← Pipeline|Pexainavolisib

Pexainavolisib

Approved
ASK-1768
Source: Trial-derived·Trials: 3
Modality
siRNA
MOA
BCMA ADC
Target
SOS1
Pathway
Hedgehog
GACTCL
Development Pipeline
Preclinical
~Feb 2016
~May 2017
Phase 1
~Aug 2017
~Nov 2018
Phase 2
~Feb 2019
~May 2020
Phase 3
~Aug 2020
~Nov 2021
NDA/BLA
~Feb 2022
~May 2023
Approved
Aug 2023
Dec 2030
ApprovedCurrent
NCT08353120
1,237 pts·CTCL
2025-092026-01·Not yet recruiting
NCT06735727
1,030 pts·GA
2024-122030-12·Completed
NCT05646988
323 pts·CTCL
2023-082025-03·Completed
2,590 total pts2 indications
CompletedCurrentUpcoming
Catalysts (3)
2025-03-171.0y agoPh3 Readout· CTCL
2026-01-123mo agoPh3 Readout· CTCL
2030-12-144.7y awayPh3 Readout· GA
Trial Timeline
Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
Approved
Complet…
Approved
Complet…
Approved
Not yet…
Catalysts
Ph3 Readout
2025-03-17 · 1.0y ago
CTCL
Ph3 Readout
2026-01-12 · 3mo ago
CTCL
Ph3 Readout
2030-12-14 · 4.7y away
GA
CompletedNot yet recruiting|StartCompletionToday
Trials (3)
NCTPhaseIndicationStatusNEP
NCT08353120ApprovedCTCLNot yet recr...1237PANSS
NCT06735727ApprovedGACompleted1030ACR20
NCT05646988ApprovedCTCLCompleted323ORR
Competitors (10)
DrugCompanyPhaseTargetMOA
TerarelsinAbbViePreclinicalSOS1SOS1i
AZN-3724AstraZenecaPreclinicalPSMABCMA ADC
RibofutibatinibAstraZenecaPhase 2/3SOS1PCSK9i
OlpatinibGSKPreclinicalPD-L1BCMA ADC
GIL-9779Gilead SciencesPhase 1IL-17ABCMA ADC
VoxacageneGilead SciencesPhase 2/3SOS1TYK2i
SRP-9822SareptaPhase 3SOS1FGFRi
SematenlimabSamsung BiologicsPhase 3PI3KαBCMA ADC
FixaosocimabTG TherapeuticsPhase 2/3SOS1PI3Ki
ZanurapivirImmunocorePhase 1SOS1PRMT5i