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 being developed for carcinoid syndrome, a condition that can occur in patients with carcinoid tumors. It is being studied for its effects on symptoms such as carcinoid syndrome diarrhea. The drug is currently in Phase 2 clinical development and has not been approved by the FDA.
Paltusotine is being developed by Crinetics Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CRNX. The company is conducting clinical trials to evaluate the safety and efficacy of Paltusotine in patients with carcinoid syndrome.
Paltusotine is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The drug has received orphan drug designation from the FDA for its intended use in carcinoid syndrome, reflecting its potential to address a rare condition.
Paltusotine has been studied in a Phase 2 clinical trial with the identifier NCT05361668, titled 'Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome.' This trial has been completed and enrolled 36 participants across multiple countries, including the United States, Argentina, Brazil, Canada, Mexico, Peru, and Poland.
No, Paltusotine is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for carcinoid syndrome. The FDA has granted orphan drug designation to Paltusotine, which is a status given to drugs intended to treat rare diseases, but this does not mean the drug has been approved for marketing.