The proposed study is a multicenter, prospective, randomized, open-label, blinded-endpoint trial involving patients with ischemic stroke who are candidates for receiving intravenous (IV) thrombolysis within 4.5 hours after stroke onset. The study aims to test the hypothesis that anterior circulation ischemic stroke patients, selected with "dual target" vessel occlusion within 4.5 hours of onset, will have improved reperfusion and early neurological improvement when treated with intra-arterial clot retrieval after IV reteplase, compared to IV alteplase. Patients will be randomized into one of three treatment arms: local institutional IV thrombolysis, IV reteplase (9 U bolus), or IV reteplase (9 U bolus + 9 U bolus). The study will assess the primary angiographic endpoint of partial or complete recanalization following administration of thrombolytics, as well as the time of recanalization and the time from symptom onset to recanalization. Additional outcome measures include early neurological improvement, assessed by a ≥4-point improvement in National Institutes of Health Stroke Scale (NIHSS) score in the first 24 hours compared to baseline. The trial will be conducted in three groups based on the site of baseline arterial occlusion: internal carotid artery (ICA), proximal middle cerebral artery (MCA - M1), or distal middle cerebral artery (MCA - M2). The study aims to evaluate third-generation thrombolytic - RETAVASE® (reteplase) and compare it to IV alteplase, in acute ischemic stroke patients.

Start Date01 Jul 2023

Sponsor / Collaborator-

NCT03992443 / WithdrawnPhase 3

A Phase 3, Open Label, Single Arm Study on the Use of CUSA-081 for Dysfunctional Central Venous Access Devices (CVADs)

Study to evaluate the efficacy and safety of CUSA-081 in the restoration of central venous access device (CVAD) functionality in participants 12 years and older.

Start Date28 Feb 2022

Sponsor / Collaborator

CHIESI Farmaceutici SpA

IRCT20220103053614N1 / RecruitingPhase 3IIT

Comparison of the effect of heparin, reteplase and taurolock in the prevention of thrombosis in hemodialysis catheters

Start Date09 Nov 2021

Sponsor / Collaborator-

100 Clinical Results associated with Reteplase

100 Translational Medicine associated with Reteplase

100 Patents (Medical) associated with Reteplase

497

Literatures (Medical) associated with Reteplase

01 Oct 2024·Health Science Reports

Investigating the effects of systemic thrombolysis on electrocardiography and pulmonary artery blood pressure in patients with pulmonary embolism

Article

Author: Askari, Vahid Reza ; Baradaran Rahimi, Vafa ; Ghorbani, Niyayesh ; Nasimi Shad, Arya ; Dastani, Mostafa

Abstract:

Background and Aims:

We aimed to evaluate the association between electrocardiography (ECG) and echocardiographic findings in patients with pulmonary embolism (PE) before and after systemic thrombolysis.

Methods:

We included 38 PE patients admitted to the hospital with approved right ventricular (RV) dysfunction who were indicated for systemic thrombolysis. Indications for systemic thrombolysis were considered as patients who were either hemodynamically unstable on admission or became unstable in the course of hospital admission. Systemic thrombolysis was performed by either Reteplase or Alteplase. ECG and echocardiographic findings were documented at baseline and 12–24 h following systemic thrombolysis.

Results:

Our results showed that TAPSE significantly increased while RV size and pulmonary artery systolic pressure (PAP) notably decreased after systemic thrombolysis (p < 0.001). The ECG abnormalities markedly diminished after systemic thrombolysis in PE patients (p < 0.001). Additionally, 100% of our patients had more than one ECG abnormality at baseline, while 55.3% had no ECG abnormalities after systemic thrombolysis. Further, the median number of ECG abnormalities remarkably attenuated after systemic thrombolysis (from 2.0 (1.0) to 0.0 (1.0), p < 0.001). Our results also revealed that delta RV size (r = 0.51, p = 0.001) and delta TAPSE (r = 0.4, p = 0.012) were positively correlated while mortality (r = −0.55, p = 0.001) was negatively associated with changes in the number of ECG abnormalities before and after systemic thrombolysis.

Conclusion:

We showed that systemic thrombolysis improved echocardiographic and electrocardiographic findings in PE patients. Additionally, a greater decreased number of ECG abnormalities after systemic thrombolysis was accompanied by more improvement in RV size and TAPSE and a lower mortality rate.

01 Oct 2024·ANNALS OF INTERNAL MEDICINE

In ischemic stroke treated within 4.5 h, reteplase vs. alteplase increased excellent functional outcome at 90 d

Article

Author: Sharma, Mukul ; Srivastva, Abhilekh

SOURCE CITATION:

Li S, Gu HQ, Li H, et al; RAISE Investigators. Reteplase versus alteplase for acute ischemic stroke. N Engl J Med. 2024;390:2264-2273. 38884332.

01 Sep 2024·PROTEIN EXPRESSION AND PURIFICATION

Heterologous expression, purification and single step efficient refolding of recombinant tissue plasminogen activator (Reteplase) from E. coli

Article

Author: Masi, Haidar Abbas ; Patel, Amrutlal ; Singh, Niraj Kumar ; Bhatt, Meha ; Joshi, Chaitanya

Reteplase (recombinant plasminogen activator, rPA) is a mutant non-glycosylated tissue-type plasminogen activator (tPA) containing 355 amino acids with longer half-life and promising thrombolytic activity than its original counterpart, full length tPA. In this study, we aimed to produce and optimize the purification process of recombinant tissue-type plasminogen activator (tPA) known as Reteplase (rPA). Reteplase cDNA synthesized from total mRNA isolated from human placenta was PCR amplified, cloned into a pET-28a(+) E. coli expression vector and expressed in Rosetta-gami 2 E. coli (Novagen^Ⓡ) host. rPA was expressed as an inclusion body in E. coli and its biological activity was achieved after single step solubilization, purification and refolding. We exploited the strategy of Slow Refolding using Gradual Dialysis (SRGD) in which a refolding buffer containing glutathione oxidized (1 mM GSSG) and glutathione reduced (3 mM GSH) and pH 9.0 was used. Using the SRGD method, we were able to successfully obtain the protein in its active form. We obtained 4.26 mg of active refolded protein from a 50 mL culture that was scaled up in a bioreactor. The purity and homogeneity of rPA was evaluated by SDS-PAGE, Western blotting and mass spectrometry. Circular dichroism spectroscopy was conducted to evaluate the refolding and stability of the refolded rPA in comparison to reference standard rPA. The thrombolytic potential of rPA was assessed by fibrin plate assay and In Vitro clot lysis assay. The presented protocol offers a viable approach for enhancing both the yield and refolding efficiency of reteplase, potentially resulting in an increase in yield.

News (Medical) associated with Reteplase

20 Jun 2024

·www.drugs.com

Reteplase Superior to Alteplase Within 4.5 Hours of Ischemic Stroke

THURSDAY, June 20, 2024 -- Reteplase is noninferior to alteplase for patients with ischemic stroke within 4.5 hours after symptom onset, according to a study published online June 14 in the New England Journal of Medicine to coincide with the 10th Annual Conference of the Chinese Stroke Association & Tiantan International Stroke Conference 2024, held from June 14 to 16 in Beijing. Shuya Li, M.D., from Beijing Tiantan Hospital, and colleagues randomly assigned patients with ischemic stroke within 4.5 hours after symptom onset to receive intravenous reteplase (bolus of 18 mg followed by a second bolus of 18 g 30 minutes later) or intravenous alteplase (0.9 mg/kg body weight up to a maximum of 90 mg; 707 and 705 patients, respectively). The researchers found that 79.5 and 70.4 percent of patients in the reteplase and alteplase groups, respectively, had an excellent functional outcome (risk ratio, 1.13; 95 percent confidence interval, 1.05 to 1.21; P < 0.001 for noninferiority and P = 0.002 for superiority). Symptomatic intracranial hemorrhage within 36 hours after disease onset occurred in 2.4 and 2.0 percent of patients in the reteplase and alteplase groups, respectively (risk ratio, 1.21; 95 percent confidence interval, 0.54 to 2.75). The incidence of any intracranial hemorrhage at 90 days was 7.7 versus 4.4 percent with reteplase versus alteplase (risk ratio, 1.59; 95 percent confidence interval, 1.00 to 2.51), and the incidence of adverse events was 91.6 versus 82.4 percent (risk ratio, 1.11; 95 percent confidence interval, 1.03 to 1.20). "The RAISE trial showed that intravenous reteplase was noninferior to intravenous alteplase in achieving an excellent functional outcome," the authors write. The study was funded by China Resources Angde Biotech Pharma.

Clinical Result

02 May 2023

·www.pharmaceutical-technology.com

BMS licenses TCR-T immunotherapy therapy from Immatics

Robert Barrie Headquarters of Bristol-Myers Squibb (BMS) Germany in Munich, Germany. BMS has exercised opt-in rights for a new TCR-T therapy from Immatics. Credit: Shutterstock/nitpicker Bristol Myers Squibb (BMS) has exercised its opt-in rights for the first T cell receptor (TCR)-engineered T cell therapy (TCR-T) from Immatics . Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. 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GlobalData Reports LOA and PTSR Model - Camrelizumab in Peripheral T-Cell Lymphomas (PTCL) GlobalData View all Companies Intelligence Novartis AG Bristol-Myers Squibb Co Immatics NV Editas Medicine Inc BMS AS View all Submit Visit our Privacy Policy for more information about our services, how GlobalData may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report. In 2019, Immatics and BMS entered an alliance to develop T cell-redirecting cancer immunotherapies. This deal was expanded to incorporate gamma delta T cell therapies in 2022. As per the agreement, BMS could exercise opt-in rights for any of the four TCR-T product candidates being developed by Immatics. The first opt-in is for a candidate targeting solid tumours. Under the deal’s structure, BMS has assumed sole responsibility for further worldwide development, manufacturing, and commercialisation of the therapy. This news comes a few weeks after BMS signaled an increased focus on cell therapy manufacturing with a takeover of former Novartis plant to boost viral vector production for T-cell therapies. Immatics will receive $15m from the global license agreement and is in line for a further $490m in milestone payments for this candidate. The exercise fee, regulatory and commercial milestone payments are specific to each programme, meaning that Immatics could be in line for $505m for each candidate BMS takes off the Tuebingen, German-based company’s hands. Immatics also has a research collaboration with gene editing company Editas Medicine to advance its T cell therapies. As part of this, Editas is eligible to receive milestone payments from Immatics. “The partnership’s goal is to leverage Immatics’ ability to develop innovative cell therapies that have the potential to deliver future breakthrough therapies for patients,” commented Harpreet Singh, Ph.D., Immatics’ CEO and co-founder. “We look forward to further advancing our own pipeline programs as well as our product candidates being developed with Bristol Myers Squibb and other partners,” Singh added. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report.

License out/inImmunotherapyCell Therapy

02 Aug 2021

·www.biospace.com

Thrombolytic Therapy Market: Increase in the incidence of hypertension to drive the market

Blood clot is one of the serious complications in the human body. When blood clots, major arteries or veins are blocked which cease the normal blood flow. The cessation of normal blood flow can implicate hemorrhage and often lead to heart attack and stroke. Thrombolytic therapy is a treatment to dissolve solid blood clots by administrating thrombolytic drugs. The length of the therapy depends upon the type or degree of complications. The treatment may require almost one hour in the case of a heart attack or may need 48 hours in the case of deep vein thrombosis. Brain CT test, electrocardiogram, and electroencephalogram are effective ways to evaluate whether patients are good candidates for thrombolytic therapy. Patients who had undergone recent surgery and blood thinning treatment or with conditions such as pregnancy, trauma, and high blood pressure are not recommended to thrombolytic therapy. Read Report Overview - Urokinase, streptokinase, and tissue plasminogen activator (tPA) are basic thrombolytic drugs available in the market for thrombolytic therapy. In 1933, the efficiency of streptokinase as a thrombolytic agent was first stated. Later on, streptokinase was applied to acute myocardial infarction. Unlike streptokinase, urokinase has the ability to catalyze fibrin formation from plasminogen. The growth of the global thrombolytic therapy market is driven by several factors such as aging population, awareness about the adverse effect of thrombosis, rate of diagnosis and treatment, and increase in the incidence of hypertension, kidney diseases, strokes, and other cardiovascular diseases. However, this market is likely to witness hindrances such as strict drug regulatory system and high drug pricing, which, in turn, might restrict the market growth. Nevertheless, new treatment options and technological breakthroughs are anticipated to highlight new avenues for the market growth in the near future. Request Brochure of Report - The global market for thrombolytic therapy has been segmented based on drug type, application, distribution channel, and region. In terms of drug type, the market is categorized into fibrin specific drugs and non-fibrin specific drugs. The fibrin specific drugs segment is further segmented into tissue plasminogen activator, reteplase, tenecteplase, and others. The non-fibrin specific drugs segment is categorized into urokinase, streptokinase, and plasminogen-activating complex. Request for Analysis of COVID-19 Impact on Thrombolytic Therapy Market- In terms of application, the global market is classified into acute myocardial infarction, pulmonary embolism, deep vein thrombosis, blocked catheters, acute ischemic strokes, and others. Most of the drugs are administered intravenously, and the doses are recommended on the basis of the patient’s medical history. In terms of distribution channel, the market is segmented into hospital pharmacies, retail pharmacies, and e-pharmacies. Increasing number of retail pharmacies, self-medication tendency, and merging of hospital pharmacies are the factors to consider in this market. The thrombolytic drugs are rarely dispensed through the e-pharmacy channel although there is the emergence of e-pharmacy worldwide. Request for Custom Research - Geographically, the global thrombolytic therapy market is distributed over North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America holds the largest market share globally, in terms of revenue, owing to high incidence of deep vein thrombosis/pulmonary embolism (1.17 per 1,000 population per year), rise in awareness, high diagnosis and treatment rate, and well-established health care infrastructure. Europe is projected to account for the second largest market share due to high diagnosis and treatment rate, considerable incidences of deep vein thrombosis/pulmonary embolism, and presence of robust health care facilities. Asia Pacific is expected to capture a significant market share during the forecast period because of the presence of large patient pool, particularly, in India and China. Latin America and Middle East & Africa are silent contributors of the global thrombolytic therapy market. Pre Book Thrombolytic Therapy Market Report - Prominent players operating in the global market for thrombolytic therapy include Eumedica, Genentech (a Roche Group Company), Microbix, Boehringer Mannheim, SEDICO Pharmaceutical, Crinos, Livzon Zhuhai, Medac, Mochida Pharmaceutical, Taj Pharmaceuticals Ltd., NDPharma, and Syner-Medica. About Us Transparency Market Research is a next-generation market intelligence provider, offering fact-based solutions to business leaders, consultants, and strategy professionals. Our reports are single-point solutions for businesses to grow, evolve, and mature. Our real-time data collection methods along with ability to track more than one million high growth niche products are aligned with your aims. The detailed and proprietary statistical models used by our analysts offer insights for making right decision in the shortest span of time. For organizations that require specific but comprehensive information we offer customized solutions through ad hoc reports. These requests are delivered with the perfect combination of right sense of fact-oriented problem solving methodologies and leveraging existing data repositories. TMR believes that unison of solutions for clients-specific problems with right methodology of research is the key to help enterprises reach right decision. 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100 Deals associated with Reteplase

External Link

KEGG	Wiki	ATC	Drug Bank
D05721	Reteplase	B01AD07	DB00015

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Acute myocardial infarction	EU	Actavis Group PTC ehf.	29 Aug 1996
Acute myocardial infarction	IS	Actavis Group PTC ehf.	29 Aug 1996
Acute myocardial infarction	LI	Actavis Group PTC ehf.	29 Aug 1996
Acute myocardial infarction	NO	Actavis Group PTC ehf.	29 Aug 1996

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Catheter related thrombosis	Phase 3	US	CHIESI Farmaceutici SpA	12 Feb 2020
Catheter related thrombosis	Phase 3	AR	CHIESI Farmaceutici SpA	12 Feb 2020
Catheter related thrombosis	Phase 3	BE	CHIESI Farmaceutici SpA	12 Feb 2020
Catheter related thrombosis	Phase 3	CZ	CHIESI Farmaceutici SpA	12 Feb 2020
Catheter related thrombosis	Phase 3	PL	CHIESI Farmaceutici SpA	12 Feb 2020
Catheter related thrombosis	Phase 3	RO	CHIESI Farmaceutici SpA	12 Feb 2020
Catheter related thrombosis	Phase 3	ES	CHIESI Farmaceutici SpA	12 Feb 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03594175 (READY1, CTgov)	Phase 3	Catheter related thrombosis	462	CUSA-081 (CUSA-081)	dhugdgkets(gmjlysimie) = zriblnnuno jxesvbxwkz (vnfdxzvpkq, hdspdcscez - qahlocgele) View more	-	23 Aug 2024
				Placebo (Placebo)	dhugdgkets(gmjlysimie) = vxiaiahwdb jxesvbxwkz (vnfdxzvpkq, dbuzvzddqa - wayklvqlpw) View more
NCT00806403 (SWEDES, CTgov)	Phase 4	ST Elevation Myocardial Infarction \| Acute myocardial infarction	205	reteplase 10+10 U (Thrombolysis)	qawypqykik(lwewbrjzla) = paafeugern lnkeetacnc (qohsvoeaqb, epwkvnhykg - gvgfhuibkj) View more	-	10 Dec 2008
				primary PCI (Invasive)	qawypqykik(lwewbrjzla) = mknqsnjrsf lnkeetacnc (qohsvoeaqb, sfqhzelorm - vwvlkljtkt) View more

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