On November 20, 2025 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) reported the first patient has been randomized in the pivotal Phase 3 CAREFNDR trial, a multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of once-daily, oral paltusotine in adults with carcinoid syndrome due to well-differentiated neuroendocrine tumors. The Phase 3 study builds on positive Phase 2 data in which paltusotine demonstrated rapid and sustained reductions in the frequency and severity of carcinoid syndrome symptoms, including flushing episodes and bowel movements.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Patients with carcinoid syndrome need a treatment option that can consistently manage symptoms without the burden of painful monthly injections," said Dana Pizzuti, M.D., Chief Medical and Development Officer of Crinetics. "Based on our encouraging Phase 2 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 3 CAREFNDR trial represents a significant milestone in our commitment to address this critical unmet need."

The Phase 3 study is designed to enroll 141 adults, both naïve and previously treated patients, with carcinoid syndrome. Participants will be randomized in a 2:1 ratio to receive either once-daily paltusotine 80 mg or matching placebo. The primary endpoint will measure the change in flushing episodes per day from baseline to Week 12, with change in bowel movements per day as a key secondary endpoint. Following the 16-week randomized controlled period, the trial includes a 104-week open-label extension (OLE) to evaluate long-term efficacy, safety and additional clinical outcomes. The OLE will also monitor long-term tumor control (progression free survival).

The Phase 3 CAREFNDR trial represents the latest step in Crinetics’ goal of expanding the value of PALSONIFY (paltusotine) beyond its lead indication for the treatment of acromegaly. Crinetics is also investigating meeting the unmet needs of NETs patients through CRN09682, the first candidate from its nonpeptide drug conjugate platform. CRN09682, an investigational anti-tumor candidate targeting SST2-expressing neuroendocrine and other solid tumors, received Investigational New Drug clearance earlier this year. This broader development strategy reflects Crinetics’ dedication to developing transformative therapies that address serious endocrine disorders and endocrine-related cancers.

For more information about the CAREFNDR trial, visit View Source Global enrollment in CAREFNDR is expected throughout 2025 and 2026.

About Paltusotine
Paltusotine, a selectively-targeted somatostatin receptor type 2 (SST2) nonpeptide, is in Phase 3 clinical development for carcinoid syndrome associated with neuroendocrine tumors (CAREFNDR). Results from a Phase 2 study in carcinoid syndrome demonstrated rapid and sustained reductions in flushing episodes and bowel movement frequency, which are the most common symptoms of carcinoid syndrome. PALSONIFY (paltusotine) is currently approved in the U.S. for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option.

About Carcinoid Syndrome
Carcinoid syndrome is found in approximately 20% of patients with neuroendocrine tumors (NETs). NETs are a rare, slow-growing type of cancer that arise most often in the digestive tract. When these tumors metastasize to the liver, carcinoid syndrome can occur and is most commonly characterized by diarrhea and flushing. While injectable depot somatostatin receptor ligand therapies are mainstay treatments for carcinoid syndrome, these injections are associated with considerable treatment burden and offer inadequate relief of carcinoid syndrome symptoms for many patients.

(Press release, Crinetics Pharmaceuticals, NOV 20, 2025, View Source [SID1234660846])