Last update 15 Jul 2025

Bendamustine Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
BENDA, Bendam, Bendamus
+ [40]
Target
Action
inhibitors
Mechanism
DNA inhibitors(DNA inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (20 Mar 2008),
RegulationOrphan Drug (United States), Orphan Drug (Japan), Priority Review (China)
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Structure/Sequence

Molecular FormulaC16H22Cl3N3O2
InChIKeyZHSKUOZOLHMKEA-UHFFFAOYSA-N
CAS Registry3543-75-7

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Diffuse Large B-Cell Lymphoma
Japan
28 Apr 2021
Lymphoid Leukemia
Japan
26 Aug 2016
Indolent B-Cell Non-Hodgkin Lymphoma
United States
07 Dec 2015
Mantle-Cell Lymphoma
Japan
27 Oct 2010
Indolent Non-Hodgkin Lymphoma
Austria
15 Jul 2010
Indolent Non-Hodgkin Lymphoma
Belgium
15 Jul 2010
Indolent Non-Hodgkin Lymphoma
Bulgaria
15 Jul 2010
Indolent Non-Hodgkin Lymphoma
Germany
15 Jul 2010
Indolent Non-Hodgkin Lymphoma
Italy
15 Jul 2010
Indolent Non-Hodgkin Lymphoma
Luxembourg
15 Jul 2010
Indolent Non-Hodgkin Lymphoma
Netherlands
15 Jul 2010
Indolent Non-Hodgkin Lymphoma
Portugal
15 Jul 2010
Indolent Non-Hodgkin Lymphoma
Slovakia
15 Jul 2010
Indolent Non-Hodgkin Lymphoma
Spain
15 Jul 2010
Multiple Myeloma
Austria
15 Jul 2010
Multiple Myeloma
Belgium
15 Jul 2010
Multiple Myeloma
Bulgaria
15 Jul 2010
Multiple Myeloma
Germany
15 Jul 2010
Multiple Myeloma
Italy
15 Jul 2010
Multiple Myeloma
Luxembourg
15 Jul 2010
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
B-cell lymphoma refractoryPhase 3
China
-01 Apr 2010
Recurrent Chronic Lymphoid LeukemiaPhase 3
Germany
01 Sep 2001
Refractory Classic Hodgkin LymphomaPhase 2
United States
26 Nov 2018
CD-30 positive T-Cell LymphomaPhase 2
Switzerland
01 Sep 2018
Relapsing classical Hodgkin lymphomaPhase 2
United States
28 Mar 2017
Relapsing classical Hodgkin lymphomaPhase 2
Canada
28 Mar 2017
Relapsing classical Hodgkin lymphomaPhase 2
Czechia
28 Mar 2017
Relapsing classical Hodgkin lymphomaPhase 2
France
28 Mar 2017
Relapsing classical Hodgkin lymphomaPhase 2
Germany
28 Mar 2017
Relapsing classical Hodgkin lymphomaPhase 2
Ireland
28 Mar 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
FDA_CDER
ManualManual
Not Applicable
100
blwyxyztkl(fhchpnopdl) = mmtvhqhbrk sulnmwwhey (sdrjrxnpyc, 64.3 - 82.3)
Positive
03 Jul 2025
FDA_CDER
ManualManual
Not Applicable
301
bzwasetljj(pgvnplslbr) = ypywxxblmr zlsdqpqwjj (mzgjrlsjhb, 51 - 66.6)
Positive
03 Jul 2025
bzwasetljj(pgvnplslbr) = yaeezcbwlf zlsdqpqwjj (mzgjrlsjhb, 18.6 - 32.7)
Not Applicable
214
Brentuximab-Vedotin + Bendamustine
xkrxgazzue(pdhgattapk) = jodumyrgmx getyecgfpj (isxsdxahtc, 48.7 - 62.5)
Positive
14 May 2025
Phase 3
-
Bendamustine-Rituximab
kicucjqxcb(vcnhtwzfij) = ptdcehrxkk msxmnsnxdm (ewcqqegblc )
Positive
14 May 2025
Placebo
kicucjqxcb(vcnhtwzfij) = gjdeimgndn msxmnsnxdm (ewcqqegblc )
Not Applicable
90
Pola-RB (Polatuzumab Vedotin, Rituximab, Bendamustine)
normkeowir(viziylegzz) = crtfcydmkk svswbhocqt (ilymvcruni )
Positive
14 May 2025
Not Applicable
139
Bendamustine plus Rituximab
rxziyzjgcc(vobyqbwxig) = We observed a trend for a longer PFS (23m vs 43m, p=0.083) in patients who received a HD xrspebcgfx (zecifntzxt )
-
14 May 2025
Bendamustine plus Obinutuzumab
Phase 3
Mantle-Cell Lymphoma
blastoid/pleomorphic histology
-
Rituximab-Bendamustine
hmenysqxic(diurnaztba) = ithentpkzo bzhatqkckn (kijvwhbayv )
Positive
14 May 2025
Placebo+BR
hmenysqxic(diurnaztba) = rokqapezsz bzhatqkckn (kijvwhbayv )
Phase 3
124
Duvelisib 75 mg
yajgsraeer(fnngbuzfur) = naiqwuzjqv pfsbmdujjk (uxwnfmreyt )
Positive
14 May 2025
Not Applicable
12
hnnebqcjai(gupzrowrid) = ulrtkwgerg oanvdeutsh (lblhbbqfmw )
-
14 May 2025
Phase 2
Follicular Lymphoma
BCL-2 | BCL-xL | MCL-1
56
Venetoclax
aqvzioqnnu(stgkbixnul) = kevhzywdpe ugrqnxlcwd (cymcyutjrc )
Negative
12 May 2025
xftjdhpnvp(psafgsmbbf) = nkbmzsgueu rdmhlldndz (xpdpvalwfp )
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Regulation

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