Pasireotide

Overview

Pasireotide is a synthetic long-acting cyclic hexapeptide with somatostatin-like activity. It is marketed as a diaspartate salt called Signifor, which is used in the treatment of Cushing's disease.

Indication

For the treatment of Cushing’s disease, specifically for those patients whom pituitary surgery has not been curative or is not an option.

Associated Conditions

Acromegaly
Cushing's Disease

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Pasireotide as Maintenance Treatment with monthly deep intramuscular injection in SSTR2/3/5-Expressing Synovial Sarcoma and Desmoplastic Small Round Cell Tumor (PAMSARC)	2024/11/12	2024-511935-86-00	Phase 2	Recruiting	Universitaetsklinikum Heidelberg AöR
A Study of Pasireotide in People With Prolactinoma	2024/03/06	NCT06295952	Phase 2	Recruiting	Memorial Sloan Kettering Cancer Center
Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia	2023/07/03	NCT05928390	Phase 2	Recruiting	RECORDATI GROUP
Pasireotide to Reduce Clinically Relevant Digestive Leakage After Complete Cytoreductive Surgery (CRS) Plus Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) for Peritoneal Carcinomatosis	2021/04/01	NCT04826432	Phase 2	Terminated	Gustave Roussy, Cancer Campus, Grand Paris
Impact of Pasireotide on Postoperative Pancreatic Fistulas Following Distal Resections	2020/02/24	NCT04281680	N/A	Completed	Helsinki University Central Hospital
A Study in Healthy Subjects to Assess the Safety, Tolerability, PK and PD of HTL0030310	2019/02/20	NCT03847207	Phase 1	Completed	Nxera Pharma UK Limited
Pasireotide in the Treatment of Hypoglycemia Following Gastric Bypass Surgery	2018/05/02	NCT03514576	Phase 4	UNKNOWN	Zealand University Hospital
Treatment Plan for an Individual Patient With Pasireotide for Hyperinsulinemic Hypoglycemia	2017/04/06	NCT03103009	Phase 1	Completed	University of Colorado, Denver
Adipokine Profile in Patients With Cushing's Disease on Pasireotide Treatment	2017/03/15	NCT03080181	Phase 4	Completed	University of Palermo
Pasireotide in Hyperinsulinemic Hypoglycemia	2017/02/15	NCT03053284	Phase 2	Withdrawn	Montefiore Medical Center

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Signifor	Recordati Rare Diseases, Inc.	55292-133	SUBCUTANEOUS	0.9 mg in 1 mL	8/3/2023
Signifor	Recordati Rare Diseases, Inc.	55292-131	SUBCUTANEOUS	0.3 mg in 1 mL	8/3/2023
Signifor	Recordati Rare Diseases, Inc.	55292-132	SUBCUTANEOUS	0.6 mg in 1 mL	8/3/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Signifor	Recordati Rare Diseases,Immeuble le Wilson,70, avenue du Général de Gaulle,92800 Puteaux,France	Authorised	4/24/2012

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
SIGNIFOR LAR POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION 60MG	Recordati AG Rare Diseases Branch (manufacture of bulk powder), Sandoz GmbH (primary packager), Abbott Biologicals B.V. (manufacture, primary and secondary packager for solvent), Synergy Health Daniken AG (sterilization site)	SIN15170P	INJECTION, POWDER, FOR SUSPENSION	60mg	2/2/2017
SIGNIFOR LAR POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION 40MG	Novartis Pharma AG (manufacture of bulk powder), Sandoz GmbH (primary packager), Abbott Biologicals B.V. (manufacture, primary and secondary packager for solvent), Synergy Health Daniken AG (sterilization site)	SIN15169P	INJECTION, POWDER, FOR SUSPENSION	40mg	2/2/2017
SIGNIFOR LAR POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION 20MG	Novartis Pharma AG (manufacture bulk powder), Sandoz GmbH (primary packager of powder), Abbott Biologicals B.V. (manufacture, primary and secondary packager for solvent), Synergy Health Daniken AG (sterilization site)	SIN15168P	INJECTION, POWDER, FOR SUSPENSION	20mg	2/2/2017

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Pasireotide Diaspartate Injection	远大医药（中国）有限公司	国药准字H20254400	化学药品	注射剂	5/27/2025

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
SIGNIFOR pasireotide 900 microgram/1 mL (as diaspartate) solution for injection ampoule	201486	Recordati Rare Diseases Australia Pty Ltd	Medicine	A	11/1/2013
SIGNIFOR pasireotide 300 microgram/1 mL (as diaspartate) solution for injection ampoule	201485	Recordati Rare Diseases Australia Pty Ltd	Medicine	A	11/1/2013
SIGNIFOR pasireotide 600 microgram/1 mL (as diaspartate) solution for injection ampoule	201484	Recordati Rare Diseases Australia Pty Ltd	Medicine	A	11/1/2013

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