The study will randomize patients with acute ischemic stroke and Direct Oral AntiCoagulants (DOAC) ingestion within 48 hours from enrollment (but otherwise eligible for thrombolysis) to administration of intravenous tenecteplase vs. placebo (1:1).
Participants will be enrolled at NIH StrokeNet sites across the US and followed for 90-days.
The primary aim is to determine the efficacy of intravenous tenecteplase (TNK) vs placebo among acute ischemic stroke patients and to determine the safety of TNK among acute ischemic stroke patients within 4.5 hours of last known well who used DOAC within 48 hours prior to thrombolysis. Efficacy and safety endpoints will be the focus of this proposed Phase III study.

Start Date01 Jan 2027

Sponsor / Collaborator

Hackensack Meridian Health, Inc.

CTIS2026-525280-40-00

/ Not yet recruitingPhase 3

Tenecteplase for the treatment of acute stroke in the late time window before inter-hospital transfer for thrombectomy: a randomized controlled trial

Start Date01 Oct 2026

Sponsor / Collaborator

Fondation A de Rothschild

ChiCTR2600133714

/ Not yet recruitingNot ApplicableIIT

A Study on the Efficacy and Safety of Tissue Natriuretic Peptide (TNK) Combined with Hemoporphyrin Ultrasound-Driven Thrombolysis in the Treatment of Acute Intracranial Large Vessel Occlusion-Type Stroke (TNK-SDT)

Start Date01 Oct 2026

Sponsor / Collaborator

The Second Military Medical University

100 Clinical Results associated with Tenecteplase

100 Translational Medicine associated with Tenecteplase

100 Patents (Medical) associated with Tenecteplase

1,123

Literatures (Medical) associated with Tenecteplase

01 Dec 2026·AMERICAN JOURNAL OF EMERGENCY MEDICINE

Safety and efficacy of tenecteplase versus alteplase for acute ischemic stroke in a real-world patient population

Article

Author: Spalding, Trevor ; Leonhardt-Caprio, Ann ; Jones, Courtney M C ; Toole, Stephanie ; Uttaro, Elizabeth ; Acquisto, Nicole M ; Bishop, Rachel ; Weaver, Aaron ; Groth, Chistine M

PURPOSE:

We compared safety and efficacy of tenecteplase (TNK) and alteplase for acute ischemic stroke (AIS) in a real-world setting.

METHODS:

Retrospective, observational, study of adult AIS patients who received TNK or alteplase within 4.5 h of symptom onset from May 2020-June 2024. Primary outcome was symptomatic intracranial hemorrhage (sICH) occurrence. Secondary outcomes were major and minor bleeding occurrence, National Institutes of Health Stroke Scale (NIHSS) score changes, angioedema occurrence, modified Rankin Scale changes, length of stay, and mortality. Univariate and stratified analyses were conducted to assess bleeding differences and specifically in subpopulations often underrepresented in the literature (advanced age, minor strokes [NIHSS, < 5], and poor pre-stroke functional status).

RESULTS:

478 patients were included; 255 (53.2%) TNK and 223 (46.7%) alteplase (median age 72 years [IQR 61-83], 33% minor strokes [33%]). There were numerically more sICH and other major bleeding events in the TNK group; 3.9%, vs. 3.1%, p = 0.65 and 20.4% vs. 15.7%, p = 0.18, respectively, although not statistically significant. There were no differences in secondary outcomes. Age < 80 years and NIHSS ≥5 at presentation were associated with a bleeding event on stratified analysis, however not maintained in the logistic regression model.

CONCLUSIONS:

There were no statistically significant differences in safety or efficacy between TNK and alteplase for AIS. These results provide real-world experience especially in a large, older patient population, with relatively minor stroke. Type II error may limit findings. Research is needed to identify patient, stroke, or fibrinolytic agent related factors that may increase bleeding occurrence.

01 Dec 2026·Journal of Central Nervous System Disease

Immediate Brainstem Hemorrhage after Thrombolysis in Ischemic Stroke With Poorly Controlled Hypertension: Insights From Three Clinical Cases

Article

Author: Mei, Bin ; Yang, Niao ; Yan, Nao ; Sun, Dong ; Shen, Lei

Objective:

To report three cases of immediate brainstem hemorrhage following intravenous thrombolysis with tenecteplase (TNK) in patients with minor ischemic stroke, resulting in poor outcomes and death.

Methods:

We describe the clinical characteristics, imaging findings, and outcomes of three patients who developed brainstem parenchymal hemorrhage immediately after TNK thrombolysis.

Results:

All three patients had minor ischemic stroke (National Institute of Health stroke scale score ≤5) and presented with elevated blood pressure on admission. Blood pressure was lowered to guideline-recommended levels (<180 mmHg) using intravenous antihypertensives before thrombolysis. Despite rapid brain protection measures, including hematoma evacuation or external ventricular drainage in two cases and conservative management in one, all patients died due to brainstem hemorrhage.

Conclusion:

These cases suggest that fatal brainstem hemorrhage may occur after TNK thrombolysis in minor stroke. For patients with a history of poorly controlled hypertension, careful risk assessment and aggressive blood pressure management are critical if thrombolysis is considered.

01 Nov 2026·Radiology case reports

High-risk pulmonary embolism in the first trimester of pregnancy: Successful thrombolysis with tenecteplase

Article

Author: Zaid, Ikram ; Bouayed, Mohamed Zakaria ; Benaini, Iliass ; Laaribi, Llyass ; Bkiyar, Houssam

Pulmonary embolism is a rare but potentially life-threatening complication during pregnancy, and its diagnosis remains challenging because of nonspecific clinical manifestations that may overlap with other pregnancy-related conditions. We report the case of a 38-year-old pregnant woman who presented with bilateral pulmonary embolism associated with hemodynamic and respiratory instability. Computed tomography pulmonary angiography was performed to confirm the diagnosis despite concerns regarding fetal radiation exposure, and the patient subsequently received thrombolytic therapy with a favorable short-term outcome. This case highlights the critical role of imaging in the diagnosis of high-risk pulmonary embolism during pregnancy and emphasizes the importance of timely multidisciplinary management. Early recognition and appropriate treatment are essential to improve maternal and fetal outcomes in this potentially fatal condition.

News (Medical) associated with Tenecteplase

28 Sep 2026

·www.biospace.com

Pharmazz Completes Enrollment in 160-Patient Phase 4 Trial of Sovateltide in Acute Ischemic Stroke

Enrollment completed in the double-blind, placebo-controlled Phase 4 study ( NCT05955326 ) of sovateltide (Tycamzzi®), with final study data expected in Q1 2027 Five sovateltide abstracts accepted at World Stroke Congress, October 21-23, 2026, Seoul, South Korea, including an interim analysis of the Phase 4 trial Global Phase 3 RESPECT-ETB trial ( NCT05691244 ) actively enrolling and remains on track for topline data in early 2028 WILLOWBROOK, Ill., Sept. 28, 2026 (GLOBE NEWSWIRE) -- Pharmazz, Inc. ("Pharmazz" or the "Company"), a biopharmaceutical company developing novel therapeutics for critical care and neurovascular conditions, today announced that enrollment is complete in its 160-patient Phase 4 clinical study of sovateltide (Tycamzzi®) in patients with acute cerebral ischemic stroke in India. The Phase 4 study ( NCT05955326 ) is a post-approval commitment required by Indian regulators. The double-blind, placebo-controlled trial utilizes the same sovateltide dosing regimen, randomization, and 24-hour treatment window as the global Phase 3 RESPECT-ETB trial, and the same protocol and eligibility criteria as the Phase 3 study that supported approval in India. The primary endpoint is the proportion of patients with adverse events and serious adverse events. Key secondary endpoints measure Day 90 neurological recovery, functional independence, and disability using the National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS), and the Barthel Index. Final data are expected in Q1 2027. Pharmazz conducted a prespecified interim analysis in September 2025, when the first 80 patients reached the Day 90 endpoint, and presented those results at the International Stroke Conference 2026 in New Orleans. In that analysis, 92% of sovateltide-treated patients achieved an mRS score of 0 to 2 at Day 90, compared with 58% in the control arm (p=0.0004889). No drug-related adverse events were observed. "Dosing the final patient in our Phase 4 study marks an important milestone in our mission to address severe neurovascular conditions with high unmet medical needs," said Dr. Anil Gulati, M.D., Ph.D., Chairman and Chief Executive Officer of Pharmazz, Inc. "Acute ischemic stroke remains a leading cause of long-term disability worldwide, and treatment options are limited. The fact that Sovateltide has been used to treat more than 140,000 patients in India since launch provides empirical real-world evidence that the selective endothelin B receptor agonist is able to promote neurogenesis, angiogenesis, and neuronal survival. We are actively enrolling in our global Phase 3 RESPECT-ETB trial and look forward to reporting final data in early 2028." Upcoming Presentations at the 18 th World Stroke Congress Five presentations will be made on-site at the upcoming 18 th World Stroke Congress, taking place October 21-23, 2026, at the Convention & Exhibition Center, Seoul, South Korea. A meta-analysis assessing the effectiveness and safety of sovateltide in patients with acute ischemic stroke A global Phase III trial (RESPECT-ETB) to evaluate safety and effectiveness of sovateltide (Tycamzzi®) in ACIS patients Effect of sovateltide (Tycamzzi®) on the thrombolytic activity of alteplase and tenecteplase An interim analysis of multicentric, randomized Phase 4 clinical trial of sovateltide (Tycamzzi®) in AIS patients The development of sovateltide for cerebral ischemic stroke patients. About Sovateltide Sovateltide (IRL-1620) is a first-in-class endothelin-B receptor agonist that promotes neurogenesis, angiogenesis, and neuronal survival following acute hypoxic and ischemic insults. The drug is currently being evaluated in clinical programs for acute ischemic conditions. The Phase 3 RESPECT-ETB (ClinicalTrials.gov ID: NCT05691244 ) trial is being conducted at 57 sites in the US, Germany, Spain, and the UK, and is designed to enroll 514 stroke patients. In September 2026, the U.S. FDA granted Orphan Drug Designation to sovateltide for the treatment of neonatal hypoxic-ischemic encephalopathy. About Orphan Drug Designation The FDA's Orphan Drug Designation program provides orphan status to investigational drugs and biological products intended to safely and effectively treat, diagnose, or prevent rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation qualifies the sponsor for specific development incentives under the Orphan Drug Act, which may include tax credits for qualified clinical testing, exemptions from prescription drug user fees (PDUFA), and potential eligibility for seven years of market exclusivity in the U.S. upon regulatory approval for the designated indication. About Pharmazz, Inc. Pharmazz, Inc. is a biopharmaceutical company focused on developing and commercializing first-in-class therapies for critical care medicine. For more information, please visit Disclaimer: Statements in this "Document" describing the Company's objectives, projections, estimates, expectations, plans or predictions, or industry conditions or events may be "forward-looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance, or achievements could differ materially from those expressed or implied. The Company undertakes no obligation to update or revise forward-looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. Contacts: Pharmazz, Inc. Investors David Costello Media Shruti Gulati Tel +1 630 780 6087 Tel +1 630 780 6087 E mail david.costello@pharmazz.com E mail shruti.gulati@pharmazz.com

Phase 3Orphan Drug

14 Sep 2026

·www.biospace.com

Pharmazz, Inc. Receives U.S. FDA Orphan Drug Designation for Sovateltide for the Treatment of Neonatal Hypoxic-Ischemic Encephalopathy (NHIE)

U.S. FDA (Office of Orphan Products Development) grants Orphan Drug Designation for Sovateltide, a potential first-in-class therapy that could transform the treatment of Neonatal Hypoxic-Ischemic Encephalopathy Five sovateltide presentations scheduled at the 18 th World Stroke Congress, 21 to 23 October 2026, Seoul, South Korea. WILLOWBROOK, Ill., Sept. 14, 2026 (GLOBE NEWSWIRE) -- Pharmazz, Inc. ("Pharmazz" or the "Company"), a biopharmaceutical company developing novel therapeutics for critical care and neurovascular conditions, today announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation (ODD) to its investigational agent, sovateltide, for the treatment of neonatal hypoxic-ischemic encephalopathy (NHIE). Neonatal hypoxic-ischemic encephalopathy is a serious, life-threatening brain injury caused by oxygen deprivation and restricted cerebral blood flow around the time of birth. NHIE remains a major cause of acute neonatal mortality and chronic neurodevelopmental disabilities, including cerebral palsy, epilepsy, and cognitive impairment, with limited therapeutic interventions currently available. "Receiving Orphan Drug Designation from FDA for sovateltide in neonatal hypoxic-ischemic encephalopathy marks an important milestone in our mission to address severe neurovascular conditions with high unmet medical needs," said Dr. Anil Gulati, M.D., Ph.D., Chairman and Chief Executive Officer of Pharmazz, Inc. "NHIE presents a devastating burden for newborns and their families. Through its selective endothelin B receptor agonist pathway promoting neural regeneration, neurovascular repair, and neuroprotection, we believe sovateltide has strong potential to improve clinical outcomes for these vulnerable patients. We look forward to advancing our clinical development program in close communication with FDA." Presentations at the Eighteenth World Stroke Congress Five presentations will be made on-site at the upcoming 18 th World Stroke Congress, taking place 21–23 October 2026, at the Convention & Exhibition Center, Seoul, South Korea. A meta-analysis assessing the effectiveness and safety of sovateltide in patients with acute ischemic stroke A global Phase III trial (RESPECT-ETB) to evaluate safety and effectiveness of sovateltide (Tycamzzi ® ) in ACIS patients Effect of sovateltide (Tycamzzi ® ) on the thrombolytic activity of alteplase and tenecteplase An interim analysis of multicentric, randomized Phase 4 clinical trial of sovateltide (Tycamzzi ® ) in AIS patients The development of sovateltide for cerebral ischemic stroke patients. About Orphan Drug Designation The FDA's Orphan Drug Designation program provides orphan status to investigational drugs and biological products intended to safely and effectively treat, diagnose, or prevent rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation qualifies the sponsor for specific development incentives under the Orphan Drug Act, which may include tax credits for qualified clinical testing, exemptions from prescription drug user fees (PDUFA), and potential eligibility for seven years of market exclusivity in the U.S. upon regulatory approval for the designated indication. About Sovateltide Sovateltide (IRL-1620) is a first-in-class endothelin-B receptor agonist that promotes neurogenesis, angiogenesis, and neuronal survival following acute hypoxic and ischemic insults. The drug is currently being evaluated in clinical programs for acute ischemic conditions. The Phase 3 RESPECT-ETB (ClinicalTrials.gov ID: NCT05691244 ) trial is being conducted at 57 sites in the US, Germany, Spain, and the UK, and is designed to enroll 514 stroke patients. About Pharmazz, Inc. Pharmazz, Inc. is a biopharmaceutical company focused on developing and commercializing first-in-class therapies for critical care medicine. For more information, please visit Disclaimer: Statements in this "Document" describing the Company's objectives, projections, estimates, expectations, plans or predictions, or industry conditions or events may be "forward-looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance, or achievements could differ materially from those expressed or implied. The Company undertakes no obligation to update or revise forward-looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. Contacts: Pharmazz, Inc. Investors David Costello Media Shruti Gulati Tel +1 630 780 6087 Tel +1 630 780 6087 E mail david.costello@pharmazz.com E mail shruti.gulati@pharmazz.com

Phase 3Orphan Drug

25 Aug 2026

·allsci.com

Basking's BB-025 rapidly reverses stroke thrombolytic in Phase I study

Phase I data show that BB-025, the oligonucleotide reversal agent for North Carolina-based Basking Biosciences' investigational stroke thrombolytic BB-031, produced complete reversal of BB-031 activity within five minutes, with no serious adverse events and no treatment discontinuations, according to a press release. The result addresses a key uncertainty in Basking's paired-drug strategy: that a clinician-controlled antidote for BB-031 could work reliably and rapidly enough to be useful in acute stroke care. BB-031 is an RNA aptamer that selectively inhibits von Willebrand factor (vWF), a central mediator of platelet-rich thrombus formation under high arterial shear. By disrupting vWF rather than activating the plasminogen cascade — the mechanism underlying both of the currently approved thrombolytics, Activase (alteplase) and TNKase (tenecteplase) — BB-031 is designed to promote thrombus dissolution without triggering systemic fibrinolysis. BB-025 is a complementary oligonucleotide that specifically binds BB-031, neutralizing its activity on demand. In the first-in-human study, 60 adults received a single intravenous bolus of BB-025 at doses up to 12 mg/kg, either alone or following a single dose of BB-031 at doses up to 6 mg/kg. When administered after BB-031, BB-025 restored vWF activity and platelet function within five minutes. The reversal held at both 30-minute and five-hour post-BB-031 timepoints, supporting a durable effect across a clinically relevant window. No deaths, life-threatening treatment-emergent adverse events (TEAEs), or serious adverse events occurred, and no TEAE led to discontinuation. Bleeding events and infusion-related reactions were non-severe and transient. BB-031 itself was also generally well tolerated at doses up to 6 mg/kg. Neither alteplase nor tenecteplase has an approved reversal agent. When patients develop symptomatic intracranial hemorrhage following thrombolysis — the most feared complication — clinicians have no direct pharmacological antidote. Basking's company asserts that BB-025 would be the first clinically validated reversal agent for any thrombolytic in the acute ischemic stroke (AIS) setting, though that claim remains contingent on regulatory approval of both agents. The BB-025 Phase I data arrive as BB-031 advances through the RAISE trial, a multicenter, randomized, double-blind, placebo-controlled Phase II study enrolling patients with AIS who present within 24 hours of symptom onset — a window five to eight times wider than the three-to-four-and-a-half-hour label for approved fibrinolytics. Part A of RAISE was completed in 2025, and Part B, expanded to approximately 180 patients, is currently recruiting at sites across North America and Australia. Preclinical work published in July 2026 showed BB-031 restored blood flow more effectively than both alteplase and tenecteplase in a microfluidic model using blood from AIS patients, including in clots matured for three to six hours. Basking said it intends to incorporate BB-025 into the BB-031 AIS development program pending FDA discussions. The Phase I study was first initiated in November 2025, conducted in Australia. Detailed results will be presented at a future medical meeting. Spot something wrong? Report an issue with this article

Phase 1Clinical ResultPhase 2Oligonucleotide

100 Deals associated with Tenecteplase

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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.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Myocardial Ischemia	Phase 3	China	Boehringer Ingelheim GmbH	17 Feb 2026
Myocardial Ischemia	Phase 3	Argentina	Boehringer Ingelheim GmbH	17 Feb 2026
Myocardial Ischemia	Phase 3	Australia	Boehringer Ingelheim GmbH	17 Feb 2026
Myocardial Ischemia	Phase 3	Bulgaria	Boehringer Ingelheim GmbH	17 Feb 2026
Myocardial Ischemia	Phase 3	Greece	Boehringer Ingelheim GmbH	17 Feb 2026
Myocardial Ischemia	Phase 3	Hungary	Boehringer Ingelheim GmbH	17 Feb 2026
Myocardial Ischemia	Phase 3	India	Boehringer Ingelheim GmbH	17 Feb 2026
Myocardial Ischemia	Phase 3	Indonesia	Boehringer Ingelheim GmbH	17 Feb 2026
Myocardial Ischemia	Phase 3	Kazakhstan	Boehringer Ingelheim GmbH	17 Feb 2026
Myocardial Ischemia	Phase 3	Malaysia	Boehringer Ingelheim GmbH	17 Feb 2026

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05635786 (Pubmed \| Stroke)	Not Applicable	Stroke	319	Tenecteplase	hdyvdnttoz(wfsfxroals) = ddakdirxbo lkukmshnud (grdrhkdohh ) View more	Positive	10 Sep 2026
				Alteplase	hdyvdnttoz(wfsfxroals) = yjbsqtyepo lkukmshnud (grdrhkdohh ) View more
NCT05172934 (ALLY \| ALLY Pilot Trial, CTgov)	Phase 2	Ischemic stroke	20	intra-arterial tenecteplase	bcjxclhihi = zessgarllo cmspjsxctq (dulklitagz, uudcmjjpts - pgoocfendi) View more	-	06 Aug 2026
NCT03889249 (AcT, Pubmed \| J Am Heart Assoc)	Phase 3	Ischemic stroke	1,577	Tenecteplase	mxhclbgrit(djaqazexgt) = cazjmdkkba mjmbcgyhiv (hzircqlofy ) View more	Positive	16 Jun 2026
				Alteplase	mxhclbgrit(djaqazexgt) = uvnitlktub mjmbcgyhiv (hzircqlofy ) View more
AAN2026	Not Applicable	Acute Ischemic Stroke	110	Alteplase	yewvgfjuai(rkjjpirmqf) = znyqzqwkvg prnusfajcd (bcgibdtcbp ) View more	Positive	25 Apr 2026
				Tenecteplase	yewvgfjuai(rkjjpirmqf) = bhiyhlrjfb prnusfajcd (bcgibdtcbp ) View more
AAN2026	Not Applicable	Acute Ischemic Stroke	124,944	Alteplase (DTN ≤60 minutes)	hdpflxayuj(pkrtsouwyg) = uidozmlplw qxprwbcwnl (ibvtlsdfci, 88.0)	Positive	25 Apr 2026
				Alteplase (DTN ≤90 minutes)	-
NCT05141305 (TRACE-3, Pubmed \| BMC Med)	Phase 3	Ischemic stroke	288	Tenecteplase	jjxcftoxdr(jwmqbwmyfb) = idqztkvtqd jdbcxvuykh (myvrskeabu )	Positive	16 Apr 2026
				Standard medical therapy	jjxcftoxdr(jwmqbwmyfb) = vgsvcrwdfu jdbcxvuykh (myvrskeabu )
NCT03889249 (AcT, Pubmed \| Stroke Vasc Interv Neurol)	Phase 3	Ischemic stroke	1,577	Tenecteplase	esifyyskhh(eqsvastsws) = glxcbtmmbf czfnmgtewo (ccpowribxj )	Positive	01 Mar 2026
				Alteplase	esifyyskhh(eqsvastsws) = yuhsuzbjva czfnmgtewo (ccpowribxj )
ISC2026	Not Applicable	Acute Ischemic Stroke	58	Tenecteplase (TNK)	xhoeasvirf(vikvzqbnhy) = sajhfzhtvq pycbpbuncv (enfykjyrnu ) View more	Positive	04 Feb 2026
ISC2026	Not Applicable	occlusions	74	Tenecteplase	dvuddjubjj(qhygssfhin) = xqgkfccqeb pdgsdmoomw (keqmsmmglq ) View more	Positive	04 Feb 2026
ISC2026	Not Applicable	-	908	Tenecteplase (TNK)	khjvjmfcup(cffynyyyxy): RD = -0.03 (95.0% CI, -0.14 to 0.09) View more	Positive	04 Feb 2026
				Alteplase (tPA)

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