PALSONIFY Film-coated tablet Ref.[116552] Active ingredients: Paltusotine

Source: European Medicines Agency (EU)  Revision Year: 2026  Publisher: Crinetics Pharmaceuticals Europe GmbH, Barbara Strozzilaan 201, 1083HN Amsterdam, Netherlands

Product name and form

Palsonify 20 mg film-coated tablets.

Palsonify 30 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Palsonify 20 mg film-coated tablets: Pink, biconvex oval film-coated tablets, 16 mm length and 8 mm width, debossed with "PAL" on one side and "20" on the other side.

Palsonify 30 mg film-coated tablets: Yellow, biconvex oval film-coated tablets, 18 mm length and 9 mm width, debossed with "PAL" on one side and "30" on the other side.

Qualitative and quantitative composition

Palsonify 20 mg film-coated tablets: Each film-coated tablet contains 20 mg of paltusotine (as paltusotine hydrochloride).

Palsonify 30 mg film-coated tablets: Each film-coated tablet contains 30 mg of paltusotine (as paltusotine hydrochloride).

For the full list of excipients, see section 6.1.

Active Ingredient

Similar to the natural hormone somatostatin (SST), paltusotine demonstrates potent suppression of GH and IGF-1 secretion. Paltusotine exerts its pharmacological activity via highly selective binding (>4 000-fold) to somatostatin receptor 2 (SST2) and exhibits little or no affinity for other SST receptor subtypes.

List of Excipients

Tablet core:

Copovidone
Cellulose, microcrystalline
Crospovidone
Silica, colloidal anhydrous
Magnesium stearate
Mannitol (E421)

Film-coating:

Palsonify 20 mg film-coated tablets

Hypromellose
Titanium dioxide (E171)
Triacetin (E1518)
Iron oxide, yellow (E172)
Iron oxide, red (E172)

Palsonify 30 mg film-coated tablets

Hypromellose
Titanium dioxide (E171)
Triacetin (E1518)
Iron oxide, yellow (E172)

Pack sizes and marketing

A heat induction sealed, white high-density polyethylene (HDPE) bottle with a white child-resistant polypropylene (PP) closure.

Each bottle contains 60 film-coated tablets and a silica gel desiccant.

Each carton contains one bottle.

Marketing authorization holder

Crinetics Pharmaceuticals Europe GmbH, Barbara Strozzilaan 201, 1083HN Amsterdam, Netherlands

Marketing authorization dates and numbers

EU/1/26/2021

Drugs

Drug Countries
PALSONIFY United States

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