Drugs / FHD-609
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | synovial sarcoma, SMARCB1-deleted tumors | 2023-04-24 | “Consequently, the FDA placed the study on partial clinical hold in the United States” foghorntx.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT04965753 | Aug 2021 → Dec 2023 | synovial sarcoma | Foghorn Therapeutics Inc. | Terminated | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2023-04-24 | Foghorn Therapeutics Inc. | Regulatory Foghorn Therapeutics Provides an Update on FHD-609 foghorntx.com ↗
Consequently, the FDA placed the study on partial clinical hold in the United States, while allowing patients currently enrolled and benefiting from therapy to continue dosing and to remain on FHD-609. |
| 2022-10-26 | Foghorn Therapeutics Inc. | Results Foghorn Therapeutics Announces New Data Demonstrating BRD9 Degradation in Patient Tumor Biopsies and Discloses New Selective CBP Program foghorntx.com ↗
Initial Phase 1 data of FHD-609 show degradation of BRD9 in on-treatment metastatic tumor synovial sarcoma biopsies |
| 2021-05-11 | Foghorn Therapeutics Inc. | Regulatory Foghorn Therapeutics Provides Corporate Update foghorntx.com ↗
Foghorn received FDA clearance of its IND application for FHD-609. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-04-24 | Foghorn Therapeutics Inc. | Foghorn Therapeutics Provides an Update on FHD-609 foghorntx.com ↗ |
| 2022-10-26 | Foghorn Therapeutics Inc. | Foghorn Therapeutics Announces New Data Demonstrating BRD9 Degradation in Patient Tumor Biopsies and Discloses New Selective CBP Program foghorntx.com ↗ |
| 2021-08-23 | Foghorn Therapeutics Inc. | Foghorn Therapeutics Announces First Patient Dosed in First-in-Human Clinical Trial of FHD-609 foghorntx.com ↗ |
| 2021-05-11 | Foghorn Therapeutics Inc. | Foghorn Therapeutics Provides Corporate Update foghorntx.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | FHD-609 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04965753 ↗ |
| Route | Intravenous | “patients received FHD-609 intravenously” PMID 39660994 ↗ Feb 2025 |
| Target | BRD9 | “FHD-609, a potent, selective, heterobifunctional degrader of bromodomain-containing protein 9 (BRD9)” PMID 39660994 ↗ Feb 2025 |