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Palsonify (PALTUSOTINE)
Palsonify works by binding to and inhibiting a specific protein involved in the regulation of growth hormone production.
At a glance
| Generic name | PALTUSOTINE |
|---|---|
| Sponsor | Crinetics |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2025 |
Mechanism of action
Similar to the natural hormone somatostatin, paltusotine suppresses growth hormone (GH) and insulin-like growth factor-1 (IGF-1) secretion. Paltusotine exerts its pharmacological activity via selective agonism (>4000-fold) at somatostatin receptor 2 (SSTR2) and exhibits little or no affinity for other SST receptor subtypes. Paltusotine inhibited cyclic adenosine monophosphate accumulation via human SSTR2 activation with an average drug (agonist) concentration that results in half-maximal response (EC 50 ) of 0.25 nM.
Approved indications
- acromegaly
Common side effects
- Diarrhea
- Abdominal pain
- Decreased appetite
- Nausea
- Hyperglycemia
- Palpitations
- Gastroenteritis
- Sinus bradycardia
- Cholelithiasis
- Obstructive pancreatitis
- Acute cholecystitis
- Biliary colic
Drug interactions
- Strong CYP3A4 Inducers
- Moderate CYP3A4 Inducers
- Proton Pump Inhibitors
- Cyclosporine
- Strong CYP3A4 Inducers
- Moderate CYP3A4 Inducers
- Proton Pump Inhibitors
- Cyclosporine
- Strong CYP3A4 Inducers
- Moderate CYP3A4 Inducers
- Proton Pump Inhibitors
- Proton Pump Inhibitors
Key clinical trials
- Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome (PHASE2)
- Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen (PHASE3)
- A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2) (PHASE3)
- A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PHASE3)
- A Study to Evaluate the Long-Term Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Advance) (PHASE2)
- A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Evolve) (PHASE2)
- An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge) (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |