Modality
ADC
MOA
CAR-T CD19
Target
CD123
Pathway
Neuroinflam
MDS
Development Pipeline
Preclinical
~Nov 2012
→ ~Feb 2014
Phase 1
~May 2014
→ ~Aug 2015
Phase 2
~Nov 2015
→ ~Feb 2017
Phase 3
May 2017
→ Mar 2030
Phase 3Current
NCT07199167
2,559 pts·MDS
2019-08→2030-03·Completed
NCT05628467
2,856 pts·MDS
2019-06→2029-06·Active
NCT05780520
275 pts·MDS
2018-02→2027-11·Completed
+1 more trial
6,573 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (4)
2025-01-111.2y agoPh3 Readout· MDS
2027-11-081.6y awayPh3 Readout· MDS
2029-06-263.2y awayPh3 Readout· MDS
2030-03-134.0y awayPh3 Readout· MDS
Trial Timeline
Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2
P3
Complet…
P3
Complet…
P3
Active
P3
Complet…
Catalysts
Ph3 Readout
2025-01-11 · 1.2y ago
MDS
Ph3 Readout
2027-11-08 · 1.6y away
MDS
Ph3 Readout
2029-06-26 · 3.2y away
MDS
Ph3 Readout
2030-03-13 · 4.0y away
MDS
ActiveCompleted|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07199167 | Phase 3 | MDS | Completed | 2559 | SRI-4 |
| NCT05628467 | Phase 3 | MDS | Active | 2856 | PFS |
| NCT05780520 | Phase 3 | MDS | Completed | 275 | ACR20 |
| NCT06810275 | Phase 3 | MDS | Completed | 883 | SRI-4 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| RHH-1546 | Roche | Phase 2/3 | C5 | |
| Datoglumide | AbbVie | Approved | CFTR | |
| GIL-2259 | Gilead Sciences | Approved | SMN2 | |
| REG-7737 | Regeneron | Preclinical | CD123 | |
| BII-4342 | Biogen | Phase 2/3 | CGRP | |
| Talasotorasib | Exelixis | Preclinical | APOC3 | |
| Ivotuximab | Madrigal Pharma | Phase 2 | CD123 | |
| Elracapivasertib | Kymera | Phase 3 | PRMT5 | |
| SND-4562 | Syndax | NDA/BLA | AuroraA | |
| Zorizumab | Beam | Approved | CD123 |