Modality
siRNA
MOA
IL-13i
Target
CDK4/6
Pathway
Incretin
RA
Development Pipeline
Preclinical
~Feb 2011
→ ~May 2012
Phase 1
~Aug 2012
→ ~Nov 2013
Phase 2
~Feb 2014
→ ~May 2015
Phase 3
~Aug 2015
→ ~Nov 2016
NDA/BLA
~Feb 2017
→ ~May 2018
Approved
Aug 2018
→ Oct 2031
ApprovedCurrent
NCT06709725
1,398 pts·RA
2023-10→2031-10·Recruiting
NCT04447027
1,476 pts·RA
2020-05→2028-03·Completed
NCT08473105
1,258 pts·RA
2018-08→2025-05·Terminated
+1 more trial
6,857 total pts1 indication
CompletedCurrentUpcoming
Catalysts (4)
2025-05-2210mo agoPh3 Readout· RA
2028-03-232.0y awayPh3 Readout· RA
2029-12-123.7y awayPh3 Readout· RA
2031-10-255.6y awayPh3 Readout· RA
Trial Timeline
Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
Approved
Termina…
Approved
Complet…
Approved
Not yet…
Approved
Recruit…
Catalysts
Ph3 Readout
2025-05-22 · 10mo ago
RA
Ph3 Readout
2028-03-23 · 2.0y away
RA
Ph3 Readout
2029-12-12 · 3.7y away
RA
Ph3 Readout
2031-10-25 · 5.6y away
RA
RecruitingCompletedTerminatedNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06709725 | Approved | RA | Recruiting | 1398 | Mayo |
| NCT04447027 | Approved | RA | Completed | 1476 | VA |
| NCT08473105 | Approved | RA | Terminated | 1258 | LiverFat |
| NCT03299431 | Approved | RA | Not yet recr... | 2725 | EDSS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Voxaderotide | Johnson & Johnson | NDA/BLA | PI3Kα | |
| RHH-7975 | Roche | Phase 3 | FXIa | |
| NVS-8902 | Novartis | Preclinical | TROP-2 | |
| Gozesotorasib | Bristol-Myers Squibb | NDA/BLA | HER2 | |
| BMY-4586 | Bristol-Myers Squibb | Preclinical | KRASG12C | |
| AMG-1919 | Amgen | Phase 2/3 | CDK2 | |
| Motavorutinib | Amgen | Phase 3 | CDK4/6 | |
| Ribozanubrutinib | Regeneron | Phase 1 | CDK4/6 | |
| MRN-5715 | Moderna | NDA/BLA | CDK4/6 | |
| ROI-3353 | Roivant Sciences | Phase 1/2 | PLK4 |