Modality
Radioligand
MOA
FXIai
Target
CFTR
Pathway
T-cell
MCL
Development Pipeline
Preclinical
~Mar 2010
→ ~Jun 2011
Phase 1
~Sep 2011
→ ~Dec 2012
Phase 2
~Mar 2013
→ ~Jun 2014
Phase 3
~Sep 2014
→ ~Dec 2015
NDA/BLA
~Mar 2016
→ ~Jun 2017
Approved
Sep 2017
→ Jun 2030
ApprovedCurrent
NCT05590418
2,018 pts·MCL
2017-09→2029-09·Active
NCT05333494
1,447 pts·MCL
2024-07→2030-06·Not yet recruiting
NCT08047920
257 pts·MCL
2024-06→2026-02·Completed
3,722 total pts1 indication
CompletedCurrentUpcoming
Catalysts (3)
2026-02-191mo agoPh3 Readout· MCL
2029-09-103.4y awayPh3 Readout· MCL
2030-06-284.2y awayPh3 Readout· MCL
Trial Timeline
Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3
Approved
Active
Approved
Complet…
Approved
Not yet…
Catalysts
Ph3 Readout
2026-02-19 · 1mo ago
MCL
Ph3 Readout
2029-09-10 · 3.4y away
MCL
Ph3 Readout
2030-06-28 · 4.2y away
MCL
ActiveCompletedNot yet recruiting|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05590418 | Approved | MCL | Active | 2018 | UPCR |
| NCT05333494 | Approved | MCL | Not yet recr... | 1447 | ACR20 |
| NCT08047920 | Approved | MCL | Completed | 257 | Safety |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Nidasacituzumab | Eli Lilly | Approved | CFTR | |
| NVS-6360 | Novartis | Approved | CD38 | |
| MRK-3745 | Merck & Co | Phase 2 | WRN | |
| Datoglumide | AbbVie | Approved | CFTR | |
| AZN-1715 | AstraZeneca | Phase 3 | AHR | |
| BMY-9931 | Bristol-Myers Squibb | Phase 1 | GPRC5D | |
| SNY-7254 | Sanofi | Phase 2 | CFTR | |
| SNY-5894 | Sanofi | Approved | CFTR | |
| NVO-7877 | Novo Nordisk | Preclinical | GPRC5D | |
| TAK-8730 | Takeda | Phase 2 | VEGF |