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# Ideaya Bio Gets Fast Track for IDE161
- URL: https://www.fdaweb.com/ideaya-bio-gets-fast-track-for-ide161/
- Published: 2023-09-26T12:00:00.000Z
- Updated: 2026-09-14T18:58:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155420

FDA has granted Ideaya Biosciences a Fast Track designation for IDE161, which it describes as a potent and selective inhibitor of poly (ADP-ribose) glycohydrolase (PARG) for treating adult patients having advanced or metastatic ovarian cancer with germline or somatic BRCA 1/2 mutations who are platinum-resistant and have received prior antiangiogenic and poly (ADP-ribose) polymerase (PARP) inhibitor therapies.

The company says the therapy is currently undergoing a Phase 1 first-in-human clinical trial evaluating the safety, tolerability, pharmacokinetic and pharmacodynamic properties and preliminary efficacy of IDE161 in patients having solid tumors with homologous recombination deficiency (HRD). “Early clinical data from the dose escalation cohorts showed preliminary tumor shrinkage in multiple patients having solid tumors with HRD, including a BRCA 1/2m endometrial cancer subject,” it says.

Ideaya says the recent data supported expansion into priority tumor indications in parallel with continuing evaluation of the optimal dose for Phase 2 studies. “The expansion portion of the Phase 1 trial will include patients having HRD+ associated breast cancer and ovarian cancer, as well as a basket of other selected solid tumors,” it adds.