Modality
Cell Therapy
MOA
GLP-1ag
Target
KIF18A
Pathway
Ferroptosis
MesoGBMObesity
Development Pipeline
Preclinical
~Sep 2012
→ ~Dec 2013
Phase 1
~Mar 2014
→ ~Jun 2015
Phase 2
~Sep 2015
→ ~Dec 2016
Phase 3
~Mar 2017
→ ~Jun 2018
NDA/BLA
~Sep 2018
→ ~Dec 2019
Approved
Mar 2020
→ Feb 2031
ApprovedCurrent
NCT06559537
2,462 pts·Obesity
2021-05→2031-02·Recruiting
NCT03400342
2,857 pts·GBM
2020-03→2028-05·Recruiting
NCT07725922
110 pts·Meso
2020-10→2030-12·Active
5,429 total pts3 indications
CompletedCurrentUpcoming
Catalysts (3)
2028-05-192.1y awayPh3 Readout· GBM
2030-12-244.7y awayPh3 Readout· Meso
2031-02-274.9y awayPh3 Readout· Obesity
Trial Timeline
2020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2
Approved
Recruit…
Approved
Active
Approved
Recruit…
Catalysts
Ph3 Readout
2028-05-19 · 2.1y away
GBM
Ph3 Readout
2030-12-24 · 4.7y away
Meso
Ph3 Readout
2031-02-27 · 4.9y away
Obesity
RecruitingActive|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06559537 | Approved | Obesity | Recruiting | 2462 | 6MWD |
| NCT03400342 | Approved | GBM | Recruiting | 2857 | NT-proBNP |
| NCT07725922 | Approved | Meso | Active | 110 | DAS28 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-8662 | Pfizer | NDA/BLA | CD19 | |
| Niranesiran | Johnson & Johnson | Phase 2 | KIF18A | |
| NVO-7840 | Novo Nordisk | Phase 2/3 | B7-H3 | |
| MRN-7601 | Moderna | Phase 2 | IL-13 | |
| Riluinavolisib | Moderna | NDA/BLA | KIF18A | |
| ARG-1250 | Argenx | Phase 2 | C5 | |
| ILM-5680 | Illumina | Phase 2 | BET | |
| NUV-2032 | Nuvalent | Preclinical | KIF18A | |
| CRS-184 | CRISPR Therapeutics | Phase 1/2 | AHR | |
| DNL-9555 | Denali | Phase 1/2 | KIF18A |