Modality
Radioligand
MOA
CFTRmod
Target
PRMT5
Pathway
Fibrosis
NB
Development Pipeline
Preclinical
~Feb 2014
→ ~May 2015
Phase 1
~Aug 2015
→ ~Nov 2016
Phase 2
~Feb 2017
→ ~May 2018
Phase 3
~Aug 2018
→ ~Nov 2019
NDA/BLA
Feb 2020
→ Oct 2029
NDA/BLACurrent
NCT05552881
2,023 pts·NB
2023-11→2029-10·Recruiting
NCT07630231
136 pts·NB
2020-02→2026-05·Recruiting
2,159 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-05-202mo awayPh3 Readout· NB
2029-10-183.6y awayPh3 Readout· NB
Trial Timeline
2020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q4
NDA/BLA
Recruit…
NDA/BLA
Recruit…
Catalysts
Ph3 Readout
2026-05-20 · 2mo away
NB
Ph3 Readout
2029-10-18 · 3.6y away
NB
Recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05552881 | NDA/BLA | NB | Recruiting | 2023 | HbA1c |
| NCT07630231 | NDA/BLA | NB | Recruiting | 136 | SRI-4 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Nirarelsin | Johnson & Johnson | Phase 2 | PRMT5 | |
| LLY-4358 | Eli Lilly | Phase 3 | B7-H3 | |
| MRK-853 | Merck & Co | Phase 1 | PRMT5 | |
| Gelinaritide | AbbVie | Preclinical | FcRn | |
| Geliderotide | Sanofi | Phase 1/2 | PRMT5 | |
| Capifutibatinib | Sanofi | Approved | PRMT5 | |
| NVO-9615 | Novo Nordisk | Phase 2/3 | PRMT5 | |
| Suracagene | GSK | Phase 3 | PRMT5 | |
| Elrarapivir | Vertex Pharma | NDA/BLA | PRMT5 | |
| Darafutibatinib | BioNTech | Preclinical | PRMT5 |