Palsonify (paltusotine)
An approved treatment for Acromegaly.
The same compound appears under different names depending on the context. Here is how to identify Paltusotine wherever you encounter it, plus the key facts at a glance.
- Generic name
- Paltusotine
- Brand name
- Palsonify
- Development code
- CRN00808
- Drug class
- Oral somatostatin agonist
- Manufacturer
- Vertex Pharmaceuticals (acquired Crinetics Pharmaceuticals, September 2026)
- How it's taken
- Palsonify is taken as an oral tablet once daily, making it much more convenient than injections.
The first once-daily oral pill for acromegaly. Unlike injectable somatostatin analogs, paltusotine is taken by mouth and offers the convenience of daily oral dosing while maintaining growth hormone and IGF-1 control.
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Where Paltusotine fits
A once-daily oral alternative to injectable somatostatin analogs for acromegaly. Mycapssa (oral octreotide capsules, taken twice daily) was approved earlier, but only for people who have responded to and tolerated octreotide or lanreotide injections. Approved for adults whose acromegaly was not controlled by surgery or who cannot have surgery, including people starting medical treatment for the first time and people switching from injections.
How Paltusotine works
Paltusotine is the first oral once-daily medicine for acromegaly. It works as a highly selective somatostatin receptor type 2 (SSTR2) agonist, very specifically telling the pituitary to stop overproducing growth hormone.
Mechanism: Selective oral non-peptide somatostatin receptor subtype 2 (SST2) agonist with sub-nanomolar potency
Side effects and safety
The most common side effects in trials were diarrhea, stomach pain, nausea, decreased appetite, a slow heart rate, high blood sugar, palpitations (a pounding or racing heartbeat) and stomach infections. Most stomach side effects started in the first 2 months and lasted a median of 6 to 18 days. The label also warns about gallstones and their complications, high or low blood sugar, a slow heart rate or heart rhythm changes, an underactive thyroid, loose or fatty stools from poor fat absorption, and low vitamin B12. Tell your doctor about stomach pain, yellowing of the skin or eyes, dizziness or fainting, or blood sugar problems.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Paltusotine
Palsonify is taken as an oral tablet once daily, making it much more convenient than injections. Take it with water on an empty stomach, at least 6 hours after a meal (for example, first thing in the morning after an overnight fast) and at least 1 hour before your next meal. The usual starting dose is 40 mg once daily, raised to 60 mg after 2 to 4 weeks if IGF-1 levels call for it. Heartburn medicines called proton pump inhibitors, such as omeprazole, lower how much of the drug you absorb, so tell your doctor about every stomach medicine you take. Your doctor will check IGF-1 levels, blood sugar and thyroid function.
Availability and cost
Only available as the brand-name product.
First once-daily oral somatostatin receptor agonist for acromegaly, eliminating the need for injections. Novel small-molecule approach to a condition traditionally managed with injectable biologics.
Help paying for Palsonify
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
Eligible commercially insured patients may pay as little as $0. Not for anyone covered by state or federal programs. No income limit; enrollment lasts 12 months.
For: private insurance · source - Free medicine program
Patient Assistance Program may provide PALSONIFY at no cost to uninsured patients or those whose insurance, including Medicare or Medicaid, excludes it. Income limits apply.
For: no insurance, underinsured, Medicare, Medicaid · source - Bridge or quick-start supply
Quick start supply lets patients begin treatment during insurance coverage delays while the CrinetiCARE team works to secure coverage.
The official page does not say who qualifies. Ask the program. · source - Insurance and case manager help
One-on-one nurse educators, help with insurance coverage, and specialty pharmacy coordination.
The official page does not say who qualifies. Ask the program. · source
Good to know: The free-drug program is for US or Puerto Rico residents. The CrinetiCARE site and palsonify.com were still Crinetics-branded as of this check, even after Vertex's acquisition, so program details could change.
- From a charity · TotalAssist (formerly PAN Foundation)Acromegaly fundOpen
Pays for: Out-of-pocket costs for approved medications, up to $5,000 per year. Requires Medicare, Medicaid or TRICARE.
- From a charity · The Assistance FundAcromegaly fundWaitlist
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
The foundation says: “WAITLIST — Accepting Waitlist Patients. TAF is currently accepting requests to join the enrollment waitlist for this program. Waitlists a…”
How acromegaly treatments compare
Five FDA-approved medications are available for acromegaly. Your endocrinologist will recommend a treatment based on your tumor size, IGF-1 levels, symptoms, and how you respond to initial therapy. This chart summarizes the key practical differences between options.
5 FDA-approved acromegaly treatments are available: Sandostatin LAR (octreotide, approved 1998); Somatuline Depot (lanreotide, approved 2007); Signifor LAR (pasireotide, approved 2014); Somavert (pegvisomant, approved 2003); Palsonify (paltusotine, approved 2025). Sandostatin LAR is typically used as first-line medical therapy (injectable).
| Drug | How it works | How it’s given | How often | Where you get it | Typical use | FDA approved |
|---|---|---|---|---|---|---|
Sandostatin LAR octreotide | Somatostatin analog — mimics a hormone that tells the pituitary to release less growth hormone | Intramuscular injection (gluteal muscle) | Every 4 weeks | Clinic or infusion center | First-line medical therapy (injectable) | 1998 |
Somatuline Depot lanreotide | Somatostatin analog — same receptor target as octreotide, but given as a deep subcutaneous gel rather than an intramuscular injection | Deep subcutaneous injection (upper outer buttock) | Every 4 weeks (FDA-approved extended dosing: 120mg every 6–8 weeks for biochemically controlled patients) | Clinic (healthcare provider administration per FDA label) | First-line medical therapy (injectable) | 2007 |
Signifor LAR pasireotide | Multi-receptor somatostatin analog — targets more receptor subtypes than first-generation options | Intramuscular injection (gluteal muscle) | Every 4 weeks | Clinic or infusion center | Second-line, after first-generation somatostatin analogs | 2014 |
Somavert pegvisomant | Growth hormone receptor antagonist — blocks GH from binding to cells instead of reducing GH release | Subcutaneous injection (self-administered) | Daily | Home (self-injection) | Second-line or add-on to somatostatin analog | 2003 |
Palsonify paltusotine You are here | Oral somatostatin agonist — activates the same SST2 receptor as injectable somatostatin analogs, taken as a pill | Oral tablet | Once daily | Home (oral, no injection needed) | First-line medical therapy, or switch from injectable somatostatin analog | 2025 |
This chart summarizes approved acromegaly treatments to help you understand the landscape. It is not medical advice. Treatment decisions depend on your individual health profile, tumor characteristics, lab results, and response to therapy. Dosing intervals shown reflect FDA labeling; your endocrinologist may adjust intervals based on your individual response. Always discuss options with your endocrinologist.
Clinical trial results
FDA approved paltusotine in September 2025 based on Phase 3 PATHFNDR trials. In PATHFNDR-2, in adults whose acromegaly was not controlled, 56% reached a normal IGF-1 at week 24 against 5% on placebo. In PATHFNDR-1, in adults already controlled on injections who switched to the pill, 83% kept a normal IGF-1 at week 36 against 4% on placebo. This was the first oral once-daily treatment approved for acromegaly.
Development history
Crinetics Pharmaceuticals developed paltusotine over many years of research into selective SSTR2 agonists, designed to maximize benefits while minimizing side effects. FDA approved it in September 2025, offering patients a simpler daily pill treatment. Vertex Pharmaceuticals completed its acquisition of Crinetics on September 1, 2026, and now markets Palsonify.
Explore Acromegaly trials
Other Acromegaly treatments
Paltusotine in Trial Friend News and Guides
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- Before You Pick a 2027 Medicare Plan, 8 Things to Check If You Take a Rare Disease DrugSeptember 25, 2026
- 1 Year of Palsonify and What Switching From Acromegaly Injections to a Pill InvolvesSeptember 15, 2026
Common questions about Paltusotine
▸What is Paltusotine (Palsonify)?
The first once-daily oral pill for acromegaly. Unlike injectable somatostatin analogs, paltusotine is taken by mouth and offers the convenience of daily oral dosing while maintaining growth hormone and IGF-1 control.
▸How does Paltusotine work?
Paltusotine is the first oral once-daily medicine for acromegaly. It works as a highly selective somatostatin receptor type 2 (SSTR2) agonist, very specifically telling the pituitary to stop overproducing growth hormone.
▸What are the side effects of Paltusotine?
The most common side effects in trials were diarrhea, stomach pain, nausea, decreased appetite, a slow heart rate, high blood sugar, palpitations (a pounding or racing heartbeat) and stomach infections. Most stomach side effects started in the first 2 months and lasted a median of 6 to 18 days. The label also warns about gallstones and their complications, high or low blood sugar, a slow heart rate or heart rhythm changes, an underactive thyroid, loose or fatty stools from poor fat absorption, and low vitamin B12. Tell your doctor about stomach pain, yellowing of the skin or eyes, dizziness or fainting, or blood sugar problems.
▸How is Paltusotine taken?
Palsonify is taken as an oral tablet once daily, making it much more convenient than injections. Take it with water on an empty stomach, at least 6 hours after a meal (for example, first thing in the morning after an overnight fast) and at least 1 hour before your next meal. The usual starting dose is 40 mg once daily, raised to 60 mg after 2 to 4 weeks if IGF-1 levels call for it. Heartburn medicines called proton pump inhibitors, such as omeprazole, lower how much of the drug you absorb, so tell your doctor about every stomach medicine you take. Your doctor will check IGF-1 levels, blood sugar and thyroid function.
▸Is Paltusotine FDA approved?
Yes, Paltusotine (Palsonify) is FDA approved (2025) for the treatment of Acromegaly.
▸What makes paltusotine unique among acromegaly treatments?
Paltusotine (Palsonify), approved in 2025, is the first once-daily oral somatostatin receptor agonist for acromegaly. Before it, the only oral somatostatin-type drug was Mycapssa (octreotide capsules), taken twice daily and approved only for long-term maintenance in people who had already responded to octreotide or lanreotide injections. Palsonify does not require that earlier response, making it a major step in convenience for patients.
▸How does paltusotine compare to injectable somatostatin analogs?
Like octreotide and lanreotide, paltusotine lowers growth hormone and IGF-1 by acting on somatostatin receptors in the pituitary. It is a daily pill instead of an injection, and its label says it acts almost only on receptor type 2, with more than 4,000-fold selectivity. No trial has compared Palsonify head to head with the injections.
▸How is Palsonify taken?
Palsonify is taken as an oral tablet once daily on an empty stomach, representing a major shift from the monthly injectable treatments that have been the standard for acromegaly. The oral route removes the need for injection training and clinic visits for shots.
▸Who developed paltusotine?
Paltusotine was developed by Crinetics Pharmaceuticals, a company focused on oral therapies for rare endocrine diseases. It received FDA approval in 2025. Vertex Pharmaceuticals completed its acquisition of Crinetics on September 1, 2026, so Palsonify is now a Vertex medicine. The CrinetiCARE patient support program continues to operate under that name.
▸What patient support is available for Palsonify?
CrinetiCARE provides patient support including copay assistance, insurance navigation, and treatment education for patients prescribed Palsonify.
▸Can patients switch from injectable somatostatin analogs to paltusotine?
Clinical studies included patients switching from injectable somatostatin analogs to oral paltusotine. Your endocrinologist can determine if switching is appropriate based on your current disease control and individual circumstances.