Crinetics Submits Palsonify for Acromegaly Approval in Brazil
Event summary
- Crinetics Pharmaceuticals submitted a Marketing Authorization Application (MAA) to Brazil’s ANVISA for Palsonify™ (paltusotine) in acromegaly.
- The submission is supported by data from 18 clinical trials, including two Phase 3 studies that met all primary and secondary endpoints.
- Palsonify is already approved in the U.S. and has received a positive opinion from Europe’s CHMP for MAA approval.
The big picture
Crinetics’ submission in Brazil marks another step in its global strategy to expand Palsonify’s reach beyond the U.S. The move aligns with broader trends in rare disease therapeutics, where oral, once-daily treatments are increasingly preferred over injectables. Success in Brazil could set a precedent for approvals in other emerging markets, reinforcing Crinetics’ position as a leader in endocrine disorder treatments.
What we're watching
- Regulatory Timelines
- How quickly ANVISA will review and approve Palsonify for acromegaly in Brazil, given its prior approvals in the U.S. and positive CHMP opinion in Europe.
- Market Penetration
- Whether Crinetics can successfully position Palsonify as a next-generation treatment in emerging markets like Brazil, following its U.S. launch.
- Pipeline Progress
- The pace at which Crinetics advances paltusotine for carcinoid syndrome and other pipeline candidates like atumelnant for congenital adrenal hyperplasia.
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