Modality
Fusion Protein
MOA
TYK2i
Target
JAK2
Pathway
PD-1/PD-L1
PBCOCD
Development Pipeline
Preclinical
~Jul 2014
→ ~Oct 2015
Phase 1
~Jan 2016
→ ~Apr 2017
Phase 2
~Jul 2017
→ ~Oct 2018
Phase 3
~Jan 2019
→ ~Apr 2020
NDA/BLA
~Jul 2020
→ ~Oct 2021
Approved
Jan 2022
→ Jun 2030
ApprovedCurrent
NCT08274397
1,372 pts·PBC
2022-10→2029-02·Not yet recruiting
NCT07108553
2,659 pts·OCD
2022-01→2030-06·Completed
NCT08601552
1,880 pts·OCD
2022-04→TBD·Not yet recruiting
5,911 total pts2 indications
CompletedCurrentUpcoming
Catalysts (2)
2029-02-012.8y awayPh3 Readout· PBC
2030-06-034.2y awayPh3 Readout· OCD
Trial Timeline
2022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3
Approved
Complet…
Approved
Not yet…
Approved
Not yet…
Catalysts
Ph3 Readout
2029-02-01 · 2.8y away
PBC
Ph3 Readout
2030-06-03 · 4.2y away
OCD
CompletedNot yet recruiting|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08274397 | Approved | PBC | Not yet recr... | 1372 | Mayo |
| NCT07108553 | Approved | OCD | Completed | 2659 | CfB |
| NCT08601552 | Approved | OCD | Not yet recr... | 1880 | MRD |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Nidasacituzumab | Eli Lilly | Approved | CFTR | |
| Lisonaritide | Eli Lilly | Phase 3 | IL-13 | |
| MRK-2473 | Merck & Co | Phase 1/2 | Nectin-4 | |
| Zorisotorasib | AstraZeneca | Phase 1 | WRN | |
| SNY-8628 | Sanofi | NDA/BLA | B7-H3 | |
| Voxacagene | Gilead Sciences | Phase 2/3 | SOS1 | |
| Sotosacituzumab | Vertex Pharma | Phase 1 | MET | |
| Sotorapivir | Moderna | Approved | FLT3 | |
| Olpainavolisib | Moderna | Phase 1 | Menin | |
| ARG-4339 | Argenx | Phase 2 | BCL-2 |