San Diego, USA – March 26, 2026
Crinetics Pharmaceuticals announced the submission of a Marketing Authorization Application (MAA) to Brazil’s ANVISA for Palsonify™ (paltusotine), marking a significant step in the global expansion of its once-daily oral therapy for acromegaly. The application is supported by a comprehensive clinical development program including 18 clinical trials and two successful Phase 3 studies, positioning the drug as a next-generation treatment option for patients with endocrine disorders.
Strong Phase 3 Clinical Evidence Supports Submission
The MAA submission is underpinned by robust Phase 3 clinical data demonstrating statistically significant efficacy and safety outcomes. In both pivotal trials, all primary and secondary endpoints were successfully met, confirming the drug’s ability to achieve biochemical control and symptom improvement in patients with acromegaly. The therapy also showed a favorable tolerability profile, reinforcing its potential as a reliable long-term treatment option.
Palsonify is a selectively targeted somatostatin receptor type 2 (SST2) nonpeptide agonist, designed to regulate hormone levels in patients who have inadequate response to surgery or are not eligible for surgical intervention. Clinical trials demonstrated that the therapy effectively maintains and reduces IGF-1 levels, a critical biomarker used to manage acromegaly, while also improving patient-reported symptoms and quality of life.
Advancing Global Regulatory Expansion Strategy
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The submission to Brazil’s regulatory authority represents a key milestone in Crinetics’ global commercialization strategy, following the drug’s FDA approval in the United States and recent positive regulatory progress in Europe. The company is actively working with international regulators to expand access to this innovative oral therapy, which offers a significant advantage over traditional injectable treatments.
A major differentiator of Palsonify is its once-daily oral administration, which has the potential to transform the treatment paradigm for acromegaly patients, many of whom currently rely on monthly injectable therapies. By simplifying treatment regimens, the drug aims to improve patient adherence, convenience, and overall treatment outcomes, addressing a critical unmet need in endocrine care.
Expanding Pipeline and Future Clinical Potential
Beyond acromegaly, Palsonify is also being evaluated in Phase 3 clinical development for carcinoid syndrome associated with neuroendocrine tumors, further highlighting its broad therapeutic potential. Early-phase studies have shown promising results, including rapid and sustained reduction in key symptoms such as flushing and bowel movement frequency, which are common challenges in these patients.
Crinetics continues to strengthen its pipeline with a focus on GPCR-targeted therapies for endocrine diseases and oncology indications, reflecting its commitment to innovative drug discovery and precision medicine approaches. The company’s strategy combines advanced pharmacology with patient-centered design, aiming to deliver therapies that are both effective and convenient for long-term use.
Overall, the MAA submission in Brazil underscores the growing importance of global regulatory expansion, late-stage clinical validation, and innovative drug delivery approaches in modern pharmaceutical development. As regulatory review progresses, Palsonify has the potential to become a key therapeutic option in the global management of acromegaly, reinforcing Crinetics’ position in the endocrine therapeutics market.
Source: Crinetics Pharmaceuticals press release
