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Metalyse
Metalyse is a Biologic drug developed by AO GENERIUM. It is currently in Phase 3 development for Acute myocardial infarction, Ankylosing spondylitis. Also known as: Tenecteplase.
Metalyse is a thrombolytic drug used to treat conditions such as acute ischemic stroke, stroke, and myocardial infarction. It is an exogenous protein that works by activating tissue-type plasminogen activator, an enzyme that breaks down blood clots.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Metalyse |
|---|---|
| Also known as | Tenecteplase |
| Sponsor | AO GENERIUM |
| Target | Plasminogen |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
- Acute myocardial infarction
- Ankylosing spondylitis
Common side effects
Key clinical trials
- Neuronavigation-assisted Stereotactic Minimally Invasive Puncture With Tenecteplase for Acute Lobar Intracerebral Hemorrhage (PHASE3)
- Low-Dose Tenecteplase for Acute Ischemic Stroke Treatment in Aging Patients (PHASE4)
- Efficacy and Safety of Intra-arterial Tenecteplase in Acute Ischemic Stroke Patients With Medium Vessel Occlusion Stroke (DATE-MeVO) (PHASE3)
- Tenecteplase Before Interhospital Transfer in Acute Basilar Artery Occlusion at 4.5 to 24 Hours (PHASE4)
- Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours (PHASE3)
- Precision Reperfusion Therapy for Disabling Minor Stroke With Large Vessel Occlusion Beyond Time Window (PHASE3)
- A Study to Test if Tenecteplase Helps People to Recover From an Acute Stroke When Given More Than 4.5 Hours After the Person Was Last Seen Well (PHASE3)
- Unknown Time of Onset Stroke RePerfusIon Without Advanced Imaging (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Metalyse CI brief — competitive landscape report
- Metalyse updates RSS · CI watch RSS
- AO GENERIUM portfolio CI
Frequently asked questions about Metalyse
What is Metalyse?
What is Metalyse used for?
Who makes Metalyse?
Is Metalyse also known as anything else?
What development phase is Metalyse in?
What does Metalyse target?
Related
- Target: All drugs targeting Plasminogen
- Manufacturer: AO GENERIUM — full pipeline
- Therapeutic area: All drugs in Other
- Indication: Drugs for Acute myocardial infarction
- Indication: Drugs for Ankylosing spondylitis
- Also known as: Tenecteplase
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing