Drugs / IDE161
last change 10 days ago re-read 9 days ago

IDE161

targets PARG via inhibition

Developed for
small cell lung carcinoma · breast cancer · colorectal cancer · endometrial cancer · head and neck cancer · non-small cell lung carcinoma · ovarian cancer · prostate cancer
Investigated by
IDEAYA Biosciences · Merck Sharp & Dohme LLC

Trials 2

202420252026202720282029
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT05787587 Apr 2023 → Oct 2026 expected breast cancer, colorectal cancer, endometrial cancer, head and neck cancer +4 IDEAYA Biosciences Active not recruiting No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT07174583 Oct 2025 → Jul 2029 expected small cell lung carcinoma IDEAYA Biosciences Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 6

DateIssuerRelease
2023-10-23 IDEAYA Biosciences Results IDEAYA Announces Top-Line Phase 2 Results at ESMO 2023 of Darovasertib and Crizotinib Combo in MUM, and Clinical Efficacy Updates for Neoadjuvant UM, GNAQ/11 Cutaneous Melanoma, and Synthetic Lethality Pipeline ideayabio.com ↗
Synthetic Lethality: Updates on PRs by RECIST 1.1 for IDE397/MAT2A and IDE161/PARG
2023-09-27 IDEAYA Biosciences Regulatory IDEAYA Biosciences Receives Fast Track Designation for IDE161 in a Second Indication for the Treatment of Pretreated, Advanced or Metastatic HR+, Her2-, BRCA1/2 mutant Breast Cancer ideayabio.com ↗
the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to IDEAYA's development program investigating IDE161
2023-09-26 IDEAYA Biosciences Regulatory IDEAYA Receives Fast Track Designation for Potential First-in-Class PARG Inhibitor, IDE161, for Treatment of Pretreated, Platinum-Resistant Advanced or Metastatic Ovarian Cancer Patients having tumors with BRCA1/2 Mutations ideayabio.com ↗
Fast Track designation granted by U.S. FDA for evaluation of IDE161 in adult patients with BRCA1/2 mutant advanced or metastatic ovarian cancer who are platinum resistant and have received prior antiangiogenic and PARP inhibitor therapies
2023-09-11 IDEAYA Biosciences Results IDEAYA Announces Phase 1 Expansion and Preliminary Clinical Proof-of-Concept for Potential First-in-Class PARG Inhibitor IDE161 in HRD Solid Tumors ideayabio.com ↗
Initiated IDE161 Phase 1 expansion based on preliminary tumor shrinkage observed in multiple HRD solid tumor patients, including an endometrial cancer subject with a first imaging assessment of a partial response and an 87% reduction of the CA-125 tumor marker
2023-01-09 IDEAYA Biosciences Regulatory IDEAYA Announces IND Clearance by U.S. FDA enabling Phase 1 Initiation for First-in-Class PARG Development Candidate IDE161 ideayabio.com ↗
2022-12-12 IDEAYA Biosciences Regulatory IDEAYA Biosciences Announces Submission of IND Application to the U.S. FDA for PARG Development Candidate IDE161 ideayabio.com ↗

All press releases naming this drug 12 releases

DateIssuerRelease

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as IDE161 “PARG Inhibitor IDE161” NCT05787587 ↗
2

NCT05787587 ↗

NCT07174583 ↗

Action Inhibit “PARG Inhibitor IDE161” NCT05787587 ↗
Route Oral “oral administration” NCT07174583 ↗
Target PARG “PARG Inhibitor IDE161” NCT05787587 ↗