Modality
Gene Therapy
MOA
GLP-1/GIP
Target
FcRn
Pathway
Epigenetic
CMLGA
Development Pipeline
Preclinical
~Jan 2012
→ ~Apr 2013
Phase 1
~Jul 2013
→ ~Oct 2014
Phase 2
~Jan 2015
→ ~Apr 2016
Phase 3
~Jul 2016
→ ~Oct 2017
NDA/BLA
Jan 2018
→ Nov 2028
NDA/BLACurrent
NCT04531504
2,597 pts·GA
2023-02→2025-08·Not yet recruiting
NCT07542169
2,001 pts·CML
2018-01→2028-11·Recruiting
4,598 total pts2 indications
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-08-237mo agoPh3 Readout· GA
2028-11-172.6y awayPh3 Readout· CML
Trial Timeline
2018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q4
NDA/BLA
Recruit…
NDA/BLA
Not yet…
Catalysts
Ph3 Readout
2025-08-23 · 7mo ago
GA
Ph3 Readout
2028-11-17 · 2.6y away
CML
RecruitingNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04531504 | NDA/BLA | GA | Not yet recr... | 2597 | EFS |
| NCT07542169 | NDA/BLA | CML | Recruiting | 2001 | PANSS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Zanuderotide | Johnson & Johnson | Phase 2/3 | TIGIT | |
| JNJ-8168 | Johnson & Johnson | Phase 2/3 | FLT3 | |
| Cevizanubrutinib | Johnson & Johnson | Preclinical | FcRn | |
| Gelinaritide | AbbVie | Preclinical | FcRn | |
| AZN-5171 | AstraZeneca | Approved | GLP-1R | |
| Talalemzoparlimab | Gilead Sciences | Phase 1 | FcRn | |
| Sovafutibatinib | Moderna | Approved | FcRn | |
| Pemiinavolisib | Sarepta | NDA/BLA | CD47 | |
| ITC-879 | Intra-Cellular | Approved | FcRn | |
| JAZ-8729 | Jazz Pharma | Phase 2/3 | FcRn |