Modality
Vaccine
MOA
CGRPant
Target
SHP2
Pathway
Notch
UCSMACKD
Development Pipeline
Preclinical
~Apr 2010
→ ~Jul 2011
Phase 1
~Oct 2011
→ ~Jan 2013
Phase 2
~Apr 2013
→ ~Jul 2014
Phase 3
~Oct 2014
→ ~Jan 2016
NDA/BLA
~Apr 2016
→ ~Jul 2017
Approved
Oct 2017
→ Oct 2029
ApprovedCurrent
NCT06906236
774 pts·UC
2020-02→2026-05·Completed
NCT08282357
817 pts·CKD
2022-10→2029-05·Terminated
NCT04091105
1,028 pts·SMA
2017-10→2029-01·Terminated
+1 more trial
3,139 total pts3 indications
CompletedCurrentUpcoming
Catalysts (4)
2026-05-011mo awayPh3 Readout· UC
2029-01-162.8y awayPh3 Readout· SMA
2029-05-183.1y awayPh3 Readout· CKD
2029-10-203.6y awayPh3 Readout· SMA
Trial Timeline
Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q4
Approved
Termina…
Approved
Complet…
Approved
Not yet…
Approved
Termina…
Catalysts
Ph3 Readout
2026-05-01 · 1mo away
UC
Ph3 Readout
2029-01-16 · 2.8y away
SMA
Ph3 Readout
2029-05-18 · 3.1y away
CKD
Ph3 Readout
2029-10-20 · 3.6y away
SMA
CompletedTerminatedNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06906236 | Approved | UC | Completed | 774 | SeizFreq |
| NCT08282357 | Approved | CKD | Terminated | 817 | eGFR |
| NCT04091105 | Approved | SMA | Terminated | 1028 | UPCR |
| NCT05919730 | Approved | SMA | Not yet recr... | 520 | HbA1c |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Terafutibatinib | Pfizer | Phase 1/2 | CD38 | |
| Sotovorutinib | Pfizer | Approved | Aβ | |
| NVS-5126 | Novartis | Phase 3 | SHP2 | |
| MRK-1380 | Merck & Co | Preclinical | SHP2 | |
| ABB-3060 | AbbVie | Phase 2 | LAG-3 | |
| ABB-1817 | AbbVie | Phase 3 | SHP2 | |
| AZN-8281 | AstraZeneca | Phase 1 | SHP2 | |
| AZN-8478 | AstraZeneca | NDA/BLA | SHP2 | |
| GIL-6239 | Gilead Sciences | Phase 2 | TNFα | |
| Tezecilimab | Regeneron | Approved | IL-23 |