Modality
Peptide
MOA
EGFRi
Target
SHP2
Pathway
Lipid Met
MDS
Development Pipeline
Preclinical
~Dec 2014
→ ~Mar 2016
Phase 1
~Jun 2016
→ ~Sep 2017
Phase 2
~Dec 2017
→ ~Mar 2019
Phase 3
~Jun 2019
→ ~Sep 2020
NDA/BLA
Dec 2020
→ Oct 2029
NDA/BLACurrent
NCT08506993
903 pts·MDS
2022-08→2029-02·Active
NCT07272826
500 pts·MDS
2020-12→2029-10·Not yet recruiting
1,403 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (2)
2029-02-182.9y awayPh3 Readout· MDS
2029-10-133.5y awayPh3 Readout· MDS
Trial Timeline
Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q4
NDA/BLA
Not yet…
NDA/BLA
Active
Catalysts
Ph3 Readout
2029-02-18 · 2.9y away
MDS
Ph3 Readout
2029-10-13 · 3.5y away
MDS
ActiveNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08506993 | NDA/BLA | MDS | Active | 903 | 6MWD |
| NCT07272826 | NDA/BLA | MDS | Not yet recr... | 500 | UPCR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Niranesiran | Johnson & Johnson | Phase 2 | KIF18A | |
| JNJ-5094 | Johnson & Johnson | Phase 2/3 | GIP-R | |
| NVS-5126 | Novartis | Phase 3 | SHP2 | |
| MRK-1380 | Merck & Co | Preclinical | SHP2 | |
| ABB-1817 | AbbVie | Phase 3 | SHP2 | |
| AZN-8281 | AstraZeneca | Phase 1 | SHP2 | |
| AZN-8478 | AstraZeneca | NDA/BLA | SHP2 | |
| GSK-2051 | GSK | Phase 1 | PSMA | |
| GIL-8529 | Gilead Sciences | Phase 1/2 | JAK1 | |
| MRN-7409 | Moderna | NDA/BLA | SHP2 |