Modality
Fusion Protein
MOA
BiTE
Target
TNFα
Pathway
RNA Splicing
RAACC
Development Pipeline
Preclinical
~Oct 2011
→ ~Jan 2013
Phase 1
~Apr 2013
→ ~Jul 2014
Phase 2
~Oct 2014
→ ~Jan 2016
Phase 3
~Apr 2016
→ ~Jul 2017
NDA/BLA
~Oct 2017
→ ~Jan 2019
Approved
Apr 2019
→ Jun 2027
ApprovedCurrent
NCT06493455
1,173 pts·ACC
2019-04→2025-01·Terminated
NCT05190318
2,649 pts·RA
2020-03→2027-06·Completed
3,822 total pts2 indications
CompletedCurrentUpcoming
Catalysts (2)
2025-01-011.2y agoPh3 Readout· ACC
2027-06-141.2y awayPh3 Readout· RA
Trial Timeline
Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3
Approved
Termina…
Approved
Complet…
Catalysts
Ph3 Readout
2025-01-01 · 1.2y ago
ACC
Ph3 Readout
2027-06-14 · 1.2y away
RA
CompletedTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06493455 | Approved | ACC | Terminated | 1173 | DAS28 |
| NCT05190318 | Approved | RA | Completed | 2649 | UPDRS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-3251 | Eli Lilly | Phase 2 | MDM2 | |
| ABB-3951 | AbbVie | Phase 2/3 | TNFα | |
| Zanutinib | Bristol-Myers Squibb | Phase 2/3 | APOC3 | |
| Bemarelsin | Daiichi Sankyo | Preclinical | GLP-1R | |
| DSN-7360 | Daiichi Sankyo | Approved | SGLT2 | |
| GIL-6239 | Gilead Sciences | Phase 2 | TNFα | |
| MRN-8225 | Moderna | Preclinical | TNFα | |
| BII-8315 | Biogen | NDA/BLA | CDK2 | |
| Sovanaritide | Argenx | Phase 3 | TNFα | |
| 369-4107 | Hansoh Pharma | Phase 2 | TNFα |