Drugs / FX-909
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT05929235 | Aug 2023 → Oct 2027 expected | urothelial carcinoma | Flare Therapeutics Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2026-04-06 | Flare Therapeutics Inc. | Results Flare Therapeutics Announces Three Upcoming Poster Presentations at AACR Annual Meeting 2026 flaretx.com ↗
In a Phase 0 study, FX-909, a first-in-class oral PPARG inhibitor, demonstrated intratumoral penetration and on-target activity, including dose-dependent PPARG modulation, increased tumor apoptosis, and enhanced CD8⁺ T-cell infiltration. |
| 2026-02-27 | Flare Therapeutics Inc. | Results Flare Therapeutics Presents Updated FX-909 Phase 1A Data in Late-Breaking Oral Presentation at 2026 ASCO Genitourinary Cancers Symposium flaretx.com ↗
These data offer encouraging signs that FX-909 may help shrink or control tumors in patients with advanced UC, with enriched responses in tumors with a luminal lineage as defined by PPARG overexpression. |
| 2025-11-07 | Flare Therapeutics Inc. | Results Flare Therapeutics Presents Correlative Biomarker Analysis from the FX-909 Phase 1A Clinical Study at SITC 2025 40th Anniversary Annual Meeting flaretx.com ↗
This analysis includes novel insights regarding FX-909’s immune modulatory mechanism of action and demonstrate that FX-909 exerts immune-modulatory activity as a single agent, supporting the rationale for combination with an anti-PD-1 inhibitor in advanced UC. |
| 2025-10-24 | Flare Therapeutics Inc. | Results Flare Therapeutics Presents Part A Data from FX-909 Phase 1 Study at AACR-NCI-EORTC International Conference flaretx.com ↗
FX-909 demonstrated early signs of clinical benefit in patients with advanced urothelial carcinoma as a monotherapy with a favorable safety profile. |
| 2023-11-03 | Flare Therapeutics Inc. | Results Flare Therapeutics Presents New Translational Data in Support of Lead Asset FX-909 for the Treatment of Muscle-Invasive Urothelial Cancer at SITC 2023 Annual Meeting flaretx.com ↗
PPARG amplification is significantly associated with shorter real-world Progression Free Survival to anti-PD1. |
| 2023-10-13 | Flare Therapeutics Inc. | Results Flare Therapeutics Presents Novel, AI-Based Method Identifying Luminal Subtype of Urothelial Cancer Supporting Lead Asset FX-909 at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics flaretx.com ↗ |
| 2023-04-17 | Flare Therapeutics Inc. | Results Flare Therapeutics Presents First Preclinical Data on Lead Asset FX-909, a Novel Small Molecule PPARG Inhibitor to Potentially Treat Urothelial Cancer, at the 2023 AACR Annual Meeting flaretx.com ↗
FX-909 is highly potent and selective for the PPARG transcription factor, and demonstrates tumor eradication in preclinical animal models of urothelial cancer at low oral doses |
All press releases naming this drug 16 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | FX-909 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05929235 ↗ |
| Action | Inhibit | “inhibits basal- and ligand-activated transcription by PPARG.” NCT05929235 ↗ |
| Modality | Small molecule | “small-molecule PPARγ inverse agonist” PMID 41760953 ↗ Feb 2026 |
| Route | Oral | “FX-909 given orally (PO)” NCT05929235 ↗ |
| Target | PPARG | “inhibits basal- and ligand-activated transcription by PPARG.” NCT05929235 ↗ |