Modality
mRNA
MOA
TNFi
Target
DLL3
Pathway
STING
PBC
Development Pipeline
Preclinical
~Oct 2011
→ ~Jan 2013
Phase 1
~Apr 2013
→ ~Jul 2014
Phase 2
~Oct 2014
→ ~Jan 2016
Phase 3
~Apr 2016
→ ~Jul 2017
NDA/BLA
~Oct 2017
→ ~Jan 2019
Approved
Apr 2019
→ Jul 2031
ApprovedCurrent
NCT08247168
719 pts·PBC
2019-04→2031-06·Recruiting
NCT05995576
2,473 pts·PBC
2022-08→2031-07·Completed
NCT06530266
1,450 pts·PBC
2019-09→TBD·Recruiting
+1 more trial
6,694 total pts1 indication
CompletedCurrentUpcoming
Catalysts (3)
2029-07-183.3y awayPh3 Readout· PBC
2031-06-265.2y awayPh3 Readout· PBC
2031-07-265.3y awayPh3 Readout· PBC
Trial Timeline
Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
Approved
Recruit…
Approved
Recruit…
Approved
Not yet…
Approved
Complet…
Catalysts
Ph3 Readout
2029-07-18 · 3.3y away
PBC
Ph3 Readout
2031-06-26 · 5.2y away
PBC
Ph3 Readout
2031-07-26 · 5.3y away
PBC
RecruitingCompletedNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08247168 | Approved | PBC | Recruiting | 719 | Mayo |
| NCT05995576 | Approved | PBC | Completed | 2473 | Safety |
| NCT06530266 | Approved | PBC | Recruiting | 1450 | eGFR |
| NCT05177554 | Approved | PBC | Not yet recr... | 2052 | Safety |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-7809 | Pfizer | Phase 1 | DLL3 | |
| Pexarelsin | AstraZeneca | Phase 1 | DLL3 | |
| AZN-7403 | AstraZeneca | Phase 2/3 | FGFR | |
| Zorivorutinib | Bristol-Myers Squibb | Approved | DLL3 | |
| Zenonesiran | GSK | Preclinical | DLL3 | |
| TAK-8262 | Takeda | NDA/BLA | Tau | |
| AMG-7379 | Amgen | Preclinical | DLL3 | |
| Talalemzoparlimab | Gilead Sciences | Phase 1 | FcRn | |
| ARG-1924 | Argenx | Preclinical | DLL3 | |
| Ribozanubrutinib | Genmab | Approved | GPRC5D |