Modality
mAb
MOA
MDM2i
Target
PI3Kα
Pathway
Wnt
GANASHPBC
Development Pipeline
Preclinical
~Oct 2010
→ ~Jan 2012
Phase 1
~Apr 2012
→ ~Jul 2013
Phase 2
~Oct 2013
→ ~Jan 2015
Phase 3
~Apr 2015
→ ~Jul 2016
NDA/BLA
~Oct 2016
→ ~Jan 2018
Approved
Apr 2018
→ Mar 2029
ApprovedCurrent
NCT08980664
740 pts·PBC
2018-04→2029-03·Terminated
740 total pts1 indication
CompletedCurrentUpcoming
Catalysts (1)
2029-03-122.9y awayPh3 Readout· PBC
Trial Timeline
Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2
Approved
Termina…
Catalysts
Ph3 Readout
2029-03-12 · 2.9y away
PBC
Terminated|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08980664 | Approved | PBC | Terminated | 740 | Biomarker |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Voxaderotide | Johnson & Johnson | NDA/BLA | PI3Kα | |
| Doxacapivasertib | Eli Lilly | Phase 3 | APOC3 | |
| Rimamavacamten | Merck & Co | Phase 1 | PI3Kα | |
| BMY-8678 | Bristol-Myers Squibb | Approved | RET | |
| Fixazanubrutinib | Amgen | Phase 2 | PI3Kα | |
| AMG-415 | Amgen | Phase 1 | CDK2 | |
| GIL-2037 | Gilead Sciences | Approved | KRASG12D | |
| Capiglumide | BioNTech | Preclinical | CGRP | |
| GMA-1468 | Genmab | NDA/BLA | PI3Kα | |
| Rimasertib | Exelixis | Phase 3 | B7-H3 |