Delving into the Latest Updates on Prednisolone Sodium Phosphate Liposomal with Synapse

Overview

Basic Info

Drug Type

Small molecule drug, Liposomal Drug

Synonyms

Nanocort

Target

GR

Action

agonists

Mechanism

GR agonists(Glucocorticoid receptor agonists)

Therapeutic Areas

Immune System DiseasesSkin and Musculoskeletal DiseasesNervous System Diseases+ [1]

Active Indication-

Inactive Indication

Clinically isolated syndromeMultiple Sclerosis, Relapsing-RemittingRheumatoid Arthritis

Originator Organization

Galapagos NV

Active Organization-

Inactive Organization

Sun Pharma Global FZE

Galapagos NV

License Organization-

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

Regulation-

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A promising strategy to reduce CVD is to directly target inflammation at the level of the vessel wall. A potential drawback of anti-inflammatory strategies pertains to the thin line between inhibiting 'inappropriate' inflammation versus inducing immuno-suppression. One of the strategies to limit systemic immunosuppression is to strive for local delivery and prolonged efficacy and low systemic burden of the drug by encapsulating the compound in liposomes.
Liposome-encapsulated drugs efficiently target lesions and accumulate at a much higher extent at desired areas of interest. Thus, local delivery and prolonged efficacy can be very important tools to overcome the potential drawback anti-inflammatory drugs; namely an inappropriate immune suppression. In the present project, the investigators therefore aim to evaluate the delivery and superior efficacy of Nanocort above Prednison or placebo in patients with peripheral artery disease due to atherosclerosis. Because these patients will undergo an endarteriectomy the investigators will be able to collect atherosclerotic material after drug administration and thus evaluate the local delivery and compare the effects of Nanocort to Prednison or Placebo.

Start Date01 May 2012

Sponsor / Collaborator

Academic Medical Center University of Amsterdam

100 Clinical Results associated with Prednisolone Sodium Phosphate Liposomal

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100 Translational Medicine associated with Prednisolone Sodium Phosphate Liposomal

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100 Patents (Medical) associated with Prednisolone Sodium Phosphate Liposomal

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2

Literatures (Medical) associated with Prednisolone Sodium Phosphate Liposomal

01 Oct 2024·Journal of Controlled Release

A bio-predictive release assay for liposomal prednisolone phosphate

Article

Author: Nagpal, Shakti ; Png, Jordan ; Kahouadji, Lyes ; Wacker, Matthias G

Predictive performance assays are crucial for the development and approval of nanomedicines and their bioequivalent successors. At present, there are no established compendial methods that provide a reliable standard for comparing and selecting these formulation prototypes, and our understanding of the in vivo release remains still incomplete. Consequently, extensive animal studies, with enhanced analytical resolution for both, released and encapsulated drug, are necessary to assess bioequivalence. This significantly raises the cost and duration of nanomedicine development. This work presents the development of a discriminatory and biopredictive release test method for liposomal prednisolone phosphate. Using model-informed deconvolution, we identified an in vivo target release. The experimental design employed a discrete L-optimal configuration to refine the analytical method and determine the impact of in vitro parameters on the dosage form. A three-point specification evaluated the key phases of in vivo release: early (T-5%), intermediate (T-20%), and late release behavior (T-40%), compared to the in vivo release profile of the reference product, NanoCort®. Various levels of shear responses and the influence of clinically relevant release media compositions were tested. This enabled an assessment of the effect of shear on the release, an essential aspect of their in vivo deformation and release behavior. The type and concentration of proteins in the medium influence liposome release. Fetal bovine serum strongly impacted the discriminatory performance at intermediate shear conditions. The method provided deep insights into the release response of liposomes and offers an interesting workflow for in vitro bioequivalence evaluation.

01 Jan 2022·Journal of Controlled ReleaseQ1 · MEDICINE

Intravenous pegylated liposomal prednisolone outperforms intramuscular methylprednisolone in treating rheumatoid arthritis flares: A randomized controlled clinical trial

Q1 · MEDICINE

Article

Author: Metselaar, Josbert M ; Raut, Atul ; Westhovens, Rene ; van Laar, Jacob M ; Wortel, Cornelis H ; Bijlsma, Johannes W J ; Lammers, Twan ; Kothekar, Mudgal ; Middelink, Leonie M ; Yao, Siu-Long ; Vonkeman, Harald E ; Bos, Reinhard

Glucocorticoids (GCs) are potent anti-inflammatory drugs but their use is limited by systemic exposure leading to toxicity. Targeted GC delivery to sites of inflammation via encapsulation in long-circulating liposomes may improve the therapeutic index. We performed a randomized, double-blind, active-controlled, multi-center study in which intravenously (i.v.) administered pegylated liposomal prednisolone sodium phosphate (Nanocort) was compared to equipotent intramuscular (i.m.) methylprednisolone acetate (Depo-Medrol®; i.e. a current standards-of-care for treating flares in rheumatoid arthritis patients). We enrolled 172 patients with active arthritis who met all eligibility criteria, eventually resulting in 150 patients randomized in three groups: (1) Nanocort 75 mg i.v. infusion plus i.m. saline injection; (2) Nanocort 150 mg i.v. infusion plus i.m. saline injection; and (3) Depo-Medrol® 120 mg i.m. injection plus i.v. saline infusion. Dosing in each group occurred at baseline and on day 15 (week 2). Study visits occurred at week 1, 2, 3, 4, 6, 8 and 12, to assess both efficacy and safety. The primary endpoint was the "European League Against Rheumatism" (EULAR) responder rate at week 1. Safety was determined by the occurrence of adverse events during treatment and 12 weeks of follow-up. Treatment with Nanocort was found to be superior to Depo-Medrol® in terms of EULAR response at week 1, with p-values of 0.007 (good response) and 0.018 (moderate response). Treatments were well tolerated with a comparable pattern of adverse events in the three treatment groups. However, the Nanocort groups had a higher incidence of hypersensitivity reactions during liposome infusion. Our results show that liposomal Nanocort is more effective than Depo-Medrol® in treating patients with rheumatoid arthritis flares and has similar safety. This is the first clinical study in a large patient population showing that i.v. administered targeted drug delivery with a nanomedicine formulation improves the therapeutic index of glucocorticoids.

100 Deals associated with Prednisolone Sodium Phosphate Liposomal

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Rheumatoid Arthritis	Phase 3	Belgium	Sun Pharma Global FZE	12 Nov 2015
Rheumatoid Arthritis	Phase 3	Netherlands	Sun Pharma Global FZE	12 Nov 2015
Clinically isolated syndrome	Phase 3	Belgium	Galapagos NV	01 Dec 2009
Clinically isolated syndrome	Phase 3	Germany	Galapagos NV	01 Dec 2009
Clinically isolated syndrome	Phase 3	Poland	Galapagos NV	01 Dec 2009
Multiple Sclerosis, Relapsing-Remitting	Phase 3	Germany	Galapagos NV	01 Dec 2009
Multiple Sclerosis, Relapsing-Remitting	Phase 3	Belgium	Galapagos NV	01 Dec 2009
Multiple Sclerosis, Relapsing-Remitting	Phase 3	Poland	Galapagos NV	01 Dec 2009