Modality
Cell Therapy
MOA
EGFRi
Target
WEE1
Pathway
Hedgehog
LGSSCDCSU
Development Pipeline
Preclinical
~Aug 2010
→ ~Nov 2011
Phase 1
~Feb 2012
→ ~May 2013
Phase 2
~Aug 2013
→ ~Nov 2014
Phase 3
~Feb 2015
→ ~May 2016
NDA/BLA
~Aug 2016
→ ~Nov 2017
Approved
Feb 2018
→ Oct 2029
ApprovedCurrent
NCT07766894
2,486 pts·CSU
2021-01→2025-08·Completed
NCT03034754
759 pts·SCD
2019-09→2029-10·Terminated
NCT06718435
158 pts·CSU
2018-02→TBD·Terminated
+1 more trial
6,011 total pts2 indications
CompletedCurrentUpcoming
Catalysts (3)
2025-08-118mo agoPh3 Readout· CSU
2025-08-167mo agoPh3 Readout· SCD
2029-10-053.5y awayPh3 Readout· SCD
Trial Timeline
2018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q4
Approved
Termina…
Approved
Termina…
Approved
Complet…
Approved
Recruit…
Catalysts
Ph3 Readout
2025-08-11 · 8mo ago
CSU
Ph3 Readout
2025-08-16 · 7mo ago
SCD
Ph3 Readout
2029-10-05 · 3.5y away
SCD
RecruitingCompletedTerminated|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07766894 | Approved | CSU | Completed | 2486 | SeizFreq |
| NCT03034754 | Approved | SCD | Terminated | 759 | PANSS |
| NCT06718435 | Approved | CSU | Terminated | 158 | DOR |
| NCT03045856 | Approved | SCD | Recruiting | 2608 | OS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Niranesiran | Johnson & Johnson | Phase 2 | KIF18A | |
| JNJ-5094 | Johnson & Johnson | Phase 2/3 | GIP-R | |
| GSK-2051 | GSK | Phase 1 | PSMA | |
| TAK-2403 | Takeda | Phase 2 | WEE1 | |
| Sovacapivasertib | Amgen | Phase 3 | WEE1 | |
| GIL-8529 | Gilead Sciences | Phase 1/2 | JAK1 | |
| Fixaglumide | Genmab | Phase 2/3 | WEE1 | |
| Sovarasimod | Halozyme | Phase 1/2 | WEE1 | |
| 207-2754 | Samsung Biologics | Phase 1/2 | KRASG12D | |
| Mavuratamab | Blueprint Medicines | NDA/BLA | BET |