Delving into the Latest Updates on Lumbricus rubellus extract with Synapse

Overview

Basic Info

Drug Type

Herbal medicine

Synonyms

Disolf

Target

Fibrinogen

Action

inhibitors

Mechanism

Fibrinogen inhibitors

Therapeutic Areas

Nervous System DiseasesCardiovascular Diseases

Active Indication

StrokeAcute Coronary SyndromePeripheral Arterial Disease+ [1]

Inactive Indication

Acrocallosal SyndromeAcute Ischemic StrokeBrain Infarction+ [5]

Originator Organization

PT Dexa Medica

Active Organization

PT Dexa Medica

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

Indonesia (01 Aug 2012),

Acute Coronary SyndromePeripheral Arterial DiseaseThrombosis

Regulation-

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Stroke is one of the most common non-communicable diseases worldwide. It is the leading cause of morbidity and mortality in many countries.
Stroke is broadly classified into ischemic and hemorrhagic stroke. Ischemic stroke is more common than hemorrhagic stroke. In Indonesia, the prevalence of ischemic stroke is 42.9% compare to hemorrhagic stroke 19.9%. Ischemic stroke defined as an episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction.
One of the main therapy in ischemic stroke is administration of anti thrombotic agent. DLBS1033 is a bioactive protein fraction isolated from Lumbricus rubellus. DLBS1033 possessed quadruple activities that inhibit platelet aggregation, induces fibrinogenolysis, fibrinolysis, and thrombolysis. This is a new proposed medication nowadays. There is still a limited study about DLBS1033. To our knowledge, research concern on the usage of DLBS1033 in stroke patients is very limited in Indonesia. This study aimed to Measure the benefit of DLBS1033 as add on therapy for ischemic stroke patients.
The hypothesis of this study :
a. The use of DLBS1033 improve functional status of ischemic stroke patients at hospital discharge. b. The use of DLBS1033 improve functional status 30-days after stroke onset.

Start Date01 Apr 2020

Sponsor / Collaborator

Universitas Kristen Duta Wacana

NCT02976701

/ TerminatedPhase 2/3

The Effect of DLBS1033 in Patients With ST Elevation Acute Coronary Syndrome (STE-ACS) After Primary Percutaneous Coronary Intervention

This is a prospective, randomized, double-blind, double-dummy, and controlled clinical study over a total of 4-week therapy with DLBS1033 in the management of STE-ACS after a primary PCI. There will be 40 STE-ACS subjects (20 subjects in each group) planned to complete the study.

Start Date01 Nov 2016

Sponsor / Collaborator

PT Dexa Medica

NCT02146664

/ WithdrawnPhase 2/3

The Role of DLBS1033 in The Management of Acute Non-ST Elevation of Myocardial Infarction (NSTEMI) Without Early Coronary Revascularization

This is a prospective, randomized, double-blind, double-dummy, and controlled study of DLBS1033 in the management of acute non-ST elevation myocardial infarction (NSTEMI) without early coronary revascularization. It is hypothesized that the combination of DLBS1033 with aspirin and clopidogrel will result in greater reduction of infarct size in comparison with that of aspirin and clopidogrel alone.

Start Date01 Nov 2015

Sponsor / Collaborator

PT Dexa Medica

100 Clinical Results associated with Lumbricus rubellus extract

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100 Translational Medicine associated with Lumbricus rubellus extract

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100 Patents (Medical) associated with Lumbricus rubellus extract

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8

Literatures (Medical) associated with Lumbricus rubellus extract

07 Apr 2021·Stroke Research and Treatment

Effect of DLBS1033 on Functional Outcomes for Patients with Acute Ischemic Stroke: A Randomized Controlled Trial

Article

Author: Tjandrawinata, Raymond R. ; Pinzon, Rizaldy Taslim ; Veronica, Vanessa ; Wijaya, Vincent Ongko

Background. There are still some unmet needs for stroke management and safety. DLBS1033 is a protein fraction extracted from the earthworm Lumbricus rubellus that has shown fibrinolytic and fibrinogenolytic activities, reduces blood viscosity, and inhibits platelet aggregation that it can be considered an add-on therapy and potential medical breakthrough in acute ischemic stroke management. Objective. This study is aimed at measuring the benefit of DLBS1033 in acute ischemic stroke management. Methods. This was a randomized, open-label trial at a referral stroke center from November 2019 to December 2020. Subjects who met the inclusion criteria were randomly divided into a control group and an experimental group. The control group received standard therapy consisting of aspirin 100 mg once daily, atorvastatin 20 mg once daily, and vitamin B12 100 mg three times daily. The experimental group received standard therapy and DLBS1033 three times daily. The functional outcomes were measured using the National Institutes of Health Stroke Scale (NIHSS), Barthel Index (BI), and modified Rankin Scale (mRS) at baseline, hospital discharge, and day 30. Results. Collected data from 180 subjects was analyzed. The NIHSS scores’ improvements were significantly greater in the experimental group compared to the control group at both hospital discharge (−5.57±2.16vs.−3.64±2.65;p<0.001) and day 30 (−6.62±2.64vs.−5.14±2.41;p=0.001). Compared with the control group, the improvements in the BI scores were significantly better in the experimental group, at both hospital discharge (10.69±5.36vs.6.64±5.04;p<0.001) and day 30 (10.9±8.19vs.8.56±7.45;p=0.003). The distribution of mRS scores was improved in both groups during 30 days of follow-up and was more favorable in the experimental group. In both groups, a favorable outcome (mRS<2) was achieved better at day 30 (86.7% vs. 80%;p=0.302) than at baseline (0% vs. 6.7%;p=0.028) and at hospital discharge (58.9% vs. 43.3%;p=0.085). There was no clinically significant adverse event related to the study product. Conclusions. DLBS1033 in addition to the standard care was more effective in improving functional status compared to standard care alone in acute ischemic stroke patients with a similar safety profile.

01 Jul 2018·Acta medica Indonesiana

A Clinical Trial on Biological Half Life of Bioactive Protein from Lumbricus rubellus, DLBS1033 in Healthy Volunteers.

Article

Author: Nafrialdi, Nafrialdi ; Gayatri, Anggi ; Setiabudy, Rahajuningsih D ; Louisa, Melva ; Tjandrawinata, Raymond R ; Rachman, Andika

BACKGROUNDDLBS1033 is a bioactive protein fraction extracted from Lumbricus rubellus, with fibrinogenolytic, fibrinolytic and anti-aggregation activities reported in an in vitro study. Plasma half-life is an important parameter to calculate its dose. This study was conducted to evaluate the biological half-life of DLBS1033 by measuring serial plasmin-antiplasmin (PAP) complex. PAP complex is a stable and inactive compound as a result of fibrinolysis process.METHODSthis was an open-label clinical trial in healthy adult subjects. Subjects were divided into two groups to receive single dose drugs (received 3 x 490 mg) or repeated administration until steady state conditions (3 x 490 mg/day for 3 days). Blood samples for PAP complex measurement were collected at time 0 (before drug administration for single dose group), then at 0.5, 1, 1.5, 2, 3, 6, 8, 10, 12, and 24 hours after drug administration. Safety parameters used in this study were creatinine, prothrombin time (PT), activated partial thromboplastin time (aPTT), SGOT, and SGPT.RESULTSthe biological half-life of DLBS1033 was calculated based on the mean of PAP complex concentration on each time sampling. In single dose group, the highest mean of PAP complex concentration was reached before drug administration. Our result showed that the activity of DLBS1033 could not be determined after single dose administration. In steady state condition, the PAP complex concentration increase in 2 hours after last drug administration. The biological half-life of DLBS1033 was 8.6 hours. There were no significant safety findings on all laboratory parameters and no serious adverse events.CONCLUSIONit is concluded that the fibrinolytic effects of DLBS1033 can be measured in steady state condition. The biological half-life of DLBS1033 in steady state condition was 8.6 hours. There were no serious adverse events on two groups of subjects.

01 Jan 2015·Biological & Pharmaceutical BulletinQ4 · MEDICINE

Tabletting Process of Pellets Containing Bioactive Fraction DLBS1033F Isolated from <i>Lumbricus rubellus</i>: Challenge and Strategy

Q4 · MEDICINE

Article

Author: Rachmawati, Heni ; Tjandrawinata, Raymond Rubianto ; Christy, Gabriela

DLBS1033 is a mixture of bioactive proteins fractinated from the earthworm Lumbricus rubellus which possesses antithrombotic and thrombolytic activities. DLBS1033 contains a potent fibrinolytic enzyme with excellent specificity for fibrin. A commercial oral enteric coated tablet for administration 3 times daily is available on the market from the DLBS manufacturer. This research aimed to develop a multiparticulate sustained-release DLBS1033 Forte (DLBS1033F) tablet (with more potent fibrinolytic activity than DLBS1033), which has targeted release in the small intestine and colon. The chemical and physical stability of the fibrinolytic enzyme was expected to be preserved in these bowel segments. The sustained-release system was designed to maintain the effective plasma concentration of the proteins and prolong the thrombolytic activity. This was done by incorporating the proteins in a multiparticulate solid that was subsequently compressed into the monolithic system of a sustained-release tablet. The challenge was to maintain pellet integrity after the compression process. A set of studies confirmed the preserved physical shape of the pellets. In addition, in vitro release studies of the multiparticulate tablet in reassembling media of the gastrointestinal tract indicated the successful formulation of DLBS1033F as an enteric as well as sustained-release solid dosage form.

100 Deals associated with Lumbricus rubellus extract

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External Link

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Stroke	Indonesia	PT Dexa Medica	28 Aug 2012
Acute Coronary Syndrome	Indonesia	PT Dexa Medica	01 Aug 2012
Peripheral Arterial Disease	Indonesia	PT Dexa Medica	01 Aug 2012
Thrombosis	Indonesia	PT Dexa Medica	01 Aug 2012

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acrocallosal Syndrome	Phase 1	Indonesia	PT Dexa Medica	01 Nov 2016
ST Elevation Myocardial Infarction	Phase 1	Indonesia	PT Dexa Medica	01 Nov 2016
Non ST segment elevation acute coronary syndrome	Phase 1	Indonesia	PT Dexa Medica	01 Nov 2015
Non-St Elevated Myocardial Infarction	Phase 1	Indonesia	PT Dexa Medica	01 Nov 2015
Diabetes Mellitus	Phase 1	Indonesia	PT Dexa Medica	03 Jun 2015
Brain Infarction	Phase 1	Indonesia	PT Dexa Medica	11 Nov 2014
Acute Ischemic Stroke	Phase 1	Indonesia	PT Dexa Medica	01 May 2012
Hemorrhage	Preclinical	Indonesia	PT Dexa Medica	01 May 2012