Last reviewed 2026-05-27 · How we verify

Thromboelastograpgy

University Hospital, Caen · Phase 2 active Biologic ✓ Verified May 2026

Thromboelastograpgy is a Biologic drug developed by University Hospital, Caen. It is currently in Phase 2 development.

Thromboelastography is a medical intervention used to study conditions such as Hemophilia A. It has been evaluated in a completed clinical trial (NCT02911233) to assess its effects on clot stability.

Likelihood of approval

13.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	Thromboelastograpgy
Sponsor	University Hospital, Caen
Modality	Biologic
Therapeutic area	Cardiovascular
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Evaluation of Clot Stability Induced by Solulin: Evaluation of New Solulin Mutants Lacking Protein C Activation Capacity

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:

Thromboelastograpgy CI brief — competitive landscape report
Thromboelastograpgy updates RSS · CI watch RSS
University Hospital, Caen portfolio CI

Frequently asked questions about Thromboelastograpgy

What is Thromboelastograpgy?

Thromboelastograpgy is a Biologic drug developed by University Hospital, Caen.

Who makes Thromboelastograpgy?

Thromboelastograpgy is developed by University Hospital, Caen (see full University Hospital, Caen pipeline at /company/university-hospital-caen).

What development phase is Thromboelastograpgy in?

Thromboelastograpgy is in Phase 2.

Manufacturer: University Hospital, Caen — full pipeline
Therapeutic area: All drugs in Cardiovascular

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing