Signifor (pasireotide) / Recordati - LARVOL DELTA

PASIPHY_PEN: Study in Healthy Subjects to Investigate the Relative Bioavailability and Safety of Pasireotide After Single Subcutaneous Dose Administration Using a Reusable ServoPen With Cartridge as Compared to Administration Using a Syringe Drawn From an Ampule (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: RECORDATI GROUP | Recruiting ➔ Completed

Trial completion

Histological Evidence of familial GH-PitNET Associated with Germline MAX Mutation. (PubMed, Eur J Endocrinol) - "Despite multimodal therapy (lanreotide, cabergoline, two debulking surgeries), disease control was achieved only after pasireotide and adjuvant proton therapy. The same variant was found in her father, who had a smaller intrasellar macroadenoma causing acromegaly. This familial observation provides the functional evidence that MAX is a driver in GH-PitNET and a candidate gene for PitNET predisposition."

Journal • Acromegaly • Endocrine Disorders • Neuroendocrine Tumor • Oncology • Solid Tumor • MAX

Cost-effectiveness of pasireotide long-acting release in acromegaly: a systematic literature review and methodology assessment. (PubMed, J Med Econ) - "Evidence on pasireotide LAR's cost-effectiveness versus pegvisomant regimens remains inconclusive. Although two studies indicated that pegvisomant is more cost-effective, the study with the highest methodological credibility found that pasireotide LAR is a cost-effective alternative."

HEOR • Journal • Review • Acromegaly • Endocrine Disorders • SSTR

Update and practical recommendations for the use of medical treatment of Cushing´s syndrome. (PubMed, Endocr Rev) - "Currently available medical treatments include adrenal steroidogenesis inhibitors that block cortisol secretion (ketoconazole, levoketoconazole, metyrapone, osilodrostat, mitotane, and etomidate), drugs that modulate pituitary ACTH secretion (pasireotide and cabergoline), and drugs that block peripheral glucocorticoid receptors (mifepristone). In this review, we summarize the main indications for medical treatment in CS, the mechanism of drug action, efficacy, recommended doses, and safety of the currently available drugs, as well as potential future treatments. We also discuss titration and block-and-replace approaches for control of hypercortisolism and provide recommendations for the use and monitoring of medical treatment in CS, including patients with endogenous hypercortisolism in special situations such as pregnancy, cyclic CS and mild autonomous cortisol secretion."

Journal • Cushing’s Disease • Endocrine Disorders

PASIPHY_PEN: Study in Healthy Subjects to Investigate the Relative Bioavailability and Safety of Pasireotide After Single Subcutaneous Dose Administration Using a Reusable ServoPen With Cartridge as Compared to Administration Using a Syringe Drawn From an Ampule (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: RECORDATI GROUP

New P1 trial

The effect of hypercortisolism treatment on dyslipidemia in Cushing syndrome: systematic review and meta-analysis. (PubMed, J Clin Endocrinol Metab) - "Our study demonstrate a significant improvement in serum lipid levels after treatment of CS. Since the cardiovascular complications of hypercortisolism depend on several factors, further studies are needed to determine whether this directly translates into an adequate reduction in the risk of major cardiovascular events."

Journal • Retrospective data • Cardiovascular • Cushing’s Disease • Dyslipidemia • Endocrine Disorders • Metabolic Disorders

Real-life data on pasireotide in monotherapy or combined in active Cushing's disease. (PubMed, Front Endocrinol (Lausanne)) - "This is a retrospective monocentric study evaluating the real-life efficacy and safety of pasireotide alone or when combined with cabergoline or metyrapone. This is the first study to report metyrapone add-on to pasireotide, but larger studies are needed to further investigate this association. Pasireotide surely worsens glucose homeostasis, but its positive effects, alone or combined, on blood pressure, lipid profile, and body weight justify its use under careful hyperglycemia management."

Journal • Monotherapy • Retrospective data • Cardiovascular • Cushing’s Disease • Diabetes • Endocrine Disorders

Use of Pasireotide in Acromegaly: Clinical Experiences From a Series of Patients in Qatar. (PubMed, Case Rep Endocrinol) - "Patient 2, 48-year-old male with a significant macroadenoma and prior cabergoline treatment, achieved partial biochemical control. Four out of these five patients showed reduction in tumour size. This case series corroborates the findings from previous studies, adding insight into treatment challenges and benefits experienced by this heterogeneous group of patients on pasireotide."

Journal • Acromegaly • Diabetes • Endocrine Disorders • Metabolic Disorders • Oncology • Pituitary Gland Carcinoma • Type 2 Diabetes Mellitus • IGF1 • SSTR

A Case of Adrenocorticotropin-dependent Cushing Syndrome with Osilodrostat Exposure in Early Pregnancy. (PubMed, JCEM Case Rep) - "After a relapse at 35 years of age, she was initially treated with metyrapone but switched to osilodrostat and hydrocortisone because of nausea, achieving reasonable cortisol control. This case prompts consideration of whether osilodrostat can be used during pregnancy if risks are justified. Pasireotide is rarely used in pregnancy and may have limited effectiveness, but when given, can cause hyperglycemia because of insulin and incretin suppression and should be monitored carefully."

Journal • Cushing’s Disease • Diabetes • Endocrine Disorders • Infectious Disease • Nephrology • Novel Coronavirus Disease • Oncology • Pituitary Gland Carcinoma • Renal Disease

Immunohistochemical analysis of filamin a expression in acromegaly and its correlation with tumor characteristics and treatment response. (PubMed, Sci Rep) - "In conclusion, our results suggest that FLNA may be associated with tumor invasiveness in GH-secreting pituitary tumors. While data on Pasireotide-treated patients are exploratory, further studies are needed to assess FLNA's potential as a treatment response marker in acromegaly."

Journal • Acromegaly • Endocrine Disorders • Oncology • Pituitary Gland Carcinoma • CDH1 • FLNA • SSTR • SSTR2 • SSTR5

Case Report: Bilateral lens dislocation as an atypical presentation of acromegaly and review of the ocular effects of GH/IGF-1 excess. (PubMed, Front Endocrinol (Lausanne)) - "It may indicate advanced disease and, if confirmed in other cohorts, could be considered among the suggestive signs of acromegaly. In our case, the use of pasireotide allowed adherence to therapy and optimal therapeutic response in a multicomplicated, non-self-sufficient patient."

Journal • Acromegaly • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Diabetes • Endocrine Disorders • Heart Failure • Hypertension • Metabolic Disorders • Osteoporosis • Pituitary Gland Carcinoma • Pulmonary Arterial Hypertension • Rheumatology • Type 2 Diabetes Mellitus • IGF1

Dual Inhibitors of c-MET and EGFR in Triple Negative Breast Cancer: Pharmacophore Modeling and Molecular Dynamics Based in Silico Drug Repositioning. (PubMed, Iran J Pharm Res) - "Considering pasireotide's potential to target c-MET and EGFR pathways, our findings provide a strong rationale for its further preclinical validation in the treatment of TNBC. The demonstrated efficacy and safety of pasireotide in this aggressive subtype of cancer can now be evaluated through subsequent studies."

Journal • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • EGFR • MET

Acromegaly treatment and bone: a bidirectional relationship. (PubMed, Pituitary) - "Recent studies have shown that first- and second-generation somatostatin receptor ligands (SRLs) can reduce the incidence of vertebral fractures (i-VFs). However, a direct effect of these molecules on bone metabolism has not yet been reported. Aims: This review summarizes the results of studies investigating the frequency of i-VFs according to different GH/IGF-I-lowering drugs and the potential effects of these treatments on bone metabolism, as well as preclinical data on potential molecular pathways that interact between GH/IGF-I-lowering drugs and bone metabolism."

Journal • Review • Acromegaly • Endocrine Disorders • Musculoskeletal Diseases • Neuroendocrine Tumor • Oncology • Orthopedics • Rare Diseases • Solid Tumor • IGF1 • SSTR

Growth hormone in disease and treatment (Review). (PubMed, Med Int (Lond)) - "Furthermore, it summarizes recent findings on the protective effects of GHRHAnts and FDA-approved SSAs, such as octreotide, lanreotide and pasireotide, in GH-related and endothelium-dependent dysfunctions. Based on the provided bibliography, an emerging body of evidence suggests that GH modulators may represent a promising therapeutic possibility towards blood brain barrier dysregulation, keratitis, direct and indirect lung injury, sepsis, and acute respiratory distress syndrome."

Journal • Review • Acromegaly • Acute Lung Injury • Acute Respiratory Distress Syndrome • Endocrine Disorders • Infectious Disease • Inflammation • Keratitis • Ocular Inflammation • Oncology • Ophthalmology • Pulmonary Disease • Respiratory Diseases • Septic Shock

Somatostatin Ameliorates Corneal Nerve Abnormalities and Inflammation Through Regulation of Macrophage Activities in Dry Eye Disease. (PubMed, Invest Ophthalmol Vis Sci) - "SOM230 alleviates nerve abnormalities in DED by suppressing inflammatory pathways (TNF-α, NF-κB) and promoting a shift in macrophage polarization from the pro-inflammatory M1 phenotype to the reparative M2 phenotype. These findings suggest that modulation of macrophage polarization is a crucial mechanism underlying the therapeutic effects of SOM230, highlighting its potential as a treatment strategy for nerve damage in DED."

Journal • Dry Eye Disease • Inflammation • Keratitis • Ocular Inflammation • Ophthalmology • Pain • TNFA

Somatostatin 5 receptor expression in prolactinomas: Is there a role for Pasireotide in the management of prolactinomas? (PubMed, Pituitary) - "In a subgroup, pasireotide inhibited prolactin secretion with comparable potency to cabergoline. Targeting SST5 with pasireotide may be a potential treatment modality for further clinical investigation in the treatment of a subset of DA resistant or intolerant prolactinomas."

Journal • PRL

Comparative Effectiveness and Safety of Prophylactic Drugs in Preventing Clinically Relevant Postoperative Pancreatic Fistula After Pancreatic Resection: A Network Meta-Analysis of RCTs (ACG 2025) - "A total of 2,782 records were screened, with 17 studies meeting inclusion criteria, comprising 2,850 patients (1,411 treatment; 1,439 control). Patient distribution included 80 hydrocortisone, 369 octreotide, 410 pasireotide, 1,376 placebo, and 137 somatostatin recipients. Somatostatin showed the greatest reduction in overall postoperative pancreatic fistula (POPF) risk (OR 0.40; 95% CI, 0.16–0.97), followed by octreotide (OR 0.55; 95% CI, 0.37–0.82), hydrocortisone (OR 0.91; 95% CI, 0.29–2.83), while pasireotide demonstrated no significant benefit (OR 1.06; 95% CI, 0.55–2.05)."

HEOR • Retrospective data • Novel Coronavirus Disease

Five-year survival outcomes following perioperative hydrocortisone versus pasireotide in patients with high risk of pancreatic fistula: Secondary analysis of the HYPAR randomized clinical trial. (PubMed, Scand J Surg) - No abstract available

Clinical • Journal

Managing post-bariatric hypoglycemia: a systematic review of pharmacological therapies. (PubMed, Diabetol Metab Syndr) - "Pharmacologic management of PBH shows promise with agents such as anakinra, empagliflozin, pasireotide, and acarbose. However, given the considerable heterogeneity, small sample sizes, and wide confidence intervals, very low quality of effect estimates, and varied definitions of PBH, these pooled estimates should be considered hypothesis-generating only, and not confirmatory. There is an urgent need for standardized PBH definitions, patient-centered outcome measures, longer follow-up, and adequately powered RCTs to establish evidence-based therapeutic guidelines."

Clinical • Journal • Hypoglycemia

Management of patients with Cushing's disease in the Gulf Region: a Delphi consensus recommendation. (PubMed, Front Endocrinol (Lausanne)) - "For persistent/recurrent disease, repeat surgery was favored when feasible (91.3%), while medical therapy (e.g., pasireotide or steroidogenesis inhibitors) was preferred for inoperable cases...The study provides structured, region-specific recommendations for CD management in the Gulf region, emphasizing surgical intervention where feasible, tailored medical therapy, and careful monitoring. These guidelines aim to standardize care, address resource limitations, and improve patient outcomes."

Journal • Cushing’s Disease • Endocrine Disorders • Pituitary Gland Carcinoma

Dumping Syndrome After Bariatric Surgery: Advanced Nutritional Perspectives and Integrated Pharmacological Management. (PubMed, Nutrients) - "In cases where nutritional interventions are insufficient, pharmacotherapy with agents such as acarbose, somatostatin analogues (octreotide and pasireotide), GLP-1 receptor agonists (liraglutide), calcium channel blockers (verapamil), and emerging therapies, including herbal medicine, may be considered. Despite advancements in understanding and treating DS, further large-scale, randomised controlled trials are essential to validate novel strategies and optimise long-term management. This review provides an updated and comprehensive overview of the aetiology, pathophysiological mechanisms, diagnostic approaches, and current management strategies for DS."

Journal • Review • Genetic Disorders • Hypoglycemia

Personalized medicine in acromegaly: insights from the ACROFAST clinical trial. (PubMed, Expert Rev Endocrinol Metab) - "ACROFAST has laid critical groundwork by demonstrating how the combination of predictive biomarkers enhances therapeutic outcomes, improving the rate of biochemical remission and in a shorter follow-up period. In addition, the application of artificial intelligence and machine learning algorithms trained on multiomic and clinical datasets may be useful to improve outcomes and reduce the trial-and-error nature of current pharmacologic management of acromegaly."

Journal • Review • Acromegaly • Endocrine Disorders • Oncology • SSTR

PASIPHY: Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia (clinicaltrials.gov) - P2 | N=93 | Active, not recruiting | Sponsor: RECORDATI GROUP | Recruiting ➔ Active, not recruiting

Enrollment closed • Hypoglycemia • SSTR

Long-Term Antitumour Effects of Pasireotide in Acromegaly. (PubMed, Eur J Endocrinol) - "Pasireotide appears to induce durable cystic degeneration in somatotroph tumours, with evidence suggesting sustained antitumor effects that may extend beyond treatment discontinuation. These findings support its potential for a broader therapeutic role, warranting validation in future prospective studies."

Journal • Acromegaly • Endocrine Disorders • Oncology • Pituitary Gland Carcinoma • IGF1 • SSTR

The influence of somatostatin analogues on the incidence of pancreatic fistulas and postoperative morbidity in patients undergoing pancreatic resection: A Bayesian network meta-analysis. (PubMed, PLoS One) - "While robust evidence confirms the efficacy of octreotide in preventing POPF, a critical concern regarding its inconsistent efficacy within the PD subgroup persists. This variability indicates that the overall clinical benefit of octreotide may be predominantly attributable to its utility in non-PD pancreatic resections."

Clinical • Journal • Retrospective data • Review • Oncology • Pancreatic Cancer • Pancreatitis • Solid Tumor