bendamustine
Trade name: treanda
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
Earliest trial started Feb 1, 2001 (NCT00168922)
Timeline
2000s
- Jan 1, 2001
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2003
Earliest Phase 3 Sponsor(trial)
- Jul 1, 2003
Cephalon — IND Organization
- Jul 1, 2003
Cephalon — IND Organization
- Jan 1, 2005
Earliest Phase 1 Sponsor(trial)
- Aug 17, 2007
Orphan Drug Designation
- Mar 20, 2008
Cephalon — Earliest FDA Approval
- Mar 20, 2008
Cephalon — NDA Organization
2010s
- Dec 7, 2015
Eagle Pharmaceuticals, Inc. — NDA Secondary Org
- Aug 18, 2017
Apotex — Marketing Organization
- Jun 15, 2018
Hospira — Marketing Organization
- Jun 15, 2018
InnoPharma — Marketing Organization
- Jun 15, 2018
Pfizer — Marketing Organization
- Nov 13, 2018
Fresenius — Marketing Organization
- Jan 25, 2019
Capstone Therapeutics — Marketing Organization
- Feb 20, 2019
Accord Research — Marketing Organization
- Feb 20, 2019
Glenmark Pharmaceuticals — Marketing Organization
- Feb 20, 2019
Mylan — Marketing Organization
- Feb 20, 2019
Esteve Labs — Marketing Organization
2020s
- Jul 2, 2020
Slayback Pharma Llc — Marketing Organization
- Oct 8, 2020
Dr. Reddy's Laboratories — Marketing Organization
- Jan 26, 2021
Nang Kuang Pharmaceutical Co., Ltd. — Marketing Organization
- Nov 12, 2021
Dr. Reddy's Laboratories — NDA Secondary Org
- Mar 18, 2022
Eugia Pharma — Marketing Organization
- Dec 7, 2022
Apotex — NDA Secondary Org
- Dec 7, 2022
Slayback Pharma Llc — NDA Secondary Org
- Dec 7, 2022
Azurity — Marketing Organization
- Dec 15, 2022
Baxalta — Marketing Organization
- Dec 15, 2022
Takeda — NDA Secondary Org
- Dec 15, 2022
Pfizer — NDA Secondary Org
- Apr 28, 2023
PHARMOBEDIENT — Marketing Organization
- Jun 5, 2023
KINDOS — Marketing Organization
- Jun 5, 2023
Meitheal — Marketing Organization
- Jul 3, 2025
AVYXA HOLDINGS — Marketing Organization
Indications
Studied for
- Acquired Immunodeficiency Syndrome · Phase 2/Phase 3
- Adolescent · Phase 2/Phase 3
- Amyloidosis · Phase 2
- Anemia · Phase 2
- Anemia, Hemolytic, Autoimmune · Phase 2
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis · Phase 1
- Astrocytoma · Phase 2
- Behavior Therapy · Phase 2
- Bendamustine Hydrochloride · Phase 3
- Brain Neoplasms · Phase 2
- Breast Neoplasms · Phase 2
- Brentuximab Vedotin · Phase 2/Phase 3
- Burkitt Lymphoma · Phase 2
- Carcinoma · Phase 1
- Carcinoma, Non-Small-Cell Lung · Phase 1
- Carcinosarcoma · Phase 1
- Child · Phase 2/Phase 3
- Colorectal Neoplasms · Phase 1
- Cyclin D1 · Phase 2
- Drug-Related Side Effects and Adverse Reactions · Phase 2
- Fallopian Tube Neoplasms · Phase 1
- Fever · Phase 2
- Glioblastoma · Phase 2
- Gliosarcoma · Phase 2
- Hamartoma · Phase 1
- Hematopoietic Stem Cell Transplantation · Phase 2
- HIV Infections · Phase 2/Phase 3
- Hodgkin Disease · Phase 4
- Hyperplasia · Phase 2
- Immune System Diseases · Phase 1
- Immunoglobulin Light-chain Amyloidosis · Phase 2
- Immunoproliferative Disorders · Phase 1
- Infections · Phase 2
- Infectious Mononucleosis · Phase 2
- Intestinal Neoplasms · Phase 1/Phase 2
- Intraocular Lymphoma · Phase 2
- Leukemia · Phase 3
- Leukemia, Biphenotypic, Acute · Phase 2
- Leukemia, Hairy Cell · Phase 2
- Leukemia, Large Granular Lymphocytic · Phase 1
- Leukemia, Lymphoid · Phase 2
- Leukemia-Lymphoma, Adult T-Cell · Phase 2
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive · Phase 2
- Leukemia, Myeloid, Acute · Phase 2
- Leukemia, Plasma Cell · Phase 1
- Leukemia, Prolymphocytic · Phase 2
- Leukemia, Prolymphocytic, B-Cell · Phase 1
- Lung Neoplasms · Phase 2
- Lupus Erythematosus, Systemic · Phase 1
- Lymphadenopathy · Phase 2
- Lymphatic Diseases · Phase 2
- Lymphocytosis · Phase 2
- Lymphoma · Phase 3
- Lymphoma, B-Cell · Phase 2
- Lymphoma, B-Cell, Marginal Zone · Phase 3
- Lymphoma, Follicular · Phase 4
- Lymphoma, Large B-Cell, Diffuse · Phase 3
- Lymphoma, Large-Cell, Anaplastic · Phase 2
- Lymphoma, Large-Cell, Immunoblastic · Phase 2/Phase 3
- Lymphoma, Mantle-Cell · Phase 3
- Lymphoma, Primary Cutaneous Anaplastic Large Cell · Phase 3
- Lymphoma, T-Cell · Phase 3
- Lymphoma, T-Cell, Cutaneous · Phase 1
- Lymphoma, T-Cell, Peripheral · Phase 2
- Lymphomatoid Granulomatosis · Phase 2
- Lymphomatoid Papulosis · Phase 1
- Lymphoproliferative Disorders · Phase 2
- Metabolism · Phase 2/Phase 3
- Multiple Myeloma · Phase 3
- Mycosis Fungoides · Phase 1
- Myelodysplastic Syndromes · Phase 2
- Myeloproliferative Disorders · Phase 2
- Myositis · Phase 1
- Neoplasms · Phase 3
- Neuroblastoma · Phase 1
- Oligodendroglioma · Phase 2
- Ovarian Neoplasms · Phase 2
- Pancreatic Neoplasms · Phase 1
- Plasmacytoma · Phase 2
- Polymorphism, Genetic · Phase 2
- Positron-Emission Tomography · Phase 2/Phase 3
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma · Phase 2
- Precursor Cell Lymphoblastic Leukemia-Lymphoma · Phase 2
- Prostatic Neoplasms · Phase 1
- Radiation Oncology · Phase 2
- Renal Insufficiency, Chronic · Phase 2
- Safety · Phase 1/Phase 2
- Sarcoma · Phase 2
- Sclerosis · Phase 1
- Sezary Syndrome · Phase 2
- Small Cell Lung Carcinoma · Phase 2
- Survival · Phase 2/Phase 3
- Sweat · Phase 2
- Testicular Neoplasms · Phase 1/Phase 2
- Therapeutics · Phase 2/Phase 3
- Thrombocytopenia · Phase 2
- Translocation, Genetic · Phase 2
- Transplantation · Phase 1
- Treatment Outcome · Phase 1/Phase 2
- Waldenstrom Macroglobulinemia · Phase 2
- Weight Loss · Phase 2
- Young Adult · Phase 2/Phase 3
Mechanism of action
- DNAINHIBITOR
DNA inhibitor
Approval history
- approvedPriority reviewMar 20, 2008
Chemistry & pharmacology
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
- ChEMBLCHEMBL487253 ↗
- WikipediaBendamustine ↗
- NCATS9266D9P3PQ ↗
- ChEMBLCHEMBL1201734 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07225985 | Phase 1/Phase 2 (Phase 2) | May 1, 2026 | University of Washington |
| NCT07259122 | Phase 2 | Dec 30, 2025 | China Academy of Chinese Medical Sciences |
| NCT07206264 | Phase 2 | Oct 31, 2025 | Tianjin Medical University |
| NCT07189065 | Phase 2 | Sep 30, 2025 | Guangzhou Lupeng Pharmaceutical Company LTD. |
| NCT07139873 | Phase 3 | Sep 8, 2025 | Dizal (Jiangsu) Pharmaceutical Co., Ltd. |
| NCT07169565 | Phase 1 | Sep 1, 2025 | China Academy of Chinese Medical Sciences |
| NCT06854003 | Phase 2 | Aug 31, 2025 | BeOne Medicines, Harvard University |
| NCT07208981 | Phase 2 | Aug 14, 2025 | Nanjing Medical University |
| NCT07126678 | N/A | Jul 15, 2025 | Nanjing Medical University |
| NCT07003464 | Phase 2 | Jun 15, 2025 | Jinlin University |
| NCT06970743 | Phase 3 | May 29, 2025 | BeOne Medicines |
| NCT06961500 | Phase 2 | May 1, 2025 | Sun Yat-Sen University |
| NCT06942507 | N/A | May 1, 2025 | Chinese Academy of Medical Sciences |
| NCT06846671 | Phase 3 | Apr 11, 2025 | BeOne Medicines |
| NCT06757894 | Phase 2 | Feb 1, 2025 | Gansu Provincial Hospital, Guangzhou Medical University, Sun Yat-Sen University |
| NCT06561347 | Phase 2 | Jan 31, 2025 | BeOne Medicines, Harvard University |
| NCT06522737 | Phase 3 | Dec 31, 2024 | Secura |
| NCT06557330 | Phase 2 | Dec 31, 2024 | Adaptive Biotechnologies, Temple University |
| NCT06761911 | Phase 4 | Dec 31, 2024 | Dalian Medical University |
| NCT06563245 | Phase 2/Phase 3 (Phase 3) | Sep 25, 2024 | Anhui 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 |
Organizations
Research & Development (304)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Cephalon | For profit | 35 | 8 | 3 | 2003 |
| National Cancer Institute (NCI) | Government | 30 | 9 | 3 | 2008 |
| Roche | For profit | 24 | 15 | 4 | 2008 |
| Mundipharma | For profit | 20 | 1 | 2 | 2001 |
| Celgene | For profit | 18 | 3 | 3 | 2009 |
| University of Texas at Houston | Academic/Hospital | 18 | 14 | 3 | 2008 |
| Genentech | For profit | 14 | 5 | 3 | 2009 |
| German CLL Study Group | Academic/Hospital | 12 | 11 | 2 | 2004 |
| Fondazione Italiana Diabete Onlus | Academic/Hospital | 10 | 10 | 2 | 2009 |
| SymBio Pharmaceuticals | For profit | 10 | 10 | 2 | 2006 |
| AbbVie | For profit | 9 | 3 | 3 | 2009 |
| Bristol-Myers Squibb | For profit | 9 | 4 | 3 | 2009 |
| Novartis | For profit | 9 | 5 | 3 | 2010 |
| University of Washington | Academic/Hospital | 9 | 8 | 2 | 2008 |
| GlaxoSmithKline | For profit | 8 | 0 | 3 | 2010 |
| Johnson and Johnson | For profit | 8 | 3 | 2 | 2011 |
| Columbia University | Academic/Hospital | 7 | 6 | 2 | 2012 |
| Mayo Clinic | Academic/Hospital | 7 | 3 | 3 | 2010 |
| National Comprehensive Cancer Network | Academic/Hospital | 7 | 0 | 2 | 2008 |
| Pavlov First Saint Petersburg State Medical University | Academic/Hospital | 7 | 7 | 1 | 2016 |
Marketing (33)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| AVYXA HOLDINGS | For profit | MKTG | Jul 3, 2025 |
| Accord Research | For profit | MKTG | Feb 20, 2019 |
| Apotex | For profit | MKTG | Aug 18, 2017 |
| Apotex | For profit | SYN | Dec 7, 2022 |
| Apotex | For profit | NDA2 | Dec 7, 2022 |
| Azurity | For profit | MKTG | Dec 7, 2022 |
| Baxalta | For profit | MKTG | Dec 15, 2022 |
| Capstone Therapeutics | For profit | MKTG | Jan 25, 2019 |
| Cephalon | For profit | NDA | Mar 20, 2008 |
| Cephalon | For profit | IND | Jul 1, 2003 |
| Dr. Reddy's Laboratories | For profit | SYN | Dec 7, 2022 |
| Dr. Reddy's Laboratories | For profit | MKTG | Oct 8, 2020 |
| Dr. Reddy's Laboratories | For profit | NDA2 | Nov 12, 2021 |
| Eagle Pharmaceuticals, Inc. | For profit | NDA2 | Dec 7, 2015 |
| Esteve Labs | For profit | MKTG | Feb 20, 2019 |
| Esteve Labs | For profit | SYN | Feb 14, 2023 |
| Eugia Pharma | For profit | MKTG | Mar 18, 2022 |
| Eugia Pharma | For profit | SYN | Jun 5, 2023 |
| Fresenius | For profit | MKTG | Nov 13, 2018 |
| Glenmark Pharmaceuticals | For profit | MKTG | Feb 20, 2019 |
| Hospira | For profit | MKTG | Jun 15, 2018 |
| Hospira | For profit | SYN | Jan 29, 2019 |
| InnoPharma | For profit | MKTG | Jun 15, 2018 |
| KINDOS | For profit | MKTG | Jun 5, 2023 |
| Meitheal | For profit | MKTG | Jun 5, 2023 |
| Mylan | For profit | MKTG | Feb 20, 2019 |
| Nang Kuang Pharmaceutical Co., Ltd. | For profit | MKTG | Jan 26, 2021 |
| PHARMOBEDIENT | For profit | MKTG | Apr 28, 2023 |
| Pfizer | For profit | NDA2 | Dec 15, 2022 |
| Pfizer | For profit | MKTG | Jun 15, 2018 |
| Slayback Pharma Llc | For profit | MKTG | Jul 2, 2020 |
| Slayback Pharma Llc | For profit | NDA2 | Dec 7, 2022 |
| Takeda | For profit | NDA2 | Dec 15, 2022 |