Two experimental mesothelioma drugs receive FDA orphan drug and fast track designations
Two experimental drugs that target the same cell-growth pathway in mesothelioma received FDA designations in 2026, according to the companies developing them. Designations can speed development, but they are not approvals, and both drugs are still being tested in clinical trials.
Last reviewed October 29, 2026 against the sources listed at the end of this page.
In short
- ODM-212 (Orion Pharma): orphan drug designation for mesothelioma, announced April 20, 2026. It is in a Phase 2 trial (TEADES).
- ISM6331 (Insilico Medicine): fast track designation for unresectable pleural mesothelioma that progressed after immunotherapy and platinum chemotherapy, announced July 29, 2026. It is in a Phase 1 trial.
- Both are pan-TEAD inhibitors, drugs aimed at the Hippo signaling pathway that is often disrupted in mesothelioma.
- Neither drug is FDA-approved. Ask your oncologist whether a clinical trial is right for you.
Event date: April and July 2026. Posted October 29, 2026; updated October 29, 2026.
What was announced
ODM-212. Orion Corporation announced on April 20, 2026 that FDA granted orphan drug designation to ODM-212 for the treatment of mesothelioma. The company describes ODM-212 as an oral pan-TEAD inhibitor being tested in a Phase 2 study called TEADES in people with pleural mesothelioma and certain other tumors whose cancer progressed after standard treatment. The trial's main goals are safety and tolerability, with response and survival as secondary measures.
ISM6331. Insilico Medicine announced on July 29, 2026 that FDA granted fast track designation to ISM6331 for adults with unresectable pleural mesothelioma that progressed on or after anti-PD-1 immunotherapy, with or without anti-CTLA-4 therapy, and platinum chemotherapy. The company says the drug received orphan drug designation in 2024 and that the first patient in its global Phase 1 trial was dosed in January 2025.
What these designations mean
Orphan drug designation is for drugs intended for rare diseases, those affecting fewer than 200,000 people in the U.S. It brings incentives such as tax credits and, if the drug is later approved, a 7-year period of market exclusivity. As Orion notes, it does not shorten development or review time or give the drug any advantage in the approval process. Fast track is meant to speed the development and review of drugs for serious conditions with unmet needs, mainly through more frequent contact with FDA. Neither designation means a drug works or is safe; that is what the trials are testing.
Where approved treatments stand
FDA-approved first treatments for pleural mesothelioma include nivolumab with ipilimumab and, since September 2024, pembrolizumab with chemotherapy. See pleural mesothelioma and treatment options. Clinical trials are listed at ClinicalTrials.gov, and your care team can help you judge whether one fits.
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Sources
- Orion Pharma's ODM-212 granted orphan drug designation in mesothelioma by the US FDA (Orion Corporation press release, April 20, 2026)
- Insilico Medicine receives FDA fast track designation for ISM6331 in advanced mesothelioma (voluntary announcement, Hong Kong Exchanges, July 29, 2026)
- Designating an orphan product: drugs and biological products (U.S. Food and Drug Administration)
- Fast track (U.S. Food and Drug Administration)
- FDA approves pembrolizumab with chemotherapy for unresectable advanced or metastatic malignant pleural mesothelioma (FDA, September 17, 2024)