Smooth Drug Development September 2025 News Release

Monthly News – September 2025

At Smooth Drug Development, we are excited to share the latest updates and achievements from September 2025:

New Projects

We are delighted to announce several new collaborations and ongoing initiatives:

• Successfully awarded two tenders, including an oncology bioequivalence trial and an international Phase I trial in patients with Hodgkin’s lymphoma.
• Signed multiple medical writing contracts, covering a bioequivalence trial with an antihistamine and a Phase III trial in diabetes.
• Entered into a new consulting agreement to design registration strategies for Phase III trials in dermatology and immunology indications.

Clinical and Scientific Departments News:

Our clinical teams continue to deliver outstanding progress:

• Cetirizine Study: All sites have been closed, and the Clinical Study Report (CSR) has been prepared.
• Human Immunoglobulin Trial: The first two sites have been successfully initiated.
• Phase I Ophthalmology Trial: Enrollment progress reached 25% completion.
• Alginic Acid Trial: Three sites are open, with one subject randomized.
• Sertaconazole Trial: Three sites are open, with one subject randomized.
• Women’s Health Phase III Trial: Four Site Initiation Visits (SIVs) conducted, and 17 patients were screened.

Business Development News:

Key Partner Engagements:

• Held a strategic meeting with a top 10 Indian sponsor to discuss upcoming trials in oncology, COPD, asthma, and a bioequivalence study.
• Preparing to attend CPHI Frankfurt 2025 (28–30 October) to connect with industry leaders and explore further opportunities in clinical trials, technology transfer, and regulatory strategy.