Modality
Degrader
MOA
FXIai
Target
CD38
Pathway
Proteasome
FTD
Development Pipeline
Preclinical
~Sep 2011
→ ~Dec 2012
Phase 1
~Mar 2013
→ ~Jun 2014
Phase 2
~Sep 2014
→ ~Dec 2015
Phase 3
~Mar 2016
→ ~Jun 2017
NDA/BLA
~Sep 2017
→ ~Dec 2018
Approved
Mar 2019
→ Sep 2031
ApprovedCurrent
NCT08141551
1,682 pts·FTD
2020-09→2026-04·Active
NCT03552475
2,503 pts·FTD
2024-06→2030-12·Recruiting
NCT03319163
2,103 pts·FTD
2019-03→2025-08·Recruiting
+1 more trial
6,966 total pts1 indication
CompletedCurrentUpcoming
Catalysts (4)
2025-08-038mo agoPh3 Readout· FTD
2026-04-284w awayPh3 Readout· FTD
2030-12-064.7y awayPh3 Readout· FTD
2031-09-225.5y awayPh3 Readout· FTD
Trial Timeline
2019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
Approved
Recruit…
Approved
Active
Approved
Recruit…
Approved
Active
Catalysts
Ph3 Readout
2025-08-03 · 8mo ago
FTD
Ph3 Readout
2026-04-28 · 4w away
FTD
Ph3 Readout
2030-12-06 · 4.7y away
FTD
Ph3 Readout
2031-09-22 · 5.5y away
FTD
RecruitingActive|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08141551 | Approved | FTD | Active | 1682 | EASI-75 |
| NCT03552475 | Approved | FTD | Recruiting | 2503 | PASI75 |
| NCT03319163 | Approved | FTD | Recruiting | 2103 | 6MWD |
| NCT05964791 | Approved | FTD | Active | 678 | UPDRS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Terafutibatinib | Pfizer | Phase 1/2 | CD38 | |
| Tirafotisoran | Roche | Phase 2 | CD38 | |
| MRK-3745 | Merck & Co | Phase 2 | WRN | |
| Doxasotorasib | AbbVie | Phase 2 | CD38 | |
| AZN-1715 | AstraZeneca | Phase 3 | AHR | |
| BMY-9931 | Bristol-Myers Squibb | Phase 1 | GPRC5D | |
| SNY-2289 | Sanofi | Phase 2/3 | CD38 | |
| NVO-1361 | Novo Nordisk | Phase 3 | CD38 | |
| NVO-7877 | Novo Nordisk | Preclinical | GPRC5D | |
| TAK-8730 | Takeda | Phase 2 | VEGF |