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← Pipeline|Nirasacituzumab

Nirasacituzumab

Phase 3
117-8907
By Sino Biopharma
Source: Trial-derived·Trials: 4
Modality
Nanobody
MOA
JAK1/2i
Target
EGFR
Pathway
Fibrosis
SMAMelanoma
Development Pipeline
Preclinical
~Apr 2016
→ ~Jul 2017
Phase 1
~Oct 2017
→ ~Jan 2019
Phase 2
~Apr 2019
→ ~Jul 2020
Phase 3
Oct 2020
→ Oct 2030
Phase 3Current
NCT05157166
1,589 pts·Melanoma
2020-10→2028-09·Completed
NCT05920209
2,441 pts·Melanoma
2021-06→2030-10·Completed
NCT04124074
2,175 pts·Melanoma
2021-11→2030-08·Not yet recruiting
+1 more trial
6,801 total pts2 indications
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (4)
2026-06-173mo awayPh3 Readout· SMA
2028-09-262.5y awayPh3 Readout· Melanoma
2030-08-154.4y awayPh3 Readout· Melanoma
2030-10-044.5y awayPh3 Readout· Melanoma
Trial Timeline
Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
P3
Complet…
P3
Active
P3
Complet…
P3
Not yet…
Catalysts
Ph3 Readout
2026-06-17 · 3mo away
SMA
Ph3 Readout
2028-09-26 · 2.5y away
Melanoma
Ph3 Readout
2030-08-15 · 4.4y away
Melanoma
Ph3 Readout
2030-10-04 · 4.5y away
Melanoma
ActiveCompletedNot yet recruiting|StartCompletionToday
Trials (4)
NCTPhaseIndicationStatusNEP
NCT05157166Phase 3MelanomaCompleted15896MWD
NCT05920209Phase 3MelanomaCompleted2441DOR
NCT04124074Phase 3MelanomaNot yet recr...2175MRD
NCT05262286Phase 3SMAActive596Biomarker
Competitors (10)
DrugCompanyPhaseTargetMOA
FixanesiranAbbViePreclinicalRETJAK1/2i
AZN-6870AstraZenecaPhase 2/3EGFRCDK2i
TAK-1836TakedaPreclinicalEGFRKIF18Ai
MotavorutinibAmgenPhase 3CDK4/6JAK1/2i
VRT-9481Vertex PharmaPhase 1/2MeninJAK1/2i
SovarelsinBioMarinPhase 2CFTRJAK1/2i
ZanurapivirNeurocrineNDA/BLAEGFRCD47i
PeminaritideSareptaNDA/BLAPLK4JAK1/2i
NiramavacamtenHansoh PharmaPhase 2SGLT2JAK1/2i
RCU-2903Arcus BioNDA/BLAEGFRHER2