Modality
Nanobody
MOA
CD47i
Target
PCSK9
Pathway
Tau
Cervical Ca
Development Pipeline
Preclinical
~Dec 2010
→ ~Mar 2012
Phase 1
~Jun 2012
→ ~Sep 2013
Phase 2
~Dec 2013
→ ~Mar 2015
Phase 3
~Jun 2015
→ ~Sep 2016
NDA/BLA
~Dec 2016
→ ~Mar 2018
Approved
Jun 2018
→ Dec 2031
ApprovedCurrent
NCT05017999
872 pts·Cervical Ca
2025-03→2031-12·Active
NCT07184825
73 pts·Cervical Ca
2018-06→2031-02·Completed
NCT08040004
235 pts·Cervical Ca
2023-11→2028-05·Not yet recruiting
+1 more trial
2,068 total pts1 indication
CompletedCurrentUpcoming
Catalysts (3)
2028-05-012.1y awayPh3 Readout· Cervical Ca
2031-02-234.9y awayPh3 Readout· Cervical Ca
2031-12-035.7y awayPh3 Readout· Cervical Ca
Trial Timeline
Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
Approved
Complet…
Approved
Termina…
Approved
Not yet…
Approved
Active
Catalysts
Ph3 Readout
2028-05-01 · 2.1y away
Cervical Ca
Ph3 Readout
2031-02-23 · 4.9y away
Cervical Ca
Ph3 Readout
2031-12-03 · 5.7y away
Cervical Ca
ActiveCompletedTerminatedNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05017999 | Approved | Cervical Ca | Active | 872 | DAS28 |
| NCT07184825 | Approved | Cervical Ca | Completed | 73 | PANSS |
| NCT08040004 | Approved | Cervical Ca | Not yet recr... | 235 | HAM-D |
| NCT05573011 | Approved | Cervical Ca | Terminated | 888 | PASI75 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Nirarelsin | Johnson & Johnson | Phase 2 | PRMT5 | |
| Cevizanubrutinib | Johnson & Johnson | Preclinical | FcRn | |
| Ceviglumide | Roche | NDA/BLA | B7-H3 | |
| NVS-1475 | Novartis | Phase 2 | Menin | |
| Zanusertib | AbbVie | Approved | PCSK9 | |
| AZN-6294 | AstraZeneca | Phase 2/3 | APOC3 | |
| Zenonesiran | GSK | Preclinical | DLL3 | |
| AMG-7379 | Amgen | Preclinical | DLL3 | |
| GIL-4361 | Gilead Sciences | Preclinical | PCSK9 | |
| REG-2172 | Regeneron | Phase 1/2 | PCSK9 |