Modality
ASO
MOA
CDK4/6i
Target
MDM2
Pathway
Neuroinflam
IPF
Development Pipeline
Preclinical
~Aug 2012
→ ~Nov 2013
Phase 1
~Feb 2014
→ ~May 2015
Phase 2
~Aug 2015
→ ~Nov 2016
Phase 3
~Feb 2017
→ ~May 2018
NDA/BLA
Aug 2018
→ Apr 2025
NDA/BLACurrent
NCT06350316
667 pts·IPF
2019-01→2025-03·Active
NCT08222576
465 pts·IPF
2018-08→2025-04·Recruiting
1,132 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-03-211.0y agoPh3 Readout· IPF
2025-04-1511mo agoPh3 Readout· IPF
Trial Timeline
Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2
NDA/BLA
Recruit…
NDA/BLA
Active
Catalysts
Ph3 Readout
2025-03-21 · 1.0y ago
IPF
Ph3 Readout
2025-04-15 · 11mo ago
IPF
RecruitingActive|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06350316 | NDA/BLA | IPF | Active | 667 | eGFR |
| NCT08222576 | NDA/BLA | IPF | Recruiting | 465 | UPDRS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-5767 | Pfizer | Phase 1/2 | BET | |
| LLY-6079 | Eli Lilly | Phase 2 | MDM2 | |
| LLY-3251 | Eli Lilly | Phase 2 | MDM2 | |
| RHH-1969 | Roche | Approved | BET | |
| Ivocapivasertib | Bristol-Myers Squibb | Phase 1 | BET | |
| Zorimavacamten | Bristol-Myers Squibb | Preclinical | Cl18.2 | |
| Fixatenlimab | GSK | Phase 1/2 | JAK1 | |
| GSK-7987 | GSK | Phase 3 | MDM2 | |
| AMG-2752 | Amgen | Preclinical | MDM2 | |
| REG-3155 | Regeneron | Phase 1/2 | MDM2 |