TheraRadar
Data updated: May 26, 2026

VIVIMUSTA (bendamustine hydrochloride)

Oncology Approved 2022-12-07

VIVIMUSTA is indicated for the treatment of Chronic Lymphocytic Leukemia; Non-Hodgkin Lymphoma.

Source: FDA Label • AZURITY
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How VIVIMUSTA Works

Bendamustine is a bifunctional mechlorethamine derivative containing a purine-like benzimidazole ring. It works by forming electrophilic alkyl groups that create covalent bonds with electron-rich nucleophilic moieties, resulting in interstrand DNA crosslinks. This process disrupts the genetic material in both quiescent (resting) and dividing cells, triggering cell death through multiple pathways. While its exact mechanism of action is not fully understood, its bifunctional alkylating activity is the primary driver of its antineoplastic effect.

Source: FDA Label
1
Indication
--
Phase 3 Trials
3
Years on Market

Details

Status
Prescription
First Approved
2022-12-07
Patent Cliff
2042

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Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

AZURITY
Active Ingredient: BENDAMUSTINE HYDROCHLORIDE

VIVIMUSTA Approval History

2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2022 to 2024
Feb 2024 SUPPL
Label · Labeling
FDA Letter Label
Feb 2024 SUPPL
Label · Labeling
FDA Letter Label
May 2023 SUPPL
Label · Labeling
FDA Letter

What VIVIMUSTA Treats

2 indications

VIVIMUSTA is approved for 2 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Chronic Lymphocytic Leukemia
  • Non-Hodgkin Lymphoma
Source: FDA Label

VIVIMUSTA Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

IDELALISIB
NATCO
2026 3 indic.
PLERIXAFOR
GLAND
2023 2 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in VIVIMUSTA's indications

See all emerging drugs →

Phase 3 candidates targeting molecules with no FDA-approved drug, in indications VIVIMUSTA treats. First-in-class if their pivotal trials read out positive.

Ceralasertib AZD6738 ~ Mixed — Ph3 readout
AstraZeneca
ATR · small-molecule ATR kinase inhibitor · 2 Phase 3 trials
Tiragolumab MTIG7192A / RG6058 ~ Mixed — Ph3 readout
Hoffmann-La Roche
TIGIT · monoclonal antibody (anti-TIGIT) · 10 Phase 3 trials

Drugs Similar to VIVIMUSTA

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

BELRAPZO
BENDAMUSTINE HYDROCHLORIDE
2 shared
EAGLE PHARMS
Shared indications:
Chronic Lymphocytic LeukemiaNon-Hodgkin Lymphoma
BENDEKA
BENDAMUSTINE HYDROCHLORIDE
2 shared
EAGLE PHARMS
Shared indications:
Chronic Lymphocytic LeukemiaNon-Hodgkin Lymphoma
IDELALISIB
IDELALISIB
2 shared
NATCO
Shared indications:
Chronic Lymphocytic LeukemiaNon-Hodgkin Lymphoma
View all 20 similar drugs Pro
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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 not yet recruiting Bendamustine Versus Fludarabine/Cyclophosphamide for Lymphodepletion in Chimeric Antigen Receptor T-cell Immunotherapy (CAR-T): a Randomized Trial.
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Key Completed Trials

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Trial Timeline

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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.

VIVIMUSTA FDA Label Details

Indications & Usage

FDA Label (PDF)

VIVIMUSTA is indicated for the treatment of Chronic Lymphocytic Leukemia; Non-Hodgkin Lymphoma.

View full patent landscape →
4 OB patents · 1 families · 8 international docs across 1 countries

VIVIMUSTA Patents & Exclusivity

Latest Patent: Jul 2042

Patents (4 active)

US12419867 Expires Jul 29, 2042
US12208086 Expires Jul 29, 2042
US11844784 Expires Jul 29, 2042
US11707450 Expires Jul 29, 2042
Source: FDA Orange Book

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Patent Timeline

  • • Cliff: 2042
  • • 4 active patents

Trial Analysis

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  • • Development stage analysis

Competitive Landscape

  • • 20 similar drugs
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA212209 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.