Modality
siRNA
MOA
DLL3 ADC
Target
CDK4/6
Pathway
Incretin
CSU
Development Pipeline
Preclinical
~Sep 2013
→ ~Dec 2014
Phase 1
~Mar 2015
→ ~Jun 2016
Phase 2
~Sep 2016
→ ~Dec 2017
Phase 3
~Mar 2018
→ ~Jun 2019
NDA/BLA
Sep 2019
→ Apr 2028
NDA/BLACurrent
NCT04943330
1,094 pts·CSU
2025-02→2028-04·Recruiting
NCT07641376
242 pts·CSU
2019-09→2027-12·Terminated
1,336 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (2)
2027-12-111.7y awayPh3 Readout· CSU
2028-04-122.0y awayPh3 Readout· CSU
Trial Timeline
Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2
NDA/BLA
Termina…
NDA/BLA
Recruit…
Catalysts
Ph3 Readout
2027-12-11 · 1.7y away
CSU
Ph3 Readout
2028-04-12 · 2.0y away
CSU
RecruitingTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04943330 | NDA/BLA | CSU | Recruiting | 1094 | BodyWt |
| NCT07641376 | NDA/BLA | CSU | Terminated | 242 | DOR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| NVS-4076 | Novartis | Preclinical | TROP-2 | |
| Rimamavacamten | Merck & Co | Phase 1 | PI3Kα | |
| AMG-9654 | Amgen | Phase 2 | GPRC5D | |
| Motavorutinib | Amgen | Phase 3 | CDK4/6 | |
| Ribozanubrutinib | Regeneron | Phase 1 | CDK4/6 | |
| MRN-5715 | Moderna | NDA/BLA | CDK4/6 | |
| Elralucimab | Axsome | Phase 2 | CDK4/6 | |
| Tixatapinarof | Arvinas | Phase 1/2 | CDK2 | |
| Rimanaritide | Agios | Phase 1 | CDK4/6 | |
| GLP-3342 | Galapagos | Phase 1/2 | PLK4 |