Crinetics Randomizes First Patient In Pivotal Phase 3 CAREFNDR Trial Evaluating Oral Paltusotine For Carcinoid Syndrome

Crinetics Pharmaceuticals has announced that the first patient has been randomized in its pivotal Phase 3 CAREFNDR trial evaluating paltusotine, an investigational once-daily oral therapy, in adults with carcinoid syndrome resulting from well-differentiated neuroendocrine tumors. The study expands on positive findings from Phase 2 research, where paltusotine showed rapid and sustained improvements in symptoms including flushing and bowel movement frequency.

Executive leadership at Crinetics noted that patients with carcinoid syndrome often struggle with current standard treatments that require painful monthly injections. They believe paltusotine has the potential to reshape treatment by offering a convenient, daily oral option that may provide meaningful relief from debilitating symptoms. The company views the initiation of the Phase 3 trial as a major step toward addressing an ongoing unmet clinical need.

The trial will enroll 141 adults who will be randomized in a 2:1 ratio to receive either paltusotine 80 mg once daily or placebo. The study’s primary endpoint measures change in flushing frequency over the first 12 weeks, with reduction in bowel movements as a key secondary endpoint. After the 16-week randomized phase, participants may enter a 104-week open-label extension to assess long-term safety, efficacy and tumor control.

This pivotal study also supports Crinetics’ broader commitment to expanding the use of PALSONIFY (paltusotine) beyond acromegaly. The company is exploring additional opportunities to treat neuroendocrine tumors through CRN09682, a nonpeptide drug conjugate targeting SST2-expressing cancers that recently received IND clearance. The initiative reflects the company’s mission to advance transformative treatments for endocrine disorders and endocrine-related cancers.