Crinetics Seeks Brazil Nod for Oral Acromegaly Drug Palsonify

SAN DIEGO, CA – March 26, 2026 – Crinetics Pharmaceuticals has taken a significant step to enter the Latin American market, announcing today the submission of a Marketing Authorization Application (MAA) to Brazil’s National Health Surveillance Agency (ANVISA). The application is for Palsonify™ (paltusotine), a novel, once-daily oral medication for the treatment of acromegaly in adults. This move follows the drug's recent approval in the United States and a positive regulatory opinion in Europe, signaling the company's ambitious global expansion strategy for what it calls a "next generation of acromegaly care."

A Potential Shift from Needle to Pill for Brazilian Patients

Acromegaly is a rare and debilitating chronic endocrine disorder caused by an excess of growth hormone, typically from a benign tumor on the pituitary gland. Patients often endure years of subtle but progressive physical changes before a diagnosis is made, by which point they may already face severe complications, including cardiovascular disease, diabetes, and joint problems.

In Brazil, the current standard of medical care for patients who are not cured by surgery relies heavily on long-acting injectable somatostatin receptor ligands (SRLs) like octreotide and lanreotide. While effective for many, these treatments require monthly, often painful, injections administered in a clinical setting. This creates a significant treatment burden, impacting patient quality of life, autonomy, and adherence.

Palsonify promises a paradigm shift. As a once-daily oral pill, it offers the potential to free patients from the cycle of monthly injections. The MAA submission is backed by a robust data package from 18 clinical trials, including two pivotal Phase 3 studies, PATHFNDR-1 and PATHFNDR-2. According to Crinetics, these trials successfully met all primary and secondary endpoints. The PATHFNDR-1 study showed that patients could safely switch from injectable SRLs to oral paltusotine while maintaining control of their IGF-1 levels—the key biomarker for managing acromegaly. The PATHFNDR-2 study demonstrated that the drug could also rapidly control hormone levels and reduce symptom burden in medically untreated patients.

"The submission of our MAA for Palsonify in Brazil represents another important global milestone for this important therapy,” said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics, in the company's official announcement. "We now look forward to working with ANVISA as they evaluate our MAA for Palsonify to treat acromegaly in adults in Brazil."

Navigating Brazil's Complex Regulatory and Access Pathway

Securing ANVISA's approval is the first major hurdle in a multi-stage journey to bring a new drug to Brazilian patients. ANVISA's review process is known for its rigor, but the agency has established an expedited pathway for rare disease treatments under regulation RDC 205. This pathway, which has significantly reduced approval times for orphan drugs to an average of around 246 days, could potentially accelerate Palsonify's review.

However, marketing authorization from ANVISA does not guarantee patient access. Following approval, Crinetics must navigate two additional critical bodies. First, the Drug Market Regulation Chamber (CMED) will determine the maximum price for the drug. Second, and perhaps most importantly, the National Committee for Health Technology Incorporation (CONITEC) will conduct a health technology assessment to decide whether Palsonify should be reimbursed by Brazil's public health system, the Sistema Único de Saúde (SUS).

This economic evaluation will be crucial. The SUS already faces a high economic burden from existing acromegaly treatments. A 2025 study analyzing 2022 data revealed that first-generation SRLs cost the public system over $15.5 million annually. For CONITEC to recommend Palsonify's inclusion, Crinetics will need to demonstrate not only its clinical superiority in terms of convenience and patient-reported outcomes but also its cost-effectiveness from the perspective of the public health system. Should the drug not be incorporated into the SUS, access for many patients could be limited or potentially sought through "judicialization"—the common practice of patients filing lawsuits to gain access to therapies based on their constitutional right to healthcare.

A Strategic Entry into a Growing Market

The move into Brazil is a calculated and strategic play for Crinetics Pharmaceuticals. As the largest pharmaceutical market in Latin America and one of the top ten globally, Brazil represents a significant commercial opportunity. The Brazilian market for acromegaly treatments was estimated at approximately $45 million in 2026 and is projected to grow to over $77 million by 2033, driven by improved diagnostics and the availability of new therapies.

By introducing Palsonify, Crinetics aims to capture a share of this growing market, challenging established injectable therapies offered by pharmaceutical giants. The drug's key differentiating factor—its oral, once-daily administration—is a powerful advantage in a landscape where patient convenience and quality of life are increasingly important considerations for treatment decisions.

This submission is a core component of Crinetics' global commercialization plan for its lead asset. With Palsonify already approved in the U.S. and on a clear path to approval in Europe, a successful entry into Brazil would solidify its position as a global therapy and provide a major foothold in the burgeoning Latin American market. The company's deep pipeline, which includes other endocrine disease candidates like atumelnant, further underscores its long-term strategy to become a leader in treating rare endocrine disorders worldwide.

While the path to full market access in Brazil is complex and fraught with regulatory and reimbursement challenges, the potential reward is substantial. For thousands of Brazilians living with acromegaly, the prospect of a simple daily pill could transform the management of their chronic condition. For Crinetics, a successful launch would validate its global strategy and unlock a vital new revenue stream, marking a true milestone in the company's growth.