Wednesday, July 8, 2026

Drug profile · INN

paltusotine hydrochloride

paltusotine hydrochloride (PALSONIFY) is an FDA-listed pharmaceutical active ingredient. Associated with Crinetics Pharmaceuticals Europe GmbH. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 9
Pipeline programs 2
News articles 2
Drug details — paltusotine hydrochloride

Quick answer

paltusotine hydrochloride (PALSONIFY) is an FDA-listed pharmaceutical active ingredient. Associated with Crinetics Pharmaceuticals Europe GmbH. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN paltusotine hydrochloride
Brand PALSONIFY
Route ORAL
Formulation TABLET

Approval history

Authority Status Date
FDA approved

Recent coverage

Pipeline programs

  1. Paltusotine Phase 3 · Crinetics Pharmaceuticals Europe · Acromegaly
  2. Paltusotine Phase 3 · Crinetics Pharmaceuticals Europe · Carcinoid Syndrome
  1. US 12208092

    Compositions and methods for administering paltusotine to patients with hepatic impairment

    Expires Mon Jan 23 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 11957674

    Formulations of a somatostatin modulator

    Expires Mon Apr 11 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 11414397

    Somatostatin modulators and uses thereof

    Expires Mon Aug 11 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 11266641

    Formulations of a somatostatin modulator

    Expires Mon Mar 03 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 10875839

    Somatostatin modulators and uses thereof

    Expires Mon Dec 24 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 10597377

    Somatostatin modulators and uses thereof

    Expires Mon Mar 19 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 10464918

    Process of making somatostatin modulators

    Expires Mon Oct 31 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 10351547

    Somatostatin modulators and uses thereof

    Expires Mon Jul 11 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 9896432

    Somatostatin modulators and uses thereof

    Expires Mon Feb 15 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is paltusotine hydrochloride?

paltusotine hydrochloride (PALSONIFY) is an FDA-listed pharmaceutical active ingredient. Associated with Crinetics Pharmaceuticals Europe GmbH. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for paltusotine hydrochloride?

PALSONIFY is a marketed brand name for paltusotine hydrochloride. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of paltusotine hydrochloride?

paltusotine hydrochloride has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.