Modality
mAb
MOA
CGRPant
Target
KIF18A
Pathway
PD-1/PD-L1
PAHBladder CaSLE
Development Pipeline
Preclinical
~Sep 2010
→ ~Dec 2011
Phase 1
~Mar 2012
→ ~Jun 2013
Phase 2
~Sep 2013
→ ~Dec 2014
Phase 3
~Mar 2015
→ ~Jun 2016
NDA/BLA
~Sep 2016
→ ~Dec 2017
Approved
Mar 2018
→ Feb 2028
ApprovedCurrent
NCT06913381
800 pts·PAH
2018-03→2028-02·Active
NCT06879663
106 pts·Bladder Ca
2024-06→2027-11·Completed
NCT07976967
840 pts·PAH
2025-05→2027-04·Recruiting
1,746 total pts2 indications
CompletedCurrentUpcoming
Catalysts (4)
2026-06-142mo awayEMA Filing· SLE
2027-04-251.1y awayPh3 Readout· PAH
2027-11-051.6y awayPh3 Readout· Bladder Ca
2028-02-041.8y awayPh3 Readout· PAH
Trial Timeline
2018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2
Approved
Active
Approved
Complet…
Approved
Recruit…
Catalysts
EMA Filing
2026-06-14 · 2mo away
SLE
Ph3 Readout
2027-04-25 · 1.1y away
PAH
Ph3 Readout
2027-11-05 · 1.6y away
Bladder Ca
Ph3 Readout
2028-02-04 · 1.8y away
PAH
RecruitingActiveCompleted|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06913381 | Approved | PAH | Active | 800 | UPDRS |
| NCT06879663 | Approved | Bladder Ca | Completed | 106 | 6MWD |
| NCT07976967 | Approved | PAH | Recruiting | 840 | PFS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Terafutibatinib | Pfizer | Phase 1/2 | CD38 | |
| Sotovorutinib | Pfizer | Approved | Aβ | |
| Niranesiran | Johnson & Johnson | Phase 2 | KIF18A | |
| ABB-3060 | AbbVie | Phase 2 | LAG-3 | |
| GIL-6239 | Gilead Sciences | Phase 2 | TNFα | |
| Tezecilimab | Regeneron | Approved | IL-23 | |
| Riluinavolisib | Moderna | NDA/BLA | KIF18A | |
| INC-2432 | Incyte | Phase 2 | CD47 | |
| Sematapinarof | Legend Biotech | NDA/BLA | VEGF | |
| Rilufotisoran | Samsung Biologics | NDA/BLA | FXIa |