Drugs / BTX-9341
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06515470 | Jul 2024 → Sep 2027 expected | breast cancer | Biotheryx, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-05-18 | Biotheryx, Inc. | Results Biotheryx Announces Data from its Phase 1 Dose Escalation Study of BTX-9341, a First-in-Class, Potent and Selective CDK4/6 Degrader, for the Treatment of Advanced/Metastatic HR+/HER2- Breast Cancer biotheryx.com ↗
Data from the Phase 1 Dose Escalation study demonstrate evidence of clinical activity, including prolonged partial response and stable disease in a heavily pretreated patient population. |
| 2024-05-07 | Biotheryx, Inc. | Regulatory Biotheryx Announces U.S. FDA Clearance of Investigational New Drug Application for BTX-9341, a First-In-Class, Dual Bifunctional Degrader of CDK4/6 biotheryx.com ↗ |
| 2023-05-25 | Biotheryx, Inc. | Results Biotheryx to Present New Preclinical Data on Bifunctional Degraders for CDK4/6 and SOS1 at 2023 ASCO Annual Meeting biotheryx.com ↗
Besides these encouraging efficacy results, BTX-9341, our oral CDK4/6 development candidate, exhibited superior blood brain barrier penetration versus inhibitors and good tumor exposure when dosed orally. |
| 2023-04-17 | Biotheryx, Inc. | Results Biotheryx Presents Preclinical CDK4/6 and SOS1 Protein Degrader Data at AACR 2023 Annual Meeting biotheryx.com ↗
The presentations highlight preclinical data for bifunctional degraders of cyclin-dependent kinase (CDK) 4/6 for the treatment of solid tumors, and bifunctional degraders of son of sevenless homolog 1 (SOS1) for the treatment of KRAS mutant cancers. |
All press releases naming this drug 8 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BTX-9341 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06515470 ↗ |
| Route | Oral | “BTX-9341 capsule(s) administered orally once daily (QD) in 28-day cycles” NCT06515470 ↗ |