Modality
Radioligand
MOA
Anti-Tau
Target
PD-1
Pathway
Ferroptosis
CKDPompeMDS
Development Pipeline
Preclinical
~Jun 2011
→ ~Sep 2012
Phase 1
~Dec 2012
→ ~Mar 2014
Phase 2
~Jun 2014
→ ~Sep 2015
Phase 3
~Dec 2015
→ ~Mar 2017
NDA/BLA
~Jun 2017
→ ~Sep 2018
Approved
Dec 2018
→ Feb 2030
ApprovedCurrent
NCT06835752
346 pts·Pompe
2021-04→2026-01·Recruiting
NCT03747880
1,991 pts·MDS
2018-12→2028-03·Recruiting
NCT08120375
2,461 pts·CKD
2023-05→2030-02·Terminated
4,798 total pts3 indications
CompletedCurrentUpcoming
Catalysts (3)
2026-01-232mo agoPh3 Readout· Pompe
2028-03-041.9y awayPh3 Readout· MDS
2030-02-023.8y awayPh3 Readout· CKD
Trial Timeline
Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2
Approved
Recruit…
Approved
Recruit…
Approved
Termina…
Catalysts
Ph3 Readout
2026-01-23 · 2mo ago
Pompe
Ph3 Readout
2028-03-04 · 1.9y away
MDS
Ph3 Readout
2030-02-02 · 3.8y away
CKD
RecruitingTerminated|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06835752 | Approved | Pompe | Recruiting | 346 | PFS |
| NCT03747880 | Approved | MDS | Recruiting | 1991 | CR |
| NCT08120375 | Approved | CKD | Terminated | 2461 | DAS28 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| JNJ-7458 | Johnson & Johnson | Phase 1/2 | PD-1 | |
| RHH-7558 | Roche | Phase 1 | SGLT2 | |
| NVS-5439 | Novartis | Preclinical | BET | |
| NVO-9630 | Novo Nordisk | Phase 2 | CD3 | |
| Pexaosocimab | Daiichi Sankyo | Phase 2 | PD-1 | |
| REG-2172 | Regeneron | Phase 1/2 | PCSK9 | |
| MRN-8133 | Moderna | Phase 2 | PD-1 | |
| Semazasiran | BeiGene | Phase 1 | PD-1 | |
| BGN-3305 | BeiGene | Phase 2 | BCMA | |
| Sovarasimod | Halozyme | Phase 1/2 | WEE1 |