Modality
mAb
MOA
CGRPant
Target
PLK4
Pathway
Innate Imm
PBCADHD
Development Pipeline
Preclinical
~Aug 2014
→ ~Nov 2015
Phase 1
~Feb 2016
→ ~May 2017
Phase 2
~Aug 2017
→ ~Nov 2018
Phase 3
~Feb 2019
→ ~May 2020
NDA/BLA
~Aug 2020
→ ~Nov 2021
Approved
Feb 2022
→ Mar 2029
ApprovedCurrent
NCT04302743
2,561 pts·PBC
2022-02→2029-03·Not yet recruiting
2,561 total pts1 indication
CompletedCurrentUpcoming
Catalysts (1)
2029-03-092.9y awayPh3 Readout· PBC
Trial Timeline
2022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2
Approved
Not yet…
Catalysts
Ph3 Readout
2029-03-09 · 2.9y away
PBC
Not yet recruiting|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04302743 | Approved | PBC | Not yet recr... | 2561 | CR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Terafutibatinib | Pfizer | Phase 1/2 | CD38 | |
| Sotovorutinib | Pfizer | Approved | Aβ | |
| ABB-3060 | AbbVie | Phase 2 | LAG-3 | |
| GIL-6239 | Gilead Sciences | Phase 2 | TNFα | |
| Tezecilimab | Regeneron | Approved | IL-23 | |
| Bemanesiran | BioNTech | Phase 3 | PLK4 | |
| INC-2432 | Incyte | Phase 2 | CD47 | |
| Peminaritide | Sarepta | NDA/BLA | PLK4 | |
| Sematapinarof | Legend Biotech | NDA/BLA | VEGF | |
| Pexaosocimab | United Therapeutics | NDA/BLA | PLK4 |