Clinical Trials

Pasireotide has been evaluated in numerous clinical trials spanning Phase 1 through Phase 4 investigations to assess its pharmacokinetics, safety, and therapeutic efficacy. These clinical studies target a broad spectrum of conditions, including Cushing's disease, acromegaly, refractory carcinoid disease, neuroendocrine carcinomas of the lung and thymus, uveal melanoma, angiodysplasia, and specialized pituitary tumors such as prolactin-producing and gonadotroph adenomas. Research initiatives are led by major pharmaceutical sponsors like Novartis Pharmaceuticals in collaboration with prominent academic institutions including Memorial Sloan Kettering Cancer Center, Columbia University, and the University of Pennsylvania. Recruitment statuses across these trial records encompass completed, currently recruiting, active not recruiting, terminated, and withdrawn cohorts.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06456359 RECRUITING
Desmoplastic Small Round Cell Tumor; Synovial Sarcoma
University Hospital Heidelberg
 2024-12-19 PHASE2
NCT06295952 RECRUITING
Prolactin-Producing Pituitary Tumor
Memorial Sloan Kettering Cancer Center
 2024-02-27 PHASE2
NCT05928390 ACTIVE_NOT_RECRUITING
Post-Bariatric Hypoglycemia
RECORDATI GROUP
 2024-01-04 PHASE2
NCT07312643 COMPLETED
Pharmacokinetics; Safety
RECORDATI GROUP
 2025-12-01 PHASE1
NCT04826432 TERMINATED
Peritoneal Carcinomatosis
Gustave Roussy, Cancer Campus, Grand Paris
 2020-09-03 PHASE2
NCT01794793 COMPLETED
Cushing's Disease; Acromegaly; Neuroendocrine Tumors; Pituitary Tumors; Ectopic ACTH Secreting (EAS) Tumors; Dumping Syndrome; Prostate Cancer; Melanoma Negative for bRAF; Melanoma Negative for nRAS
RECORDATI GROUP
 2013-06-10 PHASE4
NCT01253161 COMPLETED
Neuroendocrine Tumors; Carcinoid Tumors
H. Lee Moffitt Cancer Center and Research Institute
 2011-02-01 PHASE2
NCT02713776 COMPLETED
Enterostomy
Hospices Civils de Lyon
 2016-12-13 PHASE2
NCT02749227 TERMINATED
Pituitary Tumor; ACTH-producing Pituitary Tumour
Columbia University
 2017-07-10 PHASE2
NCT03847207 COMPLETED
Healthy
Nxera Pharma UK Limited
 2019-01-23 PHASE1
NCT01563354 COMPLETED
Neuroendocrine Carcinoma of the Lung and Thymus
Novartis Pharmaceuticals
 2013-08-16 PHASE2
NCT02215070 COMPLETED
Hematological Malignancies
Anthony Sung, MD
 2015-01-21 PHASE2
NCT01270321 COMPLETED
Thyroid Cancer
Emory University
 2010-11 PHASE2
NCT02775227 ACTIVE_NOT_RECRUITING
Pancreatic Fistula; Pancreatic Neoplasms
Helsinki University Central Hospital
 2016-05 PHASE4
NCT02780882 WITHDRAWN
Ectopic ACTH Syndrome
Cedars-Sinai Medical Center
 2015-12 PHASE2
NCT01646684 COMPLETED
Castration Resistant Prostate Cancer
Novartis Pharmaceuticals
 2013-03-08 PHASE1
NCT01469572 COMPLETED
Neuroendocrine Tumors
Emory University
 2011-12 PHASE1
NCT01590199 COMPLETED
Neuroendocrine Tumors
Novartis Pharmaceuticals
 2012-05-18 PHASE1
NCT01670110 COMPLETED
Somatostatin Analogs; Polycystic Liver Disease; Autosomal Dominant Polycystic Kidney Disease; Autosomal Dominant Polycystic Liver Disease
Mayo Clinic
 2012-08 PHASE2
NCT03514576 UNKNOWN
Hypoglycemia, Reactive
Zealand University Hospital
 2018-06-01 PHASE4
NCT02060383 COMPLETED
Cushing's Disease; Acromegaly
Novartis Pharmaceuticals
 2014-05-23 PHASE4
NCT02354508 COMPLETED
Acromegaly
Novartis Pharmaceuticals
 2015-03-31 PHASE3
NCT03053284 WITHDRAWN
Congenital Hyperinsulinism; Insulinoma; Hyperinsulinism
Montefiore Medical Center
 2017-04 PHASE2
NCT03103009 COMPLETED
Hyperinsulinemic Hypoglycemia; Post Gastrointestinal Tract Surgery Hypoglycaemia
University of Colorado, Denver
 2017-03-22 PHASE1
NCT01283542 COMPLETED
Non-functioning Pituitary Adenoma
Novartis Pharmaceuticals
 2012-11-26 PHASE2
NCT01468532 COMPLETED
Adenocarcinoma of the Prostate; Hormone-resistant Prostate Cancer; Recurrent Prostate Cancer; Stage IV Prostate Cancer
Barbara Ann Karmanos Cancer Institute
 2011-10 PHASE1; PHASE2
NCT01673646 COMPLETED
Acromegaly; Pituitary Gigantism
Novartis Pharmaceuticals
 2012-10-16 PHASE2
NCT02527993 COMPLETED
Hypoglycemia; Obesity; Surgery
Zealand University Hospital
 2015-10 PHASE4
NCT02668172 UNKNOWN
Acromegaly
Erasmus Medical Center
 2015-08 PHASE4
NCT01582061 COMPLETED
Cushing's Disease
Novartis Pharmaceuticals
 2011-08-16 PHASE3
NCT03080181 COMPLETED
Cushing Disease
University of Palermo
 2013-05 PHASE4
NCT01374906 COMPLETED
Cushing's Disease
Novartis Pharmaceuticals
 2011-11-04 PHASE3
NCT01915303 TERMINATED
Cushings Disease
Novartis Pharmaceuticals
 2014-03-06 PHASE2
NCT01639352 COMPLETED
Hepatocellular Carcinoma
Lynn Feun
 2012-07 PHASE2
NCT01252251 COMPLETED
Uveal Melanoma
Memorial Sloan Kettering Cancer Center
 2010-11 PHASE2
NCT02779257 WITHDRAWN
Gastro-enteropancreatic Neuroendocrine Tumor
University of Maryland, Baltimore
 2016-04 PHASE4
NCT01417806 UNKNOWN
Small Cell Lung Cancer
South Florida Veterans Affairs Foundation for Research and Education
 2011-07 PHASE2
NCT01364415 COMPLETED
Neuroendocrine Tumors
Novartis Pharmaceuticals
 2011-08 PHASE1
NCT00600886 COMPLETED
Acromegaly
Novartis Pharmaceuticals
 2008-02-11 PHASE3
NCT02048319 COMPLETED
Symptomatic Dominant Liver Cyst
Radboud University Medical Center
 2013-12 PHASE3
NCT01372618 TERMINATED
Ductal Carcinoma in Situ
NYU Langone Health
 2011-06 PHASE1; PHASE2
NCT01637272 COMPLETED
Dumping Syndrome
Novartis Pharmaceuticals
 2013-01-08 PHASE2
NCT01617733 TERMINATED
Nelson Syndrome
Sheffield Teaching Hospitals NHS Foundation Trust
 2011-03 PHASE2
NCT00958841 TERMINATED
Pancreatic Neoplasm; Pituitary Neoplasm; Nelson Syndrome; Ectopic ACTH Syndrome
Novartis Pharmaceuticals
 2009-09 PHASE2
NCT01652547 COMPLETED
Metastatic Melanoma and Merkel Cell Carcinoma
Novartis Pharmaceuticals
 2012-11 PHASE1
NCT01488487 COMPLETED
Advanced Adult Hepatocellular Carcinoma
UNC Lineberger Comprehensive Cancer Center
 2011-12 PHASE2
NCT01374451 TERMINATED
Islet Cell Tumor
Novartis Pharmaceuticals
 2011-06 PHASE2
NCT00804336 COMPLETED
Neuroendocrine Tumor; Carcinoid Tumor; Pancreatic Neuroendocrine Tumor
Dana-Farber Cancer Institute
 2008-10 PHASE1
NCT00994110 COMPLETED
Pancreatic Cancer
Memorial Sloan Kettering Cancer Center
 2009-10 PHASE3
NCT01578928 COMPLETED
Renal Impairment
Novartis Pharmaceuticals
 2012-05 PHASE1
NCT01263353 COMPLETED
Gastroenteropancreatic Neuroendocrine Tumor of the Pulmonary ot Gastroenteropancreatic System
Novartis Pharmaceuticals
 2010-11 PHASE1
NCT00171730 COMPLETED
Acromegaly
Novartis Pharmaceuticals
 2004-08-24 PHASE2
NCT00446082 COMPLETED
Carcinoid Tumor; Acromegaly
Novartis Pharmaceuticals
 2006-06 PHASE1
NCT00171951 COMPLETED
Cushing Disease
Novartis Pharmaceuticals
 2004-08-13 PHASE2
NCT01137682 COMPLETED
Acromegaly
Novartis Pharmaceuticals
 2010-07-19 PHASE3
NCT01234974 WITHDRAWN
Multiple Myeloma
Milton S. Hershey Medical Center
 2010-12 PHASE2
NCT01356862 COMPLETED
Breast Cancer
Alliance Pour La Recherche en Cancerologie
 2010-09 PHASE2
NCT01313559 TERMINATED
Castrate Resistant Prostate Cancer; Chemotherapy Naive Prostate Cancer; Prostate Cancer
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
 2011-06 PHASE2
NCT01620138 COMPLETED
Non-functioning Pituitary Adenomas; Prolactinomas
Universidade Federal do Rio de Janeiro
 2010-03 PHASE2; PHASE3
NCT00690430 COMPLETED
Symptomatic Refractory Resistant Carcinoid Disease
Novartis Pharmaceuticals
 2008-04 PHASE3
NCT02622906 COMPLETED
Angiodysplasia
Robert Benamouzig
 2012-03 PHASE2
NCT00929669 TERMINATED
Gonadotroph Adenomas
University of Pennsylvania
 2009-06 PHASE2
NCT01372644 COMPLETED
Atypical Ductal Breast Hyperplasia; Lobular Carcinoma in Situ (LCIS); Atypical Lobular Hyperplasia (ALH) of Breast
NYU Langone Health
 2007-11 PHASE1
NCT01128192 COMPLETED
Hyperglycemia
Robert R. Henry, MD
 2009-08 PHASE2
NCT00434148 COMPLETED
Cushing's Disease
Novartis Pharmaceuticals
 2006-12 PHASE3
NCT01895296 COMPLETED
Postoperative Dumping Syndrome
Universitaire Ziekenhuizen KU Leuven
 2008-09 PHASE2
NCT00698464 COMPLETED
Hepatic Cirrhosis; Alcoholism
Novartis Pharmaceuticals
 2008-07 PHASE1
NCT00088595 COMPLETED
Carcinoid Tumors
Novartis Pharmaceuticals
 2004-01 PHASE2
NCT00088582 COMPLETED
Acromegaly
Novartis Pharmaceuticals
 2004-03 PHASE2

(data from https://clinicaltrials.gov, updated on 2025-01-13)

Check the Pasireotide product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a multi-receptor ligand somatostatin analogue, pasireotide binds with high affinity to somatostatin receptor subtypes sst1, sst2, sst3, and sst5, thereby inhibiting downstream secretory signaling pathways. This targeted receptor activation potently suppresses the secretion of adrenocorticotropic hormone, growth hormone, and insulin-like growth factor I, providing clinical efficacy in suppressing hypercortisolemia and tumor growth in Cushing's disease, acromegaly, and neuroendocrine neoplasms.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.