Modality
Vaccine
MOA
BiTE
Target
Cl18.2
Pathway
Amyloid
CSUPNH
Development Pipeline
Preclinical
~Jan 2016
→ ~Apr 2017
Phase 1
~Jul 2017
→ ~Oct 2018
Phase 2
~Jan 2019
→ ~Apr 2020
Phase 3
~Jul 2020
→ ~Oct 2021
NDA/BLA
~Jan 2022
→ ~Apr 2023
Approved
Jul 2023
→ Mar 2027
ApprovedCurrent
NCT04969550
2,982 pts·CSU
2023-07→2027-03·Not yet recruiting
NCT07135126
985 pts·CSU
2024-04→2025-02·Completed
3,967 total pts1 indication
CompletedCurrentUpcoming
Catalysts (2)
2025-02-111.1y agoPh3 Readout· CSU
2027-03-1812mo awayPh3 Readout· CSU
Trial Timeline
Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2
Approved
Not yet…
Approved
Complet…
Catalysts
Ph3 Readout
2025-02-11 · 1.1y ago
CSU
Ph3 Readout
2027-03-18 · 12mo away
CSU
CompletedNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04969550 | Approved | CSU | Not yet recr... | 2982 | UPDRS |
| NCT07135126 | Approved | CSU | Completed | 985 | Mayo |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Mavutenlimab | Johnson & Johnson | Phase 3 | Cl18.2 | |
| JNJ-2735 | Johnson & Johnson | Phase 2/3 | Cl18.2 | |
| LLY-3251 | Eli Lilly | Phase 2 | MDM2 | |
| Ribosacituzumab | Roche | Approved | Cl18.2 | |
| Adagrazumab | Novartis | Phase 2/3 | Cl18.2 | |
| Zanutinib | Bristol-Myers Squibb | Phase 2/3 | APOC3 | |
| Zorimavacamten | Bristol-Myers Squibb | Preclinical | Cl18.2 | |
| Doxafotisoran | Daiichi Sankyo | Phase 1 | Cl18.2 | |
| Bemarelsin | Daiichi Sankyo | Preclinical | GLP-1R | |
| DSN-7360 | Daiichi Sankyo | Approved | SGLT2 |