Modality
mRNA
MOA
Menini
Target
PD-1
Pathway
Incretin
ACCNMOSDHeart Failure
Development Pipeline
Preclinical
~Jan 2010
→ ~Apr 2011
Phase 1
~Jul 2011
→ ~Oct 2012
Phase 2
~Jan 2013
→ ~Apr 2014
Phase 3
~Jul 2014
→ ~Oct 2015
NDA/BLA
~Jan 2016
→ ~Apr 2017
Approved
Jul 2017
→ May 2028
ApprovedCurrent
NCT06261659
170 pts·NMOSD
2020-12→2028-03·Recruiting
NCT04497306
235 pts·ACC
2017-07→2028-05·Active
NCT04422959
2,589 pts·Heart Failure
2020-09→2027-06·Not yet recruiting
2,994 total pts3 indications
CompletedCurrentUpcoming
Catalysts (4)
2026-05-182mo awayPh1 Dose Esc· Heart Failure
2027-06-261.2y awayPh3 Readout· Heart Failure
2028-03-172.0y awayPh3 Readout· NMOSD
2028-05-042.1y awayPh3 Readout· ACC
Trial Timeline
Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3
Approved
Active
Approved
Not yet…
Approved
Recruit…
Catalysts
Ph1 Dose Esc
2026-05-18 · 2mo away
Heart Failure
Ph3 Readout
2027-06-26 · 1.2y away
Heart Failure
Ph3 Readout
2028-03-17 · 2.0y away
NMOSD
Ph3 Readout
2028-05-04 · 2.1y away
ACC
RecruitingActiveNot yet recruiting|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06261659 | Approved | NMOSD | Recruiting | 170 | HAM-D |
| NCT04497306 | Approved | ACC | Active | 235 | HbA1c |
| NCT04422959 | Approved | Heart Failure | Not yet recr... | 2589 | MRD |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Mavutenlimab | Johnson & Johnson | Phase 3 | Cl18.2 | |
| JNJ-7458 | Johnson & Johnson | Phase 1/2 | PD-1 | |
| Ivorelsin | Eli Lilly | Approved | JAK1 | |
| NVO-2974 | Novo Nordisk | NDA/BLA | PARP | |
| Pexaosocimab | Daiichi Sankyo | Phase 2 | PD-1 | |
| MRN-8133 | Moderna | Phase 2 | PD-1 | |
| Semazasiran | BeiGene | Phase 1 | PD-1 | |
| Rimainavolisib | Illumina | Phase 2 | PD-1 | |
| Motanaritide | Intellia | Approved | PD-1 | |
| Olpafutibatinib | Immunocore | Approved | SMN2 |