Drug intelligence / Profile preview

ORIN1001

Development stage
Phase 2
Lead developer
Fosun Orinove
Modality
Small Molecules
Administration
Oral
01

Overview

ORIN1001 is a first-in-class, orally bioavailable small molecule that selectively inhibits the endoribonuclease activity of inositol-requiring enzyme 1 alpha (IRE1α), a key mediator of the unfolded protein response (UPR) in the endoplasmic reticulum. By blocking IRE1α RNase activity, ORIN1001 prevents activation of X-Box Binding Protein 1 (XBP1), disrupting cellular stress responses that promote tumor cell survival and fibrosis. The drug has demonstrated preclinical anti-tumor and anti-fibrotic efficacy both as monotherapy and in combination with standard-of-care agents across multiple cancer types—including breast, prostate, lung, liver, pancreatic, brain, colon, ovarian, esophageal cancers—and idiopathic pulmonary fibrosis (IPF). ORIN1001 is under clinical investigation for advanced solid tumors and metastatic breast cancer as well as IPF. It has received FDA Fast Track Designation[3][4][5][6][7].

Other names
IRE1 RNase inhibitor ORIN1001IRE-1 RNase inhibitor ORIN1001IRE 1 RNase inhibitor ORIN1001
02

Targets

ERN1 (Inositol-requiring enzyme 1 alpha)XBP1 (X-box-binding protein 1)

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