Modality
mAb
MOA
CFTRmod
Target
SMN2
Pathway
JAK/STAT
Heart Failure
Development Pipeline
Preclinical
~Feb 2015
→ ~May 2016
Phase 1
~Aug 2016
→ ~Nov 2017
Phase 2
~Feb 2018
→ ~May 2019
Phase 3
~Aug 2019
→ ~Nov 2020
NDA/BLA
~Feb 2021
→ ~May 2022
Approved
Aug 2022
→ Jun 2030
ApprovedCurrent
NCT05968241
1,086 pts·Heart Failure
2022-08→2030-06·Terminated
1,086 total pts1 indication
CompletedCurrentUpcoming
Catalysts (1)
2030-06-044.2y awayPh3 Readout· Heart Failure
Trial Timeline
Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3
Approved
Termina…
Catalysts
Ph3 Readout
2030-06-04 · 4.2y away
Heart Failure
Terminated|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05968241 | Approved | Heart Failure | Terminated | 1086 | SeizFreq |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-4358 | Eli Lilly | Phase 3 | B7-H3 | |
| Gelinaritide | AbbVie | Preclinical | FcRn | |
| NVO-6275 | Novo Nordisk | Phase 1 | SMN2 | |
| TAK-5300 | Takeda | Phase 1 | SMN2 | |
| GIL-2259 | Gilead Sciences | Approved | SMN2 | |
| REG-647 | Regeneron | Preclinical | SMN2 | |
| Darafutibatinib | BioNTech | Preclinical | PRMT5 | |
| ALN-8757 | Alnylam | Preclinical | TIGIT | |
| Ivotuximab | Madrigal Pharma | Phase 2 | CD123 | |
| Olpafutibatinib | Immunocore | Approved | SMN2 |