Modality
mAb
MOA
CAR-T CD19
Target
SMN2
Pathway
Ferroptosis
ET
Development Pipeline
Preclinical
~Jan 2014
→ ~Apr 2015
Phase 1
~Jul 2015
→ ~Oct 2016
Phase 2
~Jan 2017
→ ~Apr 2018
Phase 3
~Jul 2018
→ ~Oct 2019
NDA/BLA
~Jan 2020
→ ~Apr 2021
Approved
Jul 2021
→ Jan 2031
ApprovedCurrent
NCT06832101
2,679 pts·ET
2025-04→2028-08·Active
NCT06290691
2,231 pts·ET
2021-07→2026-03·Recruiting
NCT04121860
2,986 pts·ET
2024-11→2031-01·Not yet recruiting
+1 more trial
10,560 total pts1 indication
CompletedCurrentUpcoming
Catalysts (4)
2026-03-054w agoPh3 Readout· ET
2027-01-1910mo awayPh3 Readout· ET
2028-08-272.4y awayPh3 Readout· ET
2031-01-234.8y awayPh3 Readout· ET
Trial Timeline
Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2
Approved
Recruit…
Approved
Termina…
Approved
Not yet…
Approved
Active
Catalysts
Ph3 Readout
2026-03-05 · 4w ago
ET
Ph3 Readout
2027-01-19 · 10mo away
ET
Ph3 Readout
2028-08-27 · 2.4y away
ET
Ph3 Readout
2031-01-23 · 4.8y away
ET
RecruitingActiveTerminatedNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06832101 | Approved | ET | Active | 2679 | LiverFat |
| NCT06290691 | Approved | ET | Recruiting | 2231 | PFS |
| NCT04121860 | Approved | ET | Not yet recr... | 2986 | CR |
| NCT08566955 | Approved | ET | Terminated | 2664 | LiverFat |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| RHH-1546 | Roche | Phase 2/3 | C5 | |
| Datoglumide | AbbVie | Approved | CFTR | |
| NVO-6275 | Novo Nordisk | Phase 1 | SMN2 | |
| TAK-5300 | Takeda | Phase 1 | SMN2 | |
| REG-647 | Regeneron | Preclinical | SMN2 | |
| BII-4342 | Biogen | Phase 2/3 | CGRP | |
| Talasotorasib | Exelixis | Preclinical | APOC3 | |
| Olpafutibatinib | Immunocore | Approved | SMN2 | |
| Elracapivasertib | Kymera | Phase 3 | PRMT5 | |
| SND-4562 | Syndax | NDA/BLA | AuroraA |