KSHN001034 / Amneal - LARVOL DELTA

Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KSHN001034 in Healthy Postmenopausal Female Volunteers (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Kashiv BioSciences, LLC | Not yet recruiting ➔ Recruiting | Initiation date: May 2025 ➔ Aug 2025

Enrollment open • Trial initiation date

Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KSHN001034 in Healthy Postmenopausal Female Volunteers (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Kashiv BioSciences, LLC

New P1 trial

Open Label, Sequential Dosing , Single Ascending Dose and Multiple Dose Safety Tolerability and Pharmacokinetic Study (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Kashiv BioSciences, LLC

New P1 trial • Breast Cancer • Oncology • Solid Tumor

Pharmacological profiling of KSHN001034 - A novel prodrug of Fulvestrant with improved efficacy (AACR 2023) - "KSHN001034 or Faslodex® were dosed at 1mg/mouse, and 5mg/mouse either alone or in combination with oral Palbociclib 50mg/kg, QD for 28 days. Higher FLV exposures with KSHN001034 resulted in improved tumor control, addressing a significant unmet need to slow disease progression as well as its potential in window-of-opportunity trials."

Clinical • Oncology • ER