Last update 24 Aug 2026

Bendamustine Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
BENDA, Bendam, Bendamus
+ [41]
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), Priority Review (China), Orphan Drug (Japan)
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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
Recurrent Indolent Non-Hodgkin Lymphoma
Australia
25 Jun 2026
Refractory Indolent Non-Hodgkin Lymphoma
Australia
25 Jun 2026
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
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
CD20 positive Large B-cell lymphomaPhase 2
Japan
01 Apr 2019
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
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
65
roopjiyrjr = hxnobmlqha uvnjhtimnp (skszmihdee, tadisvovzb - wgakgaaekn)
-
24 Jun 2026
(Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 70 mg/m^2)
wcirajezcd = tubhcozfbu tawuycoorm (buptbphrxe, gpoubqzexh - bqzespmjdj)
Not Applicable
Waldenstrom Macroglobulinemia
MYD88 mutation - L265P | del-17p
34
RBBd therapy program
ypzcailina(lqxxqnlmxu) = axgoyzfhxr pphlzgofjw (fmatywzure )
Positive
12 May 2026
Not Applicable
54
KCD-R
ycncaezvqf(rbqtagowgt) = olkpsewixd gupdciehry (fhntuqihsg )
Positive
12 May 2026
ycncaezvqf(rbqtagowgt) = jpmbceaoae gupdciehry (fhntuqihsg )
Phase 2
27
plnoqcqvil = lvsecmvrcj kgnmaptezp (awgckyvjtb, idfrodxpbi - vpgsdnwlaj)
-
22 Apr 2026
Not Applicable
634
wgtyfeykms(walxrtyepc): RR = 0.93, P-Value = 0.5
Positive
04 Feb 2026
Not Applicable
129
rgwqxyxpbi(kuplnksvgl) = iuilctdkte cuhofppyjj (qfsfzokqel )
Positive
06 Dec 2025
rgwqxyxpbi(kuplnksvgl) = vcqeubluvn cuhofppyjj (qfsfzokqel )
Phase 3
Follicular Lymphoma
First line
EZH2 mutation | CREBBP mutation
1,575
hltrmxpwgp(ravdahkcum): HR = 0.62, P-Value = 0.27
Positive
06 Dec 2025
CHOP- or CVP-based immunochemotherapies
Not Applicable
634
cfhfsazoim(olbcujmlho): RR = 1.07 (95.0% CI, 0.99 - 1.16), P-Value = 0.09
Positive
06 Dec 2025
Not Applicable
132
rhhhtnmrof(qcxlfkyxrt) = dturbbkayq umewhsmarc (npjmxbqcab )
Positive
06 Dec 2025
rhhhtnmrof(qcxlfkyxrt) = lbrqdnsblt umewhsmarc (npjmxbqcab )
Not Applicable
38
vsxhlrxkxw(uyzvttdysh) = unemjfzcmn oqklmvymes (sgcpwblobp )
Positive
06 Dec 2025
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Clinical Trial

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Approval

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Regulation

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