Tenecteplase is a Recombinant Enzyme owned by Genentech USA, and is involved in 33 clinical trials, of which 19 were completed, 11 are ongoing, and 3 are planned.

Tenecteplase (RG-3625) is a recombinant fibrin-specific plasminogen activator that is derived from native tissue plasminogen activator (tPA) by modifications at three sites of the protein structure. It binds to the fibrin component of the thrombus (blood clot) and selectively converts thrombus-bound plasminogen to plasmin, which degrades the fibrin matrix of the thrombus. Tenecteplase has a higher fibrin specificity and greater resistance to inactivation by its endogenous inhibitor (PAI-1) compared to native t-PA.

The revenue for Tenecteplase is expected to reach a total of $23.5bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Tenecteplase NPV Report.

Tenecteplase is originated and owned by Genentech USA. F. Hoffmann-La Roche is the other company associated in development or marketing of Tenecteplase.

Tenecteplase Overview

Tenecteplase (Metalyse, Tnkase) is a fibrin-specific plasminogen activator. It is formulated as powder for solution for intravenous route of administration. It is indicated in adults for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left Bundle Branch Block within 6 hours after the onset of acute myocardial infarction (AMI) symptoms.

Tenecteplase (RG-3625) is under development for the treatment of acute ischemic stroke and Coronavirus disease 2019 (COVID-19) associated with acute respiratory failure. It was also under development for the treatment of pulmonary embolism and for restoration of function in dysfunctional hemodialysis (HD) catheters and acute respiratory distress syndrome. It is administered through intraarterial route.

F. Hoffmann-La Roche Overview

F. Hoffmann-La Roche (Roche) is a biotechnology company that develops drugs and diagnostics to treat major diseases. It provides medicines for the treatment of cancer, other auto-immune diseases, central nervous system disorders, ophthalmological disorders, infectious diseases, and respiratory diseases. The company also offers in vitro diagnostics, tissue-based cancer diagnostics, and diabetes management solutions. Roche conducts research to identify novel methods to prevent, diagnose, and treat diseases. The company offers its products and services to hospitals, commercial laboratories, healthcare professionals, researchers, and pharmacists. Together with its subsidiaries and partners, the company has operations in various countries. Roche is headquartered in Basel, Switzerland.

The company reported revenues of (Swiss Francs) CHF62,801 million for the fiscal year ended December 2021 (FY2021), an increase of 7.7% over FY2020. In FY2021, the company’s operating margin was 28.9%, compared to an operating margin of 31.8% in FY2020. In FY2021, the company recorded a net margin of 22.2%, compared to a net margin of 24.5% in FY2020.

Quick View – Tenecteplase

Report Segments
  • Innovator (NME)
Drug Name
  • Tenecteplase
Administration Pathway
  • Intraarterial
  • Intravenous
Therapeutic Areas
  • Cardiovascular
  • Infectious Disease
  • Respiratory
Key Companies
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.