Big News for Acromegaly: Crinetics Announces FDA Approval of PALSONIFY™

Crinetics announced today that the FDA has approved PALSONIFY™, the first once-daily oral therapy to treat acromegaly. PALSONIFY™ is a nonpeptide SST2 receptor agonist, which is a synthetic drug molecule that activates the somatostatin receptor subtype 2 (SST2) but is not built from amino acids like natural somatostatin. Essentially, a nonpeptide SST2 agonist is a lab-made drug that mimics a natural hormone in your body, but is designed to work better than the original.  See a more detailed explanation below.

This is excellent news for acromegaly patients, who have recently seen several new treatment options emerge for this challenging disease. Clinical trials showed outstanding results that, once approved, would position PALSONIFY™ as another valuable option for doctors to prescribe. PALSONIFY™ was shown to be well tolerated and resulted in rapid, durable, consistent biochemical control while reducing symptom burden.

“The approval of Palsonify is a significant advancement for our patients, as there is an unmet need for an easy-to-administer and safe therapeutic option with rapid action and durable response that can consistently manage acromegaly,” said Dr. Shlomo Melmed, a leading acromegaly expert and Executive Vice President of Medicine and Health Sciences and Dean of the Medical Faculty at Cedars-Sinai.

We are thrilled to see this drug approved and congratulate Crinetics, as this is their first approved drug, positioning the company as one of the premier endocrine-focused global pharmaceutical companies. The company announced the drug will be available in early October. This press release from Crinetics will provide more detailed information.

How This Novel Drug Works

We thought it would be helpful to explain how this innovative drug works in simple terms:

Your body produces a hormone called somatostatin that acts like a “brake pedal”—it tells other parts of your body to stop making certain hormones when you have enough. It does this by attaching to specific spots called SST2 receptors. However, the natural hormone breaks down quickly in your body and doesn’t work well as a medicine.

Scientists created artificial molecules that can do the same job—they activate the same “off switches” in your body—but they’re much better as medicines because they:

• Last longer in your system
• Can be taken as pills instead of injections
• Are more precise in their action

Think of it like creating a better, longer-lasting replacement part that does the same job as the original, but more effectively. PALSONIFY is an example of these nonpeptide SST2 agonists developed to treat acromegaly, offering potentially improved convenience and effectiveness compared to traditional peptide-based somatostatin analogs like octreotide.

© 2025, J D Faccinetti. All rights reserved.