Palsonify (paltusotine) / Crinetics, Suzuken - LARVOL DELTA

Crinetics Pharmaceuticals Announces Submission of Marketing Authorization Application in Brazil for Palsonify (Paltusotine) in Acromegaly (GlobeNewswire) - "The MAA submission is supported by data from 18 clinical trials, including two Phase 3 trials that evaluated paltusotine for the treatment of acromegaly in medically untreated and treated patients. All primary and secondary endpoints were met in both Phase 3 studies."

Filing • Acromegaly

Investigator-assessed disease progression in a phase 2 study of paltusotine in patients with neuroendocrine tumors and carcinoid syndrome (ENETS 2026) - "In this preliminary analysis of a phase 2 study, the observed iaPFS rate (74%) after 1 year of treatment with paltuso - tine is encouraging and warrants further investigation in the ongo - ing CAREFNDR phase 3 study."

Clinical • P2 data • Carcinoid Syndrome • Neuroendocrine Tumor • Oncology • Solid Tumor

PATHFNDR 1: A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (clinicaltrials.gov) - P3 | N=58 | Completed | Sponsor: Crinetics Pharmaceuticals Inc. | Active, not recruiting ➔ Completed

Trial completion • Acromegaly • Endocrine Disorders • IGF1 • SSTR

CRN00808-11: Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome (clinicaltrials.gov) - P2 | N=36 | Completed | Sponsor: Crinetics Pharmaceuticals Inc. | Active, not recruiting ➔ Completed

Trial completion • Carcinoid Syndrome • Carcinoid Tumor • Gastrointestinal Cancer • Liver Cancer • Oncology • Pancreatic Cancer • Small Intestinal Carcinoma • Solid Tumor

Lunch Product Theater Optimizing Disease Control in Acromegaly: A Case-Based Discussion of PALSONIFY™️ Sponsored by Crinetics Pharmaceuticals (AACE 2026) - "Through representative patient cases, faculty will review key clinical challenges, treatment goals, and decision‑making considerations across treatment‑naïve and previously treated patients. The session will also highlight clinical trial evidence supporting the role of once‑daily oral paltusotine (PALSONIFY™️) in achieving biochemical and symptom control."

Clinical • Acromegaly • Endocrine Disorders

Once-Daily Oral Paltusotine in the Treatment of Adults With Acromegaly: Initial Real-World Experience (AACE 2026) - "This analysis evaluated data from real-world use of paltusotine in the treatment of patients with acromegaly during the initial months following FDA approval in the United States."

Clinical • Real-world • Real-world evidence • Acromegaly • Endocrine Disorders

Concomitant Use of Paltusotine and Levothyroxine in Patients With Acromegaly: A Post Hoc Analysis of Phase 3 Clinical Trial Data (AACE 2026) - "Post hoc analyses of phase 3 clinical trial data show that concomitant use of paltusotine and levothyroxine in patients with acromegaly did not impact thyroid function or IGF-I outcomes."

Clinical • P3 data • Retrospective data • Acromegaly • Endocrine Disorders • IGF1

CRN00808-11: Study to Evaluate the Safety, Pharmacokinetics, and Dose Response of Paltusotine Treatment in Subjects with Carcinoid Syndrome (clinicaltrialsregister.eu) - P1/2 | N=2 | Completed | Sponsor: Crinetics Pharmaceuticals Inc. | Active, not recruiting ➔ Completed

Trial completion • Carcinoid Syndrome • SSTR

CAREFNDR: Phase III, randomized, placebo -controlled study of paltusotine in adults with carcinoid syndrome due to well -differentiated neuroendocrine tumors (ENETS 2026) - No abstract available

Clinical • P3 data • Carcinoid Syndrome • Neuroendocrine Tumor • Oncology • Solid Tumor

Paltusotine: The first FDA approved oral treatment for acromegaly. (PubMed, Ann Med Surg (Lond)) - No abstract available

FDA event • Journal • Acromegaly • Endocrine Disorders

Efficacy and Safety of Pharmacologic Therapies in Acromegaly: A Systematic Literature Review and Network Meta-Analysis. (PubMed, J Clin Endocrinol Metab) - "This systematic review and NMA consolidate recent high-quality RCT evidence for acromegaly treatments. Paltusotine emerges as a promising alternative to injectable SRLs, with favorable efficacy, safety, and AE-related discontinuation patterns. These findings may inform clinical decision-making and guideline development, if confirmed by clinical experience."

Journal • Retrospective data • Acromegaly • Endocrine Disorders • SSTR

On 26 February 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Palsonify, intended for the treatment of adults with acromegaly. (European Medicines Agency)

CHMP • Acromegaly

Once-daily oral paltusotine in the treatment of patients with carcinoid syndrome: Biomarker analysis results from a phase 2, randomized, parallel-group study. (ASCO-GI 2026) - P2, P3 | "Paltusotine significantly reduced serotonin and 5-HIAA levels, with effects maintained at 48 weeks. Biomarker reductions paralleled reductions in BM and flushing frequency. These findings support further investigation in the ongoing phase 3 study (CAREFNDR, NCT07087054)."

Biomarker • Clinical • P2 data • Gastrointestinal Cancer • Oncology • SSTR • SSTR2

Paltusotine and Its Place in the Treatment Armamentarium for Acromegaly. (PubMed, J Clin Endocrinol Metab) - No abstract available

Journal • Acromegaly • Endocrine Disorders

A new era in oral treatment for acromegaly with the FDA-approved drug paltusotine. (PubMed, Ann Med Surg (Lond)) - No abstract available

FDA event • Journal • Acromegaly • Endocrine Disorders

Paltusotine: First Approval. (PubMed, Drugs) - "Paltusotine received its first approval in the USA in September 2025, based on results from the PATHFNDR-1 and PATHFNDR-2 phase III clinical trials in patients with acromegaly. This article summarizes the milestones in the development of paltusotine leading to this first approval for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option."

Journal • Acromegaly • Endocrine Disorders • IGF1 • SSTR • SSTR2

Crinetics Announces First Patient Randomized in Pivotal Phase 3 CAREFNDR Trial Evaluating Paltusotine in Carcinoid Syndrome (GlobeNewswire) - "The Phase 3 study is designed to enroll 141 adults, both naïve and previously treated patients, with carcinoid syndrome. Participants will be randomized in a 2:1 ratio to receive either once-daily paltusotine 80 mg or matching placebo....Global enrollment in CAREFNDR is expected throughout 2025 and 2026."

Trial status • Carcinoid Syndrome

Paltusotine Hydrochloride. (PubMed, Am J Health Syst Pharm) - No abstract available

Journal

PALSONIFY (Paltusotine) Launched in the U.S. with Encouraging Early Feedback from Patients and Physicians, and Positive Reimbursement Trends (Crinetics Press Release) - "Additionally, approximately 95% of filled prescriptions are from switch patients and 5% are from naïve patients, reflecting the demographics of the acromegaly population. Payer reimbursement has not been a barrier to treatment, with approximately 50% of filled prescriptions reimbursed."

Launch US • Acromegaly

A Phase 1, Single-Dose, Open-Label, Randomized, Three-Period, Two-Sequence, Crossover Study to Evaluate the Relative Bioavailability of Paltusotine Low Drug Load (LDL) Tablets 60 mg (2 × 30 mg LDL tablet) and High Drug Load (HDL) Tablet 60 mg (1 × 60 mg HDL tablet) in Healthy Volunteers. (ANZCTR) - P1 | N=20 | Not yet recruiting | Sponsor: Crinetics Pharmaceuticals, Inc

New P1 trial • Acromegaly • Carcinoid Syndrome • Endocrine Disorders

Paltusotine: The first selective nonpeptide agonist of somatostatin receptor 2 (SSTR2) for the treatment of acromegaly. (PubMed, Drug Discov Ther) - "With its rapid onset and durable biochemical control, this novel agent has the potential to reshape the current paradigm of acromegaly pharmacotherapy and offer patients a more convenient and effective treatment option. Nevertheless, its long-term safety and efficacy warrant further evaluation in real-world clinical settings."

Journal • Acromegaly • Endocrine Disorders • Pain • IGF1 • SSTR • SSTR2

Rapid and Sustained Response of Biochemically Uncontrolled Acromegaly to Once-Daily Oral Paltusotine Treatment. (PubMed, J Clin Endocrinol Metab) - "IGF-I normalized in significantly more patients with uncontrolled acromegaly treated with paltusotine versus placebo. Paltusotine was associated with rapid, sustained IGF-I reduction, significant symptom improvement, and stable or reduced pituitary tumor size and was well tolerated."

Clinical • Journal • Acromegaly • Endocrine Disorders • Oncology • Pain • Pituitary Gland Carcinoma • IGF1 • SSTR • SSTR2

Paltusotine versus octreotide: different effects on radioligand uptake in neuroendocrine tumours. (PubMed, Endocr Oncol) - "Treatment with paltusotine did not significantly reduce radioligand binding of 18F-SiTATE in vitro, indicating no influence on SSTR2 targeting. This might enable a continuation of somatostatin receptor analogue therapy with paltusotine during PRRT, potentially improving symptom control in GEP-NET patients with the carcinoid syndrome."

Journal • Carcinoid Syndrome • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor • SSTR • SSTR2

Crinetics to Highlight Neuroendocrine Tumor Research Progress at the 2025 North American Neuroendocrine Tumor Society Annual Meeting (Crinetics Press Release) - "A preliminary analysis of Phase 2 data from the open-label trial of paltusotine in the treatment of patients with carcinoid syndrome due to NETs will be featured in a poster presentation, showing an overall investigator-assessed progression free survival rate of 74% following one year of treatment....Two additional poster presentations will feature study details from the randomized, Phase 3 trial of paltusotine in carcinoid syndrome due to NETs and the first-in-human study of NDC candidate CRN09682 in patients with somatostatin receptor 2-expressing tumors."

Clinical data • Carcinoid Syndrome • Neuroendocrine Tumor

Investigator-Assessed Disease Progression in a Phase 2 Study of Paltusotine in Patients with Neuroendocrine Tumors and Carcinoid Syndrome (NANETS 2025) - "Other reported targetable alterations in GEP-NENs include KRAS, ALK, BRCA1/2, ATM, NTRK, FGFR, and RET. CONCLUSIONS The observed PFS rate (74%) after 1 year of treatment with paltusotine, in this preliminary analysis of a phase 2 study, is encouraging data and warrants further investigation in the ongoing CAREFNDR Phase 3 study."

Clinical • P2 data • Neuroendocrine Tumor • Oncology • Solid Tumor • ALK • BRAF • BRCA1 • BRCA2 • FGFR • KRAS • NTRK • SSTR