Delving into the Latest Updates on Pelargonium sidoides root extract with Synapse

Overview

Basic Info

Drug Type

Herbal medicine

Synonyms

EPs® 7630, V Clear EPs 7630

Target-

Action-

Mechanism-

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

Common ColdCough

Inactive Indication-

Originator Organization

Dr. Willmar Schwabe GmbH & Co. KG

Active Organization

Johnson & Johnson Pacific Pty Ltd.

Inactive Organization

Dr. Willmar Schwabe GmbH & Co. KG

License Organization-

Drug Highest PhaseApproved

First Approval Date

Australia (01 May 2024),

Common ColdCough

Regulation-

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This randomized controlled study aims to evaluate the effectiveness and safety of the pharmaceutical extract EPs® 7630 from P.sidoides in treating hand, foot, and mouth disease in children. The study will investigate the impact of EPs® 7630 on the severity of the disease over a specific period and its effects on hospitalization rates and potential complications. This research aims to contribute to the treatment of hand, foot, and mouth disease in children.

Start Date01 Jun 2019

Sponsor / Collaborator

Eskisehir Osmangazi üniversitesi

[+1]

NCT02174653

/ CompletedPhase 3

Safety and Intake Effect of EPs® 7630 (an Extract of the Roots of Pelargonium Sidoides) A Prospective, Monocentric, Randomised, Double-blind, Placebo-controlled Clinical Trial

The aim of the study is to evaluate the safety of the intake of EPs® 7630 during a long-term (4 months) medication. The protective effects of EPs®7630 and its effects during a cold episode will also be studied.

Start Date01 Mar 2014

Sponsor / Collaborator

Dr. Willmar Schwabe GmbH & Co. KG

ISRCTN65790556

/ CompletedPhase 4

EPs® 7630 film-coated tablets in subjects (greater than or equal to 18 years old) suffering from common cold: a prospective, multicentre, single-arm, open-label, phase IV clinical post-marketing safety study

Start Date10 Jan 2011

Sponsor / Collaborator

Dr. Willmar Schwabe GmbH & Co. KG

100 Clinical Results associated with Pelargonium sidoides root extract

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100 Translational Medicine associated with Pelargonium sidoides root extract

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100 Patents (Medical) associated with Pelargonium sidoides root extract

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10

Literatures (Medical) associated with Pelargonium sidoides root extract

01 Oct 2020·Journal of Molecular MedicineQ2 · MEDICINE

The herbal extract EPs® 7630 increases the antimicrobial airway defense through monocyte-dependent induction of IL-22 in T cells

Q2 · MEDICINE

Article

Author: Witte, Katrin ; Wolk, Kerstin ; Koch, Egon ; Sabat, Robert ; Volk, Hans-Dieter

AbstractThe phytotherapeutic compound EPs® 7630, an extract manufactured from Pelargonium sidoides roots, is frequently used for the treatment of airway infections. Nevertheless, the knowledge of the mode of action of EPs® 7630 is still sparse. Our study aimed at further elucidating the underlying pharmacological mechanisms by focusing on antimicrobial defense mechanisms of EPs® 7630. While investigating the influence of EPs® 7630 on lymphokine production by PBMCs, we found that EPs® 7630 is a novel inducer of IL-22 and IL-17. This cytokine-inducing effect was most pronounced for IL-22 and clearly dose-dependent starting from 1 μg/ml of the extract. Furthermore, EPs® 7630 pretreatment selectively enhanced the IL-22 and IL-17 production capacity of CD3/28-activated PBMCs while strongly limiting the IFN-γ production capacity of innate lymphoid cells. The relevance of EPs® 7630–induced IL-22 production was proven in vitro and in vivo, where IL-22 provoked a strong increase of the antimicrobial protein S100A9 in lung epithelial cells and pulmonary tissue, respectively. A detailed analysis of IL-22 induction modi revealed no direct influence of EPs® 7630 on the basal or anti-CD3/CD28 antibody-induced IL-22 production by CD4+ memory T cells. In fact, EPs® 7630–induced IL-22 production by CD4+ memory T cells was found to be essentially dependent on soluble mediators (IL-1/IL-23) as well as on direct cellular contact with monocytes. In summary, our study reveals a new immune-modulating function of EPs® 7630 that might confer IL-22 and IL-17-induced protection from bacterial airway infection.Key messages

EPs® 7630 selectively strengthens IL-22 and IL-17 production of memory T cells.

EPs® 7630 limits the IFN-y production capacity of innate lymphoid cells.

EPs® 7630–caused IL-22 production by T cells is essentially dependent on monocytes.

IL-22 increase antimicrobial proteins (AMPs) in airway epithelium.

EPs® 7630 might protect against airway infection by induction of AMP-inducers.

01 Dec 2019·Pilot and Feasibility Studies

HATRIC: a study of Pelargonium sidoides root extract EPs®7630 (Kaloba®) for the treatment of acute cough due to lower respiratory tract infection in adults—study protocol for a double blind, placebo-controlled randomised feasibility trial

Article

Author: Griffiths, Gareth ; Moore, Michael ; Simpson, Catherine ; Little, Paul ; Bostock, Jennifer ; Butler, Chris ; Wrixon, Emma ; Hay, Alastair D ; Willcox, Merlin ; Bell, Margaret ; Yao, Lily ; Webley, Frances ; Whitehead, Amy

BACKGROUNDAcute lower respiratory tract infection is a common acute infection managed in primary care. The current dominant management strategy in the UK is antibiotics, despite widespread publicity regarding antimicrobial resistance and evidence that the small benefits of antibiotics do not outweigh the harms. There is a need to address the rising problem of antibiotic resistance by providing credible alternative strategies, which reduce symptom burden. There is sufficient evidence to recommend the use of Pelargonium sidoides root extract in order to warrant undertaking an independent clinical trial.We propose a feasibility study to demonstrate our ability to recruit and retain patients and conduct a placebo-controlled trial of Pelargonium sidoides extract EPs®7630 in lower respiratory tract infection where pneumonia is not suspected. Both the tablet and liquid formulations will be included.METHODSThe HATRIC trial is a double-blind randomised placebo-controlled feasibility study aiming to determine the potential to conduct a fully powered trial of Pelargonium sidoides root extract as an alternative to the inappropriate use of antibiotics for acute bronchitis in UK primary care.Primary care sites will be equally randomised to one of two formulation groups (tablet or liquid preparation). Additionally, within each site, patients will be evenly randomised to active or placebo treatment. Antibiotic consumption will be monitored during the trial, but the use of a delayed prescription strategy is encouraged. The target sample size for this study is 160 patients overall or 40 per arm, recruited from approximately 20 primary care sites. The analysis will be descriptive focusing on estimation with no formal comparison of groups taking place.DISCUSSIONIf this trial demonstrates the feasibility of recruitment and delivery, we will seek funding for a fully powered placebo-controlled trial of Pelargonium sidoides root extract for the treatment of lower respiratory tract infections in primary care.TRIAL REGISTRATIONHATRIC was registered on the ISRCTN registry (ISRCTN17672884) on 16 August 2018.

01 May 2012·Antiviral ResearchQ2 · MEDICINE

EPs® 7630 (Umckaloabo®), an extract from Pelargonium sidoides roots, exerts anti-influenza virus activity in vitro and in vivo

Q2 · MEDICINE

Article

Author: Linda L. Theisen ; Claude P. Muller

A prodelphinidin-rich extract from Pelargonium sidoides DC, EPs® 7630 (Umckaloabo®), which is licensed to treat respiratory tract infections such as acute bronchitis, was investigated for its antiviral effects. EPs® 7630 showed dose-dependent anti-influenza activity at non-toxic concentrations against pandemic H1N1, oseltamivir-sensitive and -resistant seasonal H1N1, seasonal H3N2 and the laboratory H1N1 strain A/Puerto Rico/8/34, while it had no antiviral activity against adenovirus or measles virus. The extract inhibited an early step of influenza infection and impaired viral hemagglutination as well as neuraminidase activity. However, EPs® 7630 did not exhibit a direct virucidal effect, as virus preincubation (unlike cell preincubation) with the extract did not influence infectivity. Importantly, EPs® 7630 showed no propensity to resistance development in vitro. Analysis of EPs® 7630 constituents revealed that prodelphinidins represent the active principle. Chain length influenced antiviral activity, as monomers and dimers were less effective than oligo- and polymers. Importantly, gallocatechin and its stereoisomer epigallocatechin exert antiviral activity also in their monomeric form. In addition, EPs® 7630 administered by inhalation significantly improved survival, body weight and body temperature of influenza-infected mice, without obvious toxicity, demonstrating the benefit of EPs® 7630 in treatment of influenza.

100 Deals associated with Pelargonium sidoides root extract

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Common Cold	Australia	Johnson & Johnson Pacific Pty Ltd.	01 May 2024
Cough	Australia	Johnson & Johnson Pacific Pty Ltd.	01 May 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Common Cold	Preclinical	United Kingdom	Dr. Willmar Schwabe GmbH & Co. KG	01 Mar 2014

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06353477 (Pubmed)	Phase 2/3	Hand, Foot and Mouth Disease human enteroviruses (EVs) \| coxsackieviruses (CVs)	208	EPs® 7630	rvfqmpsjxo(ukgrdranar) = No side effects were observed, except for unpleasant taste, which was reported in 5 patients (EPs® 7630 group) spnkojdnme (vkqadpfnkh )	Positive	01 Jan 2024
				EPs® 7630 (Control)