Modality
ASO
MOA
CDK4/6i
Target
BET
Pathway
RNA Splicing
MSPBC
Development Pipeline
Preclinical
~Jan 2015
→ ~Apr 2016
Phase 1
~Jul 2016
→ ~Oct 2017
Phase 2
~Jan 2018
→ ~Apr 2019
Phase 3
~Jul 2019
→ ~Oct 2020
NDA/BLA
~Jan 2021
→ ~Apr 2022
Approved
Jul 2022
→ Jan 2029
ApprovedCurrent
NCT05636356
2,654 pts·PBC
2022-07→2029-01·Terminated
2,654 total pts1 indication
CompletedCurrentUpcoming
Catalysts (1)
2029-01-112.8y awayPh3 Readout· PBC
Trial Timeline
Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029
Approved
Termina…
Catalysts
Ph3 Readout
2029-01-11 · 2.8y away
PBC
Terminated|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05636356 | Approved | PBC | Terminated | 2654 | ACR20 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-5767 | Pfizer | Phase 1/2 | BET | |
| NVS-5439 | Novartis | Preclinical | BET | |
| Ivocapivasertib | Bristol-Myers Squibb | Phase 1 | BET | |
| Zorimavacamten | Bristol-Myers Squibb | Preclinical | Cl18.2 | |
| Fixatenlimab | GSK | Phase 1/2 | JAK1 | |
| VRT-4938 | Vertex Pharma | Preclinical | HER2 | |
| VRT-5441 | Vertex Pharma | Phase 3 | GLP-1R | |
| Adagracapivasertib | BeiGene | NDA/BLA | BET | |
| NBI-3153 | Neurocrine | Approved | Aβ | |
| Pemicapivasertib | Legend Biotech | Phase 3 | VEGF |