mogamulizumab
Trade name: poteligeo
mAbapprovedOrphan Drug FDABreakthrough Therapy FDA
Approved
Aug 8, 2018
Mogamulizumab, sold under the brand name Poteligeo, is a humanized, afucosylated monoclonal antibody targeting CC chemokine receptor type 4 (CCR4). It is given by injection into a vein. — Wikipedia
Clinical trial activity
35 trials · 35 clinical orgs · 1 marketing orgs
Phase 1
19
Phase 2
21
Phase 3
2
Phase 4
1
Earliest trial started Feb 1, 2007 (NCT00355472)
Timeline
2010s
- Nov 2, 2010
Orphan Drug Designation
- Jan 1, 2012
Earliest Phase 3 Sponsor(trial)
- Aug 8, 2018
Kyowa Kirin — Earliest FDA Approval
- Aug 8, 2018
Kyowa Kirin — Marketing Organization
- Aug 8, 2018
Kyowa Kirin — NDA Organization
Indications
Studied for
- Asthma · Phase 1
- Carcinoma · Phase 1/Phase 2
- Carcinoma, Hepatocellular · Phase 1/Phase 2
- Carcinoma, Non-Small-Cell Lung · Phase 1
- Esophageal Neoplasms · Phase 1
- Kidney Neoplasms · Phase 1
- Leukemia-Lymphoma, Adult T-Cell · Phase 2
- Leukemia, T-Cell · Phase 2
- Lung Neoplasms · Phase 1
- Lymphoma · Phase 2
- Lymphoma, B-Cell · Phase 1/Phase 2
- Lymphoma, Large B-Cell, Diffuse · Phase 1/Phase 2
- Lymphoma, Non-Hodgkin · Phase 2
- Lymphoma, T-Cell · Phase 2
- Lymphoma, T-Cell, Cutaneous · Phase 4
- Lymphoma, T-Cell, Peripheral · Phase 2
- Mouth Neoplasms · Phase 1
- Mycosis Fungoides · Phase 2
- Neoplasms · Phase 1/Phase 2
- Paraparesis, Tropical Spastic · Phase 3
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma · Phase 2
- Sezary Syndrome · Phase 2
- Stomach Neoplasms · Phase 1
Mechanism of action
- C-C chemokine receptor type 4CROSS-LINKING AGENT
CCR4 cross-linking agent
- C-C chemokine receptor type 4INHIBITOR
CCR4 inhibitor
Approval history
- approvedPriority reviewBreakthroughAug 8, 2018
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
First in class
Sources
- WikipediaMogamulizumab ↗
- NCATSYI437801BE ↗
- ChEMBLCHEMBL2109340 ↗
- ChEMBLCHEMBL1743041 ↗
Also known as
- amg761
- amg 761
- amg 761
- amg-761
- amg-761
- amg-761
- amg-761
- km8761
- km-8761
- kw0761
- kw 0761
- kw-0761
- kw-0761
- kw-0761
- kw-0761
- mogamulizumab
- mogamulizumab
- mogamulizumab
- mogamulizumab
- mogamulizumab
- mogamulizumab (genetical recombination)
- mogamulizumab-kpkc
- poteligeo
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06698003 | Phase 2 | Nov 15, 2024 | Memorial Sloan-Kettering Cancer Center |
| NCT05996185 | Phase 2 | Jan 31, 2024 | Kyowa Hakko Kirin, Yale University |
| NCT06235281 | Early Phase 1 (Phase 1) | Jan 18, 2024 | Kyowa Hakko Kirin, University of South Florida |
| NCT05956041 | Phase 2 | Dec 31, 2023 | Hoosier Cancer Research Network, Merck, University of Michigan |
| NCT06285370 | Phase 4 | May 29, 2023 | Kyowa Hakko Kirin, Tsinghua University |
| NCT05414500 | Phase 1 | Feb 1, 2023 | Kyowa Hakko Kirin, Seattle Genetics, University of Alabama, Birmingham |
| NCT04930653 | Phase 2 | Dec 15, 2021 | City of Hope National Medical Center, National Cancer Institute (NCI) |
| NCT04848064 | Phase 1 | Nov 1, 2021 | Ohio State University |
| NCT04745234 | Phase 2 | Aug 16, 2021 | Kyowa Hakko Kirin |
| NCT04541017 | Phase 1/Phase 2 (Phase 2) | Jan 4, 2021 | City of Hope National Medical Center, National Cancer Institute (NCI) |
| NCT04676087 | Phase 1/Phase 2 (Phase 2) | Jan 1, 2021 | Emory University |
| NCT04256018 | Phase 2 | Aug 31, 2020 | Stanford University |
| NCT04128072 | Phase 2 | May 31, 2020 | European Organisation for Research and Treatment of Cancer, The Christie NHS Foundation Trust, Universidad Complutense de Madrid, University of Birmingham |
| NCT04185220 | Phase 1 | Dec 9, 2019 | National Cancer Institute (NCI) |
| NCT03309878 | Phase 1/Phase 2 (Phase 2) | Jun 29, 2018 | Johns Hopkins University, National Cancer Institute (NCI) |
| NCT03191526 | Phase 3 | May 22, 2017 | Kyowa Hakko Kirin |
| NCT02867007 | Phase 1 | Aug 1, 2016 | Kyowa Hakko Kirin |
| NCT02946671 | Phase 1 | Mar 1, 2016 | Clinical Study Support, Inc., Fiverings Co., Ltd., Kyowa Hakko Kirin, Ono Pharmaceuticals, Osaka University |
| NCT02705105 | Phase 1/Phase 2 (Phase 2) | Dec 1, 2015 | Bristol-Myers Squibb, Kyowa Hakko Kirin |
| NCT02476123 | Phase 1 | Jun 1, 2015 | Kyowa Hakko Kirin, Ono Pharmaceuticals |
Showing 20 of 35 trials
Page 1 / 2
Organizations
Research & Development (35)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Kyowa Hakko Kirin | For profit | 23 | 17 | 4 | 2007 |
| National Cancer Institute (NCI) | Government | 4 | 3 | 2 | 2018 |
| City of Hope National Medical Center | Academic/Hospital | 2 | 1 | 1 | 2021 |
| Ono Pharmaceuticals | For profit | 2 | 0 | 1 | 2015 |
| Aichi Medical University | Academic/Hospital | 1 | 1 | 1 | 2013 |
| Amgen | For profit | 1 | 1 | 1 | 2011 |
| AstraZeneca | For profit | 1 | 0 | 1 | 2014 |
| Bristol-Myers Squibb | For profit | 1 | 0 | 1 | 2015 |
| Clinical Study Support, Inc. | For profit | 1 | 0 | 1 | 2016 |
| Cornell University | Academic/Hospital | 1 | 1 | 1 | 2014 |
| Emory University | Academic/Hospital | 1 | 1 | 1 | 2021 |
| European Organisation for Research and Treatment of Cancer | Academic/Hospital | 1 | 1 | 1 | 2020 |
| Fiverings Co., Ltd. | For profit | 1 | 0 | 1 | 2016 |
| Georgetown University | Academic/Hospital | 1 | 0 | 1 | 2015 |
| Hoosier Cancer Research Network | Academic/Hospital | 1 | 0 | 1 | 2023 |
| Johns Hopkins University | Academic/Hospital | 1 | 0 | 1 | 2018 |
| Kyowa Kirin | For profit | 1 | 0 | 1 | 2015 |
| Memorial Sloan-Kettering Cancer Center | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Merck | For profit | 1 | 0 | 1 | 2023 |
| Ohio State University | Academic/Hospital | 1 | 1 | 1 | 2021 |
35 organizations
Page 1 / 2
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Kyowa Kirin | For profit | MKTG | Aug 8, 2018 |
| Kyowa Kirin | For profit | NDA | Aug 8, 2018 |