MedPath

Pasireotide

Generic Name
Pasireotide
Brand Names
Signifor
Drug Type
Small Molecule
Chemical Formula
C58H66N10O9
CAS Number
396091-73-9
Unique Ingredient Identifier
98H1T17066

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

Research Report

Published: Aug 2, 2025

Pasireotide (Signifor®, Signifor LAR®): A Comprehensive Monograph on a Multireceptor-Targeted Somatostatin Analog

Executive Summary and Introduction

Overview

Pasireotide is a second-generation, multireceptor-targeted somatostatin analog (SSA) representing a significant evolution in the medical management of certain endocrine disorders.[1] Developed initially by Novartis and now part of the portfolio of Recordati Rare Diseases, Pasireotide is a synthetic, long-acting cyclic hexapeptide engineered to mimic the inhibitory actions of the natural hormone somatostatin.[2] It is commercially available under two distinct brand names corresponding to its formulation and route of administration: Signifor®, a solution for subcutaneous (SC) injection, and Signifor LAR®, a long-acting release (LAR) formulation for intramuscular (IM) injection.[6]

Primary Indications

Pasireotide holds orphan drug status and is approved for two primary indications. It is used for the treatment of adult patients with Cushing's disease, a condition of chronic hypercortisolism, for whom pituitary surgery is not a viable option or has not been curative.[6] Additionally, the long-acting formulation, Signifor LAR®, is approved for the treatment of acromegaly, a disorder of excessive growth hormone (GH) secretion, in adult patients who have demonstrated an inadequate response to surgery or for whom surgery is not an option.[6]

Core Mechanism and Clinical Distinction

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2024/11/12
Phase 2
Recruiting
2024/03/06
Phase 2
Recruiting
2023/07/03
Phase 2
Recruiting
2021/04/01
Phase 2
Terminated
2020/02/24
N/A
Completed
2019/02/20
Phase 1
Completed
2018/05/02
Phase 4
UNKNOWN
2017/04/06
Phase 1
Completed
2017/03/15
Phase 4
Completed
2017/02/15
Phase 2
Withdrawn

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Recordati Rare Diseases, Inc.
55292-133
SUBCUTANEOUS
0.9 mg in 1 mL
8/3/2023
Recordati Rare Diseases, Inc.
55292-131
SUBCUTANEOUS
0.3 mg in 1 mL
8/3/2023
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
Authorised
4/24/2012

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
SIGNIFOR 20 MG POLVO Y DISOLVENTE PARA SUSPENSION INYECTABLE
112753013
POLVO Y DISOLVENTE PARA SUSPENSIÓN INYECTABLE
Diagnóstico Hospitalario
Commercialized
SIGNIFOR 0,9 MG SOLUCION INYECTABLE
12753012
SOLUCIÓN INYECTABLE
Diagnóstico Hospitalario
Not Commercialized
SIGNIFOR 0,3 MG SOLUCION INYECTABLE
12753003
SOLUCIÓN INYECTABLE
Diagnóstico Hospitalario
Not Commercialized
SIGNIFOR 60 MG POLVO Y DISOLVENTE PARA SUSPENSION INYECTABLE
112753016
POLVO Y DISOLVENTE PARA SUSPENSIÓN INYECTABLE
Diagnóstico Hospitalario
Commercialized
SIGNIFOR 40 MG POLVO Y DISOLVENTE PARA SUSPENSION INYECTABLE
112753014
POLVO Y DISOLVENTE PARA SUSPENSIÓN INYECTABLE
Diagnóstico Hospitalario
Commercialized
SIGNIFOR 0,3 MG SOLUCION INYECTABLE
12753004
SOLUCIÓN INYECTABLE
Diagnóstico Hospitalario
Not Commercialized
SIGNIFOR 0,6 MG SOLUCION INYECTABLE
12753008
SOLUCIÓN INYECTABLE
Diagnóstico Hospitalario
Not Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

Help Us Improve

Your feedback helps us provide better drug information and insights.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.