FDA & Government News

FDA Approves First Once-Daily Oral Therapy for Acromegaly

Once-daily paltusotine offers an oral alternative to monthly injections for eligible adults.

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7 Key Takeaways

  • 1

    PALSONIFY™ is the first oral medication for acromegaly.

  • 2

    Approved by the FDA for adults with inadequate response to surgery.

  • 3

    Paltusotine is a nonpeptide somatostatin receptor type 2 agonist.

  • 4

    Clinical trials PATHFNDR-1 and PATHFNDR-2 showed efficacy in controlling IGF-1 levels.

  • 5

    Offers a significant shift from monthly injectable treatments.

  • 6

    Received Orphan Drug Designation for treating a rare disease.

  • 7

    Represents a commitment to enhancing patient quality of life.

Original Source(s)

FDA Approves First Once-Daily Oral Therapy for Acromegaly

Once-daily paltusotine offers an oral alternative to monthly injections for eligible adults.

  • by Kathryn Wighton

  • September 26, 2025

  • 2 min

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