- ODD granted for the treatment of soft tissue sarcomas (STS)
- Thermosome adds 4 patents to its growing patent estate

Munich, Germany – May 12, 2025 – Thermosome, a drug development company focused on targeted tumor therapies, today announced that its lead compound, THE001, has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of soft tissue sarcomas (STS). This designation complements the ODD already granted by the European Medicines Agency (EMA) and validates the clinical potential of THE001.

The FDA's ODD program supports the development of drugs for rare diseases and provides benefits such as tax credits for qualified clinical trials, exemption from user fees, and seven years of market exclusivity following approval. In its decision, the FDA recognized that Thermosome's innovative doxorubicin-encapsulating thermosensitive liposomes may be clinically superior to currently approved non-liposomal forms of doxorubicin due to its potential for increased efficacy.