Modality
Gene Therapy
MOA
CD47i
Target
MET
Pathway
RNA Splicing
RCCNSCLCCeliac
Development Pipeline
Preclinical
~Aug 2009
→ ~Nov 2010
Phase 1
~Feb 2011
→ ~May 2012
Phase 2
~Aug 2012
→ ~Nov 2013
Phase 3
~Feb 2014
→ ~May 2015
NDA/BLA
~Aug 2015
→ ~Nov 2016
Approved
Feb 2017
→ Jul 2029
ApprovedCurrent
NCT06178619
21 pts·Celiac
2017-09→2026-05·Completed
NCT05627141
1,063 pts·RCC
2021-05→2029-05·Completed
NCT06070907
1,518 pts·RCC
2017-02→2027-06·Terminated
+1 more trial
2,681 total pts2 indications
CompletedCurrentUpcoming
Catalysts (4)
2026-05-131mo awayPh3 Readout· Celiac
2027-06-081.2y awayPh3 Readout· RCC
2029-05-103.1y awayPh3 Readout· RCC
2029-07-273.3y awayPh3 Readout· RCC
Trial Timeline
2017Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q4
Approved
Termina…
Approved
Complet…
Approved
Recruit…
Approved
Complet…
Catalysts
Ph3 Readout
2026-05-13 · 1mo away
Celiac
Ph3 Readout
2027-06-08 · 1.2y away
RCC
Ph3 Readout
2029-05-10 · 3.1y away
RCC
Ph3 Readout
2029-07-27 · 3.3y away
RCC
RecruitingCompletedTerminated|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06178619 | Approved | Celiac | Completed | 21 | SRI-4 |
| NCT05627141 | Approved | RCC | Completed | 1063 | OS |
| NCT06070907 | Approved | RCC | Terminated | 1518 | UPCR |
| NCT03866431 | Approved | RCC | Recruiting | 79 | SRI-4 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Nirarelsin | Johnson & Johnson | Phase 2 | PRMT5 | |
| Cevizanubrutinib | Johnson & Johnson | Preclinical | FcRn | |
| Ceviglumide | Roche | NDA/BLA | B7-H3 | |
| NVS-1475 | Novartis | Phase 2 | Menin | |
| AZN-6294 | AstraZeneca | Phase 2/3 | APOC3 | |
| SNY-5783 | Sanofi | Phase 1/2 | MET | |
| Zenonesiran | GSK | Preclinical | DLL3 | |
| AMG-7379 | Amgen | Preclinical | DLL3 | |
| Sotosacituzumab | Vertex Pharma | Phase 1 | MET | |
| BGN-3859 | BeiGene | Approved | PSMA |