Modality
ADC
MOA
Anti-Tau
Target
BET
Pathway
Notch
PNHCeliacCF
Development Pipeline
Preclinical
~Jul 2014
→ ~Oct 2015
Phase 1
~Jan 2016
→ ~Apr 2017
Phase 2
~Jul 2017
→ ~Oct 2018
Phase 3
~Jan 2019
→ ~Apr 2020
NDA/BLA
~Jul 2020
→ ~Oct 2021
Approved
Jan 2022
→ Dec 2030
ApprovedCurrent
NCT05861155
2,802 pts·Celiac
2025-12→2030-12·Terminated
NCT08689348
959 pts·CF
2022-01→2025-12·Recruiting
3,761 total pts2 indications
CompletedCurrentUpcoming
Catalysts (2)
2025-12-074mo agoPh3 Readout· CF
2030-12-254.7y awayPh3 Readout· Celiac
Trial Timeline
2022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
Approved
Recruit…
Approved
Termina…
Catalysts
Ph3 Readout
2025-12-07 · 4mo ago
CF
Ph3 Readout
2030-12-25 · 4.7y away
Celiac
RecruitingTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05861155 | Approved | Celiac | Terminated | 2802 | HAM-D |
| NCT08689348 | Approved | CF | Recruiting | 959 | UPDRS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-5767 | Pfizer | Phase 1/2 | BET | |
| RHH-1969 | Roche | Approved | BET | |
| RHH-7558 | Roche | Phase 1 | SGLT2 | |
| NVS-5439 | Novartis | Preclinical | BET | |
| Ivocapivasertib | Bristol-Myers Squibb | Phase 1 | BET | |
| NVO-9630 | Novo Nordisk | Phase 2 | CD3 | |
| REG-2172 | Regeneron | Phase 1/2 | PCSK9 | |
| Adagracapivasertib | BeiGene | NDA/BLA | BET | |
| BGN-3305 | BeiGene | Phase 2 | BCMA | |
| Sovarasimod | Halozyme | Phase 1/2 | WEE1 |