Last reviewed 2026-04-23 · How we verify

Freezed-dried plasma

University Hospital, Lille · Phase 3 active Small molecule

Freezed-dried plasma is a Blood product / Hemostatic agent Small molecule drug developed by University Hospital, Lille. It is currently in Phase 3 development for Acute bleeding due to coagulation factor deficiency, Massive transfusion protocol support, Reversal of anticoagulation in emergency settings.

Freeze-dried plasma reconstitutes fresh frozen plasma to restore coagulation factors and hemostatic function in patients with bleeding or coagulopathy.

Freeze-dried plasma reconstitutes fresh frozen plasma to restore coagulation factors and hemostatic function in patients with bleeding or coagulopathy. Used for Acute bleeding due to coagulation factor deficiency, Massive transfusion protocol support, Reversal of anticoagulation in emergency settings.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	Freezed-dried plasma
Sponsor	University Hospital, Lille
Drug class	Blood product / Hemostatic agent
Modality	Small molecule
Therapeutic area	Hematology / Hemostasis
Phase	Phase 3

Mechanism of action

Freeze-dried plasma is a lyophilized form of human plasma that contains all vitamin K-dependent coagulation factors (II, V, VII, X), fibrinogen, and other plasma proteins. Upon reconstitution with sterile water, it restores hemostatic capacity in patients with factor deficiencies, massive transfusion, or coagulopathy. It serves as an alternative to fresh frozen plasma with improved shelf-life and storage stability.

Approved indications

Acute bleeding due to coagulation factor deficiency
Massive transfusion protocol support
Reversal of anticoagulation in emergency settings

Common side effects

Thromboembolic events
Transfusion-related acute lung injury (TRALI)
Allergic reactions
Infection transmission risk

Key clinical trials

Freeze-dried Plasma in the Initial Management of Coagulopathy in Trauma Patients (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:

Freezed-dried plasma CI brief — competitive landscape report
Freezed-dried plasma updates RSS · CI watch RSS
University Hospital, Lille portfolio CI

Frequently asked questions about Freezed-dried plasma

What is Freezed-dried plasma?

Freezed-dried plasma is a Blood product / Hemostatic agent drug developed by University Hospital, Lille, indicated for Acute bleeding due to coagulation factor deficiency, Massive transfusion protocol support, Reversal of anticoagulation in emergency settings.

How does Freezed-dried plasma work?

Freeze-dried plasma reconstitutes fresh frozen plasma to restore coagulation factors and hemostatic function in patients with bleeding or coagulopathy.

What is Freezed-dried plasma used for?

Freezed-dried plasma is indicated for Acute bleeding due to coagulation factor deficiency, Massive transfusion protocol support, Reversal of anticoagulation in emergency settings.

Who makes Freezed-dried plasma?

Freezed-dried plasma is developed by University Hospital, Lille (see full University Hospital, Lille pipeline at /company/university-hospital-lille).

What drug class is Freezed-dried plasma in?

Freezed-dried plasma belongs to the Blood product / Hemostatic agent class. See all Blood product / Hemostatic agent drugs at /class/blood-product-hemostatic-agent.

What development phase is Freezed-dried plasma in?

Freezed-dried plasma is in Phase 3.

What are the side effects of Freezed-dried plasma?

Common side effects of Freezed-dried plasma include Thromboembolic events, Transfusion-related acute lung injury (TRALI), Allergic reactions, Infection transmission risk.

Drug class: All Blood product / Hemostatic agent drugs
Manufacturer: University Hospital, Lille — full pipeline
Therapeutic area: All drugs in Hematology / Hemostasis
Indication: Drugs for Acute bleeding due to coagulation factor deficiency
Indication: Drugs for Massive transfusion protocol support
Indication: Drugs for Reversal of anticoagulation in emergency settings

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