Modality
Vaccine
MOA
Menini
Target
GIP-R
Pathway
Hedgehog
ALL
Development Pipeline
Preclinical
~Jun 2011
→ ~Sep 2012
Phase 1
~Dec 2012
→ ~Mar 2014
Phase 2
~Jun 2014
→ ~Sep 2015
Phase 3
~Dec 2015
→ ~Mar 2017
NDA/BLA
~Jun 2017
→ ~Sep 2018
Approved
Dec 2018
→ Aug 2031
ApprovedCurrent
NCT08030463
847 pts·ALL
2020-05→2025-07·Recruiting
NCT03540193
1,140 pts·ALL
2018-12→2031-08·Terminated
1,987 total pts1 indication
CompletedCurrentUpcoming
Catalysts (2)
2025-07-109mo agoPh3 Readout· ALL
2031-08-185.4y awayPh3 Readout· ALL
Trial Timeline
Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
Approved
Termina…
Approved
Recruit…
Catalysts
Ph3 Readout
2025-07-10 · 9mo ago
ALL
Ph3 Readout
2031-08-18 · 5.4y away
ALL
RecruitingTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08030463 | Approved | ALL | Recruiting | 847 | HbA1c |
| NCT03540193 | Approved | ALL | Terminated | 1140 | SeizFreq |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Mavutenlimab | Johnson & Johnson | Phase 3 | Cl18.2 | |
| JNJ-5094 | Johnson & Johnson | Phase 2/3 | GIP-R | |
| Ivorelsin | Eli Lilly | Approved | JAK1 | |
| RHH-3592 | Roche | Phase 1/2 | GIP-R | |
| AZN-5978 | AstraZeneca | Phase 2/3 | GIP-R | |
| NVO-2974 | Novo Nordisk | NDA/BLA | PARP | |
| Ivotuximab | GSK | NDA/BLA | GIP-R | |
| Elrarapivir | Regeneron | Phase 1 | GIP-R | |
| Capifutibatinib | Intra-Cellular | Phase 3 | GIP-R | |
| Olpafutibatinib | Immunocore | Approved | SMN2 |