Palsonify
Pronunciation: pal-SAHN-ih-fy
Generic name: paltusotine
Brand name: Palsonify
Dosage form: tablet (20 mg, 30 mg)
What is Palsonify? Acromegaly Treatment
Palsonify is used to treat acromegaly in adults for whom pituitary surgery was unsuccessful or surgery is not an option. It is an oral tablet taken once daily.
Key Facts About Palsonify
- Generic name: Paltusotine
- Drug class: Somatostatin receptor agonist
- FDA approval: September 25, 2025
- Patient eligibility: Adults with acromegaly when pituitary surgery is unsuccessful/not an option
- Administration: Daily tablet.
Clinical Evidence & Key Benefits | PATHFNDR Studies
Palsonify approval was based on PATHFNDR-1 and PATHFNDR-2 Phase 3 clinical trials investigating paltusotine in previously treated and treatment-naive acromegaly patients.
- Results showed rapid biochemical control, sustained efficacy, significant symptom reduction (headaches, joint pain, fatigue), and good tolerability with no serious adverse events.
- Long-term data confirmed durable IGF-1 control and consistent safety.
How Palsonify (Paltusotine) Works: Mechanism of Action for Acromegaly
Palsonify mimics somatostatin, a natural hormone that regulates growth hormone production.
What Palsonify Does:
- Reduces excess growth hormone (GH), the primary cause of acromegaly symptoms
- Lowers insulin-like growth factor-1 (IGF-1), controlled by growth hormone
How It Works:
- Targets somatostatin receptor 2 (SSTR2) specifically
- Highly selective binding (over 4,000 times more selective for SSTR2)
- Blocks growth hormone signals by preventing cyclic adenosine monophosphate accumulation
- Very potent medication. Effective at low concentrations (EC50 of 0.25 nM)
Palsonify Side Effects
Most Common Side Effects
- Diarrhea
- Stomach area (abdominal) pain
- Nausea and vomiting
- Decreased appetite
- Slow heart rate (bradycardia)
- High blood sugar levels (hyperglycemia)
- Irregular heartbeat (palpitations).
Serious Side Effects - Seek Medical Attention:
Gallbladder Problems:
Palsonify may cause problems with the gallbladder. Tell your healthcare provider if you have:
- Sudden upper right abdominal pain
- Right shoulder pain or pain between the shoulder blades
- Yellowing of skin or eyes (jaundice)
- Pale stools.
Blood Sugar Problems (Diabetes Risk):
Palsonify may change hormone levels that can lead to high blood sugar (hyperglycemia), low blood sugar (hypoglycemia), or diabetes. Tell your healthcare provider if you have problems with high or low blood sugar. Your healthcare provider will check your blood sugar when you start taking Palsonify or when your dose is changed.
Heart Problems:
Cardiac conduction abnormalities and other ECG changes, such as PR interval prolongation, bradycardia, sinus arrest, and atrioventricular block, may occur in patients with acromegaly and were reported in Palsonify clinical trials. Dosage adjustments of other drugs that slow the heart rate may be necessary.
Thyroid problems:
Palsonify may keep your thyroid from releasing thyroid hormones, leading to hypothyroidism. Your thyroid function may be checked from time to time during your treatment with Palsonify.
Fat malabsorption:
Palsonify may cause your body to have problems absorbing dietary fats. Tell your healthcare provider if you have any new or worsening symptoms, including fatty stools, changes in the color of your stools, loose stools, stomach (abdominal) bloating, or weight loss.
Low vitamin B12 levels:
Your healthcare provider may check your vitamin B12 levels during treatment with Palsonify.
These are not all the possible side effects of Palsonify. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about the side effects of Palsonify. You may report side effects to the FDA at 1-800-FDA-1088.
Before Taking
Before you take Palsonify, tell your healthcare provider about all of your medical conditions, including if you:
- have gallbladder problems
- have blood sugar control problems (low blood sugar or high blood sugar)
- have problems with low heart rate
- are pregnant or plan to become pregnant. It is not known if Palsonify will harm your unborn baby
- are breastfeeding or plan to breastfeed. It is not known if Palsonify passes into your breast milk Talk to your healthcare provider about the best way to feed your baby if you take Palsonify.
Important Patient Considerations:
- Pregnancy: Unknown safety, discuss with your doctor
- Breastfeeding: Unknown if passes into breast milk
- Children: Not approved for pediatric acromegaly treatment
- Interacting medicines: Tell your doctor about all your prescriptions, OTC drugs, vitamins, and supplements
How Should I Take Palsonify?
Administration Instructions:
- Take once daily with water
- Take on an empty stomach at least 6 hours after eating (after an overnight fast) or at least 1 hour before the next meal
- Follow your doctor's instructions exactly.
Dosing Information
Recommended Acromegaly Treatment Dosage:
- Starting dose: 40 mg once daily
- Temporary reduction: 20 mg daily if needed for tolerability
- Titration: Increase to 60 mg daily after 2-4 weeks based on IGF-1 levels.
Important Drug Interactions with Palsonify
Tell your healthcare provider about ALL the medications you take, including prescription medicines, over-the-counter medicines, herbal medicines, and supplements. Especially tell your healthcare provider if you take:
- Strong CYP3A4 Inducers (may require Palsonify dose increase), such as rifampin (antibiotic), carbamazepine (seizure medication), phenytoin (seizure medication), or St. John's Wort (herbal supplement)
- Moderate CYP3A4 Inducers (may require Palsonify dose increase), such as efavirenz (HIV medication), modafinil (sleep disorder medication), or bosentan (pulmonary hypertension medication)
- Proton Pump Inhibitors (may require Palsonify dose increase), such as omeprazole (Prilosec) •, esomeprazole (Nexium), lansoprazole (Prevacid), or pantoprazole (Protonix)
- Cyclosporine (may require cyclosporine dose adjustment):
- Heart Rate Medications (requires heart rate monitoring), such as beta-blockers (metoprolol, atenolol), calcium channel blockers (diltiazem, verapamil), and digoxin.
Keep a complete list of all your medications and bring it to all doctor visits, pharmacy visits, and emergency room visits. Update when starting new medications, stopping medications, or changing doses.
Storage
- Store Palsonify at room temperature between 68°F to 77°F (20°C to 25°C).
- Store in the original container.
- Keep out of the reach of children.
What are the ingredients in Palsonify?
Active ingredient: paltusotine
Inactive ingredients: colloidal silicon dioxide, copovidone, crospovidone, magnesium stearate, mannitol, and microcrystalline cellulose. Additionally, the 20 mg tablets contain Opadry pink coating (hypromellose, iron oxide red, iron oxide yellow, titanium dioxide, and triacetin) and the 30 mg tablets contain Opadry yellow coating (hypromellose, iron oxide yellow, titanium dioxide, and triacetin).
Manufacturer
Palsonify is manufactured for Crinetics Pharmaceuticals, Inc., San Diego, California 92121.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.