New in acromegaly
You’ll wonder how you ever treated acromegaly before PALSONIFY
PALSONIFY is the first and only once-daily oral with biochemical and symptom control in adults with acromegaly1*
First line1
Approved for treatment-naïve patients and patients switching from iSRLs
Fast acting1
Lowered IGF-1 in 2 to 4 weeks
Reduces symptom severity1†
Reduced the severity of common acromegaly symptoms
Acromegaly control. Finally, in a pill.1
- *PALSONIFY is approved for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option.1
- †Numerically lower severity of symptom scores associated with acromegaly vs placebo, as measured by a patient-reported symptom severity tool.1
- IGF-1=insulin-like growth factor 1; iSRLs=injected somatostatin receptor ligands.
First and only nonpeptide SST2-selective agonist1,2
Targets SST2 receptors with potency and precision after efficient GI absorption1,3
- Nonpeptide molecule enables efficient gut absorption that’s not possible for peptide-based therapies2-4
- 28-hour half-life supports consistent therapeutic levels with once-daily dosing1-3
GI=gastrointestinal; SST2=somatostatin receptor subtype 2.
Acromegaly control across a range of patients1-3,5-7
In patients switching from iSRLs and those who were biochemically uncontrolled, including treatment naïve, PALSONIFY provided reliable, consistent, and sustained biochemical and symptom control.1-3,5-7
Megan,
living with acromegalyPATHFNDR-1 CLINICAL TRIAL
PALSONIFY seamlessly maintained IGF-1 control in patients who switched from SRL injections (octreotide or lanreotide).1,2
PATHFNDR-2 CLINICAL TRIAL
PALSONIFY proved effective in patients who were biochemically uncontrolled, including treatment naïve.1
View clinical dataOnce-daily oral dosing—optimized for convenience1
PALSONIFY gives you the flexibility of titrating your patient’s dose.1
- After 2 to 4 weeks on PALSONIFY 40 mg once daily, based on IGF-1 levels, increase PALSONIFY dosage to 60 mg once daily1
- During initiation period, 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 daily1
Dosing instructions
Administration
Take with water on an empty stomach at least 6 hours after a meal (eg, after overnight fasting).1
Dose at least 1 hour before next meal.1
Switching from depot injection
In the PATHFNDR-1 study, patients started PALSONIFY the same week as the next injection would be due.2,8
Well-tolerated safety profile1
The safety of PALSONIFY was evaluated in 169 adults with acromegaly during the randomized control period of 2 double-blind, placebo-controlled phase 3 studies.1
PATHFNDR-1: SWITCHING FROM SRL INJECTIONS1
| Adverse reaction* | PALSONIFY (n=30) n (%) |
Placebo (n=28) n (%) |
|---|---|---|
| Diarrhea | 7 (23) | 3 (11) |
| Nausea | 4 (13) | 1 (4) |
| Decreased appetite† | 3 (10) | 0 |
| Palpitations | 2 (7) | 0 |
| Gastroenteritis | 2 (7) | 0 |
PATHFNDR-2: UNCONTROLLED/TREATMENT NAÏVE1
| Adverse reaction* | PALSONIFY (n=54) n (%) |
Placebo (n=57) n (%) |
|---|---|---|
| Diarrhea | 18 (33) | 8 (14) |
| Abdominal pain‡ | 10 (19) | 3 (5) |
| Nausea | 5 (9) | 1 (2) |
| Sinus bradycardia | 4 (7) | 0 |
| Hyperglycemia§ | 4 (7) | 1 (2) |
Key safety outcomes from the randomized control period of phase 3 studies
No serious AEs
None occurred with PALSONIFY vs 2.4% with placebo.9
GI AEs resolved
Most GI AEs occurred within the first 2 months, lasted a median duration of 6 to 18 days, were generally mild to moderate, and usually resolved without discontinuing PALSONIFY.1,3
Low discontinuation rate
<4% of patients taking PALSONIFY discontinued due to AEs.9¶
Tumor control
No patients receiving PALSONIFY had a clinically significant increase in tumor volume in either study. In PATHFNDR-2, clinically significant decreases were observed in 4 (12%) patients taking PALSONIFY but not in any patients taking placebo.2,10#
- *Adverse reactions occurring in ≥5% of PALSONIFY-treated participants and 5% greater incidence than placebo-treated participants during the randomized controlled period.1
- †Decreased appetite also includes early satiety.1
- ‡Abdominal pain also includes abdominal discomfort.1
- §Hyperglycemia also includes impaired fasting glucose and diabetes mellitus.1
- ¶Comparable to the discontinuation rate of those taking placebo (1.2%).9
- #Clinical significance was defined as >25% in PATHFNDR-1 and >20% in PATHFNDR-2.2,10
AEs=adverse events.
CrinetiCARE®
Access and reimbursement support
CrinetiCARE offers personalized support to help your eligible patients throughout their treatment journey with PALSONIFY.
Benefits investigation
Prior authorization support
Appeals support
Patricia,
living with acromegalyINDICATION:
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.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS:
- Cholelithiasis and Its Complications: Cholelithiasis, including related complications such as acute cholecystitis and pancreatitis, have been reported. Monitor patients periodically. Discontinue PALSONIFY if complications of cholelithiasis occur and treat appropriately.
- Hyperglycemia and Hypoglycemia: Hyperglycemia, diabetes mellitus, or hypoglycemia, may occur. Monitor blood glucose levels when PALSONIFY treatment is initiated or when dosage is altered. Adjust antidiabetic treatment accordingly.
- Cardiovascular Abnormalities: 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 concomitant drugs that have bradycardic effects may be necessary.
- Thyroid Function Abnormalities: Somatostatin analogs may suppress the secretion of thyroid-stimulating hormone, which may result in hypothyroidism. Periodic assessment of thyroid function is recommended.
- Steatorrhea and Malabsorption of Dietary Fats: Somatostatin analog treatment may result in malabsorption of dietary fats and subsequent symptoms of steatorrhea, loose stools, abdominal bloating, and weight loss. If new or worsening symptoms are reported with PALSONIFY, evaluate patients for potential pancreatic exocrine insufficiency and manage accordingly.
- Vitamin B12 Deficiency: Vitamin B12 deficiency may occur. Monitor vitamin B12 levels, if clinically indicated.
ADVERSE REACTIONS:
Most common adverse reactions (>5%) are diarrhea, abdominal pain, nausea, decreased appetite, sinus bradycardia, hyperglycemia, palpitations, and gastroenteritis.
DRUG INTERACTIONS:
- Strong or Moderate CYP3A4 Inducers: may decrease PALSONIFY exposure. May require an increased dosage of PALSONIFY.
- Proton Pump Inhibitors: may decrease PALSONIFY exposure. May require an increased dosage of PALSONIFY. Avoid concomitant use of proton pump inhibitors in patients who are already on PALSONIFY 60 mg.
- Cyclosporine: may decrease cyclosporine exposure. May require cyclosporine dosage adjustment when used with PALSONIFY; follow therapeutic monitoring recommendations.
Please report adverse events to Crinetics Pharmaceuticals at 1-833-CRN-INFO (1-833-276-4636) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see Full Prescribing Information including Patient Information.
References: 1. PALSONIFY. Prescribing information 09/2025. Crinetics Pharmaceuticals, Inc; 2025. 2. Gadelha MR, Casagrande A, Strasburger CJ, et al. Acromegaly disease control maintained after switching from injected somatostatin receptor ligands to oral paltusotine. J Clin Endocrinol Metab. 2025;110(1):228-237. doi:10.1210/clinem/dgae385 3. Data on file. CRN00808-08 NDA 2.5 clinical overview. Crinetics Pharmaceuticals, Inc; 2025. 4. Gadelha MR, Wildemberg LE, Kasuki L. The future of somatostatin receptor ligands in acromegaly. J Clin Endocrinol Metab. 2022;107(2):297-308. doi:10.1210/clinem/dgab726 5. Clemmons D, Quock TP, Casagrande A, Wang Y, Krasner A. Paltusotine results in improved symptom stability in biochemically controlled acromegaly. Poster presented at: Endocrine Society Annual Meeting; July 12-15, 2025; San Francisco, CA. 6. Data on file. PATHFNDR studies week 60 open-label extension data and PATHFNDR-2 baseline IGF-1 levels. Crinetics Pharmaceuticals, Inc; 2025. 7. Data on file. Clinical study report CRN00808-08. Crinetics Pharmaceuticals, Inc; 2025. 8. Data on file. Clinical study report CRN00808-09. Crinetics Pharmaceuticals, Inc; 2025. 9. Data on file. CRN00808-08 NDA 2.7.4 summary of clinical safety. Crinetics Pharmaceuticals, Inc; 2025. 10. Data on file. CRN00808-08 NDA 2.7.3 summary of clinical efficacy. Crinetics Pharmaceuticals, Inc; 2025. 11. Martin S, Bender RH, Krasner A, Marmon T, Monahan M, Nelson L. Development and evaluation of the Acromegaly Symptom Diary. J Patient Rep Outcomes. 2023;7:15. doi:10.1186/s41687-023-00541-7