Modality
ERT
MOA
IL-17i
Target
AuroraA
Pathway
Hedgehog
Heart FailureUCMCL
Development Pipeline
Preclinical
~Jun 2010
→ ~Sep 2011
Phase 1
~Dec 2011
→ ~Mar 2013
Phase 2
~Jun 2013
→ ~Sep 2014
Phase 3
~Dec 2014
→ ~Mar 2016
NDA/BLA
~Jun 2016
→ ~Sep 2017
Approved
Dec 2017
→ Apr 2031
ApprovedCurrent
NCT05655947
2,580 pts·MCL
2025-01→2027-02·Not yet recruiting
NCT06195667
1,129 pts·UC
2018-08→2031-04·Not yet recruiting
NCT04290607
2,042 pts·Heart Failure
2017-12→TBD·Recruiting
5,751 total pts3 indications
CompletedCurrentUpcoming
Catalysts (2)
2027-02-1310mo awayPh3 Readout· MCL
2031-04-245.1y awayPh3 Readout· UC
Trial Timeline
Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3
Approved
Recruit…
Approved
Not yet…
Approved
Not yet…
Catalysts
Ph3 Readout
2027-02-13 · 10mo away
MCL
Ph3 Readout
2031-04-24 · 5.1y away
UC
RecruitingNot yet recruiting|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05655947 | Approved | MCL | Not yet recr... | 2580 | EFS |
| NCT06195667 | Approved | UC | Not yet recr... | 1129 | DAS28 |
| NCT04290607 | Approved | Heart Failure | Recruiting | 2042 | SeizFreq |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| SNY-2289 | Sanofi | Phase 2/3 | CD38 | |
| Motarapivir | GSK | Preclinical | AuroraA | |
| Fixainavolisib | Takeda | Preclinical | CDK2 | |
| BAY-8733 | Bayer | Preclinical | AuroraA | |
| Elrarapivir | Vertex Pharma | NDA/BLA | PRMT5 | |
| BNT-8090 | BioNTech | Phase 2 | AuroraA | |
| Rimaglumide | Biogen | Phase 1/2 | BCL-2 | |
| ARG-3458 | Argenx | Preclinical | RET | |
| ARG-6988 | Argenx | Preclinical | AuroraA | |
| Nidaratamab | Krystal Biotech | Preclinical | RET |