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
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
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2017/02/15 | Phase 2 | Withdrawn |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 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
SIGNIFOR LAR POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION 60MG | SIN15170P | INJECTION, POWDER, FOR SUSPENSION | 60mg | 2/2/2017 | |
SIGNIFOR LAR POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION 40MG | SIN15169P | INJECTION, POWDER, FOR SUSPENSION | 40mg | 2/2/2017 | |
SIGNIFOR LAR POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION 20MG | SIN15168P | INJECTION, POWDER, FOR SUSPENSION | 20mg | 2/2/2017 |
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. |
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 | Medicine | A | 11/1/2013 | |
SIGNIFOR pasireotide 300 microgram/1 mL (as diaspartate) solution for injection ampoule | 201485 | Medicine | A | 11/1/2013 | |
SIGNIFOR pasireotide 600 microgram/1 mL (as diaspartate) solution for injection ampoule | 201484 | Medicine | A | 11/1/2013 |
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. |
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