odevixibat
Trade name: BYLVAY
Small moleculeapprovedOrphan Drug FDAFast Track FDA
Approved
Jul 20, 2021
Clinical trial activity
12 trials · 4 clinical orgs · 2 marketing orgs
Phase 1
3
Phase 2
8
Phase 3
6
Phase 4
0
Earliest trial started Jul 1, 2013 (NCT02963077)
Timeline
2010s
Indications
Approved for
Mechanism of action
- Ileal bile acid transporterANTAGONIST
SLC10A2 antagonist
- Ileal bile acid transporterINHIBITOR
Ileal bile acid transporter inhibitor
Approval history
- approvedPriority reviewFast trackJul 20, 2021
Chemistry & pharmacology
Loading structure…
SMILES
CCCCC1(CCCC)CN(c2ccccc2)c2cc(SC)c(OCC(=O)N[C@@H](C(=O)N[C@@H](CC)C(=O)O)c3ccc(O)cc3)cc2S(=O)(=O)N1- Mol. weight
- 740.94 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
First in class
Sources
- ChEMBLCHEMBL4297588 ↗
Also known as
- a4250
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05426733 | Phase 3 | Jul 5, 2022 | Albireo |
| NCT05035030 | Phase 3 | Sep 3, 2021 | Albireo |
| NCT04674761 | Phase 3 | Jan 31, 2021 | Albireo |
| NCT04336722 | Phase 3 | Jun 30, 2020 | Albireo |
| NCT03659916 | Phase 3 | Sep 28, 2018 | Albireo |
| NCT03608319 | Phase 1 | Jul 5, 2018 | Albireo, Celerion |
| NCT03566238 | Phase 3 | May 16, 2018 | Albireo |
| NCT03082937 | Phase 1 | Jan 31, 2017 | Albireo |
| NCT02630875 | Phase 2 | Aug 1, 2015 | Albireo, Karolinska Institute |
| NCT02360852 | Phase 2 | Jan 1, 2015 | Albireo, University of Gothenburg |
| NCT02963077 | Phase 1 | Jul 1, 2013 | Albireo |
| NCT04483531 | N/A | — | Albireo |
Showing 12 of 12 trials
Page 1 / 1
Organizations
Research & Development (4)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Albireo | For profit | 12 | 11 | 4 | 2013 |
| Celerion | For profit | 1 | 0 | 1 | 2018 |
| Karolinska Institute | Academic/Hospital | 1 | 0 | 1 | 2015 |
| University of Gothenburg | Academic/Hospital | 1 | 1 | 1 | 2015 |
4 organizations
Page 1 / 1