Modality
Bispecific Ab
MOA
CD47i
Target
AHR
Pathway
RNA Splicing
MGMDDFSGS
Development Pipeline
Preclinical
~Jul 2009
→ ~Oct 2010
Phase 1
~Jan 2011
→ ~Apr 2012
Phase 2
~Jul 2012
→ ~Oct 2013
Phase 3
~Jan 2014
→ ~Apr 2015
NDA/BLA
~Jul 2015
→ ~Oct 2016
Approved
Jan 2017
→ Apr 2028
ApprovedCurrent
NCT06048523
373 pts·MDD
2017-10→2028-04·Active
NCT03435179
1,706 pts·MG
2017-01→TBD·Recruiting
NCT06957524
463 pts·FSGS
2024-01→TBD·Not yet recruiting
2,542 total pts3 indications
CompletedCurrentUpcoming
Catalysts (1)
2028-04-192.1y awayPh3 Readout· MDD
Trial Timeline
2017Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3
Approved
Recruit…
Approved
Active
Approved
Not yet…
Catalysts
Ph3 Readout
2028-04-19 · 2.1y away
MDD
RecruitingActiveNot yet recruiting|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06048523 | Approved | MDD | Active | 373 | ORR |
| NCT03435179 | Approved | MG | Recruiting | 1706 | Biomarker |
| NCT06957524 | Approved | FSGS | Not yet recr... | 463 | HbA1c |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-2901 | Pfizer | Phase 2 | AHR | |
| Nirarelsin | Johnson & Johnson | Phase 2 | PRMT5 | |
| Cevizanubrutinib | Johnson & Johnson | Preclinical | FcRn | |
| Ceviglumide | Roche | NDA/BLA | B7-H3 | |
| NVS-1475 | Novartis | Phase 2 | Menin | |
| AZN-1715 | AstraZeneca | Phase 3 | AHR | |
| AZN-6294 | AstraZeneca | Phase 2/3 | APOC3 | |
| Zenonesiran | GSK | Preclinical | DLL3 | |
| BAY-6520 | Bayer | Phase 2 | AHR | |
| AMG-7379 | Amgen | Preclinical | DLL3 |