Modality
ASO
MOA
MDM2i
Target
RET
Pathway
Cell Cycle
AS
Development Pipeline
Preclinical
~May 2011
→ ~Aug 2012
Phase 1
~Nov 2012
→ ~Feb 2014
Phase 2
~May 2014
→ ~Aug 2015
Phase 3
~Nov 2015
→ ~Feb 2017
NDA/BLA
~May 2017
→ ~Aug 2018
Approved
Nov 2018
→ Feb 2030
ApprovedCurrent
NCT04148716
325 pts·AS
2018-11→2030-02·Terminated
NCT05418684
1,625 pts·AS
2020-03→2030-02·Recruiting
NCT08457894
1,663 pts·AS
2023-04→2027-03·Recruiting
+1 more trial
3,705 total pts1 indication
CompletedCurrentUpcoming
Catalysts (4)
2026-08-235mo awayPh3 Readout· AS
2027-03-2712mo awayPh3 Readout· AS
2030-02-053.9y awayPh3 Readout· AS
2030-02-183.9y awayPh3 Readout· AS
Trial Timeline
Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2
Approved
Termina…
Approved
Active
Approved
Recruit…
Approved
Recruit…
Catalysts
Ph3 Readout
2026-08-23 · 5mo away
AS
Ph3 Readout
2027-03-27 · 12mo away
AS
Ph3 Readout
2030-02-05 · 3.9y away
AS
Ph3 Readout
2030-02-18 · 3.9y away
AS
RecruitingActiveTerminated|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04148716 | Approved | AS | Terminated | 325 | PFS |
| NCT05418684 | Approved | AS | Recruiting | 1625 | EDSS |
| NCT08457894 | Approved | AS | Recruiting | 1663 | PFS |
| NCT05429092 | Approved | AS | Active | 92 | OS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Doxacapivasertib | Eli Lilly | Phase 3 | APOC3 | |
| RHH-5389 | Roche | Preclinical | RET | |
| Fixanesiran | AbbVie | Preclinical | RET | |
| AMG-415 | Amgen | Phase 1 | CDK2 | |
| GIL-2037 | Gilead Sciences | Approved | KRASG12D | |
| VRT-1576 | Vertex Pharma | Phase 2/3 | RET | |
| Capiglumide | BioNTech | Preclinical | CGRP | |
| ARG-3458 | Argenx | Preclinical | RET | |
| Rimasertib | Exelixis | Phase 3 | B7-H3 | |
| 180-6098 | Innovent Bio | Phase 1 | ALK |