Palsonify (paltusotine)

P1, N=20, Not yet recruiting, Crinetics Pharmaceuticals, Inc

IGF-I normalized in significantly more patients with uncontrolled acromegaly treated with paltusotine versus placebo. Paltusotine was associated with rapid, sustained IGF-I reduction, significant symptom improvement, and stable or reduced pituitary tumor size and was well tolerated.

Treatment with paltusotine did not significantly reduce radioligand binding of 18F-SiTATE in vitro, indicating no influence on SSTR2 targeting. This might enable a continuation of somatostatin receptor analogue therapy with paltusotine during PRRT, potentially improving symptom control in GEP-NET patients with the carcinoid syndrome.

P3, N=141, Recruiting, Crinetics Pharmaceuticals Inc.

This paper provides a comprehensive analysis of the cellular and molecular mechanisms of SSAs. SSAs remain integral to the management of NENs, providing effective tumor stabilization and symptom control. However, resistance mechanisms and tumor heterogeneity necessitate innovative approaches, including high-dose regimens, combination strategies, and next-generation formulations. Future research should focus on refining these strategies to optimize patient outcomes, enhance long-term efficacy, and expand the therapeutic landscape for NENs.

Adverse events with both OOC and paltusotine were reflective of those recognized with iSRL and occurred at a similar frequency. OOC and paltusotine are well-received additions to the therapeutic armamentarium in medical therapy for the management of acromegaly; however, further data on efficacy, tumour control and shrinkage are required to allow positioning of this medication within the management algorithm for acromegaly.

P3, N=111, Active, not recruiting, Crinetics Pharmaceuticals Inc. | Trial completion date: Jan 2026 --> Jan 2028

P3, N=58, Active, not recruiting, Crinetics Pharmaceuticals Inc. | Trial completion date: Jun 2025 --> Jun 2027

P2, N=36, Active, not recruiting, Crinetics Pharmaceuticals Inc. | Recruiting --> Active, not recruiting

P2, N=30, Recruiting, Crinetics Pharmaceuticals Inc.

P2, N=43, Active, not recruiting, Crinetics Pharmaceuticals Inc. | Trial completion date: Jan 2026 --> Mar 2028 | Trial primary completion date: Mar 2025 --> Mar 2028

There were no changes in paltusotine plasma exposure that would be considered clinically meaningful or sufficient to warrant dose adjustment for mild, moderate, or severe hepatic impairment. Support: Crinetics Pharmaceuticals.