What Was Approved?
On September 25, 2025, the U.S. Food and Drug Administration approved Palsonify (paltusotine) for adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option.
Palsonify is an oral treatment and should not be described as a general first-line treatment for every patient with acromegaly.
How Does Palsonify Work?
Palsonify is a somatostatin receptor agonist.
Somatostatin signaling can reduce growth hormone secretion, which in turn may help lower insulin-like growth factor-1, or IGF-1, a key marker used in the management of acromegaly.
How Is Palsonify Taken?
Palsonify is taken by mouth once daily on an empty stomach.
The recommended initial dose is 40 mg once daily.
Based on IGF-1 levels and tolerability, the dose may be increased to 60 mg once daily after 2 to 4 weeks.
What Did the Clinical Trials Show?
FDA approval was supported by two randomized, placebo-controlled clinical trials involving 169 adults with acromegaly.
In one study:
- 55.6% of patients receiving Palsonify achieved biochemical control of IGF-1 at Week 24
- 5.3% receiving placebo achieved the same outcome
In another study involving patients previously controlled on injectable somatostatin analog therapy:
- 83.3% receiving Palsonify maintained biochemical control
- 3.6% receiving placebo did so
These trial results do not guarantee the same response for every patient.
What Are the Main Safety Concerns?
The FDA information lists several important safety considerations, including:
- Gallbladder abnormalities
- High or low blood glucose
- Slow heart rate
- Thyroid function changes
- Fat malabsorption
- Low vitamin B12 levels
What Are Common Side Effects?
Common adverse reactions included:
- Diarrhea
- Abdominal pain
- Nausea
- Decreased appetite
- Sinus bradycardia
- Hyperglycemia
- Palpitations
- Gastroenteritis
Bottom Line
Palsonify (paltusotine) is an FDA-approved once-daily oral treatment for adults with acromegaly who did not have an adequate response to surgery or for whom surgery is not an option.
Treatment should be individualized using IGF-1 levels, clinical response, tolerability, and appropriate monitoring.
Sources
- U.S. Food and Drug Administration (FDA) — Novel Drug Approvals for 2025.
- U.S. Food and Drug Administration (FDA) — Drug Trials Snapshot: Palsonify.
- U.S. Food and Drug Administration (FDA) — Palsonify (paltusotine) Prescribing Information, September 2025.