The purpose of this study is to determine the safety and feasibility of using intra-arterial Tenecteplase in patients undergoing blood clot extraction for treatment of acute ischemic (non-bleeding) stroke. Tenecteplase is a drug that is currently FDA-approved to treat a heart attack but not currently approved for stroke treatment.

Start Date01 May 2025

Sponsor / Collaborator

Wake Forest School of Medicine

[+1]

NCT06801054

/ Not yet recruitingPhase 1IIT

SAFETY OF A SECOND DOSE OF TENECTEPLASE IN SELECTED ACUTE ISCHEMIC STROKE PATIENTS NOT RESPONDING TO THE FIRST DOSE

In this pilot safety study, we will give a second dose of Intravenous Tenecteplase (IV TNK) to patients receiving the initial TNK dose within 3 hrs of last known normal (LKN), have a baseline National Institutes of Health Stroke Scale (NIHSS) > 6, and who do not clinically improve within 45 minutes of the first dose, or who improve but then deteriorate, and can still be treated within 4.5 hours from LKN. Patients will require a second computed tomography (CT) scan to rule out any bleeding, and meet the usual inclusion and exclusion criteria for TNK treatment, before the second dose which must be given within 4.5 hrs of LKN. Both TNK doses will be 0.25 mg/kg. The initial TNK dose may be given on the Mobile Stroke Unit (MSU) or Emergency Department (ED), and the second dose in the ED. Informed consent will be obtained before the second dose is given.
The primary outcome will be symptomatic intracranial hemorrhage (sICH) (SITS-MOST criteria) or serious systemic bleeding within 36 hours. Secondary outcomes will be any intracranial hemorrhage, any bleeding, discharge NIHSS and modified Rankin Score (mRS), and mRS at 90 days (sliding dichotomy).
20 patients will be enrolled. Enrollment will be stopped if more than 3 sICH occur (> 80% confidence that sICH rate is > 5%. If successful, this study will be followed by a larger phase 2b controlled safety confirmation and pilot efficacy study,

Start Date01 Mar 2025

Sponsor / Collaborator

Memorial Hermann Health System

[+1]

IRCT20241023063472N1

/ SuspendedPhase 3IIT

Comparison of thrombolytic therapy with Alteplase and Tenecteplase for in patients with acute ischemic stroke in a clinical trial phase 3.

Start Date19 Feb 2025

Sponsor / Collaborator-

100 Clinical Results associated with Tenecteplase

100 Translational Medicine associated with Tenecteplase

100 Patents (Medical) associated with Tenecteplase

953

Literatures (Medical) associated with Tenecteplase

31 Dec 2025·Hospital Practice

Assessment of transition from use of alteplase to tenecteplase in the treatment of acute ischemic stroke in a large system of community hospitals

Article

Author: Hasse, Adam ; Poland, Russell E. ; Korwek, Kimberly ; Guy, Jeffrey

OBJECTIVEPharmacologic thrombolytic treatment for acute ischemic stroke has primarily been managed by intravenous alteplase. Tenecteplase is a variant that has been shown to be non-inferior to alteplase in clinical trials. In this study, we present a real-world assessment of patient outcomes with the facility-wide transition to the use of tenecteplase versus altepase for acute ischemic stroke in a large system of community hospitals in the United States.METHODSThis retrospective analysis assessed adult patients who received either alteplase or tenecteplase between 1 April 2020 and 31 March 2023. Propensity matching was used to estimate the covariate-adjusted association with outcomes of discharge expired/hospice, intracranial hemorrhage and readmission to a facility in the same healthcare system within 30, 60, or 90 days.RESULTSAmong 12,766 patients, gross mortality was 7.6% (n = 285) with tenecteplase and 8.2% (n = 739) with alteplase (p = 0.314); intracranial hemorrhage was 2.4% with either. The propensity match analysis found that the relative risk of mortality/hospice for patients given tenecteplase versus alteplase was 0.993 (95% CI: 0.848-1.162, p = 1.000). When limited to five facilities with the highest volume of thrombolytic use, there were no significant differences in outcomes. While the time from emergency department arrival to thrombolytic administration (door-to-needle) was shorter among patients receiving tenecteplase, there was no significant difference in the odds of mortality based on door-to-needle time.CONCLUSIONIn alignment with previous studies, these findings demonstrate the lack of potential harm with a transition from alteplase to tenecteplase in clinical practice for acute ischemic stroke patients treated in community hospitals.

01 Apr 2025·Neurology and Therapy

Efficacy and Safety of Various Intravenous Thrombolytics for Acute Ischemic Stroke (AIS) at Various Dosages: A Systematic Review and Network Meta-Analysis

Review

Author: Ma, Yizheng ; Wang, Kangfeng ; Li, He ; Hu, Yibin ; Zhang, Haixuan ; Wu, Shengxian ; Zhang, Lijuan

BACKGROUNDCurrently, there is limited evidence on the efficacy and safety of various thrombolytic drugs at different dosages for the treatment of acute ischemic stroke (AIS). From current randomized clinical trials, the optimal type and dosage of thrombolytics for patients with AIS are unclear.METHODSThis systematic review was registered in PROSPERO (CRD42024563757). We searched four databases using a combination of keywords that contained various intravenous thrombolytics, as well as acute ischemic stroke. Only data from participants with AIS treated with various intravenous thrombolytics within the 4.5-h time window were included. Among initially identified studies, 16 met the selection criteria. Network meta-analysis was conducted for efficacy (90 day modified Rankin scale score) and safety (intracranial hemorrhage events, mortality at 90 days) using Stata 17.0 software, with a fixed-effects model. Cochrane risk of bias tool assessed all risk of bias domains, and the CINeMA Evidence Assessment Tool evaluated the level of evidence for each outcome.RESULTSA total of 9056 studies were retrieved through the literature search, and 12,792 patients screened from 16 randomized controlled trials were included in the network meta-analysis. The risk of bias in the included studies ranged from moderate to low. The network meta-analysis results indicated that reteplase at 18 + 18 mg ranked highest in efficacy, though its safety was lower compared to 0.25 mg/kg tenecteplase and alteplase. The dose of 0.25 mg/kg tenecteplase emerged as the optimal dose, demonstrating both superior efficacy and a lower risk of bleeding compared to alteplase, making it a potential alternative to alteplase. The dose of 50 mg prourokinase was associated with the highest risk of symptomatic intracranial hemorrhage and was inferior to reteplase in terms of both efficacy and safety. The CINeMA Evidence Assessment Tool identified one outcome with a high level of evidence, several with moderate levels, and the remainder with low levels.CONCLUSIONSReteplase at 18 + 18 mg may be more suitable for patients with lower incidence of adverse events evaluated by physicians. Compared to 0.9 mg/kg alteplase, 0.25 mg/kg tenecteplase is more effective, with the lowest risk of intracranial hemorrhage. However, as tenecteplase's dosages increase (0.32 mg/kg and 0.4 mg/kg), its efficacy in improving neurological deficits decreases, while the risk of intracranial hemorrhage and death (especially at 0.4 mg/kg) increases. Clinicians are supposed to carefully assess the needs of patients with AIS and the risks then choose decent thrombolytics.

01 Apr 2025·Journal of Stroke and Cerebrovascular Diseases

Corrigendum to “Door-to-Needle Time Trends After Transition to Tenecteplase: A Multicenter Texas Stroke Registry” [Journal of Stroke and Cerebrovascular Diseases 33 (2024) 107774]

Author: Stone, Suzanne ; Warach, Steven J ; Cruz-Flores, Salvador ; Bandela, Sujani ; Jones, Erica M ; Prasad, Sidarrth ; Goldberg, Mark P ; Savitz, Sean I ; Gebreyohanns, Mehari ; Olson, DaiWai M ; Birnbaum, Lee A ; Anderson, Jane A ; Ifejika, Nneka L ; Brown, Gretchel Gealogo ; Rodriguez, Nathaniel ; Kwon, Yoon

News (Medical) associated with Tenecteplase

06 Mar 2025

·www.drugs.com

FDA Approves TNKase for Acute Ischemic Stroke

THURSDAY, March 6, 2025 -- The U.S. Food and Drug Administration has approved TNKase (tenecteplase), a thrombolytic or clot-dissolving agent, for the treatment of acute ischemic stroke in adults. TNKase is delivered as a single five-second intravenous bolus. This is considerably faster than the standard of care, Activase (alteplase), which is administered as an intravenous bolus followed by a 60-minute infusion. Genentech, the manufacturer of TNKase, says a new 25-mg vial configuration will be available in the coming months. The approval is based on a study comparing TNKase to Activase in patients with acute ischemic stroke who presented with a disabling neurological deficit. Results show that TNKase was comparable to Activase in terms of efficacy and safety. Stroke affects more than 795,000 people each year in the United States. It is the leading cause of long-term disability and the fifth leading cause of death. Since brain damage occurs and progresses rapidly during an acute ischemic stroke, immediate, fast-acting medical care is vital. "Today's approval is a significant step forward and underscores our commitment to advancing stroke treatment options for patients," Levi Garraway, M.D., Ph.D., the chief medical officer and head of global product development at Genentech, said in a statement. "TNKase provides a faster and simpler administration, which can be critical for anyone who is dealing with an acute stroke." Approval of TNKase was granted to Genentech. More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Drug Approval

05 Mar 2025

·pmlive.com

Roche’s Genentech granted FDA approval for TNKase in acute ischaemic stroke

Roche’s Genentech unit has received approval from the US Food and Drug Administration (FDA) for TNKase (tenecteplase) in acute ischaemic stroke (AIS). The drug, which has been authorised for use in adults, is now the first stroke medicine to be approved by the regulator in almost three decades. Stroke is the fifth leading cause of death and the leading cause of long-term disability in the US, affecting more than 795,000 people every year. An AIS occurs when the blood supply to part of the brain is blocked or reduced, preventing brain tissue from receiving oxygen and nutrients. TNKase is a tissue plasminogen activator, clot-dissolving, thrombolytic medicine that starts a biochemical reaction that can break down fibrin, a component of blood clots. Until now, the only FDA-approved medicine for AIS was Roche/Genentech’s Activase (alteplase), which is administered as an intravenous (IV) bolus followed by a 60-minute infusion. TNKase, delivered as a single five-second IV bolus, offers a faster and simpler administration compared to Activase. The drug is also already approved in the US to treat acute ST-elevation myocardial infarction in adults. The FDA’s latest decision was supported by results from a large multi-centre non-inferiority study demonstrating that TNKase is comparable to Activase in AIS patients in terms of safety and efficacy. Levi Garraway, Genentech’s chief medical officer and head of global product development, said: “[This] approval is a significant step forward and underscores our commitment to advancing stroke treatment options for patients. “TNKase provides a faster and simpler administration, which can be critical for anyone who is dealing with an acute stroke.” The authorisation comes less than a month after the FDA approved a tablet formulation of Roche’s spinal muscular atrophy treatment Evrysdi (risdiplam). Evrysdi was originally authorised by the US regulator in 2020 to treat the progressive neuromuscular disease in patients aged two months and older, before being granted expanded approval in 2022 for infants aged under two months. It is hoped that the tablet formulation, which can either be swallowed whole or dispersed in water and stored at room temperature, will provide more freedom and independence over the original oral solution.

Drug Approval

04 Mar 2025

·pipelinereview.com

FDA Approves Genentech’s TNKase®in Acute Ischemic Stroke in Adults

– TNKase ® (tenecteplase) is the first stroke medicine approved by the FDA in nearly 30 years – – Single five-second intravenous bolus provides faster and simpler administration than the approved standard-of-care – – Genentech has developed the only two FDA-approved medicines to treat acute ischemic stroke, TNKase and Activase ® (alteplase)– SOUTH SAN FRANCISCO, CA, USA I March 03, 2025 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved TNKase ® (tenecteplase), a thrombolytic or clot-dissolving agent, for the treatment of acute ischemic stroke (AIS) in adults. This approval of TNKase marks Genentech’s second approval for stroke, reinforcing the company’s long-standing dedication to advancing stroke care as the developer of the only two FDA-approved medicines for AIS, TNKase and Activase ® (alteplase). TNKase is delivered as a single five-second intravenous (IV) bolus, a faster and simpler administration compared to the standard-of-care, Activase, which is administered as an IV bolus followed by a 60-minute infusion. Genentech will also be introducing a new 25 mg vial configuration in the coming months to support the approval of TNKase for AIS. “Today’s approval is a significant step forward and underscores our commitment to advancing stroke treatment options for patients,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. “TNKase provides a faster and simpler administration, which can be critical for anyone who is dealing with an acute stroke.” Stroke is the fifth leading cause of death, and the leading cause of long-term disability in the United States, affecting more than 795,000 people each year. During an AIS, brain damage occurs and progresses rapidly, meaning every moment without intervention leads to irreversible loss of nervous tissue, making immediate medical care crucial. The approval is based on a large multi-center non-inferiority study demonstrating that TNKase is comparable to Activase in AIS patients in terms of safety and efficacy. The AcT (Alteplase compared to Tenecteplase) trial compared TNKase to Activase in treating patients with acute ischemic stroke that presented with a disabling neurological deficit. This investigator-initiated study was conducted by the University of Calgary, was funded by the Canadian Institute of Health Research, and enrolled patients across 22 stroke centers in Canada. TNKase is also FDA approved for the treatment of acute ST-elevation myocardial infarction (STEMI) in adults. About TNKase ® (tenecteplase) TNKase ® (tenecteplase) is a tissue plasminogen activator, clot-dissolving, thrombolytic medicine. TNKase is administered as a single five-second intravenous bolus and starts a biochemical reaction that can break down fibrin, a component of blood clots. The most frequent adverse reactions associated with tenecteplase are bleeding and hypersensitivity. TNKase is now indicated for the treatment of acute ischemic stroke (AIS) in adults. The Dosage and Administration section of the label recommends to initiate treatment as soon as possible and within 3 hours after the onset of stroke symptoms. TNKase is also indicated to reduce the risk of death associated with acute ST-elevation myocardial infarction (STEMI). The Dosage and Administration section of the label recommends initiating treatment as soon as possible after the onset of STEMI symptoms. Alteplase and tenecteplase are marketed and supplied by Genentech in the United States and Canada under the brands Activase and TNKase; and by Boehringer Ingelheim in all other countries except the United States, Canada and Japan under the brands Actilyse® and Metalyse®. Important Safety Information Please see full Prescribing Information for additional Dosing and Administration and Important Safety Information. For more information, go to https://www.tnkase.com . About Activase ® (alteplase) Activase ® (alteplase) is indicated for treating patients with acute ischemic stroke (sudden stroke), which is caused by a blood clot in the brain’s blood vessels. Patients can receive Activase only if they begin treatment within 3 hours after their stroke symptoms start and only after bleeding in the brain has been ruled out. Important Safety Information Who should not be given Activase? Activase should not be used in patients who have: current bleeding in the brain; bleeding in the area between the brain and the thin tissues that cover the brain; active internal bleeding; recent (within 3 months) brain or spinal surgery or major head trauma; some brain tumor, an abnormal connection between veins and arteries in the brain, or an abnormal bulge in the wall of an artery that supplies blood to the brain; problems with blood clotting; or current severe uncontrolled high blood pressure. What are the possible serious side effects of Activase? Bleeding: The most common side effect with Activase is bleeding. Some patients may or may not benefit from Activase because of an increased risk of bleeding, including those with the following conditions: recent major surgery; disease of blood vessels in the brain; recent bleeding in the brain; recent digestive or urinary tract bleeding; recent trauma; uncontrolled high blood pressure; inflammation of the sac around the heart; infection of the inner lining of the heart and the heart valves; increased bleeding risk associated with liver or kidney problems; abnormal liver function; pregnancy; bleeding problems in the eyes; swelling and infection associated with blood clots; elderly patients; patients on blood thinning drugs. Allergic reaction (hypersensitivity): Allergic reactions including hives and severe or life-threatening allergic reactions can occur very quickly. Rare reports of death from severe allergic reactions have been reported. Swelling of the mouth and throat (angioedema) has been observed in patients treated for sudden stroke (acute ischemic stroke) and sudden heart attack (acute myocardial infarction). This occurred during and up to 2 hours after infusion of Activase. In many cases, patients were also taking angiotensin-converting enzyme inhibitors (a type of medication that can make blood vessels expand). Migrated blood clot (thromboembolism): The use of drugs to help dissolve blood clots can increase the risk of a clot breaking up and migrating in patients with high risk of clots in the left side of the heart, such as those with narrowed heart valves or some abnormal heart rhythms. Activase has not been shown to adequately treat deep vein blood clot in patients with pulmonary embolism. Blood clots that migrate can cause decreased blood flow to the area that they migrated to. A healthcare provider should evaluate this risk in these patients. Cholesterol Embolization: A plug of cholesterol that blocks an artery (cholesterol embolism) has been reported rarely in patients treated with all types of clot dissolving agents. This is a serious condition, which can be lethal, and is also associated with invasive medical procedures involving the arteries and veins. What is the most common side effect with Activase? The most common side effect with Activase is bleeding. Please see accompanying full Prescribing Information for Activase for additional important safety information. About Genentech in Stroke For decades, Roche and Genentech have been conducting neuroscience research and clinical trials aimed at exploring areas of the highest medical need. We have grown and advanced our neuroscience portfolio to be one of the most diverse and promising in the industry. From the approval of Activase in 1996, the first clot-dissolving medicine approved for the treatment of acute ischemic stroke and the standard-of-care in the United States, Genentech has a long-standing commitment to advancing stroke care. About Genentech Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com . SOURCE: Genentech

Drug Approval

100 Deals associated with Tenecteplase

External Link

KEGG	Wiki	ATC	Drug Bank
D06070	Tenecteplase	B01AD11	DB00031

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Acute Ischemic Stroke	United States	Genentech, Inc.	28 Feb 2025
ST Elevation Myocardial Infarction	United States	Genentech, Inc.	28 Feb 2025
Acute myocardial infarction	United States	Genentech, Inc.	02 Jun 2000

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Ischemic Stroke	NDA/BLA	European Union	Boehringer Ingelheim International GmbH	14 Dec 2023
Heart Arrest	Phase 1	Belgium	Boehringer Ingelheim GmbH	01 Jan 2004
Heart Arrest	Phase 1	Germany	Boehringer Ingelheim GmbH	01 Jan 2004
Heart Arrest	Phase 1	Switzerland	Boehringer Ingelheim GmbH	01 Jan 2004
Heart Arrest	Phase 1	Sweden	Boehringer Ingelheim GmbH	01 Jan 2004
Heart Arrest	Phase 1	Austria	Boehringer Ingelheim GmbH	01 Jan 2004
Heart Arrest	Phase 1	Italy	Boehringer Ingelheim GmbH	01 Jan 2004
Heart Arrest	Phase 1	Spain	Boehringer Ingelheim GmbH	01 Jan 2004
Heart Arrest	Phase 1	France	Boehringer Ingelheim GmbH	01 Jan 2004
Acute myocardial infarction	Discovery	-	Boehringer Ingelheim GmbH	01 May 2000

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03889249 (FDA_CDER) Manual	Phase 3	Acute Ischemic Stroke	1,147	TNKase	(arvkftiwxv) = xofaovqlcg nbzbplclas (qzskcvdttf )	Positive	28 Feb 2025
				Activase	(arvkftiwxv) = pjfubacjvb nbzbplclas (qzskcvdttf )
ISC2025	Not Applicable	Retinal Artery Occlusion	-	Tenecteplase	tqpmvleajp(hgizaxskap) = mhvngmzkbn icekgcoiph (ppmjjaoceb ) View more	Positive	30 Jan 2025
				Alteplase	tqpmvleajp(hgizaxskap) = uhovsrzaau icekgcoiph (ppmjjaoceb ) View more
ISC2025	Not Applicable	Acute Ischemic Stroke	-	Tenecteplase	kjedejpzba(qdinjkaemk) = shmgquaenb xxjkakqvrt (hflxqmswnv ) View more	Positive	30 Jan 2025
				Alteplase	kjedejpzba(qdinjkaemk) = tlqcmmhatd xxjkakqvrt (hflxqmswnv ) View more
ISC2025	Not Applicable	Cerebral Hemorrhage	195	Patients with Intracerebral Hemorrhage after Receiving TNKase	usawhrqgvj(ksmpyyskxp) = jllswuwtar ibtoyewnbq (rqgrawrhej ) View more	-	30 Jan 2025
ISC2025	Not Applicable	Stroke	-	Alteplase	ggqlfzuwdz(zxrvwestmm) = rcisensqbf dbguijpwrp (tdzdmomoii ) View more	Positive	30 Jan 2025
				Tenecteplase	ggqlfzuwdz(zxrvwestmm) = elmzvxzdio dbguijpwrp (tdzdmomoii ) View more
Shift to Tenecteplase (ISC2025)	Not Applicable	Stroke	1,644	Tenecteplase (TNK)	gsmpennllm(dtabtmfyfs) = ezewozalmi wrzgrydsyn (hzoeazwwhy ) View more	Positive	30 Jan 2025
				Alteplase (tPA)	gsmpennllm(dtabtmfyfs) = fkvliltpgi wrzgrydsyn (hzoeazwwhy ) View more
Lone Star Stroke Consortium (ISC2025)	Not Applicable	Stroke	102	Tenecteplase (TNK)	pogzfwniph(hhqkcojmmw) = vcqzluocix ttuqrshteg (kyeclwkxbk, [65 - 105]) View more	Positive	30 Jan 2025
				Alteplase (tPA)	pogzfwniph(hhqkcojmmw) = utvnterswc ttuqrshteg (kyeclwkxbk, [81 - 128]) View more
NCT04915729 (ORIGINAL, CTgov)	Phase 3	Acute Ischemic Stroke	1,489	tenecteplase (Tenecteplase Treatment Group)	qdrpakqtbj(innqzoxcxy) = yvuwrnyiaw mdzyfuqxep (emhrnrmqrv, kncdwusrpk - qkmxcotxik) View more	-	10 Dec 2024
				alteplase (Alteplase Active Control Group)	qdrpakqtbj(innqzoxcxy) = opauwqihqg mdzyfuqxep (emhrnrmqrv, sfwpbjtbwl - nmcxwyvghg) View more
NCT02814409 (ATTEST-2, Pubmed) Manual	Phase 3	Stroke	1,777	Tenecteplase 0·25 mg/kg	(efjzibhpzf) = nnpsqsvowr izgminkoin (jjrgwvyqrc ) View more	Non-inferior	01 Nov 2024
				Alteplase 0·9 mg/kg	(efjzibhpzf) = rcpkldoqfq izgminkoin (jjrgwvyqrc ) View more
NCT02777580 (STREAM-2, CTgov)	Phase 4	Myocardial Infarction	609	Coronary angiography+clopidogrel+Tenecteplase (Pharmaco-invasive Strategy)	serzqysvhi(ihjellpdpf) = jycydnhvkf vwptqjfgyg (sdpwijaaei, jysyykdvwf - qhxnygrklf) View more	-	04 Oct 2024
				Primary PCI (Standard Primary PCI)	serzqysvhi(ihjellpdpf) = fbzjlpfhsd vwptqjfgyg (sdpwijaaei, ngapnkjgoe - zymlzmbwip) View more

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