Published on Wednesday November 05, 2025

Smooth Drug Development October 2025 News Release

Monthly News – October 2025

Driving Growth Across Regions and Therapeutic Areas

October marked another strong month of expansion for Smooth Drug Development, with new partnerships, competitive tender wins, and continued operational excellence across our growing clinical portfolio.

New Projects

We successfully won two competitive tenders from a pharmaceutical company in the EAEU region, including an oncology bioequivalence study and an international Phase I clinical trial in patients with Hodgkin’s lymphoma — reinforcing our strong expertise in early-phase development and oncology research.

We signed a contract to provide medical writing services for a Phase III clinical trial involving polyethylene glycol, further strengthening our regulatory and documentation capabilities.

Additional contracts were secured to organize and conduct:

A Phase IV clinical trial with Risdiplam
A bioequivalence study of Agomelatine
A Phase III clinical trial involving a combination of Tenofovir, Elsulfavirine, and Emtricitabine

We are also finalizing a bioequivalence study of Mebhydrolin and entering start-up activities for two major Phase III programs in Hemophilia B (Turkey) and Relapsed/Refractory Classical Hodgkin Lymphoma (Uzbekistan).

In parallel, we advanced to the Master Service Agreement (MSA) stage with a German sponsor for a Phase III diarrhea trial in the EAEU region — marking another important milestone in our European collaborations.

Clinical and Scientific Departments News:

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

Phase I Ophthalmology Trial – 100% patient enrollment completed
Immunoglobulin Study – Three sites activated; first patient progressing through screening
Phase III Hepatitis Trial – Regulatory approvals secured in Pakistan and Uzbekistan; Site Initiation Visits scheduled
Obesity Bioequivalence Study – Active engagement with regulatory authorities
Sertaconazole Trial – Patient enrollment completed
Mirtazapine Trial – Site initiation visit successfully performed

Business Development News:

Participation in CPHI Frankfurt 2025 strengthened global partnerships, expanded our international visibility, and initiated new strategic discussions that will shape future collaborations.

Members of our Scientific and Corporate Development teams also participated in the Clinical Trials Dialogues conference in the EAEU region, contributing to discussions on ensuring continuity of drug development across complex regulatory environments.