inotuzumab ozogamicin
Trade name: besponsa
mAbapprovedADCOrphan Drug FDABreakthrough Therapy FDA
Approved
Aug 17, 2017
Inotuzumab ozogamicin, sold under the brand name Besponsa, is an antibody-drug conjugate medication used to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). It is administered by intravenous infusion. — Wikipedia
Clinical trial activity
57 trials · 57 clinical orgs · 2 marketing orgs
Phase 1
20
Phase 2
41
Phase 3
6
Phase 4
2
Earliest trial started Aug 1, 2003 (NCT00073749)
Timeline
2000s
Indications
Approved for
Studied for
- Antigens, CD · Phase 2
- Biomarkers · Phase 2
- Bone Marrow Cells · Phase 1/Phase 2
- Burkitt Lymphoma · Phase 1/Phase 2
- Hematopoietic Stem Cell Transplantation · Phase 2
- Immunotherapy · Phase 2
- Inotuzumab Ozogamicin · Phase 2
- Leukemia · Phase 4
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 2
- Leukemia, Lymphoid · Phase 2
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive · Phase 1/Phase 2
- Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative · Phase 2
- Leukemia, Myeloid, Chronic-Phase · Phase 1/Phase 2
- Lymphoma · Phase 2
- Lymphoma, B-Cell · Phase 2
- Lymphoma, Follicular · Phase 3
- Lymphoma, Large B-Cell, Diffuse · Phase 2
- Lymphoma, Large-Cell, Immunoblastic · Phase 3
- Lymphoma, Non-Hodgkin · Phase 3
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma · Phase 4
- Precursor Cell Lymphoblastic Leukemia-Lymphoma · Phase 4
- Testicular Neoplasms · Phase 3
Mechanism of action
Approval history
- approvedPriority reviewBreakthroughAug 17, 2017
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
- Payload
- ozogamicin
Oral
No
Parenteral
Yes
Topical
No
Black box warningFirst in class
Sources
- WikipediaInotuzumab ozogamicin ↗
- NCATSP93RUU11P7 ↗
- ChEMBLCHEMBL4297558 ↗
- ChEMBLCHEMBL2108611 ↗
Also known as
- besponsa
- cmc544
- cmc544
- cmc 544
- cmc-544
- cmc-544
- cmc-544
- inotuzumab ozogamicin
- inotuzumab ozogamicin
- inotuzumab ozogamicin
- inotuzumab ozogamicin
- inotuzumab ozogamicin
- inotuzumab ozogamicin
- inotuzumab ozogamicin
- inotuzumab ozogamycin
- pf-05208773
- way-207294
- way-207294
- way-207294 cmc-544
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06863259 | Phase 1 | May 21, 2025 | University of Cincinnati |
| NCT06985485 | Phase 2 | May 17, 2025 | Soochow University |
| NCT06861348 | Phase 2 | Mar 1, 2025 | Zhejiang University |
| NCT06533748 | Phase 2 | Dec 31, 2024 | Amgen, Pfizer, St. Jude Children's Hospital |
| NCT06554626 | Phase 2 | Aug 15, 2024 | Zhejiang University |
| NCT06287229 | Phase 1/Phase 2 (Phase 2) | Jul 11, 2024 | University of Texas at Houston |
| NCT06427330 | Phase 2 | Jul 2, 2024 | China Academy of Chinese Medical Sciences |
| NCT06387121 | Phase 2 | Apr 15, 2024 | China Academy of Chinese Medical Sciences |
| NCT06087419 | Phase 1/Phase 2 (Phase 2) | Oct 30, 2023 | China Academy of Chinese Medical Sciences |
| NCT05748171 | Phase 2 | May 17, 2023 | Pfizer |
| NCT05645718 | Phase 2 | Apr 30, 2023 | University of Texas at Houston |
| NCT05303792 | Phase 2 | Feb 28, 2023 | Harvard University, National Cancer Institute (NCI) |
| NCT05687032 | Phase 4 | Feb 24, 2023 | Pfizer |
| NCT05603156 | N/A | Oct 30, 2022 | Chinese Academy of Medical Sciences |
| NCT05940961 | Phase 2 | Aug 1, 2022 | Bengbu Medical College, Nanjing Medical University, Nantong University, Soochow University, Suzhou Hospital of Traditional Chinese Medicine, The Second People's Hospital of Huai'an |
| NCT05456698 | Phase 2 | Aug 1, 2022 | Chinese Academy of Medical Sciences |
| NCT05167643 | N/A | Jan 23, 2022 | Central South University, Tianjin Medical University |
| NCT05016947 | Phase 1 | Sep 24, 2021 | AbbVie, Harvard University |
| NCT04747912 | Phase 2 | Mar 2, 2021 | University of Chicago |
| NCT04307576 | Phase 3 | Apr 1, 2020 | Aamu Pediatric Cancer Foundation, Acreditar - Associação de Pais e Amigos das Crianças com Cancro, Cancer Research UK, CTC Bio, Inc., Fundação Rui Osório de Castro, Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany, Grupo Português De Leucemias Pediátricas, Karolinska Institute, Katholieke Universiteit Leuven, NordForsk, Pfizer, Servier, The Swedish Childhood Cancer Foundation, The Swedish Research Council |
Showing 20 of 57 trials
Page 1 / 3
Organizations
Research & Development (57)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Pfizer | For profit | 29 | 15 | 5 | 2003 |
| University of Texas at Houston | Academic/Hospital | 10 | 10 | 2 | 2010 |
| Hoosier Cancer Research Network | Academic/Hospital | 8 | 0 | 3 | 2006 |
| National Cancer Institute (NCI) | Government | 6 | 4 | 3 | 2014 |
| China Academy of Chinese Medical Sciences | Academic/Hospital | 3 | 3 | 1 | 2023 |
| Cancer Research UK | Academic/Hospital | 2 | 0 | 2 | 2013 |
| Chinese Academy of Medical Sciences | Academic/Hospital | 2 | 2 | 2 | 2022 |
| Harvard University | Academic/Hospital | 2 | 1 | 2 | 2021 |
| Soochow University | Academic/Hospital | 2 | 2 | 1 | 2022 |
| St. Jude Children's Hospital | Academic/Hospital | 2 | 2 | 1 | 2019 |
| Zhejiang University | Academic/Hospital | 2 | 2 | 1 | 2024 |
| Aamu Pediatric Cancer Foundation | Academic/Hospital | 1 | 0 | 1 | 2020 |
| AbbVie | For profit | 1 | 0 | 1 | 2021 |
| Acreditar - Associação de Pais e Amigos das Crianças com Cancro | Academic/Hospital | 1 | 0 | 1 | 2020 |
| Amgen | For profit | 1 | 0 | 1 | 2024 |
| Bengbu Medical College | Academic/Hospital | 1 | 0 | 1 | 2022 |
| Case Western Reserve University | Academic/Hospital | 1 | 1 | 1 | 2017 |
| Central South University | Academic/Hospital | 1 | 0 | 1 | 2022 |
| CTC Bio, Inc. | For profit | 1 | 0 | 1 | 2020 |
| Fundação Rui Osório de Castro | Academic/Hospital | 1 | 0 | 1 | 2020 |
57 organizations
Page 1 / 3