Product Description
SIM0501 is an oral, non-covalent, and highly selective inhibitor of USP1. USP1 is found to be overexpressed in various tumors and plays a key role in DNA damage response and repair. The inhibition of USP1 can promote apoptosis in tumors, especially in tumors with homologous recombination deficiency (“HRD”). Following the success of the PARP inhibitor (“PARPi”), the USP1 inhibitor is expected to provide innovative solutions for more patients with solid tumors in the field of “synthetic lethality”. In preclinical in vitro and in vivo pharmacology studies, SIM0501 has shown significant anti-proliferation activity against HRD tumors as a monotherapy or in combination with PARPi, which demonstrates high potential for clinical development. On December 2, 2023, the Investigational New Drug (IND) application of SIM0501 to initiate clinical trials for advanced solid tumors was approved by the U.S. Food and Drug Administration (FDA). (Sourced from: https://www.simcere.com/en/news/detail.aspx?mtt=421)
Mechanisms of Action: USP1 Inhibitor
Novel Mechanism: Yes
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Jiangsu Simcere
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: China
Active Clinical Trial Count: 1
Highest Development Phases
Phase 1: Oncology Solid Tumor Unspecified
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| SIM0501-101 | P1 |
Recruiting |
Oncology Solid Tumor Unspecified |
2026-06-30 |
50% |