Modality
Degrader
MOA
EZH2i
Target
FcRn
Pathway
Neuroinflam
CholangiocarcinomaBreast Ca
Development Pipeline
Preclinical
~Mar 2011
→ ~Jun 2012
Phase 1
~Sep 2012
→ ~Dec 2013
Phase 2
~Mar 2014
→ ~Jun 2015
Phase 3
~Sep 2015
→ ~Dec 2016
NDA/BLA
~Mar 2017
→ ~Jun 2018
Approved
Sep 2018
→ Nov 2031
ApprovedCurrent
NCT03182345
2,112 pts·Breast Ca
2024-05→2030-07·Active
NCT04181154
1,977 pts·Breast Ca
2024-11→2028-09·Completed
NCT08542180
929 pts·Breast Ca
2018-09→2030-11·Completed
+1 more trial
5,761 total pts1 indication
CompletedCurrentUpcoming
Catalysts (5)
2025-08-118mo agoAdCom· Cholangiocarcinoma
2028-09-062.4y awayPh3 Readout· Breast Ca
2030-07-014.3y awayPh3 Readout· Breast Ca
2030-11-214.6y awayPh3 Readout· Breast Ca
2031-11-055.6y awayPh3 Readout· Breast Ca
Trial Timeline
Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
Approved
Complet…
Approved
Complet…
Approved
Active
Approved
Complet…
Catalysts
AdCom
2025-08-11 · 8mo ago
Cholangiocarcinoma
Ph3 Readout
2028-09-06 · 2.4y away
Breast Ca
Ph3 Readout
2030-07-01 · 4.3y away
Breast Ca
Ph3 Readout
2030-11-21 · 4.6y away
Breast Ca
Ph3 Readout
2031-11-05 · 5.6y away
Breast Ca
ActiveCompleted|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03182345 | Approved | Breast Ca | Active | 2112 | HbA1c |
| NCT04181154 | Approved | Breast Ca | Completed | 1977 | PANSS |
| NCT08542180 | Approved | Breast Ca | Completed | 929 | ORR |
| NCT05395647 | Approved | Breast Ca | Completed | 743 | Mayo |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Cevizanubrutinib | Johnson & Johnson | Preclinical | FcRn | |
| Adagrazumab | Novartis | Phase 2/3 | Cl18.2 | |
| Ribotuximab | Merck & Co | Phase 2 | GPRC5D | |
| Gelinaritide | AbbVie | Preclinical | FcRn | |
| NVO-9615 | Novo Nordisk | Phase 2/3 | PRMT5 | |
| Talalemzoparlimab | Gilead Sciences | Phase 1 | FcRn | |
| Sovafutibatinib | Moderna | Approved | FcRn | |
| ITC-879 | Intra-Cellular | Approved | FcRn | |
| Polalucimab | Jazz Pharma | Preclinical | PLK4 | |
| JAZ-8729 | Jazz Pharma | Phase 2/3 | FcRn |