Crinetics Secures EU Nod for Acromegaly Drug PALSONIFY
Event summary
- European Commission approved PALSONIFY® (paltusotine) for treating adult acromegaly patients on April 27, 2026.
- Approval based on Phase 3 trial data showing efficacy and safety in both treatment-naïve and previously treated patients.
- First once-daily oral therapy for acromegaly approved in the EU, with initial commercialization planned in Germany and Austria.
- PALSONIFY already FDA-approved in the U.S. and under review in Japan and Brazil.
The big picture
Crinetics’ EU approval for PALSONIFY marks a critical step in its strategy to become a global leader in endocrinology. The once-daily oral therapy addresses an unmet need in acromegaly treatment, positioning Crinetics against established injectable therapies. Success in the EU could accelerate its market penetration and set the stage for further international expansion.
What we're watching
- Market Expansion
- How quickly Crinetics can scale PALSONIFY’s commercialization in the EU, particularly in Germany and Austria.
- Regulatory Momentum
- Whether Japan and Brazil will follow with approvals, expanding PALSONIFY’s global reach.
- Pipeline Progress
- The pace at which Crinetics advances its other endocrinology-focused drug candidates, including atumelnant for Cushing’s syndrome.