Modality
Radioligand
MOA
BCMA ADC
Target
CDK4/6
Pathway
RAS/MAPK
CeliacCSUHNSCC
Development Pipeline
Preclinical
~Aug 2012
→ ~Nov 2013
Phase 1
~Feb 2014
→ ~May 2015
Phase 2
~Aug 2015
→ ~Nov 2016
Phase 3
Feb 2017
→ Dec 2027
Phase 3Current
NCT03844856
1,422 pts·CSU
2025-10→2027-12·Active
NCT08715926
1,463 pts·Celiac
2017-02→2027-04·Recruiting
2,885 total pts2 indications
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2027-04-141.0y awayPh3 Readout· Celiac
2027-12-051.7y awayPh3 Readout· CSU
Trial Timeline
2017Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q4
P3
Recruit…
P3
Active
Catalysts
Ph3 Readout
2027-04-14 · 1.0y away
Celiac
Ph3 Readout
2027-12-05 · 1.7y away
CSU
RecruitingActive|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03844856 | Phase 3 | CSU | Active | 1422 | HAM-D |
| NCT08715926 | Phase 3 | Celiac | Recruiting | 1463 | PASI75 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| AZN-3724 | AstraZeneca | Preclinical | PSMA | |
| Olpatinib | GSK | Preclinical | PD-L1 | |
| Motavorutinib | Amgen | Phase 3 | CDK4/6 | |
| GIL-9779 | Gilead Sciences | Phase 1 | IL-17A | |
| Ribozanubrutinib | Regeneron | Phase 1 | CDK4/6 | |
| MRN-5715 | Moderna | NDA/BLA | CDK4/6 | |
| Sematenlimab | Samsung Biologics | Phase 3 | PI3Kα | |
| Elralucimab | Axsome | Phase 2 | CDK4/6 | |
| Tixatapinarof | Recursion | Approved | FGFR | |
| Terazumab | Recursion | Phase 3 | AHR |