Modality
ERT
MOA
CFTRmod
Target
CDK2
Pathway
Notch
RAMCL
Development Pipeline
Preclinical
~Jun 2021
→ ~Sep 2022
Phase 1
Dec 2022
→ Apr 2031
Phase 1Current
NCT04862457
54 pts·RA
2024-09→2026-01·Completed
NCT08593065
2,497 pts·RA
2022-12→2031-04·Not yet recruiting
2,551 total pts1 indication
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-01-073mo agoPh2 Data· RA
2031-04-015.0y awayPh2 Data· RA
Trial Timeline
2023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2
P1/2
Not yet…
P1/2
Complet…
Catalysts
Ph2 Data
2026-01-07 · 3mo ago
RA
Ph2 Data
2031-04-01 · 5.0y away
RA
CompletedNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04862457 | Phase 1/2 | RA | Completed | 54 | LiverFat |
| NCT08593065 | Phase 1/2 | RA | Not yet recr... | 2497 | BodyWt |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| LLY-4358 | Eli Lilly | Phase 3 | B7-H3 | |
| NVS-3297 | Novartis | Preclinical | CDK2 | |
| Gelinaritide | AbbVie | Preclinical | FcRn | |
| Fixainavolisib | Takeda | Preclinical | CDK2 | |
| AMG-1919 | Amgen | Phase 2/3 | CDK2 | |
| AMG-415 | Amgen | Phase 1 | CDK2 | |
| AMG-9052 | Amgen | Phase 2/3 | CDK2 | |
| Zanuratamab | Gilead Sciences | Phase 1/2 | CDK2 | |
| Nirabrutinib | BioNTech | Phase 2/3 | CDK2 |