SDK001: A Promising Oral Therapy for Acute Promyelocytic Leukemia (APL)
SDK001 is an oral liquid formulation of arsenic trioxide, designed to transform the treatment landscape for Acute Promyelocytic Leukemia (APL). Already approved in Hong Kong, SDK001 has been extensively studied in over 400 patients—both newly diagnosed and relapsed—showing long-term efficacy and safety.
Why SDK001?
Based on completed clinical studies in Hong Kong
Proven Efficacy
with SDK001
Reduced treatment burden for patients and caregivers
Lower healthcare resource utilization
Clinical trial work to support an approval in the North America and Europe is ongoing.
Key Achievements
June 2024
SDK Therapeutics acquires exclusive rights to develop and commercialize SDK001 in North America and Europe.
Nov/Dec 2024
SDK001 receives Orphan Drug Designation (ODD) from the FDA and EMA, recognizing its potential to address unmet needs in APL treatment.
January 2025
The FDA clears the Investigational New Drug (IND) application for SDK001 in APL.
What’s Next?
March 2025
Initiation of the Pharmacokinetics, Food Effect, Drug-Drug Interaction Study
Q3 2025
Global Phase 3 registration study begins.
SDK001 is paving the way for a patient-friendly treatment for APL.
“We are thrilled to move forward with the clinical development of SDK001 in efforts to bring an oral therapy to patients with Acute Promyelocytic Leukemia, the physicians that treat them, and their caregivers.”
Danelle James, M.D., M.S., Chief Medical Officer, SDK Therapeutics
Expanded Access Policy
Compassionate Use
SDK Therapeutics recognizes the potential interest in accessing our investigational therapies before they receive regulatory approval via compassionate use (expanded access).
We are dedicated to making oral arsenic trioxide treatment available to as many patients with acute myelocytic leukemia as possible. To reach this objective, we are concentrating on securing regulatory approval for SDK001. Currently, we are not able to provide a compassionate use program, but we will continually assess the possibility of offering compassionate use for SDK001 in the future. For more information, please contact [email protected].
Information on ongoing SDK Tx clinical studies
Visit ClinicalTrials.gov to view information on all registered clinical studies for SDK Therapeutics.
The U.S. Food & Drug Administration’s website provides valuable information on Expanded Access/Compassionate Use.