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Thromboelastography
Thromboelastography is a Biologic drug developed by University Hospital, Caen. It is currently in Phase 2 development.
Thromboelastography is a method of testing the efficiency of blood coagulation, primarily used in surgery, anesthesiology, and emergency departments. It is used to assess coagulation profiles in various conditions, including coagulation disorders, cirrhosis, liver disease, variceal hemorrhage, and burns.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Thromboelastography |
|---|---|
| Sponsor | University Hospital, Caen |
| Modality | Biologic |
| Therapeutic area | Cardiovascular |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Bleeding Management İn Open Heart Surgery (NA)
- Thrombo-Elastography Guided Management of ECMO
- Characterising the Loss of Haemostasis in Haemorrhagic Fever With Renal Syndrome
- Validation of Point-of-care Thromboelastography (TEG 6s) in Pediatric Patients (NA)
- Platelet Transfusion and Repeat TEG-PM in Patients With Severe TBI on Antiplatelet Therapy (Repeat TEG-PM)
- DDAVP Effect by TEG6 in Cardiac Surgery
- Venous Thromboembolism in Myotonic Dystrophy Type 1 (NA)
- Evaluation of the Effectiveness of Prophylactic LMWH by Thromboelastography
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:
- Thromboelastography CI brief — competitive landscape report
- Thromboelastography updates RSS · CI watch RSS
- University Hospital, Caen portfolio CI
Frequently asked questions about Thromboelastography
What is Thromboelastography?
Who makes Thromboelastography?
What development phase is Thromboelastography in?
Related
- Manufacturer: University Hospital, Caen — full pipeline
- Therapeutic area: All drugs in Cardiovascular
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing