Modality
ERT
MOA
BCL-2i
Target
AuroraA
Pathway
Epigenetic
WilmsMDD
Development Pipeline
Preclinical
~Dec 2012
→ ~Mar 2014
Phase 1
~Jun 2014
→ ~Sep 2015
Phase 2
~Dec 2015
→ ~Mar 2017
Phase 3
~Jun 2017
→ ~Sep 2018
NDA/BLA
~Dec 2018
→ ~Mar 2020
Approved
Jun 2020
→ Feb 2026
ApprovedCurrent
NCT04827012
2,841 pts·MDD
2025-03→2026-02·Completed
NCT06511071
448 pts·Wilms
2020-06→TBD·Active
3,289 total pts2 indications
CompletedCurrentUpcoming
Catalysts (1)
2026-02-092mo agoPh3 Readout· MDD
Trial Timeline
Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026
Approved
Active
Approved
Complet…
Catalysts
Ph3 Readout
2026-02-09 · 2mo ago
MDD
ActiveCompleted|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04827012 | Approved | MDD | Completed | 2841 | Mayo |
| NCT06511071 | Approved | Wilms | Active | 448 | BodyWt |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-5501 | Pfizer | Phase 1 | BTK | |
| RHH-3592 | Roche | Phase 1/2 | GIP-R | |
| Geliderotide | Novartis | NDA/BLA | IL-17A | |
| Motarapivir | GSK | Preclinical | AuroraA | |
| Tezecilimab | Takeda | NDA/BLA | Tau | |
| BAY-8733 | Bayer | Preclinical | AuroraA | |
| Rimaosocimab | Amgen | Preclinical | FXIa | |
| BNT-8090 | BioNTech | Phase 2 | AuroraA | |
| ARG-6988 | Argenx | Preclinical | AuroraA | |
| Capifutibatinib | Incyte | Phase 3 | PCSK9 |