Crinetics Pharmaceuticals has randomised the first subject in its pivotal Phase III CAREFNDR trial assessing Palsonify (paltusotine), a once-daily oral therapy, for adults with carcinoid syndrome due to well-differentiated neuroendocrine tumours.
The placebo-controlled, randomised, double-blind study follows encouraging Phase II data where paltusotine led to sustained symptom reduction, including improvements in flushing and bowel movement frequency.
The Phase III trial aims to enrol 141 participants, including both treatment-naive and those who were previously treated.
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Subjects will be randomised in a ratio of 2:1 to receive either paltusotine 80mg or matching placebo daily.
The primary endpoint is evaluating changes in daily flushing episodes from baseline through week 12, with bowel movement frequency as a key secondary endpoint.
After the 16-week randomised controlled period, a 104-week open-label extension will assess progression-free survival, long-term efficacy, and safety for tumour control.
This Phase III study is part of Crinetics’ wider strategy to extend the use of Palsonify, beyond acromegaly, and to address additional unmet needs in subjects with neuroendocrine tumours.
Crinetics chief medical and development officer Dana Pizzuti said: “Patients with carcinoid syndrome need a treatment option that can consistently manage symptoms without the burden of painful monthly injections.
“Based on our encouraging Phase II results and data from our open-label extension, we believe paltusotine has the potential to transform the treatment landscape with a once-daily, oral therapy that may offer meaningful benefits for patients managing the challenging day-to-day impacts of carcinoid syndrome.
“The initiation of our Phase III CAREFNDR trial represents a significant milestone in our commitment to address this critical unmet need.”
In July 2025, Crinetics revealed new data from its clinical development programme for Palsonify
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