Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication PALSONIFY is indicated for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. PALSONIFY is a somatostatin receptor agonist indicated for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option ( 1 ). FDA label
Also known as CRN00808
Paltusotine · 5 trials · 11 indications
Treatment group difference of change from baseline to Week 12 in flushing episodes/day averaged over the 14 days prior to Week 12.
Change from baseline in IGF-1 level at Week 13/End of Treatment (W13/EoT) in Group 1 subjects Efficacy Analysis Set (EAS).
Proportion of subjects who meet responder criteria (based on the mean of two consecutive IGF-1 measurements ≤ upper limit of normal \[ULN\])
Total radioactivity in urine and feces following a single oral dose \[14C\]-CRN00808 (expressed as a percentage of the total radioactive dose administered)
Absolute bioavailability is calculated from the areas under the curve of intravenous and oral administration
ECG, clinical laboratory parameters, vital signs, physical examinations, telemetry, Holter monitoring
ECG, clinical laboratory parameters, vital signs, physical examinations
| Arm | Type | Description |
|---|---|---|
| Paltusotine 80 mg daily | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Paltusotine | EXPERIMENTAL | - |
| Part A: [14C]-CRN00808 Oral Solution | EXPERIMENTAL | Single oral dose of CRN00808 containing \[14C\]-CRN00808 |
| Part B: CRN00808 Oral Capsule w/ [14C]-CRN00808 IV microtracer | EXPERIMENTAL | Single oral dose of CRN00808 followed by \[14C\]-CRN00808 IV microtracer injection |
| CRN00808 Oral Solution | EXPERIMENTAL | CRN00808 oral solution, single-dose |
| CRN00808 Oral Capsule | EXPERIMENTAL | CRN00808 oral capsule, single-dose and multiple-doses |
| Placebo Oral Solution | PLACEBO_COMPARATOR | Placebo oral solution, single-dose |
| Placebo Oral Capsule | PLACEBO_COMPARATOR | Placebo oral capsule, single-dose and multiple doses |
| Midazolam Oral Solution | OTHER | Midazolam oral solution, two single-doses as part of the drug-drug interaction arm of the study |
| Name | Type | Description |
|---|---|---|
| Paltusotine | DRUG | Experimental Drug: Randomized |
| Placebo | DRUG | Matching Placebo Drug: Randomized |
| [14C]-CRN00808 | DRUG | Investigational drug |
| CRN00808 | DRUG | Investigational drug |
| Placebo Oral Solution | DRUG | Placebo |
| Midazolam oral solution | DRUG | Midazolam as part of the drug-drug interaction arm of the study |
| Placebo oral capsule | DRUG | Placebo |
Inclusion Criteria: * Male or female ≥18 years of age, at the time of Screening. * Willing and able to comply with the study procedures as specified in the protocol, including at least 70% compliance with the study diary for the 2-week period. * Documented carcinoid syndrome requiring medical thera...
Paltusotine is an investigational oral small molecule being developed for acromegaly and carcinoid syndrome. It is designed as a once-daily oral treatment, and it holds an orphan drug designation from the FDA. It is not yet approved and remains in clinical development.
Paltusotine targets somatostatin receptor type 2, or SSTR2, and acts as an agonist at that receptor. By binding and activating SSTR2, it is intended to reduce hormone secretion relevant to acromegaly and carcinoid syndrome. It is a small molecule given orally.
Paltusotine is being developed by Crinetics Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker CRNX. The company is running clinical programs in acromegaly and carcinoid syndrome, including a Phase 3 carcinoid syndrome study and completed Phase 2 acromegaly studies.
Paltusotine is in Phase 2 development for acromegaly, with completed Phase 2 trials, and a Phase 3 trial in carcinoid syndrome that is active but not recruiting. It is investigational and has not been approved by the FDA. It holds an orphan drug designation.
Paltusotine has been studied in two completed Phase 2 acromegaly trials, ACROBAT Evolve (NCT03792555) and ACROBAT Edge (NCT03789656), and in an active Phase 3 carcinoid syndrome trial (NCT07087054). The Phase 3 study is randomized, double-blind, and placebo-controlled, enrolling 141 adults across multiple countries.
Yes, Paltusotine is an oral small molecule developed as a once-daily regimen. The Phase 3 carcinoid syndrome trial is titled as an efficacy study featuring an oral daily paltusotine regimen. Oral dosing distinguishes it from injectable somatostatin receptor ligands used in these conditions.