Pasireotide

Also known as: SOM230 · Signifor

FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval FDA-approved 2 applications
Randomized controlled trials 54 of 844 publications on PubMed
Registered clinical trials 87 8 active
Adverse event reports 2,698 2,028 classified as serious
  • Pasireotide is an FDA-approved drug, marketed as Signifor (first approval: December 14, 2012).
  • PubMed lists 844 publications mentioning it, including 54 randomized controlled trials and 56 animal-only studies.
  • ClinicalTrials.gov lists 87 registered studies testing it (8 active).
  • FDA's adverse event system (FAERS) holds 2,698 reports mentioning it; 2,028 classified as serious. Reports do not prove causation.

Research topics

  • Somatostatin 111
  • Acromegaly 70
  • Human Growth Hormone 41
  • Octreotide 37
  • Receptors, Somatostatin 34
  • Pituitary Neoplasms 30
  • Adenoma 27
  • Insulin-Like Growth Factor I 26
  • Pituitary ACTH Hypersecretion 23
  • Growth Hormone-Secreting Pituitary Adenoma 16

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

Application Product Status First approval Sponsor
NDA200677 SIGNIFOR Approved, marketed December 14, 2012 RECORDATI RARE
NDA203255 SIGNIFOR LAR KIT Approved, marketed December 15, 2014 RECORDATI RARE

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

  • All publications 844
  • Human (MeSH) 635
  • Animal only 56
  • Clinical trials 89
  • Randomized controlled trials 54
  • Systematic reviews & meta-analyses 36
  • Case reports 84
  • Retracted 0

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered
87
Active
8
With posted results
40

Conditions studied

  • Acromegaly 13
  • Cushing's Disease 5
  • Neuroendocrine Tumors 5
  • Acromegaly Due to Pituitary Adenoma 2
  • Hyperglycemia 2
  • Gastro-enteropancreatic Neuroendocrine Tumor 2
  • Congenital Hyperinsulinism 2
  • Ectopic ACTH Syndrome 2
  • Cushings Disease 2
  • Dumping Syndrome 2
  • Prostate Cancer 2
  • Cushing Disease 2
Study Status Phase Start
Effects of Pasireotide Lar Therapy on Bone Metabolism
NCT07179926 Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Recruiting — September 8, 2025
Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
NCT07866846 Leiden University Medical Center
Recruiting N/A July 29, 2025
Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET
NCT06784752 Novartis Pharmaceuticals
Recruiting Phase 3 May 30, 2025
Pasireotide as Maintenance Treatment in Synovial Sarcoma and Desmoplastic Small Round Cell Tumor
NCT06456359 University Hospital Heidelberg
Recruiting Phase 2 December 19, 2024
A Study of Pasireotide in People With Prolactinoma
NCT06295952 Memorial Sloan Kettering Cancer Center
Recruiting Phase 2 February 27, 2024
Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia
NCT05928390 RECORDATI GROUP
Active, not recruiting Phase 2 January 4, 2024
Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET
NCT03972488 Advanced Accelerator Applications Results posted
Active, not recruiting Phase 3 January 8, 2020
HYPAR Trial - Hydrocortisone vs. Pasireotide in Reducing Pancreatic Surgery Complications
NCT02775227 Helsinki University Central Hospital
Active, not recruiting Phase 4 May 2016
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
NCT07312643 RECORDATI GROUP
Completed Phase 1 December 1, 2025
The RApid Switch From 1st Generation Somatostatin Analogues to PaSireOtiDe In Acromegaly
NCT06597383 IRCCS San Raffaele
Unknown status — November 24, 2023
Show 40 more studies
Study Status Phase Start
Pasireotide to Reduce Clinically Relevant Digestive Leakage After Complete Cytoreductive Surgery (CRS) Plus Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) for Peritoneal Carcinomatosis
NCT04826432 Gustave Roussy, Cancer Campus, Grand Paris
Terminated Phase 2 September 3, 2020
A Study in Healthy Subjects to Assess the Safety, Tolerability, PK and PD of HTL0030310
NCT03847207 Nxera Pharma UK Limited
Completed Phase 1 January 23, 2019
Pasireotide in the Treatment of Hypoglycemia Following Gastric Bypass Surgery
NCT03514576 Zealand University Hospital
Unknown status Phase 4 June 1, 2018
Pasireotide LAR Therapy of Silent Corticotroph Pituitary Tumors
NCT02749227 Columbia University Results posted
Terminated Phase 2 July 10, 2017
Pasireotide in Hyperinsulinemic Hypoglycemia
NCT03053284 Montefiore Medical Center
Withdrawn Phase 2 Apr 2017
Treatment Plan for an Individual Patient With Pasireotide for Hyperinsulinemic Hypoglycemia
NCT03103009 University of Colorado, Denver
Completed Phase 1 March 22, 2017
Reduction by Pasireotide of the Effluent Volume in High-output Enterostomy in Patients Refractory to Usual Medical Treatment
NCT02713776 Hospices Civils de Lyon
Completed Phase 2 December 13, 2016
Safety and Efficacy Study of SOM230 s.c. in Cluster Headache
NCT02619617 Novartis Pharmaceuticals Results posted
Terminated Phase 2 October 31, 2016
Pasireotide Treatment for Neuroendocrine Tumor
NCT02779257 University of Maryland, Baltimore
Withdrawn Phase 4 Apr 2016
SOM230 Ectopic ACTH-producing Tumors
NCT02780882 Cedars-Sinai Medical Center
Withdrawn Phase 2 Dec 2015
Treatment of Hypoglycemia Following Gastric Bypass Surgery
NCT02527993 Zealand University Hospital
Completed Phase 4 Oct 2015
Pasireotide LAR and Pegvisomant Study in Acromegaly
NCT02668172 Erasmus Medical Center
Unknown status Phase 4 Aug 2015
Pasireotide in Patients With Acromegaly Inadequately Controlled With First Generation Somatostatin Analogues
NCT02354508 Novartis Pharmaceuticals Results posted
Completed Phase 3 March 31, 2015
Pasireotide in Prevention of GI Toxicity
NCT02215070 Anthony Sung, MD Results posted
Completed Phase 2 January 21, 2015
Impact of Pasireotide on Postoperative Pancreatic Fistulas Following Distal Resections
NCT04281680 Helsinki University Central Hospital
Completed — July 1, 2014
Study of Management of Pasireotide-induced Hyperglycemia in Adult Patients With Cushing's Disease or Acromegaly
NCT02060383 Novartis Pharmaceuticals Results posted
Completed Phase 4 May 23, 2014
Study of the Efficacy and Safety of Pasireotide s.c. +/- Cabergoline in Patients With Cushing's Disease
NCT01915303 Novartis Pharmaceuticals Results posted
Terminated Phase 2 March 6, 2014
Efficacy of Combining Pasireotide With Aspiration Sclerotherapy to Improve Volume Reduction of Hepatic Cysts
NCT02048319 Radboud University Medical Center
Completed Phase 3 Dec 2013
3-arm Trial to Evaluate Pasireotide LAR/Everolimus Alone/in Combination in Patients With Lung/Thymus NET - LUNA Trial
NCT01563354 Novartis Pharmaceuticals Results posted
Completed Phase 2 August 16, 2013
Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies
NCT01794793 RECORDATI GROUP Results posted
Completed Phase 4 June 10, 2013
Adipokine Profile in Patients With Cushing's Disease on Pasireotide Treatment
NCT03080181 University of Palermo
Completed Phase 4 May 2013
Long Term Safety and Efficacy of Pasireotide s.c. in Patients With Cushing's Disease
NCT02310269 RECORDATI GROUP Results posted
Completed — March 28, 2013
Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Pasireotide LAR in Patients With Castration Resistant Prostate Cancer
NCT01646684 Novartis Pharmaceuticals
Completed Phase 1 March 8, 2013
Phase II Study Evaluating Efficacy, Safety and Pharmacokinetics of Pasireotide in Patients With Dumping Syndrome
NCT01637272 Novartis Pharmaceuticals Results posted
Completed Phase 2 January 8, 2013
Evaluate the Efficacy and Safety of Pasireotide LAR (Long Acting Release) on the Treatment of Patients With Clinically Non-Functioning Pituitary Adenoma.
NCT01283542 Novartis Pharmaceuticals Results posted
Completed Phase 2 November 26, 2012
A Phase I, Exploratory, Intra-patient Dose Escalation Study to Investigate the Preliminary Safety, Pharmacokinetics, and Anti-tumor Activity of Pasireotide (SOM230) s.c.Followed by Pasireotide LAR in Patients With Metastaticmelanoma or Metastatic Merkel Cell Carcinoma
NCT01652547 Novartis Pharmaceuticals
Completed Phase 1 Nov 2012
Efficacy and Safety of Pasireotide LAR (Long-acting Release) in Japanese Patients With Acromegaly or Pituitary Gigantism
NCT01673646 Novartis Pharmaceuticals Results posted
Completed Phase 2 October 16, 2012
Pasireotide LAR in Severe Polycystic Liver Disease
NCT01670110 Mayo Clinic Results posted
Completed Phase 2 Aug 2012
Phase II Trial of SOM230 in Patients With Unresectable Hepatocellular Carcinoma
NCT01639352 Lynn Feun Results posted
Completed Phase 2 Jul 2012
Evaluate Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs
NCT01590199 Novartis Pharmaceuticals
Completed Phase 1 May 18, 2012
A Phase l Study to Evaluate the Pharmacokinetics and Safety Pasireotide in Subjects With Varying Degrees of Renal Impairment Compared to Healthy Volunteers
NCT01578928 Novartis Pharmaceuticals
Completed Phase 1 May 2012
Pasireotide for the Treatment of Gastrointestinal Angiodysplasia in Endoscopic Treatment Failure
NCT02622906 Robert Benamouzig
Completed Phase 2 Mar 2012
Efficacy of Medical Treatment With SOM230 LAR in Patients With Primary Inoperable Thymoma and/or With Local Recurrent Thymoma to Reduce Tumor Size
NCT02021942 Prof. Dr. Berthold Schalke Results posted
Completed Phase 2 Mar 2012
SOM230 Alone or in Combination With RAD001 in Patients With Medullary Thyroid Cancer
NCT01625520 Federico II University
Completed Phase 2 Feb 2012
Pasireotide, Everolimus and Selective Internal Radioembolization Therapy for Unresectable Hepatic Metastases
NCT01469572 Emory University
Completed Phase 1 Dec 2011
Everolimus and Pasireotide (SOM230) in Patients With Advanced or Metastatic Hepatocellular Carcinoma
NCT01488487 UNC Lineberger Comprehensive Cancer Center Results posted
Completed Phase 2 Dec 2011
SOM230 LAR With Bortezomib and Dexamethasone for Refractory or Relapsed Multiple Myeloma
NCT01329289 University of Pittsburgh
Withdrawn Phase 2 Dec 2011
Efficacy and Safety of Pasireotide Administered Monthly in Patients With Cushing's Disease
NCT01374906 Novartis Pharmaceuticals Results posted
Completed Phase 3 November 4, 2011
Docetaxel, Prednisone, and Pasireotide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
NCT01468532 Barbara Ann Karmanos Cancer Institute Results posted
Completed Phase 1, Phase 2 Oct 2011
Phase I Trial of Combination of FOLFIRI and SOM 230
NCT01434069 H. Lee Moffitt Cancer Center and Research Institute
Completed Phase 1 Sep 2011

All 87 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports
2,698
Serious
2,028
With death outcome
185

Most reported reactions

  • Hyperglycaemia 414
  • Diabetes mellitus 295
  • Nausea 274
  • Blood glucose increased 269
  • Diarrhoea 232
  • Fatigue 226
  • Headache 191
  • Off label use 181
  • Drug ineffective 172
  • Vomiting 157
  • Dizziness 148
  • Asthenia 116

Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.

Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query

FDA prescribing information

Official US prescribing information. Dosing sections are intentionally not shown.

  • Signifor HUMAN PRESCRIPTION DRUG Recordati Rare Diseases, Inc. February 17, 2026
  • Signifor LAR HUMAN PRESCRIPTION DRUG Recordati Rare Diseases, Inc. July 16, 2024

Source: DailyMed / openFDA

Change history

No changes since monitoring began on October 30, 2026.