Modality
Gene Therapy
MOA
CDK2i
Target
GPRC5D
Pathway
Fibrosis
PAH
Development Pipeline
Preclinical
~Aug 2016
→ ~Nov 2017
Phase 1
Feb 2018
→ Oct 2031
Phase 1Current
NCT04877256
1,077 pts·PAH
2023-03→2030-04·Not yet recruiting
NCT03421612
2,782 pts·PAH
2018-02→2031-10·Active
3,859 total pts1 indication
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2030-04-244.1y awayInterim· PAH
2031-10-175.5y awayInterim· PAH
Trial Timeline
2018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
P1
Active
P1
Not yet…
Catalysts
Interim
2030-04-24 · 4.1y away
PAH
Interim
2031-10-17 · 5.5y away
PAH
ActiveNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04877256 | Phase 1 | PAH | Not yet recr... | 1077 | EASI-75 |
| NCT03421612 | Phase 1 | PAH | Active | 2782 | MRD |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| Tirafotisoran | Roche | Phase 2 | CD38 | |
| Pexatenlimab | Novartis | Phase 1/2 | GPRC5D | |
| Ribotuximab | Merck & Co | Phase 2 | GPRC5D | |
| ABB-3951 | AbbVie | Phase 2/3 | TNFα | |
| AZN-6870 | AstraZeneca | Phase 2/3 | EGFR | |
| BMY-9931 | Bristol-Myers Squibb | Phase 1 | GPRC5D | |
| NVO-7877 | Novo Nordisk | Preclinical | GPRC5D | |
| Tirasotorasib | Takeda | NDA/BLA | IL-17A | |
| Mavuglumide | Bayer | Approved | GLP-1R |