berotralstat
Trade name: Orladeyo
Small moleculeapprovedOrphan Drug FDAFast Track FDA
Approved
Dec 3, 2020
Clinical trial activity
12 trials · 10 clinical orgs · 1 marketing orgs
Phase 1
4
Phase 2
6
Phase 3
5
Phase 4
0
Earliest trial started May 1, 2015 (NCT02448264)
Timeline
2010s
Indications
Approved for
Mechanism of action
- Plasma kallikreinANTAGONIST
KLKB1 antagonist
- Plasma kallikreinINHIBITOR
Plasma kallikrein inhibitor
Approval history
- approvedFast trackDec 3, 2020
Chemistry & pharmacology
Loading structure…
SMILES
N#Cc1cccc(C(NCC2CC2)c2ccc(F)c(NC(=O)c3cc(C(F)(F)F)nn3-c3cccc(CN)c3)c2)c1- Mol. weight
- 562.57 g/mol
- Lipinski Ro5
- 2 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL6067995 ↗
- ChEMBLCHEMBL5189739 ↗
- ChEMBLCHEMBL4594272 ↗
- ChEMBLCHEMBL4594271 ↗
Also known as
- bcx7353
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05453968 | Phase 3 | Oct 25, 2022 | BioCryst, University of Bristol |
| NCT04933721 | Phase 3 | Jun 30, 2021 | BioCryst, PHI University |
| NCT03873116 | Phase 3 | Feb 28, 2019 | BioCryst, Saiyu Soka Hospital |
| NCT03472040 | Phase 2/Phase 3 (Phase 3) | Feb 16, 2018 | BioCryst, Semmelweis University |
| NCT03485911 | Phase 3 | Feb 6, 2018 | BioCryst, University of California, San Diego |
| NCT03240133 | Phase 2 | Jul 31, 2017 | Barts & The London NHS Trust, BioCryst |
| NCT03202784 | Phase 1 | Feb 27, 2017 | BioCryst, Quotient |
| NCT03136237 | Phase 1 | Feb 17, 2017 | BioCryst, Covance |
| NCT02870972 | Phase 2 | Aug 1, 2016 | BioCryst, J. W. Goethe University |
| NCT02819102 | Phase 1 | Mar 1, 2016 | BioCryst, Quotient |
| NCT02448264 | Phase 1 | May 1, 2015 | BioCryst, Quotient |
| NCT04428632 | N/A | — | BioCryst |
Showing 12 of 12 trials
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Organizations
Research & Development (10)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| BioCryst | For profit | 12 | 12 | 4 | 2015 |
| Quotient | For profit | 3 | 0 | 1 | 2015 |
| Barts & The London NHS Trust | Academic/Hospital | 1 | 0 | 1 | 2017 |
| Covance | For profit | 1 | 0 | 1 | 2017 |
| J. W. Goethe University | Academic/Hospital | 1 | 0 | 1 | 2016 |
| PHI University | Academic/Hospital | 1 | 0 | 1 | 2021 |
| Saiyu Soka Hospital | Academic/Hospital | 1 | 0 | 1 | 2019 |
| Semmelweis University | Academic/Hospital | 1 | 0 | 1 | 2018 |
| University of Bristol | Academic/Hospital | 1 | 0 | 1 | 2022 |
| University of California, San Diego | Academic/Hospital | 1 | 0 | 1 | 2018 |
10 organizations
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