Modality
ASO
MOA
BCMA ADC
Target
PI3Kα
Pathway
mTOR
DLBCLT2DHeart Failure
Development Pipeline
Preclinical
~Mar 2013
→ ~Jun 2014
Phase 1
~Sep 2014
→ ~Dec 2015
Phase 2
~Mar 2016
→ ~Jun 2017
Phase 3
Sep 2017
→ Jun 2029
Phase 3Current
NCT07666509
282 pts·Heart Failure
2019-10→2029-06·Active
NCT05293123
1,200 pts·T2D
2017-09→2027-09·Not yet recruiting
NCT05182887
280 pts·T2D
2020-05→2026-06·Recruiting
+1 more trial
2,762 total pts2 indications
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (4)
2025-09-186mo agoPh3 Readout· Heart Failure
2026-06-183mo awayPh3 Readout· T2D
2027-09-271.5y awayPh3 Readout· T2D
2029-06-253.2y awayPh3 Readout· Heart Failure
Trial Timeline
Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3
P3
Not yet…
P3
Active
P3
Recruit…
P3
Termina…
Catalysts
Ph3 Readout
2025-09-18 · 6mo ago
Heart Failure
Ph3 Readout
2026-06-18 · 3mo away
T2D
Ph3 Readout
2027-09-27 · 1.5y away
T2D
Ph3 Readout
2029-06-25 · 3.2y away
Heart Failure
RecruitingActiveTerminatedNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07666509 | Phase 3 | Heart Failure | Active | 282 | EDSS |
| NCT05293123 | Phase 3 | T2D | Not yet recr... | 1200 | LiverFat |
| NCT05182887 | Phase 3 | T2D | Recruiting | 280 | DAS28 |
| NCT07585831 | Phase 3 | Heart Failure | Terminated | 1000 | ORR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Voxaderotide | Johnson & Johnson | NDA/BLA | PI3Kα | |
| Rimamavacamten | Merck & Co | Phase 1 | PI3Kα | |
| AZN-3724 | AstraZeneca | Preclinical | PSMA | |
| Olpatinib | GSK | Preclinical | PD-L1 | |
| Fixazanubrutinib | Amgen | Phase 2 | PI3Kα | |
| GIL-9779 | Gilead Sciences | Phase 1 | IL-17A | |
| GMA-1468 | Genmab | NDA/BLA | PI3Kα | |
| 369-789 | Hansoh Pharma | Phase 3 | PI3Kα | |
| Mavutuximab | Hansoh Pharma | Phase 2/3 | PI3Kα | |
| ROI-1081 | Roivant Sciences | Phase 1/2 | PI3Kα |