Palsonify (paltusotine) is the first once-daily pill for acromegaly, FDA-approved in September 2025. It lowers growth hormone and IGF-1 the same way monthly octreotide or lanreotide shots do, but as a tablet taken each morning on an empty stomach. It is for adults whose acromegaly wasn't cured by surgery, or who can't have surgery.
Acromegaly is caused by a benign pituitary tumor that makes too much growth hormone (GH). Over time, excess GH and its partner hormone IGF-1 enlarge the hands, feet, and facial features, and raise the risk of diabetes, high blood pressure, heart disease, sleep apnea, and joint problems. Surgery to remove the tumor is usually the first step, but many patients need long-term medicine to keep IGF-1 normal. Learn more in our pituitary disorders guide.
How Does Palsonify Work?
The body's natural hormone somatostatin acts as a “brake” on growth hormone release. Paltusotine is a small-molecule medicine that selectively switches on somatostatin type 2 (SST2) receptors on the pituitary tumor, which lowers GH production and, in turn, IGF-1. This is the same target as the long-acting injectable somatostatin analogs (octreotide and lanreotide), but paltusotine is absorbed from a pill.
Palsonify vs. Monthly Injections
| Palsonify | Octreotide LAR / Lanreotide | |
|---|---|---|
| Form | Pill, once daily | Injection, usually every 4 weeks |
| Given by | Yourself, at home | Usually a nurse or clinic (lanreotide can be self-injected) |
| Food rules | Empty stomach (see below) | None |
| Target | SST2 receptor | SST2 receptor |
| Common side effects | Diarrhea, stomach pain, nausea, gallstones | Diarrhea, stomach pain, gallstones, injection-site pain |
How to Take Palsonify
- Take it once a day with water
- Take it on an empty stomach: at least 6 hours after a meal and at least 1 hour before your next meal. For most people, the easiest routine is first thing in the morning, then wait an hour before breakfast
- Food matters a lot: in studies, taking it with a meal cut the amount absorbed by roughly three-quarters
- Take it at about the same time every day
💊 Tell us about acid reducers. Proton pump inhibitors (such as omeprazole or pantoprazole) lower Palsonify levels, and certain seizure and HIV medicines (strong or moderate CYP3A4 inducers like carbamazepine) lower them a lot. Your dose may need to change. Palsonify can also lower cyclosporine levels. Bring a full medicine list to your visit.
Dosing
| Step | Dose |
|---|---|
| Start | 40 mg once daily (may be lowered to 20 mg for a short time if side effects are a problem) |
| After 2–4 weeks | Increase to 60 mg once daily if IGF-1 is still above target |
| Usual maximum | 60 mg once daily |
Your endocrinologist will check your IGF-1 level to guide the dose. If you are switching from monthly injections, we will plan the timing of your first pill around your last shot.
How Well Does It Work?
In the PATHFNDR-1 trial, adults whose acromegaly was already controlled on monthly octreotide or lanreotide injections were switched to Palsonify or placebo. After 36 weeks, 83% on Palsonify kept a normal IGF-1, compared with only 4% on placebo. A second trial (PATHFNDR-2) in people not currently on treatment also met its goal, and both trials showed improvement in acromegaly symptoms.
Side Effects
The most common side effects are diarrhea, stomach pain, and nausea, usually mild. Other reported effects include decreased appetite, palpitations, and a slow heart rate.
⚠️ What we monitor: Gallstones (about 6% in trials — call us for pain in the upper right belly, fever, or yellowing skin); slow heart rate or heart rhythm problems (tell us about dizziness or fainting, and if you take beta-blockers or other heart-slowing medicines); blood sugar changes (check more often if you have diabetes); thyroid function (it can cause an underactive thyroid); and, if needed, vitamin B12 and signs of fatty, oily stools.
Who Might Choose Palsonify?
Palsonify may suit adults with acromegaly who want to avoid monthly injections, have injection-site pain or scheduling challenges with clinic visits, or travel often. It may be harder for people who can't keep an empty-stomach routine, or who need acid reducers they can't stop. Your endocrinologist will weigh these factors along with your IGF-1 levels and tumor status.
Key Takeaways
- Palsonify (paltusotine) is the first once-daily pill for acromegaly, approved September 2025
- For adults whose acromegaly wasn't controlled by surgery, or who can't have surgery
- Take it with water on an empty stomach: 6 hours after a meal and 1 hour before the next
- Starts at 40 mg daily; may increase to 60 mg after 2–4 weeks based on IGF-1
- Kept IGF-1 normal in 83% of patients switched from monthly injections
- Watch for gallstones, slow heart rate, blood sugar changes, and thyroid changes; tell us about acid reducers
Our Team Can Help
All five of our providers diagnose and manage endocrine conditions. Book with any member of our team:
Book an Appointment → or call 832-968-7003