Modality
Nanobody
MOA
C5i
Target
JAK2
Pathway
Proteasome
HSHNSCCHCC
Development Pipeline
Preclinical
~Mar 2015
→ ~Jun 2016
Phase 1
~Sep 2016
→ ~Dec 2017
Phase 2
~Mar 2018
→ ~Jun 2019
Phase 3
~Sep 2019
→ ~Dec 2020
NDA/BLA
~Mar 2021
→ ~Jun 2022
Approved
Sep 2022
→ Oct 2029
ApprovedCurrent
NCT05379019
539 pts·HS
2024-10→2025-06·Recruiting
NCT05769454
628 pts·HCC
2022-09→2029-10·Completed
1,167 total pts2 indications
CompletedCurrentUpcoming
Catalysts (2)
2025-06-0510mo agoPh3 Readout· HS
2029-10-153.5y awayPh3 Readout· HCC
Trial Timeline
Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q4
Approved
Complet…
Approved
Recruit…
Catalysts
Ph3 Readout
2025-06-05 · 10mo ago
HS
Ph3 Readout
2029-10-15 · 3.5y away
HCC
RecruitingCompleted|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05379019 | Approved | HS | Recruiting | 539 | CR |
| NCT05769454 | Approved | HCC | Completed | 628 | EDSS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| DSN-2247 | Daiichi Sankyo | NDA/BLA | EZH2 | |
| GMA-5010 | Genmab | Phase 3 | JAK2 | |
| Teravorutinib | Illumina | Phase 2 | JAK2 | |
| Rimabrutinib | Madrigal Pharma | Phase 1/2 | GPRC5D | |
| AXS-4984 | Axsome | Preclinical | JAK2 | |
| Capirapivir | TG Therapeutics | Approved | JAK2 | |
| XEN-577 | Xenon Pharma | Phase 2/3 | C5 | |
| Zenorelsin | Disc Medicine | NDA/BLA | JAK2 | |
| IRO-8712 | Disc Medicine | Preclinical | JAK2 | |
| Sovainavolisib | Biomea Fusion | Preclinical | JAK2 |