Development & Regulatory History

A Translational Program Built Over More Than 15 Years

The DSC platform has progressed through successive stages of scientific and therapeutic development.

Discovery & Biology→ Process Development→ Preclinical & Toxicology→ Clinical Translation→ Manufacturing Development→ Regulatory Development→ Published Clinical Experience→ Next: Controlled Clinical Development
Decinova DSC platform clinical-development pathway diagram

Historical platform-development milestones include prior clinical, regulatory and regional development experience associated with earlier licensed programs — including regulatory interactions, orphan-drug designations and an IND-cleared Phase IIb development program in the United States held under those earlier licensees. Any historical regulatory status should be read with its original date, jurisdiction and current status, and should not be interpreted as a current marketing authorization, nor as Decinova being the historical sponsor or holder of these designations.

Next Value Inflection Point

Advance DSC through its next controlled clinical-development program in SR-aGVHD, generating the efficacy, safety, manufacturing and regulatory evidence required for subsequent development.