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 oral small molecule being studied for carcinoid syndrome, a condition that can occur in people with carcinoid tumors. It was evaluated 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 by Crinetics Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker CRNX. The company sponsored the Phase 2 study of paltusotine in carcinoid syndrome that has been completed.
Paltusotine is in Phase 2 development for carcinoid syndrome. It is an investigational drug and has not been approved by the FDA for this indication. The Phase 2 trial evaluating its safety, pharmacokinetics, and dose response in patients with carcinoid syndrome has been completed.
Paltusotine was studied in one completed Phase 2 trial, NCT05361668, titled a study to evaluate the safety, PK, and dose response of paltusotine in subjects with carcinoid syndrome. The trial enrolled 36 adults across the United States, Argentina, Brazil, Canada, Mexico, Peru, and Poland.
Paltusotine has received an orphan drug designation from the FDA for its development in carcinoid syndrome. It remains an investigational therapy and has not been approved for marketing. The Phase 2 trial NCT05361668 was randomized and controlled, enrolling 36 patients with carcinoid syndrome.