lanadelumab
Trade name: takhzyro
mAbapprovedOrphan Drug FDAFast Track FDABreakthrough Therapy FDA
Approved
Aug 23, 2018
Lanadelumab, sold under the brand name Takhzyro, is a human monoclonal antibody that targets plasma kallikrein (pKal) in order to promote prevention of angioedema in people with hereditary angioedema. Lanadelumab, was approved in the United States as the first monoclonal antibody indicated for prophylactic treatment to prevent hereditary angioedema attacks. Lanadelumab is the first treatment for hereditary angioedema prevention made by using cells within a lab, not human plasma. — Wikipedia
Clinical trial activity
22 trials · 10 clinical orgs · 2 marketing orgs
Phase 1
8
Phase 2
13
Phase 3
9
Phase 4
1
Earliest trial started Aug 1, 2013 (NCT01923207)
Timeline
2010s
2020s
- Jan 1, 2020
Earliest Phase 2 Sponsor(trial)
Indications
Approved for
Mechanism of action
- Plasma kallikreinINHIBITOR
KLKB1 inhibitor
- Kallikrein 1INHIBITOR
KLK1 inhibitor
Approval history
- approvedPriority reviewFast trackBreakthroughAug 23, 2018
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- ChEMBLCHEMBL3545189 ↗
- WikipediaLanadelumab ↗
- NCATS2372V1TKXK ↗
Also known as
- dx-2930
- lanadelumab (shp643)
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07281157 | Phase 2 | Nov 1, 2025 | Tianjin Medical University |
| NCT06818474 | Phase 4 | Jun 1, 2024 | Bernstein Clinical Research Center |
| NCT05297786 | Phase 2 | Jul 27, 2022 | Vanderbilt University |
| NCT05460325 | Phase 3 | Jun 22, 2022 | Takeda |
| NCT04848272 | Phase 1 | Apr 30, 2021 | St Vincent's Institute of Medical Research |
| NCT04687137 | Phase 3 | Feb 10, 2021 | Takeda |
| NCT04444895 | Phase 3 | Feb 1, 2021 | Shire, Takeda |
| NCT04590586 | Phase 3 | Nov 24, 2020 | Amgen |
| NCT04278885 | Phase 2 | Oct 31, 2020 | Humboldt University, Shire |
| NCT04460105 | Phase 1 | Oct 31, 2020 | Shire, Takeda |
| NCT04503603 | Phase 1 | Aug 10, 2020 | Takeda |
| NCT04422509 | Phase 1/Phase 2 (Phase 2) | Jun 25, 2020 | Radboud University, Takeda |
| NCT04206605 | Phase 3 | Dec 20, 2019 | Shire |
| NCT04180163 | Phase 3 | Nov 30, 2019 | Shire |
| NCT04070326 | Phase 3 | Aug 30, 2019 | Shire |
| NCT03918239 | Phase 1 | May 14, 2019 | Shire |
| NCT03401671 | Phase 1 | Jan 15, 2018 | Shire |
| NCT02741596 | Phase 3 | Sep 1, 2016 | Shire |
| NCT02586805 | Phase 3 | Mar 3, 2016 | Dyax, Shire |
| NCT02093923 | Phase 1 | Apr 1, 2014 | Shire |
Showing 20 of 22 trials
Page 1 / 2
Organizations
Research & Development (10)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Shire | For profit | 13 | 12 | 4 | 2013 |
| Takeda | For profit | 7 | 3 | 4 | 2020 |
| Dyax | For profit | 2 | 0 | 2 | 2013 |
| Amgen | For profit | 1 | 1 | 1 | 2020 |
| Bernstein Clinical Research Center | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Humboldt University | Academic/Hospital | 1 | 1 | 1 | 2020 |
| Radboud University | Academic/Hospital | 1 | 1 | 1 | 2020 |
| St Vincent's Institute of Medical Research | Academic/Hospital | 1 | 1 | 1 | 2021 |
| Tianjin Medical University | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Vanderbilt University | Academic/Hospital | 1 | 1 | 1 | 2022 |
10 organizations
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