Modality
ERT
MOA
CDK2i
Target
C5
Pathway
Hedgehog
Crohn'sMDDFL
Development Pipeline
Preclinical
~Jul 2015
→ ~Oct 2016
Phase 1
~Jan 2017
→ ~Apr 2018
Phase 2
~Jul 2018
→ ~Oct 2019
Phase 3
~Jan 2020
→ ~Apr 2021
NDA/BLA
Jul 2021
→ Jun 2027
NDA/BLACurrent
NCT03712280
516 pts·Crohn's
2021-07→2027-06·Completed
NCT05225195
2,569 pts·Crohn's
2023-12→2026-12·Active
3,085 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (3)
2025-11-135mo agoNDA· FL
2026-12-128mo awayPh3 Readout· Crohn's
2027-06-061.2y awayPh3 Readout· Crohn's
Trial Timeline
Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3
NDA/BLA
Complet…
NDA/BLA
Active
Catalysts
NDA
2025-11-13 · 5mo ago
FL
Ph3 Readout
2026-12-12 · 8mo away
Crohn's
Ph3 Readout
2027-06-06 · 1.2y away
Crohn's
ActiveCompleted|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03712280 | NDA/BLA | Crohn's | Completed | 516 | VA |
| NCT05225195 | NDA/BLA | Crohn's | Active | 2569 | DOR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| LLY-9749 | Eli Lilly | Phase 3 | C5 | |
| LLY-1184 | Eli Lilly | NDA/BLA | C5 | |
| RHH-1546 | Roche | Phase 2/3 | C5 | |
| Tirafotisoran | Roche | Phase 2 | CD38 | |
| ABB-3951 | AbbVie | Phase 2/3 | TNFα | |
| AZN-6870 | AstraZeneca | Phase 2/3 | EGFR | |
| Tirasotorasib | Takeda | NDA/BLA | IL-17A | |
| BAY-6035 | Bayer | Phase 1 | C5 | |
| Mavuglumide | Bayer | Approved | GLP-1R |