Modality
mAb
MOA
IL-13i
Target
AuroraA
Pathway
Tau
EpilepsyFSGSMeso
Development Pipeline
Preclinical
~Sep 2013
→ ~Dec 2014
Phase 1
~Mar 2015
→ ~Jun 2016
Phase 2
~Sep 2016
→ ~Dec 2017
Phase 3
~Mar 2018
→ ~Jun 2019
NDA/BLA
~Sep 2019
→ ~Dec 2020
Approved
Mar 2021
→ May 2030
ApprovedCurrent
NCT08722678
2,033 pts·Epilepsy
2025-05→2028-01·Recruiting
NCT04689650
1,282 pts·Meso
2023-04→TBD·Active
NCT06676479
2,729 pts·FSGS
2021-03→2030-05·Completed
6,044 total pts3 indications
CompletedCurrentUpcoming
Catalysts (2)
2028-01-061.8y awayPh3 Readout· Epilepsy
2030-05-164.1y awayPh3 Readout· FSGS
Trial Timeline
2021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3
Approved
Complet…
Approved
Active
Approved
Recruit…
Catalysts
Ph3 Readout
2028-01-06 · 1.8y away
Epilepsy
Ph3 Readout
2030-05-16 · 4.1y away
FSGS
RecruitingActiveCompleted|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08722678 | Approved | Epilepsy | Recruiting | 2033 | Mayo |
| NCT04689650 | Approved | Meso | Active | 1282 | SRI-4 |
| NCT06676479 | Approved | FSGS | Completed | 2729 | UPCR |
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 | |
| Motarapivir | GSK | Preclinical | AuroraA | |
| BAY-8733 | Bayer | Preclinical | AuroraA | |
| AMG-1919 | Amgen | Phase 2/3 | CDK2 | |
| Ribozanubrutinib | Regeneron | Phase 1 | CDK4/6 | |
| BNT-8090 | BioNTech | Phase 2 | AuroraA |