With FDA Nod in Rare Hormone Disease, Crinetics Can Challenge Blockbuster Meds From Novartis, Ipsen

MedCity News September 26, 2025
Frank Vinluan

FDA approval of Crinetics Pharmaceuticals’ Palsonify makes it the first oral first-line therapy for acromegaly, a rare endocrine disorder. The once-daily pill will compete with blockbuster acromegaly drugs from Novartis and Ipsen that are administered as injections.

Drugs for the rare hormone disorder acromegaly include older engineered peptides administered as frequent injections. A new FDA approval brings acromegaly patients the choice of a once-daily pill that also gives its developer, Crinetics Pharmaceuticals, the opportunity to compete with and take market share from blockbuster products that are well-established in the acromegaly space.

The new drug, paltusotine, is the first commercial product for Crinetics, which specializes in developing therapies for endocrine disorders. The late Thursday regulatory decision covers the pill’s use as...

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