Orion Pharma’s ODM-212 granted Orphan Designation
Orion Corporation’s investigational drug ODM-212 has received Orphan Designation from the European Commission, based on the recommendation from the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP), for the treatment of malignant mesothelioma, which is a rare and difficult to treat cancer.
The US Food and Drug Administration (FDA) has previously granted Orphan Drug Designation to ODM-212 for the treatment of mesothelioma.
ODM-212
ODM-212 is an oral small-molecule pan-TEAD (Transcriptional Enhanced Associate Domain) inhibitor being tested in a Phase 2 clinical study (TEADES) for the treatment of malignant pleural mesothelioma (MPM), epithelioid hemangioendothelioma (EHE) and other solid tumors with dysfunction in Hippo pathway. The trial includes patients who have progressed after receiving standard treatments and have no further treatment options. This is a global trial conducted at leading oncology centers in the US and Europe.
“The Orphan Designation for ODM-212 is an important milestone for Orion Pharma. It highlights the need for new treatments in mesothelioma and reinforces our commitment to developing innovative therapies for patients with rare cancers,” said Praveen Aanur, Chief Medical Officer, Oncology Therapy Area, Orion Pharma.
Published: June 29, 2026
