Paltusotine is a prescription medicine indicated for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. It is available as tablets for oral use. MedsAcross supplies Paltusotine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
PALSONIFY is indicated for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. PALSONIFY is a somatostatin receptor agonist indicated for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option.
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
Take orally once daily with water on an empty stomach (at least 6 hours after a meal) and at least 1 hour before the next meal. Recommended initial dosage is 40 mg once daily. During initiation, PALSONIFY may be temporarily reduced to 20 mg once daily if needed, based on tolerability. Once adverse reactions have resolved, resume PALSONIFY 40 mg once daily. After 2 to 4 weeks, based on IGF-1 levels, titrate to 60 mg once daily.
Source: US FDA prescribing information
None. None
Source: US FDA prescribing information
Cholelithiasis and its Complications: Monitor periodically. If complications of cholelithiasis occur, discontinue PALSONIFY and treat appropriately. Hyperglycemia and Hypoglycemia: Monitor glucose and adjust antidiabetic treatment as needed. Cardiovascular Abnormalities: Bradycardia or conduction abnormalities may occur. Dosage adjustments of concomitantly used drugs with bradycardia effects may be necessary. Thyroid Function Abnormalities: Hypothyroidism may occur. Assess thyroid function periodically. Steatorrhea and Malabsorption of Dietary Fats: New onset steatorrhea, stool discoloration, loose stools, abdominal bloating, and weight loss may occur. If new occurrence or worsening of these symptoms are reported, evaluate for potential pancreatic exocrine insufficiency. Vitamin B 12 Deficiency: Monitor vitamin B 12 levels during treatment if indicated.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: Cholelithiasis and Complications of Cholelithiasis Hyperglycemia and Hypoglycemia Cardiovascular Abnormalities Thyroid Function Abnormalities Steatorrhea and Malabsorption of Dietary Fats Changes in Vitamin B 12 Levels Most common adverse reactions (≥5%) are diarrhea, abdominal pain, nausea, decreased appetite, sinus bradycardia, hyperglycemia, palpitations, and gastroenteritis.
Source: US FDA prescribing information
Strong CYP3A4 Inducers: may decrease paltusotine exposure. May require PALSONIFY dosage increase. Moderate CYP3A4 Inducers: may decrease paltusotine exposure. Proton Pump Inhibitors: may decrease paltusotine exposure. Cyclosporine: may decrease cyclosporine exposure. May require cyclosporine dosage adjustment.
Source: US FDA prescribing information
Store tablets at 20°C to 25°C (68°F to 77°F). Excursions permitted 15°C to 30°C (59°F to 86°F). Store and dispense in original container or USP equivalent tight container.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Paltusotine, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Palsonify 20 mg tabletOral | Crinetics Pharmaceuticals | US FDA | Available on request |
| Palsonify 30 mg tabletOral | Crinetics Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 2 presentations of Paltusotine and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Paltusotine, including Palsonify.
Yes. The US FDA first approved Paltusotine on 25 September 2025, according to Drugs@FDA.
Yes. Paltusotine has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Paltusotine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Paltusotine is classified under ATC code H01CB06 (Paltusotine).
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