Modality
Multispecific
MOA
FcRni
Target
CD47
Pathway
Ferroptosis
CKD
Development Pipeline
Preclinical
~Mar 2012
→ ~Jun 2013
Phase 1
~Sep 2013
→ ~Dec 2014
Phase 2
~Mar 2015
→ ~Jun 2016
Phase 3
~Sep 2016
→ ~Dec 2017
NDA/BLA
~Mar 2018
→ ~Jun 2019
Approved
Sep 2019
→ Dec 2026
ApprovedCurrent
NCT05106027
1,313 pts·CKD
2025-11→TBD·Active
NCT03189561
94 pts·CKD
2019-09→2026-12·Completed
1,407 total pts1 indication
CompletedCurrentUpcoming
Catalysts (1)
2026-12-239mo awayPh3 Readout· CKD
Trial Timeline
Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q4
Approved
Complet…
Approved
Active
Catalysts
Ph3 Readout
2026-12-23 · 9mo away
CKD
ActiveCompleted|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05106027 | Approved | CKD | Active | 1313 | EDSS |
| NCT03189561 | Approved | CKD | Completed | 94 | SeizFreq |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-8903 | Eli Lilly | Preclinical | CD47 | |
| ABB-2476 | AbbVie | Phase 1/2 | USP1 | |
| GSK-4334 | GSK | Preclinical | CD47 | |
| Suracagene | GSK | Phase 3 | PRMT5 | |
| Motainavolisib | Amgen | NDA/BLA | CD47 | |
| REG-6699 | Regeneron | Phase 2/3 | TIM-3 | |
| BMR-1165 | BioMarin | Phase 2 | CD47 | |
| INC-2432 | Incyte | Phase 2 | CD47 | |
| Cevifotisoran | Neurocrine | Approved | CD47 | |
| Pemiinavolisib | Sarepta | NDA/BLA | CD47 |