bendamustine

Trade name: treanda

Small moleculeapprovedOrphan Drug FDA

Approved

Mar 20, 2008

Bendamustine, brand name Treanda, is a chemotherapeutic agent that displays a unique pattern of cytotoxicity compared with conventional alkylating agents. Treanda is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL), in addition Trenda in phase III of clinical trial for the treatment patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Bendamustine is a bifunctional mechlorethamine derivative. Mechlorethamine and its derivatives dissociate into electrophilic alkyl groups. These groups form covalent bonds with electron-rich nucleophilic moieties. The bifunctional covalent linkage can lead to cell death via several pathways. The exact mechanism of action of bendamustine remains unknown. Molecular analyses have revealed that bendamustine differs from other alkylating agents in its mechanism of action. Differences have been observed about its effects on DNA repair and cell cycle progression. Moreover, bendamustine can induce cell death through both apoptotic and nonapoptotic pathways, thereby retaining activity even in cells without a functional apoptotic pathway. Bendamustine possesses the typical adverse reactions for the nitrogen mustards, and include nausea, fatigue, vomiting, diarrhea, fever, constipation, loss of appetite, cough, headache, unintentional weight loss. — NCATS

Clinical trial activity

376 trials · 304 clinical orgs · 23 marketing orgs

Phase 1
126
Phase 2
295
Phase 3
77
Phase 4
4

Earliest trial started Feb 1, 2001 (NCT00168922)

Timeline

2000s

  1. Jan 1, 2001

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2003

    Earliest Phase 3 Sponsor(trial)

  3. Jul 1, 2003

    Cephalon — IND Organization

  4. Jul 1, 2003

    Cephalon — IND Organization

  5. Jan 1, 2005

    Earliest Phase 1 Sponsor(trial)

  6. Aug 17, 2007

    Orphan Drug Designation

  7. Mar 20, 2008

    Cephalon — Earliest FDA Approval

  8. Mar 20, 2008

    Cephalon — NDA Organization

2010s

  1. Dec 7, 2015

    Eagle Pharmaceuticals, Inc. — NDA Secondary Org

  2. Aug 18, 2017

    Apotex — Marketing Organization

  3. Jun 15, 2018

    Hospira — Marketing Organization

  4. Jun 15, 2018

    InnoPharma — Marketing Organization

  5. Jun 15, 2018

    Pfizer — Marketing Organization

  6. Nov 13, 2018

    Fresenius — Marketing Organization

  7. Jan 25, 2019

    Capstone Therapeutics — Marketing Organization

  8. Feb 20, 2019

    Accord Research — Marketing Organization

  9. Feb 20, 2019

    Glenmark Pharmaceuticals — Marketing Organization

  10. Feb 20, 2019

    Mylan — Marketing Organization

  11. Feb 20, 2019

    Esteve Labs — Marketing Organization

2020s

  1. Jul 2, 2020

    Slayback Pharma Llc — Marketing Organization

  2. Oct 8, 2020

    Dr. Reddy's Laboratories — Marketing Organization

  3. Jan 26, 2021

    Nang Kuang Pharmaceutical Co., Ltd. — Marketing Organization

  4. Nov 12, 2021

    Dr. Reddy's Laboratories — NDA Secondary Org

  5. Mar 18, 2022

    Eugia Pharma — Marketing Organization

  6. Dec 7, 2022

    Apotex — NDA Secondary Org

  7. Dec 7, 2022

    Slayback Pharma Llc — NDA Secondary Org

  8. Dec 7, 2022

    Azurity — Marketing Organization

  9. Dec 15, 2022

    Baxalta — Marketing Organization

  10. Dec 15, 2022

    Takeda — NDA Secondary Org

  11. Dec 15, 2022

    Pfizer — NDA Secondary Org

  12. Apr 28, 2023

    PHARMOBEDIENT — Marketing Organization

  13. Jun 5, 2023

    KINDOS — Marketing Organization

  14. Jun 5, 2023

    Meitheal — Marketing Organization

  15. Jul 3, 2025

    AVYXA HOLDINGS — Marketing Organization

Indications

Studied for

Mechanism of action

  • DNAINHIBITOR

    DNA inhibitor

Approval history

  • approvedPriority reviewMar 20, 2008

Chemistry & pharmacology

Loading structure…

SMILES

Cn1c(CCCC(=O)O)nc2cc(N(CCCl)CCCl)ccc21
Mol. weight
358.27 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • bendamustine
  • bendamustine
  • bendamustine
  • bendamustine
  • bendamustine
  • bendamustine
  • bendamustine
  • bendamustine
  • bendamustine
  • bendamustine
  • bendamustine hcl
  • bendamustine hcl
  • bendamustine hcl
  • bendamustine hydrochloride
  • bendamustine hydrochloride
  • bendamustine hydrochloride
  • bendamustine hydrochloride
  • bendamustine hydrochloride
  • levact
  • levact
  • ribomustine
  • ribomustine
  • ribomustine
  • sdx-105
  • sdx-105
  • treanda
  • treanda
  • treanda
  • treanda

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07225985Phase 1/Phase 2 (Phase 2)May 1, 2026University of Washington
NCT07259122Phase 2Dec 30, 2025China Academy of Chinese Medical Sciences
NCT07206264Phase 2Oct 31, 2025Tianjin Medical University
NCT07189065Phase 2Sep 30, 2025Guangzhou Lupeng Pharmaceutical Company LTD.
NCT07139873Phase 3Sep 8, 2025Dizal (Jiangsu) Pharmaceutical Co., Ltd.
NCT07169565Phase 1Sep 1, 2025China Academy of Chinese Medical Sciences
NCT06854003Phase 2Aug 31, 2025BeOne Medicines, Harvard University
NCT07208981Phase 2Aug 14, 2025Nanjing Medical University
NCT07126678N/AJul 15, 2025Nanjing Medical University
NCT07003464Phase 2Jun 15, 2025Jinlin University
NCT06970743Phase 3May 29, 2025BeOne Medicines
NCT06961500Phase 2May 1, 2025Sun Yat-Sen University
NCT06942507N/AMay 1, 2025Chinese Academy of Medical Sciences
NCT06846671Phase 3Apr 11, 2025BeOne Medicines
NCT06757894Phase 2Feb 1, 2025Gansu Provincial Hospital, Guangzhou Medical University, Sun Yat-Sen University
NCT06561347Phase 2Jan 31, 2025BeOne Medicines, Harvard University
NCT06522737Phase 3Dec 31, 2024Secura
NCT06557330Phase 2Dec 31, 2024Adaptive Biotechnologies, Temple University
NCT06761911Phase 4Dec 31, 2024Dalian Medical University
NCT06563245Phase 2/Phase 3 (Phase 3)Sep 25, 2024Anhui Medical University, Central South University, Children's Cancer Group, China, Hebei University, Huazhong University of Science and Technology, Jiao Tong University, Shandong University, Sichuan University, Sun Yat-Sen University, Tianjin Medical University, Tongji University, Zhengzhou University
Showing 20 of 376 trials
Page 1 / 19

Organizations

Research & Development (304)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
CephalonFor profit35832003
National Cancer Institute (NCI)Government30932008
RocheFor profit241542008
MundipharmaFor profit20122001
CelgeneFor profit18332009
University of Texas at HoustonAcademic/Hospital181432008
GenentechFor profit14532009
German CLL Study GroupAcademic/Hospital121122004
Fondazione Italiana Diabete OnlusAcademic/Hospital101022009
SymBio PharmaceuticalsFor profit101022006
AbbVieFor profit9332009
Bristol-Myers SquibbFor profit9432009
NovartisFor profit9532010
University of WashingtonAcademic/Hospital9822008
GlaxoSmithKlineFor profit8032010
Johnson and JohnsonFor profit8322011
Columbia UniversityAcademic/Hospital7622012
Mayo ClinicAcademic/Hospital7332010
National Comprehensive Cancer NetworkAcademic/Hospital7022008
Pavlov First Saint Petersburg State Medical UniversityAcademic/Hospital7712016
304 organizations
Page 1 / 16

Marketing (33)

OrganizationOrg typeRelationshipDate
AVYXA HOLDINGSFor profitMKTGJul 3, 2025
Accord ResearchFor profitMKTGFeb 20, 2019
ApotexFor profitMKTGAug 18, 2017
ApotexFor profitSYNDec 7, 2022
ApotexFor profitNDA2Dec 7, 2022
AzurityFor profitMKTGDec 7, 2022
BaxaltaFor profitMKTGDec 15, 2022
Capstone TherapeuticsFor profitMKTGJan 25, 2019
CephalonFor profitNDAMar 20, 2008
CephalonFor profitINDJul 1, 2003
Dr. Reddy's LaboratoriesFor profitSYNDec 7, 2022
Dr. Reddy's LaboratoriesFor profitMKTGOct 8, 2020
Dr. Reddy's LaboratoriesFor profitNDA2Nov 12, 2021
Eagle Pharmaceuticals, Inc.For profitNDA2Dec 7, 2015
Esteve LabsFor profitMKTGFeb 20, 2019
Esteve LabsFor profitSYNFeb 14, 2023
Eugia PharmaFor profitMKTGMar 18, 2022
Eugia PharmaFor profitSYNJun 5, 2023
FreseniusFor profitMKTGNov 13, 2018
Glenmark PharmaceuticalsFor profitMKTGFeb 20, 2019
HospiraFor profitMKTGJun 15, 2018
HospiraFor profitSYNJan 29, 2019
InnoPharmaFor profitMKTGJun 15, 2018
KINDOSFor profitMKTGJun 5, 2023
MeithealFor profitMKTGJun 5, 2023
MylanFor profitMKTGFeb 20, 2019
Nang Kuang Pharmaceutical Co., Ltd.For profitMKTGJan 26, 2021
PHARMOBEDIENTFor profitMKTGApr 28, 2023
PfizerFor profitNDA2Dec 15, 2022
PfizerFor profitMKTGJun 15, 2018
Slayback Pharma LlcFor profitMKTGJul 2, 2020
Slayback Pharma LlcFor profitNDA2Dec 7, 2022
TakedaFor profitNDA2Dec 15, 2022