Research | IND-Enabling | Phase 1 | Phase 2 | Phase 3 | Regulatory Submission |
Approved |
---|---|---|---|---|---|---|
Ripretinib
KIT Inhibitor
-
GIST after 3TKIs⁽¹⁾
-
GIST 2nd Line KIT Exon 11 + 17/18 (INSIGHT Phase 3 Study)⁽²⁾
Vimseltinib
CSF1R Inhibitor
-
TGCT (Phase 3 MOTION Study)⁽³⁾
-
TGCT (Phase 1/2 Study)
-
cGVHD (Phase 2 Study)
DCC-3116
ULK Inhibitor
-
+ KRAS G12C Inhibitor (Sotorasib)
-
+ KIT Inhibitor (Ripretinib)
Updated as of May 2025; 3TKI=prior treatment with 3 or more kinase inhibitors, including imatinib; cGVHD=chronic graft versus host disease; CSF1R=colony-stimulating factor 1 receptor; GCN2=general control nonderepressible; GIST=gastrointestinal stromal tumor; G12C=single point mutation with a glycine-to-cysteine substitution at codon 12; IND=Investigational New Drug; ISR=Integrated Stress Response; KIT=KIT proto-oncogene receptor tyrosine kinase; KRAS= Kirsten rat sarcoma gene; RAF=rapidly accelerated fibrosarcoma; TGCT=tenosynovial giant cell tumor; ULK=unc-51-like autophagy-activating kinase; (1) Exclusive development and commercialization license with Zai Lab in Greater China for QINLOCK; (2) The patient population for the INSIGHT study consists of second-line GIST patients with mutations in KIT exon 11 and 17 and/or 18 and the absence of mutations in KIT exon 9, 13, and/or 14 (also referred to as KIT exon 11 + 17/18 patients)