Signifor (pasireotide) / Recordati - LARVOL DELTA

Cost-utility analysis of second line acromegaly treatment in France. (PubMed, Ann Endocrinol (Paris)) - "The aim of this study is to assess the cost-utility of second-line treatments of acromegaly accounting for the overall management recommended in France, considering surgery, first-line treatments, radiotherapy and the impact of treatments on tumor volume, in addition to IGF-1 normalization. All evaluated treatments were included in an efficiency frontier. This addition has shown that radiotherapy and the impact on tumor volume are decisive in the management of second-line treatments for acromegaly. Indeed, radiotherapy enables patients to achieve complete remission, i.e. without the need for drug treatment. This is an important factor for patients, given that acromegaly treatments are chronic and usually lifelong. This study is an additional tool for treatment choice including both a clinical and economic perspective."

HEOR • Journal • Acromegaly • Endocrine Disorders • Oncology • IGF1

Impact of pasireotide on lipid and glucose metabolism in patients with acromegaly: a systematic review and meta-analysis. (PubMed, J Endocrinol Invest) - "In this large meta-analysis, PasiLAR was associated with increased HDL-C, FPG, HbA1c, and frequency of DM in patients with acromegaly. There was no effect on triglycerides, total cholesterol, and LDL-C."

Journal • Retrospective data • Review • Acromegaly • Diabetes • Dyslipidemia • Endocrine Disorders • Metabolic Disorders

management of an adrenal cortical carcinoma induced non-islet cell tumor hypoglycemia: a case report (ENDO 2025) - "She was started on adjuvant mitotane, and chemotherapy (cisplatin, etoposide, and doxorubicin) which induced cardiomyopathy...Osilodrostat was initiated for Cushing syndrome...Patient had recurrent severe hypoglycemic episodes, which were refractory to increasing carbohydrate intake, high-dose prednisone, and octreotide...She also received pasireotide 60mg and diazoxide 5mg/kg every 8 hours...Upon applying for alpelisib approval, her clinical status rapidly declined, and she died after 3 months of NITCH diagnosis...IGF2-mediated hypoglycemia was refractory to numerous therapeutic interventions, including paseriotide, pembrolizumab, olaparib, ivosidenib, and cabozantinib. This case emphasizes rare manifestations of metastatic ACC and limitations of existing medical therapies for NITCH."

Case report • Clinical • Adrenal Cortex Carcinoma • Cardiomyopathy • Cardiovascular • Cushing’s Disease • Diabetes • Endocrine Disorders • Hypoglycemia • Metabolic Disorders • Oncology • Pancreatic Cancer • Severe Hypoglycemia • Solid Tumor • IGF1 • IGF2

Osilodrostat for Ectopic Cushing's Syndrome: A Superior Off-Label Option After Failure of Other Therapies - A Case Report (ENDO 2025) - "We present a case of ectopic CS managed with multiple medications, including metyrapone and pasireotide, with successful control ultimately achieved using osilodrostat.Clinical Case:A 76-year-old male presented with uncontrolled, new-onset diabetes mellitus (A1c: 13.5%). Osilodrostat, though off-label, is an effective and user-friendly option for managing ectopic CS, allowing for straightforward monitoring and improved patient adherence"

Case report • Clinical • Anorexia • Cushing’s Disease • Diabetes • Endocrine Cancer • Endocrine Disorders • Lung Cancer • Metabolic Disorders • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Small Cell Lung Cancer • Solid Tumor • SSTR2 • SSTR5

Managing a Resistant GH-Secreting Adenoma: A Case Report Highlighting Barriers to Patient Care (ENDO 2025) - "Post-surgery, Octreotide and Pasireotide were ineffective, the latter discontinued due to hyperglycemia...In such cases, Pegvisomant, a GH antagonist, is preferred, though it has no impact on tumor size...Our patient highlights the impact of low health literacy and language barriers on treatment adherence and outcomes. Physicians must adopt a patient-centered approach that includes clear communication, culturally sensitive education, and the involvement of interpreters or community resources as needed."

Case report • Clinical • Acromegaly • Diabetes • Endocrine Disorders • Metabolic Disorders • Oncology • Pain • Pituitary Gland Carcinoma • IGF1 • SSTR

Long-Term Safety of Pasireotide in Patients With Cushing's Disease: Final Results From a 10-Year Open-Label Phase IV Rollover Study (B2412) (ENDO 2025) - P4 | "Data are reported for CD pts from 4 parent studies who received pasireotide long-acting release (LAR; n=33) or subcutaneous (sc; n=29) and ≥1 dose during the rollover (except for 1 pt who only received pasireotide sc in the parent study). Pasireotide is a well-tolerated long-term treatment option for CD pts, with pts having received treatment for ≤16 years from parent study entry. Few pts discontinued because of AEs, including hyperglycemia, and hyperglycemia was infrequent during the study."

Clinical • P4 data • Acromegaly • Back Pain • Colon Cancer • Colorectal Cancer • Cushing’s Disease • Diabetes • Endocrine Disorders • Gastroenterology • Hypoglycemia • Infectious Disease • Metabolic Disorders • Musculoskeletal Pain • Nephrology • Oncology • Pain • Pneumonia • Respiratory Diseases • Septic Shock • Solid Tumor • SSTR

Effects of Switching from Metyrapone to Osilodrostat on Steroid Hormone Profiles and Clinical Outcomes in Patients with persistent Cushing's Disease (ENDO 2025) - "Surgical removal of the tumor is the primary treatment, but medical therapy is required in cases of persistent or recurrent disease or when surgery is infeasible.Drug therapies include agents targeting ACTH secreting tumor (e.g., pasireotide, cabergoline) and those inhibiting adrenal cortisol production (e.g., metyrapone, osilodrostat, ketoconazole)...Steroid hormone concentrations, including cortisol, progesterone, 17-hydroxyprogesterone (17Prog), and 17-hydroxypregnenolone (17Preg), were measured using high-performance liquid chromatography–mass spectrometry...These data suggest that in patients with Cushing's disease receiving metyrapone, switching to osilodrostat may benefit cases with inadequate disease control and complications including hypertension, manifestation of masculinization, and gastric discomfort.ConclusionSwitching from metyrapone to osilodrostat significantly altered steroid hormone profiles and improved clinical outcomes in patients with..."

Clinical • Clinical data • Cardiovascular • Cushing’s Disease • Endocrine Disorders • Hypertension • Oncology • Otorhinolaryngology • Pituitary Gland Carcinoma • CYP11B1

Adverse reactions of second-generation somatostatin receptor ligandPasireotide: analysis based on FAERS database (ENDO 2025) - "In cases of adverse reactions or disease progression, prompt intervention measures should be implemented to ensure the safe and rational use of pasireotide. These findings underscore the importance of vigilant monitoring and proactive management to optimize patient safety and therapeutic outcomes."

Acromegaly • Diabetes • Endocrine Cancer • Endocrine Disorders • Metabolic Disorders • Neuroendocrine Tumor • Oncology • Solid Tumor • SSTR

PASIPHY: Phase II Study to Evaluate the Efficacy and Safety of Pasireotide Treatment for Patients With Post-bariatric Hypoglycemia (ENDO 2025) - P2 | "PASIPHY will yield important data on the efficacy and safety of pasireotide, determining the optimal dose with the best benefit:risk ratio and whether it is a viable treatment option for pts with PBH."

Clinical • P2 data • Gastrointestinal Disorder • Hypoglycemia • SSTR

Evaluating Drug-Induced Effects on Cell Viability in Acromegaly Using a Patient-Derived 3D Culture Model (ENDO 2025) - "The culture cells were treated with therapeutic agents—octreotide (Oct) 10 nM, cabergoline (Cab) 10 nM, pasireotide (Pas) 10 nM, or vehicle—under standardized conditions. Among the 27 cases, 9 (33%) responded to Oct, with an association observed in tumors with T2WI hypointensity on MRI (p = 0.04). The responsiveness to Cab was observed in 9 cases (33%), with an association in patients who responded to the bromocriptine test (p = 0.04). Pas exhibited the highest response rate (11 cases, 40%), which was associated with sparsely granulated tumors (p = 0.04).The use of a 3D tumor culture system derived from Acro patients provided insights into drug-specific responsiveness, aligning with previously identified predictive factors for Oct, Cab, and Pas."

Acromegaly • Endocrine Disorders • Oncology

Evaluation of novel, high-affinity SSTR2/SSTR5 somatostatin analogs in pancreatic and pituitary neuroendocrine tumor models. (EACR 2025) - "Currently approved SSAs exhibit high affinity for specific SSTR subtypes, with octreotide and lanreotide targeting SSTR2, while pasireotide binds to SSTR5, SSTR3 and SSTR2... These results indicate that the newly synthesized SSAs effectively inhibit both hormone secretion and cell proliferation in NET models. Further investigations in 3D cultures and in vivo models will be essential to confirm their therapeutic potential and optimize their clinical applicability."

Preclinical • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Pituitary Gland Carcinoma • Solid Tumor • SSTR • SSTR2 • SSTR5

Somatostatin Analogs for Preventing Postoperative Pancreatic Fistula: Past Evidence Reveals New Opportunities. (PubMed, Ann Surg Oncol) - "Despite additional studies demonstrating a significant reduction in POPF with the use of newer SSAs including pasireotide and lanreotide, surgical practices in the use of somatostatin analogs in preventing POPF are highly variable. Herein, we review three decades of available data on SSA for POPF prophylaxis and highlight the need for pragmatic, focused, and data-driven design for future trials with modern agents."

Journal • Review

NETTER-3: Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET (clinicaltrials.gov) - P3 | N=240 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting | Trial completion date: Jul 2032 ➔ Jan 2034 | Trial primary completion date: Jun 2028 ➔ Sep 2030

Enrollment open • Trial completion date • Trial primary completion date • Endocrine Cancer • Neuroendocrine Tumor • Solid Tumor

Structural insights into the binding modes of lanreotide and pasireotide with somatostatin receptor 1. (PubMed, Acta Pharm Sin B) - "Combined with the biochemical assays and molecular dynamics simulations, our results provide a comparative analysis of binding characteristics within the SSTR family, highlighting subtle differences in SSTR1 activation by Lan and Pas. These insights pave the way for designing next-generation therapies with enhanced efficacy and reduced side effects through improved receptor subtype selectivity."

Journal • Neuroendocrine Tumor • SSTR

Clinical Implications of Molecular and Genetic Biomarkers in Cushing's Disease: A Literature Review. (PubMed, J Clin Med) - "The immunohistochemical evaluation of its granulation pattern, Ki-67 proliferation index, and E-cadherin expressions have been linked to a tumor's invasiveness and surgical outcomes, while somatostatin and dopamine receptor expressions may influence its response to Pasireotide and cabergoline therapy. This narrative review provides an update on the latest evidence regarding the roles of molecular biomarkers in corticotropinomas, emphasizing their role in prognosis, recurrence risk, and the response to different treatment options. A better understanding and integration of these biomarkers into clinical practice could lead to a better patient stratification, more efficient therapeutic strategies, and personalized treatment approaches for patients with CD."

Biomarker • Journal • Review • Cushing’s Disease • Endocrine Cancer • Endocrine Disorders • Gene Therapies • Neuroendocrine Tumor • Oncology • Rare Diseases • Solid Tumor • CDH1 • TP53 • USP8

Pasireotide Exerts Anti-Inflammatory Effects in the Endothelium. (PubMed, J Biochem Mol Toxicol) - "Endothelial cells were treated with PAS before LPS exposure to evaluate the corresponding effects on cell viability, inflammation, and barrier function. Since PAS suppressed LPS-triggered endothelial injury, it is suggested that this compound could be repurposed for endothelium-dependent disorder treatment."

Journal • Inflammation • SSTR

Cost-effectiveness analysis of second-line medical therapies in acromegaly: a real-life study. (PubMed, Front Endocrinol (Lausanne)) - "To assess the use of pasireotide and pegvisomant in a third-level center under routine clinical practice. Pasireotide affected carbohydrate metabolism (P = .001), but the effect was generally mild. Pasireotide was found to be a more cost-effective option in patients with first-line treatment failure."

HEOR • Journal • Acromegaly • Diabetes • Endocrine Disorders • Metabolic Disorders • Type 2 Diabetes Mellitus

PASIPHY: Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia (clinicaltrials.gov) - P2 | N=72 | Recruiting | Sponsor: RECORDATI GROUP | Trial primary completion date: Apr 2025 ➔ Apr 2026

Trial primary completion date • Hypoglycemia • SSTR

Osilodrostat effectiveness in the treatment of Cushing's disease (CD) and ectopic Cushing’s syndrome (ECS)- a single-center real-life experience (ESPE-ESE 2025) - "Osilodrostat was first-line in 11, second-line in 10 (after metyrapone, ketoconazole, or pasireotide), and third/fourth-line in 2...At osilodrostat initiation: 17 required potassium supplementation (9 needed spironolactone), 19 had diabetes (9 on insulin), 21 had hypertension...Of 23 analyzable patients (13 CD, 10 ECS), mean diagnosis age was 57.8 years; 61% were women. Seven (30.4%) died. Mean morning serum cortisol at diagnosis: 42.7 μg/dL; ACTH: 180.3 pg/mL."

Clinical • Cardiovascular • Cushing’s Disease • Diabetes • Endocrine Disorders • Hypertension • Metabolic Disorders

Pasireotide Induces Long-term Cystic Degeneration of Somatotrophic Pituitary Neuroendocrine Tumors (PitNETs) (ESPE-ESE 2025) - "Background: Pasireotide LAR is a long-acting somatostatin analog with potential antitumor activity, as demonstrated by treatment induced increased MRI T2-signal intensity of somatotrophic PitNETs (1), but long- term follow-up data are lacking. Forty-four patients, 43 % female, median (IQR) age 52 (15 years) were included. Median treatment duration was 31.0 months. The median IR of the PitNETs increased between baseline and MRI at 7 years (1.09 vs."

Acromegaly • Endocrine Cancer • Endocrine Disorders • Neuroendocrine Tumor • Oncology • Solid Tumor • IGF1

Long-Term Safety and Efficacy of Once-Daily Oral Paltusotine in the Treatment of Patients With Acromegaly: ACROBAT Advance Year 4 Analysis (ESPE-ESE 2025) - "In Edge, at enrollment all patients were candidates for combination drug therapy: either sub-optimally controlled on an injected SRL (octreotide or lanreotide) alone or in combination with cabergoline, or required combination therapy or pasireotide to achieve normal IGF-I levels...Adjunctive treatment with cabergoline or pegvisomant was allowed in patients who did not attain normal IGF-I levels on the maximum dose of paltusotine... Long-term results (up to ~4 years) show that once-daily oral paltusotine treatment was well tolerated, with stable biochemical and symptom control relative to that observed with injected SRLs."

Clinical • Acromegaly • Carcinoid Syndrome • Endocrine Disorders • Gastroenterology • IGF1

Long-term safety of pasireotide in patients with acromegaly: Final results from a 10-year open-label Phase IV rollover study (B2412) (ESPE-ESE 2025) - P4 | "Here, we report data from the final analysis in patients with acromegaly who received pasireotide long-acting release (LAR) during the rollover. Pasireotide is a well-tolerated long-term treatment option for patients with acromegaly, with patients having received treatment for ≤17 years from parent study entry. Hyperglycaemia was infrequent, and AEs, including hyperglycaemia, were mostly manageable without treatment discontinuation during the rollover."

Clinical • P4 data • Acromegaly • Back Pain • Cardiovascular • Congestive Heart Failure • Cushing’s Disease • Diabetes • Endocrine Disorders • Growth Hormone Deficiency • Heart Failure • Hypertension • Infectious Disease • Metabolic Disorders • Musculoskeletal Pain • Novel Coronavirus Disease • Pain • Pulmonary Embolism • Respiratory Diseases • SSTR

Medical treatment in acromegaly: imunohistochemical features of responder patients (ESPE-ESE 2025) - "Materials and The retrospective analysis included 38 naive acromegaly patients (without preoperative medical treatment), with active disease following transsphenoidal (TS) surgery, treated with octreotide / lanreotide (n=38) or pasireotide (n=9) and/or pegvisomant (n=8) if uncontrolled under first generation SRLs (fgSRLs). Pituitary neuroendocrine tumor granularity represents a good predictor for the response to first and second generation SRLs in active acromegaly. Besides this, SSTR5 expression is predictive for the response to pasireotide. There are distinct IHC profiles that may help predict response to targeted medical therapy in acromegaly, and treatment should be initiated and individualized based on postoperative IHC features."

Clinical • Acromegaly • Endocrine Cancer • Endocrine Disorders • Neuroendocrine Tumor • Oncology • Solid Tumor • SSTR • SSTR2 • SSTR5

Dealing with Pituitary Invaders: A Corticotroph Macroadenoma Case (ESPE-ESE 2025) - "Medical management included ketoconazole, cabergoline, and the planned introduction of Pasireotide to address tumor control and residual hypercortisolism. Advanced therapies, like Pasireotide, offer promising outcomes in managing persistent disease. This case underscores the importance of individualized care in achieving optimal results for complex pituitary tumors."

Clinical • Cardiovascular • Cushing’s Disease • Diabetes • Endocrine Cancer • Endocrine Disorders • Hypertension • Metabolic Disorders • Oncology • Pituitary Gland Carcinoma • Type 2 Diabetes Mellitus

The clinical course and the systemic inflammation biomarkers (SIBs) differ between giant and not-giant aggressive prolactinomas. (ESPE-ESE 2025) - "Other therapeutic options included temozolomide (1/22), pasireotide (1/22), and lanreotide (3/22). The clinical course of the disease and SIBs differ between giant and not-giant aggressive prolactinomas. Further studies are needed to understand the nature of this condition. Keywords: Aggressive prolactinoma, prolactinoma, cabergoline, pasireotide"

Biomarker • Clinical • Inflammation • Oncology • Pain • Retinal Disorders