seladelpar
Trade name: LIVDELZI
Small moleculeapprovedOrphan Drug FDABreakthrough Therapy FDA
Approved
Aug 14, 2024
Seladelpar, sold under the brand name Livdelzi, is a medication used for the treatment of primary biliary cholangitis. It is used as the lysine dihydrate salt. It is a peroxisome proliferator-activated receptor delta (PPARδ) receptor agonist. The compound was licensed from Janssen Pharmaceutica NV. — Wikipedia
Clinical trial activity
13 trials · 1 clinical orgs · 1 marketing orgs
Phase 1
2
Phase 2
10
Phase 3
5
Phase 4
0
Earliest trial started Aug 1, 2007 (NCT00701883)
Timeline
2000s
- Jan 1, 2007
Earliest Phase 2 Sponsor(trial)
2010s
2020s
- Aug 14, 2024
Gilead Sciences — Earliest FDA Approval
- Aug 14, 2024
Gilead Sciences — NDA Organization
Indications
Approved for
Mechanism of action
Approval history
- approvedPriority reviewAcceleratedBreakthroughAug 14, 2024
Chemistry & pharmacology
Loading structure…
SMILES
CCO[C@H](COc1ccc(C(F)(F)F)cc1)CSc1ccc(OCC(=O)O)c(C)c1- Mol. weight
- 444.47 g/mol
- Lipinski Ro5
- 1 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
- ChEMBLCHEMBL230158 ↗
- WikipediaSeladelpar ↗
- ChEMBLCHEMBL3989960 ↗
- ChEMBLCHEMBL3545019 ↗
Also known as
- (2-methyl-4-(5-methyl-2-(4-trifluoromethyl-phenyl)-2h-(1,2,3)triazol-4-ylmethylsulfanyl)phenoxy)acetic acid
- mbx-8025
- mbx-8025
- mbx-8025
- mbx-8025
- mbx-8025
- rwj-800025
- seladelpar
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06051617 | Phase 3 | Sep 7, 2023 | CymaBay Therapeutics, Inc. |
| NCT06060665 | Phase 3 | Sep 5, 2023 | CymaBay Therapeutics, Inc. |
| NCT04950764 | Phase 1 | Sep 17, 2021 | CymaBay Therapeutics, Inc. |
| NCT04620733 | Phase 3 | Jan 31, 2021 | CymaBay Therapeutics, Inc. |
| NCT04024813 | Phase 2 | Jul 31, 2019 | CymaBay Therapeutics, Inc. |
| NCT03602560 | Phase 3 | Nov 30, 2018 | CymaBay Therapeutics, Inc. |
| NCT03551522 | Phase 2 | Apr 30, 2018 | CymaBay Therapeutics, Inc. |
| NCT03301506 | Phase 2/Phase 3 (Phase 3) | Dec 12, 2017 | CymaBay Therapeutics, Inc. |
| NCT03369002 | Phase 1 | Nov 27, 2017 | CymaBay Therapeutics, Inc. |
| NCT02955602 | Phase 2 | Dec 1, 2016 | CymaBay Therapeutics, Inc. |
| NCT02609048 | Phase 2 | Nov 1, 2015 | CymaBay Therapeutics, Inc. |
| NCT02472535 | Phase 2 | Apr 1, 2015 | CymaBay Therapeutics, Inc. |
| NCT00701883 | Phase 2 | Aug 1, 2007 | CymaBay Therapeutics, Inc. |
Showing 13 of 13 trials
Page 1 / 1
Organizations
Research & Development (1)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| CymaBay Therapeutics, Inc. | For profit | 13 | 13 | 3 | 2007 |
1 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Gilead Sciences | For profit | NDA | Aug 14, 2024 |