Circle Pharma Secures FDA Orphan Drug Designation for CID-078 to Treat Small Cell Lung Cancer
Tuesday, June 17, 2025
Circle Pharma, a clinical-stage biopharmaceutical firm focused on macrocycle-based cancer therapies, has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for its investigational therapy, CID-078, for the treatment of small cell lung cancer (SCLC).
SCLC is a fast-growing and aggressive form of lung cancer, accounting for around 13–15% of all lung cancer cases. It is often linked to tobacco use and is known for its high recurrence rates and poor prognosis, despite available treatments. While new therapies are helping to improve survival outcomes, the disease continues to progress rapidly in many patients.
The FDA’s Orphan Drug Designation is awarded to encourage the development of medicines for rare conditions affecting fewer than 200,000 individuals in the United States. This designation offers a range of incentives such as tax credits for clinical research, eligibility for research grants, and a seven-year period of market exclusivity upon approval.
Circle Pharma has already begun a Phase 1 clinical trial (NCT06577987) to assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumour activity of CID-078 in patients with advanced solid tumours, including those with SCLC.
CID-078 is an oral macrocyclic compound designed to inhibit cyclin A and B RxL activity. It works by selectively targeting tumour cells with cell cycle-related genetic changes. In both laboratory and animal studies, this candidate has shown a strong ability to block interactions between cyclins and key molecules involved in cell cycle regulation. These preclinical results include tumour regression in several animal models, supporting its further clinical development. The Phase 1 trial is currently enrolling participants at multiple centres.
Source: businesswire.com
