Modality
Radioligand
MOA
PI3Ki
Target
PI3Kα
Pathway
Angiogenesis
PAHRASCLC
Development Pipeline
Preclinical
~Sep 2011
→ ~Dec 2012
Phase 1
~Mar 2013
→ ~Jun 2014
Phase 2
~Sep 2014
→ ~Dec 2015
Phase 3
~Mar 2016
→ ~Jun 2017
NDA/BLA
Sep 2017
→ Nov 2031
NDA/BLACurrent
NCT04735791
2,837 pts·PAH
2017-09→2031-11·Not yet recruiting
NCT04931879
1,862 pts·RA
2024-02→2031-02·Completed
4,699 total pts2 indications
Approved
CompletedCurrentUpcoming
Catalysts (2)
2031-02-164.9y awayPh3 Readout· RA
2031-11-035.6y awayPh3 Readout· PAH
Trial Timeline
Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
NDA/BLA
Not yet…
NDA/BLA
Complet…
Catalysts
Ph3 Readout
2031-02-16 · 4.9y away
RA
Ph3 Readout
2031-11-03 · 5.6y away
PAH
CompletedNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04735791 | NDA/BLA | PAH | Not yet recr... | 2837 | CR |
| NCT04931879 | NDA/BLA | RA | Completed | 1862 | 6MWD |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Voxaderotide | Johnson & Johnson | NDA/BLA | PI3Kα | |
| Tiramavacamten | Roche | Preclinical | SGLT2 | |
| NVS-5126 | Novartis | Phase 3 | SHP2 | |
| Rimamavacamten | Merck & Co | Phase 1 | PI3Kα | |
| Voxacilimab | AstraZeneca | Phase 1/2 | GLP-1R | |
| Capifutibatinib | Sanofi | Approved | PRMT5 | |
| Rimatenlimab | Novo Nordisk | Phase 2/3 | SGLT2 | |
| Fixazanubrutinib | Amgen | Phase 2 | PI3Kα | |
| REG-3155 | Regeneron | Phase 1/2 | MDM2 | |
| GMA-1468 | Genmab | NDA/BLA | PI3Kα |