Modality
mAb
MOA
DLL3 ADC
Target
PI3Kα
Pathway
Complement
UCFSGS
Development Pipeline
Preclinical
~Jan 2016
→ ~Apr 2017
Phase 1
~Jul 2017
→ ~Oct 2018
Phase 2
~Jan 2019
→ ~Apr 2020
Phase 3
~Jul 2020
→ ~Oct 2021
NDA/BLA
Jan 2022
→ Sep 2031
NDA/BLACurrent
NCT08051646
1,604 pts·FSGS
2022-01→2031-09·Not yet recruiting
NCT08843088
1,956 pts·UC
2023-05→2029-07·Not yet recruiting
3,560 total pts2 indications
Approved
CompletedCurrentUpcoming
Catalysts (3)
2026-05-192mo awayEMA Filing· FSGS
2029-07-023.3y awayPh3 Readout· UC
2031-09-165.5y awayPh3 Readout· FSGS
Trial Timeline
2022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
NDA/BLA
Not yet…
NDA/BLA
Not yet…
Catalysts
EMA Filing
2026-05-19 · 2mo away
FSGS
Ph3 Readout
2029-07-02 · 3.3y away
UC
Ph3 Readout
2031-09-16 · 5.5y away
FSGS
Not yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08051646 | NDA/BLA | FSGS | Not yet recr... | 1604 | FEV1 |
| NCT08843088 | NDA/BLA | UC | Not yet recr... | 1956 | ACR20 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Voxaderotide | Johnson & Johnson | NDA/BLA | PI3Kα | |
| NVS-4076 | Novartis | Preclinical | TROP-2 | |
| Rimamavacamten | Merck & Co | Phase 1 | PI3Kα | |
| Fixazanubrutinib | Amgen | Phase 2 | PI3Kα | |
| AMG-9654 | Amgen | Phase 2 | GPRC5D | |
| GMA-1468 | Genmab | NDA/BLA | PI3Kα | |
| 369-789 | Hansoh Pharma | Phase 3 | PI3Kα | |
| Mavutuximab | Hansoh Pharma | Phase 2/3 | PI3Kα | |
| Sematenlimab | Samsung Biologics | Phase 3 | PI3Kα | |
| ROI-1081 | Roivant Sciences | Phase 1/2 | PI3Kα |