Smooth Drug Development November 2025 News Release

Monthly News – November 2025

Expanding Our Clinical Footprint

November demonstrated continued acceleration in both project onboarding and clinical delivery

• A contract was prepared for a Phase I clinical trial with Chorionic Gonadotropin.
• We signed a new agreement to conduct a bioequivalence study of Selexipag.
• We initiated work on a Phase III diarrhea program for a German sponsor in the EAEU region, further strengthening our cross-border execution capabilities.

Our clinical operations teams continue to deliver measurable progress across multiple therapeutic areas:

• Phase IV – Spinal Muscular Atrophy: Clinical Trial Application submitted; project launch expected in early 2026
• Phase III – Gynecology: 41 patients randomized
• Ataluren Bioequivalence Study: Clinical phase successfully completed
• Immunoglobulin Study: Four sites initiated in Turkey; first patient screened
• Agomelatine Trial: One site initiated; 10 subjects screened
• Sertaconazole Trial: Database lock completed
• Alginic Acid Trial: 168 patients randomized
• Mirtazapine Trial: All randomized patients completed participation

Business Development News:

Our Business Development team reinforced regional presence through participation in Pharmtech and RegLek conferences and expanded dialogue with several Chinese pharmaceutical partners.