The European Commission has approved Palsonify (paltusotine) for the treatment of acromegaly in adults, making it the first once-daily oral therapy authorized for the condition across the 27 EU member states and three European Economic Area countries. The decision marks Crinetics Pharmaceuticals’ first regulatory approval outside the United States and establishes paltusotine, a nonpeptide somatostatin receptor type 2 (SST2) agonist, as the first oral agent in its mechanistic class to reach patients in the EU.
The EC approval covers the medical treatment of adult patients with acromegaly and is valid across all EU member states. Crinetics said initial commercialization efforts are planned for Germany and Austria. The drug carries Orphan Drug Designation in the EU. In the US, the FDA had previously approved Palsonify for first-line treatment of adults with acromegaly who had an inadequate response to surgery or for whom surgery is not an option. The EU label, as described in the source material, applies more broadly to medical treatment of acromegaly in adults without specifying a surgical history requirement in the same terms.
The EC decision was supported by data from two pivotal Phase III studies, PATHFNDR-1 and PATHFNDR-2, which evaluated paltusotine in previously treated and medically untreated adults with acromegaly, respectively. Across both trials, the company said paltusotine demonstrated rapid onset and sustained biochemical control, with IGF-1 — the primary biomarker used to manage acromegaly — used as the central efficacy measure. PATHFNDR-1 assessed patients switching from monthly injectable somatostatin receptor ligands, while PATHFNDR-2 enrolled treatment-naive patients. Patient-reported outcomes were captured using the Acromegaly Symptom Diary, a validated instrument measuring symptoms including headaches, joint pain, sweating, and fatigue. Treatment was described as generally well-tolerated, with no serious adverse events reported in the randomized controlled portions of the trials. The most common adverse reactions were gastrointestinal, including diarrhea, abdominal pain, nausea, and abdominal discomfort.
Acromegaly is a rare endocrine disorder driven predominantly by growth hormone-secreting pituitary adenomas, with excess IGF-1 production as the downstream consequence. The existing standard of care relies heavily on injectable somatostatin receptor ligands such as octreotide and lanreotide, administered monthly, alongside pegvisomant and dopamine agonists. An oral formulation of octreotide, Mycapssa, holds FDA approval for acromegaly maintenance, but paltusotine represents a distinct mechanistic approach as a nonpeptide SST2 agonist rather than a peptide-based agent. The EU approval places Palsonify into a treatment landscape where injectable administration has long been the norm, and where a subset of patients experience incomplete biochemical control or tolerability issues with existing therapies. Crinetics is also advancing paltusotine in Phase III development for carcinoid syndrome associated with neuroendocrine tumors through the CAREFNDR trial, and a new drug application has been submitted in Japan by partner Sanwa Kagaku Kenkyusho, with a marketing authorization application also filed in Brazil. The EU approval is Crinetics’ first international authorization following the US FDA clearance.
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