Crinetics Pharmaceuticals announces EMA validation of marketing authorisation application and orphan drug designation for paltusotine in acromegaly

Crinetics Pharmaceuticals

27 March 2025 - Crinetics Pharmaceuticals today announced that the EMA has validated the marketing authorisation application for paltusotine, the first once daily, oral, selectively-targeted somatostatin receptor type 2 non-peptide agonist, for the proposed treatment and long-term maintenance therapy of acromegaly, a serious, rare and progressive endocrine disorder characterised by consistently elevated levels of growth hormone. 

Additionally, the EMA on 27 February 2025 granted paltusotine orphan drug designation for the treatment of acromegaly.

Read Crinetics Pharmaceuticals press release

Michael Wonder

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Michael Wonder

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Medicine , Europe , Dossier