Paltusotine is the INN for Crinetics Pharmaceuticals' once-daily oral SST2 nonpeptide agonist, marketed as Palsonify. Unlike injectable somatostatin analogs that bind multiple receptor subtypes, paltusotine is selective for SST2 and avoids the GI tolerability and injection-site issues of long-acting depot formulations.
FDA approval for acromegaly came in 2025; the European Commission added approval April 27, 2026. Crinetics also has paltusotine in Phase 3 development for carcinoid syndrome — a separate hormone-secretion indication where the same SST2 mechanism drives benefit. The Q1 2026 print on May 7 disclosed Palsonify net product revenue of $10.3M in its first full commercial quarter, with R&D up 17.6% to $100.1M to fund the Phase 3 carcinoid program plus the atumelnant CAH and Cushing's programs.
Stories here cover trial readouts, regulatory milestones, and the launch trajectory. See #palsonify for the brand-name page, #crinetics, and #acromegaly.
Crinetics Pharmaceuticals reported Q1 2026 results May 7 — total revenue $10.7M (vs $8.5M consensus, +25.7% beat), Palsonify (paltusotine) net product revenue $10.3M in its first full commercial quarter (up from $5.4M in Q4 2025), 263 unique prescribers (up from 125 at year-end), 232 new patient enrollment forms in the quarter, and approximately 70% of patients reimbursed with payer coverage above 60% (target above 75% by Q3). Cash, equivalents, and investments closed at $1.3B. R&D rose 17.6% to $100.1M to fund Phase 3 paltusotine in carcinoid syndrome plus atumelnant Phase 3 programs in congenital adrenal hyperplasia and Cushing's syndrome. Shares rose 4.3% in after-hours trading.
Crinetics Pharmaceuticals reports Q1 2026 financial results after market close May 7, with a 4:30 p.m. ET conference call. Investors will be looking for first commercial color on Palsonify (paltusotine), the once-daily oral SST2 nonpeptide agonist that won European Commission approval April 27 for adult acromegaly across the 27 EU member states plus three EEA countries (Iceland, Liechtenstein, Norway). First launches are planned for Germany and Austria. Q1 commentary on CRN09682 — the first-in-class SSTR2 non-peptide drug conjugate currently in Phase 1/2 BRAVESST2 in metastatic neuroendocrine tumors — is also expected, with the program designed as a direct challenge to peptide-based PRRT including Lutathera and Perspective Therapeutics' alpha-PRRT.
Crinetics Pharmaceuticals announced April 27 that the European Commission approved Palsonify (paltusotine), a selectively-targeted somatostatin receptor type 2 nonpeptide agonist, as the first once-daily oral therapy for acromegaly in adults across all 27 EU member states plus three EEA countries. The approval rests on two pivotal Phase 3 trials in medical-naïve and previously treated patients, with diarrhea, abdominal pain, and nausea reported as the most common adverse reactions and no serious adverse events in the randomized portion. First launches are planned for Germany and Austria, marking Crinetics' first regulatory approval outside the U.S. and a competitive challenge to injectable somatostatin analogs.