Modality
Nanobody
MOA
AHRant
Target
CFTR
Pathway
Checkpoint
NMOSD
Development Pipeline
Preclinical
~Nov 2010
→ ~Feb 2012
Phase 1
~May 2012
→ ~Aug 2013
Phase 2
~Nov 2013
→ ~Feb 2015
Phase 3
~May 2015
→ ~Aug 2016
NDA/BLA
~Nov 2016
→ ~Feb 2018
Approved
May 2018
→ Nov 2029
ApprovedCurrent
NCT04046407
2,500 pts·NMOSD
2023-01→2026-08·Terminated
NCT05683529
778 pts·NMOSD
2025-10→2029-11·Active
NCT04834005
645 pts·NMOSD
2022-01→2028-12·Completed
+1 more trial
5,192 total pts1 indication
CompletedCurrentUpcoming
Catalysts (4)
2026-08-225mo awayPh3 Readout· NMOSD
2027-09-281.5y awayPh3 Readout· NMOSD
2028-12-102.7y awayPh3 Readout· NMOSD
2029-11-163.6y awayPh3 Readout· NMOSD
Trial Timeline
Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q4
Approved
Recruit…
Approved
Complet…
Approved
Termina…
Approved
Active
Catalysts
Ph3 Readout
2026-08-22 · 5mo away
NMOSD
Ph3 Readout
2027-09-28 · 1.5y away
NMOSD
Ph3 Readout
2028-12-10 · 2.7y away
NMOSD
Ph3 Readout
2029-11-16 · 3.6y away
NMOSD
RecruitingActiveCompletedTerminated|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04046407 | Approved | NMOSD | Terminated | 2500 | LiverFat |
| NCT05683529 | Approved | NMOSD | Active | 778 | Biomarker |
| NCT04834005 | Approved | NMOSD | Completed | 645 | ACR20 |
| NCT05871749 | Approved | NMOSD | Recruiting | 1269 | NT-proBNP |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Nidasacituzumab | Eli Lilly | Approved | CFTR | |
| Datoglumide | AbbVie | Approved | CFTR | |
| AZN-5978 | AstraZeneca | Phase 2/3 | GIP-R | |
| SNY-7254 | Sanofi | Phase 2 | CFTR | |
| SNY-5894 | Sanofi | Approved | CFTR | |
| BII-5449 | Biogen | Phase 3 | FXIa | |
| Sovarelsin | BioMarin | Phase 2 | CFTR | |
| Fixatuximab | Legend Biotech | Preclinical | CFTR | |
| Elratapinarof | Halozyme | Phase 2 | C5 | |
| Nidaratamab | Exelixis | Phase 3 | FLT3 |