Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Randomized: Paltusotine · 1 trial · 9 indications
Incidence of TEAEs, including serious TEAEs and TEAEs leading to discontinuation; change from baseline to the EOR in safety parameters: clinical laboratory tests, physical exam findings, vital signs, 12-lead ECG, and 24-hour continuous cardiac monitoring (only for subjects on 120 mg dose). In addition to all-cause mortality, deaths were categorized by primary cause (e.g., cardiovascular) based on medical adjudication. Events were coded using MedDRA and summarized by treatment group, system organ class, and preferred term. TEAEs were reported per randomized arm. There were 2 randomized arms (40 mg and 80 mg paltusotine, with up-or down-dose titration permitted for symptom control). Results are analyzed based on the initially assigned randomization arm, regardless of the actual dose received.
| Arm | Type | Description |
|---|---|---|
| 40 mg Paltusotine | EXPERIMENTAL | Participants received paltusotine 40mg, in tablet form, orally, daily, for 8 weeks. |
| 80 mg Paltusotine | EXPERIMENTAL | Participants received paltusotine 80mg, in tablet form, orally, daily for 8 weeks. |
| Name | Type | Description |
|---|---|---|
| Randomized: 40 mg Paltusotine | DRUG | Two 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 80 mg) |
| Randomized: 80 mg Paltusotine | DRUG | Four 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 120 mg) |
Inclusion Criteria: 1\. Male or female subjects ≥18 years of age. 2. Documented carcinoid syndrome requiring medical therapy. 1. Not currently treated with somatostatin receptor ligands agonists for at least 12 weeks prior to screening and actively symptomatic. This can include treatment-naïve sub...
Paltusotine is an investigational small molecule developed by Crinetics Pharmaceuticals, Inc. (ticker CRNX) for the treatment of carcinoid syndrome. It has been studied in a Phase 2 clinical trial in adults with carcinoid syndrome, including patients with carcinoid tumors of the ileum, cecum, liver, and pancreas.
Paltusotine is being developed for carcinoid syndrome, a condition that can occur in patients with carcinoid tumors. Crinetics Pharmaceuticals, Inc. (CRNX) evaluated the drug in a Phase 2 study of adults with carcinoid syndrome, including carcinoid syndrome diarrhea, across sites in the United States, Argentina, Brazil, Canada, Mexico, Peru, and Poland.
Paltusotine is developed by Crinetics Pharmaceuticals, Inc., which trades under the ticker CRNX. The company sponsored the Phase 2 clinical trial of paltusotine in carcinoid syndrome.
Paltusotine is in Phase 2 development for carcinoid syndrome. It is investigational and has not been approved by the FDA. One Phase 2 trial has been completed, and no active trials are currently listed for this asset.
Paltusotine has been studied in the Phase 2 trial NCT05361668, titled Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome. The trial was completed, enrolled 36 participants, was randomized and controlled, and included adults aged 18 years and older.