02583, CDR0000697580 | Ph 1, Ph 2 | completed | Veliparib, Bendamustine Hydrochloride, and Rituximab in Treating Patients With Relapsed or Refractory Lymphoma, Multiple Myeloma, or Solid Tumors |
| NCT00987493 | SAKK 38/08 SWS-SAKK-38/08, 2009-012559-67 | Ph 1, Ph 2 | completed | Rituximab, Bendamustine Hydrochloride, and Lenalidomide in Treating Patients With Aggressive B-Cell Lymphoma |
| NCT02240719 | 637004 637004, CRAD001NUS235T | Ph 1 | completed | Everolimus and Bendamustine Hydrochloride in Treating Patients With Relapsed or Refractory Hematologic Cancer |
| NCT01165112 TREC results posted | PSOC 2502 NCI-2010-00907, PSOC 2502 | Ph 1, Ph 2 | completed | Bendamustine Hydrochloride, Rituximab, Etoposide, and Carboplatin in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma or Hodgkin Lymphoma |
| NCT02168907 | IRB00027759 NCI-2014-01280, CCCWFU 28114 | Ph 1 | terminated | CPI-613, Bendamustine Hydrochloride, and Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma |
| NCT02420210 results posted | IRB14-1120 NCI-2015-00355, IRB14-1120 | Ph 2 | terminated | Bendamustine, Obinutuzumab, and Dexamethasone in Older Patients With Diffuse Large B-cell Lymphoma |
| NCT01369849 results posted | NCI-2011-02675 NCI-2011-02675, CDR0000701372 | Ph 1, Ph 2 | completed | Akt Inhibitor MK2206, Bendamustine Hydrochloride, and Rituximab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma |
| NCT01141725 results posted | 2413.00 NCI-2010-01253, K12CA076930 | Ph 1, Ph 2 | completed | Bendamustine and Idarubicin in Treating Older Patients With Previously Untreated AML or MDS |
| NCT00823797 results posted | 6803 NCI-2010-00714, 6803 | Ph 2 | completed | Bendamustine Hydrochloride in Treating Patients With Recurrent or Progressive Anaplastic Glioma |
| NCT01110135 results posted | 7176 NCI-2010-00509 | Ph 2 | completed | Bendamustine Hydrochloride, Etoposide, Dexamethasone, and Filgrastim For Peripheral Blood Stem Cell Mobilization in Treating Patients With Refractory or Recurrent Lymphoma or Multiple Myeloma |
| NCT00939328 | S0902 S0902, U10CA032102 | Ph 2 | withdrawn | S0902 Bendamustine and Rituximab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia That Has Not Responded to Previous Treatment |
| NCT00984542 results posted | VICC THO 0920 P30CA068485, VU-VICC-THO-0920 | Ph 2 | completed | Bendamustine as Second-Line Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer |
| NCT00947388 | CASE1907 NCI-2010-00272 | Ph 1 | terminated | Bendamustine Plus Alemtuzumab for Refractory Chronic Lymphocytic Leukemia (CLL) |
| NCT01238146 | NCI-2011-02536 OSU-10040, U01CA076576 | Ph 1, Ph 2 | withdrawn | Obatoclax Mesylate, Rituximab, and Bendamustine Hydrochloride in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma |
| NCT01108341 results posted | C18083/2048 2009-016725-34 | Ph 2 | completed | 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) |
| NCT07593482 FC-BALANCE | SCI-003_FC-BALANCE 2026-525792-36-00, U1111-1335-8513 | Ph 2 | recruiting | Bendamustine Versus Fludarabine/Cyclophosphamide for Lymphodepletion in Chimeric Antigen Receptor T-cell Immunotherapy (CAR-T): a Randomized Trial. |
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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.
GOBARDEN FDA Label Details
Indications & Usage
FDA Label (PDF)GOBARDEN is FDA-approved to treat 2 conditions — same approved indications as BELRAPZO.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.