Modality
Nanobody
MOA
HER2
Target
FLT3
Pathway
Complement
ETIgAN
Development Pipeline
Preclinical
~Feb 2012
→ ~May 2013
Phase 1
~Aug 2013
→ ~Nov 2014
Phase 2
~Feb 2015
→ ~May 2016
Phase 3
~Aug 2016
→ ~Nov 2017
NDA/BLA
~Feb 2018
→ ~May 2019
Approved
Aug 2019
→ Mar 2028
ApprovedCurrent
NCT05664010
430 pts·ET
2025-09→2025-12·Completed
NCT04240203
2,812 pts·ET
2021-10→2028-03·Recruiting
NCT08964954
688 pts·IgAN
2019-08→2027-11·Recruiting
3,930 total pts2 indications
CompletedCurrentUpcoming
Catalysts (3)
2025-12-094mo agoPh3 Readout· ET
2027-11-131.6y awayPh3 Readout· IgAN
2028-03-262.0y awayPh3 Readout· ET
Trial Timeline
Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2
Approved
Recruit…
Approved
Recruit…
Approved
Complet…
Catalysts
Ph3 Readout
2025-12-09 · 4mo ago
ET
Ph3 Readout
2027-11-13 · 1.6y away
IgAN
Ph3 Readout
2028-03-26 · 2.0y away
ET
RecruitingCompleted|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05664010 | Approved | ET | Completed | 430 | ACR20 |
| NCT04240203 | Approved | ET | Recruiting | 2812 | CfB |
| NCT08964954 | Approved | IgAN | Recruiting | 688 | ACR20 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-7809 | Pfizer | Phase 1 | DLL3 | |
| JNJ-8168 | Johnson & Johnson | Phase 2/3 | FLT3 | |
| LLY-8903 | Eli Lilly | Preclinical | CD47 | |
| SNY-7254 | Sanofi | Phase 2 | CFTR | |
| Datobrutinib | Sanofi | Phase 3 | Aβ | |
| TAK-9344 | Takeda | Phase 3 | CGRP | |
| Sotorapivir | Moderna | Approved | FLT3 | |
| Nidaratamab | Exelixis | Phase 3 | FLT3 | |
| Voxaderotide | Viking Therapeutics | Approved | PD-L1 | |
| Adagrarapivir | Ideaya Bio | Phase 1/2 | IL-17A |