In April 2026, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to ODM-212, an experimental medication being studied as a treatment for mesothelioma. The drug is made by Orion Pharma, a pharmaceutical company based in Finland.
Mesothelioma is a rare and aggressive cancer caused by asbestos exposure, and it has few effective treatment options once it stops responding to standard therapies.
The new FDA designation is meant to support the development of better treatments for diseases like mesothelioma, where patients urgently need new options.
“Receiving orphan drug designation for mesothelioma is an important milestone for the ODM-212 program. It underscores the importance of developing urgently needed innovative therapies for patients living with mesothelioma.”
ODM-212 is currently being tested in a phase 2 clinical trial called TEADES, which is enrolling patients whose cancer has grown despite standard treatment.
How ODM-212 Works Against Mesothelioma
ODM-212 is a pill that targets a cancer growth system in the body called the Hippo pathway. This pathway normally helps control how cells grow, divide, and stop growing when they’re supposed to.
In mesothelioma, the Hippo pathway becomes faulty. When that happens, certain proteins called YAP and TAZ get switched on and tell cancer cells to keep multiplying.
ODM-212 works by blocking proteins called TEAD transcription factors, which help send signals that tell cancer cells to grow and spread. By shutting down TEAD activity, the drug interferes with the signals that mesothelioma relies on to survive.
Because ODM-212 targets cancer cells specifically, it may cause fewer side effects than traditional chemotherapy.
ODM-212 is part of a growing class of drugs known as TEAD inhibitors. Other TEAD inhibitors, like VT3989, have already shown early promise in mesothelioma clinical trials.
Get our Free Mesothelioma Guide to learn more about the latest treatments and clinical trials helping patients improve their prognosis.
Inside the TEADES Clinical Trial
ODM-212 is being studied in a global phase 2 trial known as TEADES. The study is taking place at leading cancer centers in the United States and Europe.
The TEADES trial is enrolling people with:
- Pleural mesothelioma, the most common type of mesothelioma that develops in the lung lining
- Epithelioid hemangioendothelioma (EHE), a rare cancer that affects the lining of blood vessels
- Other solid tumors linked to problems in the Hippo pathway
Importantly, this clinical trial is open to patients who’ve already tried standard mesothelioma treatments and have no other options left. This is a group with very few choices today, which is why new research like this matters so much.
What Cancer Researchers Are Measuring
Doctors leading the TEADES trial want to learn two main things: whether ODM 212 is safe enough for patients to take and whether it actually helps slow mesothelioma down.
The TEADES ODM-212 study is tracking:
- Overall response rate: The percentage of patients whose tumors shrink after treatment
- Overall survival: The average length of time patients live after starting treatment, usually reported in months
- Progression-free survival: The average length of time before the cancer grows or spreads, also reported in months
For patients and families, these numbers are what will ultimately tell us whether ODM-212 lives up to its early promise. A treatment that’s easier on the body — and can be taken as a daily pill at home — could make a significant difference in quality of life, not just survival.
Safety and tolerability data are especially important for patients with mesothelioma, who are often already managing fatigue, breathing problems, and the lingering effects of earlier chemotherapy.
If you’re interested in joining a clinical trial like TEADES, our team can help you understand whether you may qualify and what to expect. Eligibility usually depends on the type of mesothelioma you have, which treatments you’ve already tried, and your overall health.
What Orphan Drug Designation Means
Orphan Drug Designation is a status granted by the FDA to medicines being developed for rare diseases, which are defined as conditions affecting fewer than 200,000 people in the United States. Around 3,000 people are diagnosed with mesothelioma each year in the U.S., which qualifies it as a rare disease.
Here’s what the designation provides to Orion Pharma:
- Exemption from certain FDA application fees
- Seven years of market exclusivity if the drug is eventually approved
- Tax credits for the costs of running clinical trials
This designation doesn’t mean ODM-212 has been approved yet. However, it gives drugmakers more support to continue developing treatments for diseases that might otherwise not get the attention they need.
Hope for Mesothelioma Patients and Families
Every step forward in mesothelioma research offers hope to patients and caregivers. ODM-212 joins a growing list of new therapies, including immunotherapy combinations and other targeted drugs, that are slowly expanding what doctors can offer.
For patients who have run out of standard options, clinical trials like TEADES may also offer the chance to try cutting-edge treatments now.
If you or a loved one has been diagnosed with mesothelioma, our team can:
- Explain your diagnosis and treatment options
- Connect you with top mesothelioma specialists and active clinical trials
- Offer support for managing symptoms and side effects
- Help explore financial and legal options related to your care
You don’t have to face this alone. Contact Mesothelioma Hope now or call (866) 608-8933 to speak with our team and get the help you need.
