Signifor (pasireotide) / Recordati - LARVOL DELTA

PASIPHY: Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia (clinicaltrials.gov) - P2 | N=93 | Active, not recruiting | Sponsor: RECORDATI GROUP | Trial completion date: Apr 2026 ➔ Oct 2026 | Trial primary completion date: Apr 2026 ➔ Oct 2026

Trial completion date • Trial primary completion date • Hypoglycemia • SSTR

Tirzepatide for pasireotide-induced hyperglycemia in a GH/TSH-producing pituitary adenoma/PitNET: a case report and literature review. (PubMed, Endocr J) - "Oral sitagliptin and semaglutide were sequentially introduced; however, glycemic control remained suboptimal. In conclusion, once-weekly subcutaneous tirzepatide may be a therapeutic option for selected patients with pasireotide-induced hyperglycemia. However, further studies are needed to determine whether its effects differ from those of intensified GLP-1RA therapy."

Journal • Diabetes • Oncology • Pituitary Gland Carcinoma • SSTR • SSTR5

Case Report: Pasireotide treatment in neonatal congenital hyperinsulinism due to a homozygous ABCC8 mutation. (PubMed, Front Endocrinol (Lausanne)) - "In conclusion, intermittent pasireotide injections were not associated with clinical improvement in this infant with medically refractory CHI, and its use potentially contributed to increased glycemic variability and instability. Further studies are needed to evaluate the safety and efficacy of pasireotide in this vulnerable patient population."

Journal • Diabetes • Hypoglycemia • KCNJ11 • SSTR

Cost-effectiveness of pasireotide as second-line therapy for adult acromegaly patients from the perspective of the Brazilian Unified Health System. (PubMed, Front Endocrinol (Lausanne)) - "Resistance to first-line medical treatment necessitates effective second-line therapies, including pasireotide long-acting release (PAS LAR) and pegvisomant (PEG). Compared to FGSRLs, PAS LAR provided better outcomes with higher costs. With limited options for second-line medical treatment in Brazil, the reimbursement of PAS LAR in acromegaly can be considered a cost-effective strategy for acromegaly patients."

HEOR • Journal • Acromegaly • Endocrine Disorders • Pituitary Gland Carcinoma

Management and safety of somatostatin receptor ligands and pegvisomant in pregnant women with acromegaly: a narrative review of the literature. (PubMed, Endocrine) - "Pregnancy in acromegaly is generally characterized by clinical stability, supporting the safety of treatment withdrawal upon conception in most patients. While early therapy discontinuation is standard, SRL and/or PEG treatment is a viable option for patients requiring tumor and biochemical control. Individualized multidisciplinary management is essential."

Journal • Review • Acromegaly • Diabetes • Endocrine Disorders • Gestational Diabetes • Gynecology • Metabolic Disorders • Oncology • Pituitary Gland Carcinoma • SSTR

Can acromegaly be controlled in all cases? (PubMed, J Neuroendocrinol) - "In this review, we will report on the most recent aims of treatment and cure in patients with acromegaly, on the efficacy and predictors of response to conventional treatments (such as first- and second-generation somatostatin receptor ligands and growth hormone receptor antagonist). A specific section will focus on the rarer aggressive disease pictures and on the treatment with systemic therapies (such as temozolomide and capecitabine) and on target therapies (such as neo-angiogenesis and immune checkpoint inhibitors)."

Clinical • IO biomarker • Journal • Review • Acromegaly • Endocrine Disorders • Neuroendocrine Tumor • Oncology • Pituitary Gland Carcinoma • Rare Diseases • Solid Tumor • IGF1 • SSTR

Ex Vivo drug sensitivity in patient-derived 3D cultures in acromegaly and its association with clinical predictors. (PubMed, Pituitary) - "Spheroid-based Pd3D ex vivo viability assays revealed modest but significant cohort-level effects and sample-level concordance with clinical predictors, suggesting its potential utility as an exploratory model. Additionally, AI-based quantification of SSTR2 dynamics captured functional receptor shifts."

Journal • Preclinical • Acromegaly • Endocrine Disorders • Oncology • Pituitary Gland Carcinoma • SSTR2

Comparative Efficacy and Safety of Octreotide, Lanreotide, and Pasireotide in ADPKD and PLD: A Network Meta-analysis with Real-world Evidence from the FAERS Database. (PubMed, Clin Transl Gastroenterol) - "Age and drug were independent predictors of cholelithiasis. Younger patients or those receiving pasireotide are at higher risk of cholelithiasis."

HEOR • Journal • Real-world evidence • Retrospective data • Autosomal Dominant Polycystic Kidney Disease • Gastroenterology • Genetic Disorders • Hepatology • Nephrology • Polycystic Kidney Disease • Renal Disease

Pasireotide induces proteins related to autophagy in cancer cells. (PubMed, Endocrine) - "Our findings suggest that the beneficial effects of PAS in cancers may involve autophagy. Further studies will attempt to elucidate the underlying mechanisms mediating those effects."

Journal • Gastrointestinal Neuroendocrine Tumor • Neuroendocrine Tumor • Oncology • Solid Tumor • BECN1

Beyond biochemical control: headache resolution with pasireotide in a patient with acromegaly and residual tumor. (PubMed, JCEM Case Rep) - "Despite transsphenoidal surgery, radiotherapy, and sequential medical therapy with octreotide, cabergoline, and pegvisomant over 3 years, insulin-like growth factor 1 (IGF-1) levels remained elevated and headache burden persisted. Initiation of pasireotide long-acting release was followed by rapid normalization of IGF-1 levels and complete resolution of headache, with improvement in other acromegaly related symptoms. This case supports the potential role of pasireotide in selected patients with biochemically and clinically treatment-resistant acromegaly and contributes to the growing real-world evidence regarding its use in patients with residual disease in surgically challenging locations."

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

Beyond the catalytic site: Voxilaprevir and Pasireotide as repurposed therapeutics for conformational inhibition of ADAR1. (PubMed, J Mol Graph Model) - "Given their established intersections with cancer biology, particularly Pasireotide's intrinsic antiproliferative activity, these findings champion a novel mechanism of ADAR1 inhibition via conformational trapping and steric occlusion. While experimental validation is required, these findings suggest an expanded and previously underexplored chemical space for ADAR1 modulation and support drug repositioning as a promising strategy for next-generation cancer immunotherapy."

Journal • Oncology • ADAR

Safety and Efficacy of Once-Daily Oral Paltusotine in Acromegaly: ACROBAT Advance Open-Label Extension Up to 4 Years. (PubMed, J Clin Endocrinol Metab) - "Once-daily oral paltusotine treatment was well tolerated and resulted in long-term disease control, including biochemical, symptom, and pituitary tumor stability, for up to 4 years."

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

Approach to the patient: Precision Medicine-Guided Evaluation and Treatment of Acromegaly. (PubMed, J Clin Endocrinol Metab) - "Precision medicine has become a practical reality in acromegaly. A biomarker-guided strategy improves therapeutic efficiency and should be incorporated into contemporary clinical practice."

Journal • Acromegaly • Endocrine Disorders • Oncology

Combination therapy of pasireotide and pegvisomant for aggressive acromegaly with an immature PIT1-lineage PitNET. (PubMed, Endocrinol Diabetes Metab Case Rep) - "In patients with predictors of poor response to first-generation somatostatin analogs, such as T2-weighted MRI hyperintensity and poor GH suppression during acute octreotide testing, early consideration of pasireotide (PAS) or combination therapy with PAS and pegvisomant (PEG) may be appropriate. In this case, PAS up to 60 mg every 4 weeks failed to adequately control IGF-1 levels, whereas subsequent combination therapy with PAS and PEG achieved biochemical remission and tumor stabilization, highlighting the potential role of combination strategies in aggressive acromegaly."

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

Malignant Insulinoma Complicated by Refractory Hypoglycemia (ENDO 2026) - "He underwent neoadjuvant chemotherapy with Temozolomide (following Capecitabine intolerance) and completed 3 rounds of Lu 177 dotatate peptide receptor radionuclide therapy. Refractory hypoglycemia in malignant insulinoma can be challenging to manage. While diazoxide and somatostatin analogs (SSAs) like Octreotide are first-line medical therapies, the response to SSAs can be unpredictable; some patients experience paradoxical worsening of hypoglycemia if the tumor predominantly expresses SSTR5 over SSTR2, or if glucagon/growth hormone suppression outweighs insulin suppression. Second-generation SSAs like Pasireotide (SSTR5 >>2) have shown promise in refractory cases as has everolimus."

Diabetes • Endocrine Disorders • Hypoglycemia • Neuroendocrine Tumor • Severe Hypoglycemia • Solid Tumor • SSTR2 • SSTR5

Safety of Pasireotide Versus First-Generation Somatostatin Analogs: A Comparative Analysis Base on the FAERS (ENDO 2026) - "These findings highlight the need for individualized monitoring based on the specific risk profiles of each SRL, such as enhanced blood glucose management and cardiovascular evaluation when using pasireotide, to optimize treatment safety. Further real-world studies are needed to validate the safety characteristics of Pasireotide"

Clinical • Acromegaly • Cardiovascular • Diabetes • Endocrine Disorders • Gastroenterology • Metabolic Disorders • SSTR

Comparative Efficacy and Safety of Oral vs Injectable Medical Therapies for Acromegaly: A Systematic Review and Network Meta-Analysis (ENDO 2026) - "SUCRA rankings favored Pasireotide, paltusotine, pegvisomant for efficacy, while oral octreotide ranked highest for safety and patient preference, reflecting reduced injection-site reactions and improved treatment acceptability. Conclusion This network meta-analysis demonstrates that while pasireotide and pegvisomant provide the highest efficacy, paltusotine emerges as the most effective oral therapy, offering a favorable balance of biochemical control, safety, and patient acceptability."

Retrospective data • Review • Acromegaly • Endocrine Disorders • IGF1

MON-030 - Eleven Years of Primary Medical Therapy with Somatostatin Analogs and Pegvisomant in A Young Man with Acromegaly (ENDO 2026) - "He was started on octreotide long-acting release, later switching to lanreotide Autogel at a dose of 120 mg every 4 weeks...Treatment options of surgery, addition of cabergoline, and switch to pasireotide have all been discussed and recommended to avoid complications of GH/IGF-1 excess, but the patient has so far continued to decline these options as he overall feels well... To our knowledge, this is the longest reported case of primary medical therapy in the treatment of acromegaly. While some studies have demonstrated effectiveness of long-term medical therapy for IGF-1 normalization and tumor shrinkage, our patient continues to have markedly elevated IGF-1, placing him at risk for continued complications of acromegaly. Our case underscores the need for individualized treatment approaches and counseling strategies for biochemical control in patients with acromegaly who do not undergo surgery."

Acromegaly • Cardiomyopathy • Endocrine Disorders • Metabolic Disorders • Pituitary Gland Carcinoma • IGF1

Eleven Years of Primary Medical Therapy with Somatostatin Analogs and Pegvisomant in A Young Man with Acromegaly (ENDO 2026) - "He was started on octreotide long-acting release, later switching to lanreotide Autogel at a dose of 120 mg every 4 weeks...Treatment options of surgery, addition of cabergoline, and switch to pasireotide have all been discussed and recommended to avoid complications of GH/IGF-1 excess, but the patient has so far continued to decline these options as he overall feels well... To our knowledge, this is the longest reported case of primary medical therapy in the treatment of acromegaly. While some studies have demonstrated effectiveness of long-term medical therapy for IGF-1 normalization and tumor shrinkage, our patient continues to have markedly elevated IGF-1, placing him at risk for continued complications of acromegaly. Our case underscores the need for individualized treatment approaches and counseling strategies for biochemical control in patients with acromegaly who do not undergo surgery."

Acromegaly • Cardiomyopathy • Endocrine Disorders • Metabolic Disorders • Pituitary Gland Carcinoma • IGF1

Long-Term Safety and Efficacy of Once-Daily Oral Paltusotine in Combination with Cabergoline for the Treatment of Patients with Acromegaly (ENDO 2026) - P2 | "At enrollment in Edge, all patients were candidates for combination drug therapy: patients were either suboptimally controlled on an injected SRL (octreotide or lanreotide) alone or in combination with cabergoline, or they required combination therapy or pasireotide to achieve normal IGF-I levels...Adjunctive treatment (eg, cabergoline, pegvisomant) was allowed as of Week 12 in patients who did not attain normal IGF-I levels on the maximum dose of paltusotine...One serious drug-related AE (cholelithiasis) was reported, and 1 patient discontinued the study due to an AE (headache; considered possibly related to study medication). In patients with acromegaly who were candidates for combination therapy based on treatment history, long-term results (up to 4 years) show that once-daily oral paltusotine in combination with cabergoline was well tolerated, with improved biochemical control and no new safety findings."

Clinical • Combination therapy • Acromegaly • Endocrine Disorders • Gastroenterology • Musculoskeletal Pain • IGF1 • SSTR

Sustained Progression-Free Survival after 2 Years of Immune Checkpoint Inhibitor Therapy in A Patient with Metastatic Pituitary Carcinoma (ENDO 2026) - "The European Society of Endocrinology recommends temozolomide (TMZ) as first line chemotherapy and consideration of immune checkpoint inhibitors in patients with rapid tumor progression not responsive to surgery or radiation. There are limited cases describing ipilimumab/nivolumab dual therapy followed by nivolumab maintenance...Due to rising ACTH >1000 pg/mL and ongoing hypercortisolism, he was trialed on cabergoline and mifepristone, but the latter was complicated by severe hypokalemia, and he underwent bilateral adrenalectomy...He received pasireotide twice daily for one month and then transitioned to TMZ...Additionally, this case highlights the importance of utilizing FDG versus DOTATATE imaging when monitoring patients with aggressive PitNETs that lose somatostatin receptor positivity, as his disease progression was likely missed on repeat DOTATATE scans. Optimal timing of immunotherapy initiation and duration of use warrant further study in the management of PC."

Checkpoint inhibition • Clinical • Metastases • Cardiovascular • Cushing’s Disease • Diabetes • Endocrine Disorders • Hypertension • Metabolic Disorders • Neuroendocrine Tumor • Oncology • Pituitary Gland Carcinoma • Solid Tumor • Type 2 Diabetes Mellitus • SSTR

ORF28-01 - Safety of Pasireotide Versus First-Generation Somatostatin Analogs: A Comparative Analysis Base on the FAERS (ENDO 2026) - "These findings highlight the need for individualized monitoring based on the specific risk profiles of each SRL, such as enhanced blood glucose management and cardiovascular evaluation when using pasireotide, to optimize treatment safety. Further real-world studies are needed to validate the safety characteristics of Pasireotide"

Clinical • Acromegaly • Cardiovascular • Diabetes • Endocrine Disorders • Gastroenterology • Metabolic Disorders • SSTR

Immune Signatures and Lymphocyte Activation Pathways as Determinants of Somatostatin Analog Response in Acromegaly (ENDO 2026) - "Recognize pasireotide's structural effects on pituitary adenoma Explore ketone body infusion as a novel metabolic therapy in acromegaly. Identify immune pathways influencing somatostatin analog response."

Acromegaly • Endocrine Disorders • Pituitary Gland Carcinoma

Beyond Hormonal Control: Structural Effects of Pasireotide in Acromegaly (ENDO 2026) - "Recognize pasireotide's structural effects on pituitary adenoma Explore ketone body infusion as a novel metabolic therapy in acromegaly. Identify immune pathways influencing somatostatin analog response."

Acromegaly • Endocrine Disorders • Pituitary Gland Carcinoma

Recurrent Cushing's disease due to postoperative seeding of tumor cells in the sphenoid sinus: a case report with review of the literature. (PubMed, Endocr J) - "Despite long-term medical therapy including cabergoline, metyrapone, and pasireotide, the hypercortisolism gradually progressed. Awareness of this mechanism is crucial for evaluating MRI-negative recurrences. Careful inspection of the sphenoid sinus and meticulous irrigation during surgery may help prevent iatrogenic seeding and improve long-term outcomes."

Journal • Cushing’s Disease • Endocrine Disorders • Neuroendocrine Tumor • Oncology • Solid Tumor