← Pipeline|Tirainavolisib

Tirainavolisib

Approved
300-6541
Source: Trial-derived·Trials: 3
Modality
Nanobody
MOA
TROP-2 ADC
Target
SHP2
Pathway
Proteasome
IPF
Development Pipeline
Preclinical
~Mar 2010
~Jun 2011
Phase 1
~Sep 2011
~Dec 2012
Phase 2
~Mar 2013
~Jun 2014
Phase 3
~Sep 2014
~Dec 2015
NDA/BLA
~Mar 2016
~Jun 2017
Approved
Sep 2017
Jun 2031
ApprovedCurrent
NCT03941849
1,655 pts·IPF
2021-092030-02·Terminated
NCT03402177
1,014 pts·IPF
2017-09TBD·Not yet recruiting
NCT05489667
121 pts·IPF
2019-032031-06·Terminated
2,790 total pts1 indication
CompletedCurrentUpcoming
Catalysts (3)
2026-01-222mo agoPh1 Dose Esc· IPF
2030-02-053.9y awayPh3 Readout· IPF
2031-06-015.2y awayPh3 Readout· IPF
Trial Timeline
Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3
Approved
Not yet…
Approved
Termina…
Approved
Termina…
Catalysts
Ph1 Dose Esc
2026-01-22 · 2mo ago
IPF
Ph3 Readout
2030-02-05 · 3.9y away
IPF
Ph3 Readout
2031-06-01 · 5.2y away
IPF
TerminatedNot yet recruiting|StartCompletionToday
Trials (3)
NCTPhaseIndicationStatusNEP
NCT03941849ApprovedIPFTerminated1655LiverFat
NCT03402177ApprovedIPFNot yet recr...1014PANSS
NCT05489667ApprovedIPFTerminated121ORR
Competitors (10)
DrugCompanyPhaseTargetMOA
NVS-5126NovartisPhase 3SHP2PI3Ki
MRK-1380Merck & CoPreclinicalSHP2SOS1i
ABB-1817AbbViePhase 3SHP2WRNi
AZN-8281AstraZenecaPhase 1SHP2BTKi
AZN-8478AstraZenecaNDA/BLASHP2KRASG12Ci
BAY-6520BayerPhase 2AHRTROP-2 ADC
BemazumabRegeneronPhase 1VEGFTROP-2 ADC
MRN-7409ModernaNDA/BLASHP2CDK2i
GMA-5010GenmabPhase 3JAK2TROP-2 ADC
INC-1582IncytePhase 1/2APOC3TROP-2 ADC