Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Paltusotine · 3 trials · 10 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 \[ULN\])
| Arm | Type | Description |
|---|---|---|
| Paltusotine 80 mg daily | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Paltusotine | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Paltusotine | DRUG | Experimental Drug: Randomized |
| Placebo | DRUG | Matching Placebo Drug: Randomized |
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 small molecule being developed for acromegaly and carcinoid syndrome. It is an orally administered drug targeting the somatostatin receptor type 2 (SSTR2) as an agonist. It is not yet approved and is currently in clinical development, with Phase 2 trials completed for acromegaly and a Phase 3 trial ongoing for carcinoid syndrome.
Paltusotine targets the somatostatin receptor type 2 (SSTR2), acting as an agonist. By activating SSTR2, it is designed to inhibit the secretion of hormones such as growth hormone and serotonin, which are implicated in acromegaly and carcinoid syndrome. This mechanism is being evaluated in clinical trials for these conditions.
Paltusotine is being developed by Crinetics Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker CRNX. The company is conducting clinical trials to evaluate the drug's safety and efficacy for acromegaly and carcinoid syndrome.
Paltusotine is in Phase 3 clinical development for carcinoid syndrome, with a recruiting trial (NCT07087054). For acromegaly, two Phase 2 trials (ACROBAT Edge and ACROBAT Evolve) have been completed. It has received orphan drug designation from the FDA, but it is not yet approved.
Paltusotine has been studied in two completed Phase 2 trials for acromegaly: ACROBAT Edge (NCT03789656) with 47 participants and ACROBAT Evolve (NCT03792555) with 13 participants. A Phase 3 trial for carcinoid syndrome (NCT07087054) is currently recruiting, with a planned enrollment of 141 participants.
Paltusotine is the sole name provided for this investigational drug; no alternative names have been identified. It is a distinct small molecule being developed by Crinetics Pharmaceuticals for acromegaly and carcinoid syndrome, and it is not known to be marketed under any other brand name.