Modality
Gene Therapy
MOA
SHP2i
Target
PSMA
Pathway
STING
DLBCLGAPsA
Development Pipeline
Preclinical
~Apr 2012
→ ~Jul 2013
Phase 1
~Oct 2013
→ ~Jan 2015
Phase 2
~Apr 2015
→ ~Jul 2016
Phase 3
~Oct 2016
→ ~Jan 2018
NDA/BLA
~Apr 2018
→ ~Jul 2019
Approved
Oct 2019
→ May 2028
ApprovedCurrent
NCT06054301
545 pts·GA
2020-01→TBD·Not yet recruiting
NCT04728451
2,588 pts·PsA
2022-10→2028-02·Completed
NCT03243356
2,917 pts·PsA
2019-10→2028-05·Recruiting
6,050 total pts2 indications
CompletedCurrentUpcoming
Catalysts (2)
2028-02-091.9y awayPh3 Readout· PsA
2028-05-272.2y awayPh3 Readout· PsA
Trial Timeline
Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3
Approved
Recruit…
Approved
Not yet…
Approved
Complet…
Catalysts
Ph3 Readout
2028-02-09 · 1.9y away
PsA
Ph3 Readout
2028-05-27 · 2.2y away
PsA
RecruitingCompletedNot yet recruiting|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06054301 | Approved | GA | Not yet recr... | 545 | EASI-75 |
| NCT04728451 | Approved | PsA | Completed | 2588 | OS |
| NCT03243356 | Approved | PsA | Recruiting | 2917 | Safety |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-2191 | Pfizer | NDA/BLA | GLP-1R | |
| AZN-3724 | AstraZeneca | Preclinical | PSMA | |
| GSK-2051 | GSK | Phase 1 | PSMA | |
| GIL-2445 | Gilead Sciences | Phase 2/3 | PSMA | |
| VRT-1576 | Vertex Pharma | Phase 2/3 | RET | |
| Sovafutibatinib | Moderna | Approved | FcRn | |
| BII-1564 | Biogen | Phase 2 | PSMA | |
| BGN-3859 | BeiGene | Approved | PSMA | |
| Daratuximab | BioMarin | Phase 1 | PRMT5 | |
| Nirafotisoran | Jazz Pharma | Phase 2/3 | TROP-2 |