Modality
Fusion Protein
MOA
PLK4i
Target
GLP-1R
Pathway
Sphingolipid
CTCLCSUMDD
Development Pipeline
Preclinical
~Nov 2012
→ ~Feb 2014
Phase 1
~May 2014
→ ~Aug 2015
Phase 2
~Nov 2015
→ ~Feb 2017
Phase 3
May 2017
→ Dec 2030
Phase 3Current
NCT06309597
2,174 pts·MDD
2023-12→2030-12·Not yet recruiting
NCT03407092
2,871 pts·CSU
2020-04→2026-07·Terminated
NCT07946788
531 pts·MDD
2022-07→2027-05·Completed
+1 more trial
7,658 total pts3 indications
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (4)
2025-10-185mo agoPh3 Readout· CTCL
2026-07-214mo awayPh3 Readout· CSU
2027-05-231.1y awayPh3 Readout· MDD
2030-12-134.7y awayPh3 Readout· MDD
Trial Timeline
Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
P3
Not yet…
P3
Termina…
P3
Complet…
P3
Not yet…
Catalysts
Ph3 Readout
2025-10-18 · 5mo ago
CTCL
Ph3 Readout
2026-07-21 · 4mo away
CSU
Ph3 Readout
2027-05-23 · 1.1y away
MDD
Ph3 Readout
2030-12-13 · 4.7y away
MDD
CompletedTerminatedNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06309597 | Phase 3 | MDD | Not yet recr... | 2174 | CR |
| NCT03407092 | Phase 3 | CSU | Terminated | 2871 | DAS28 |
| NCT07946788 | Phase 3 | MDD | Completed | 531 | ORR |
| NCT03273558 | Phase 3 | CTCL | Not yet recr... | 2082 | UPCR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-2191 | Pfizer | NDA/BLA | GLP-1R | |
| Riboinavolisib | Johnson & Johnson | Phase 2/3 | GLP-1R | |
| Tirzepatide | Eli Lilly | Approved | GLP-1R | |
| MRK-5413 | Merck & Co | Phase 1 | GLP-1R | |
| Voxacilimab | AstraZeneca | Phase 1/2 | GLP-1R | |
| AZN-5171 | AstraZeneca | Approved | GLP-1R | |
| Mavuglumide | Bayer | Approved | GLP-1R | |
| Bemarelsin | Daiichi Sankyo | Preclinical | GLP-1R | |
| AMG-2597 | Amgen | Phase 2/3 | CD38 | |
| VRT-5441 | Vertex Pharma | Phase 3 | GLP-1R |