Last reviewed 2026-05-14 · How we verify

French Lyophilized Plasma

French Defence Health Service · Phase 3 active Biologic

French Lyophilized Plasma is a Plasma product / Hemostatic agent Biologic drug developed by French Defence Health Service. It is currently in Phase 3 development for Massive hemorrhage and coagulopathy, Acute bleeding in patients with multiple clotting factor deficiencies, Perioperative hemostatic support.

French Lyophilized Plasma replaces clotting factors and other plasma proteins to restore hemostatic function in patients with coagulopathy or massive hemorrhage.

French Lyophilized Plasma replaces clotting factors and other plasma proteins to restore hemostatic function in patients with coagulopathy or massive hemorrhage. Used for Massive hemorrhage and coagulopathy, Acute bleeding in patients with multiple clotting factor deficiencies, Perioperative hemostatic support.

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	French Lyophilized Plasma
Sponsor	French Defence Health Service
Drug class	Plasma product / Hemostatic agent
Modality	Biologic
Therapeutic area	Hematology / Hemostasis / Critical Care
Phase	Phase 3

Mechanism of action

This is a freeze-dried (lyophilized) human plasma product that contains multiple coagulation factors, fibrinogen, and other plasma proteins. When reconstituted, it restores the balance of clotting factors needed for normal hemostasis, making it useful in acute bleeding scenarios where specific factor replacement is not immediately available or where multiple factor deficiencies exist.

Approved indications

Massive hemorrhage and coagulopathy
Acute bleeding in patients with multiple clotting factor deficiencies
Perioperative hemostatic support

Common side effects

Transfusion-related acute lung injury (TRALI)
Allergic/anaphylactic reactions
Thromboembolic events
Fluid overload

Key clinical trials

Pre-hospital Administration of Lyophilized Plasma for Post-traumatic Coagulopathy Treatment (PREHO-PLYO) (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:

French Lyophilized Plasma CI brief — competitive landscape report
French Lyophilized Plasma updates RSS · CI watch RSS
French Defence Health Service portfolio CI

Frequently asked questions about French Lyophilized Plasma

What is French Lyophilized Plasma?

French Lyophilized Plasma is a Plasma product / Hemostatic agent drug developed by French Defence Health Service, indicated for Massive hemorrhage and coagulopathy, Acute bleeding in patients with multiple clotting factor deficiencies, Perioperative hemostatic support.

How does French Lyophilized Plasma work?

French Lyophilized Plasma replaces clotting factors and other plasma proteins to restore hemostatic function in patients with coagulopathy or massive hemorrhage.

What is French Lyophilized Plasma used for?

French Lyophilized Plasma is indicated for Massive hemorrhage and coagulopathy, Acute bleeding in patients with multiple clotting factor deficiencies, Perioperative hemostatic support.

Who makes French Lyophilized Plasma?

French Lyophilized Plasma is developed by French Defence Health Service (see full French Defence Health Service pipeline at /company/french-defence-health-service).

What drug class is French Lyophilized Plasma in?

French Lyophilized Plasma belongs to the Plasma product / Hemostatic agent class. See all Plasma product / Hemostatic agent drugs at /class/plasma-product-hemostatic-agent.

What development phase is French Lyophilized Plasma in?

French Lyophilized Plasma is in Phase 3.

What are the side effects of French Lyophilized Plasma?

Common side effects of French Lyophilized Plasma include Transfusion-related acute lung injury (TRALI), Allergic/anaphylactic reactions, Thromboembolic events, Fluid overload.

Drug class: All Plasma product / Hemostatic agent drugs
Manufacturer: French Defence Health Service — full pipeline
Therapeutic area: All drugs in Hematology / Hemostasis / Critical Care
Indication: Drugs for Massive hemorrhage and coagulopathy
Indication: Drugs for Acute bleeding in patients with multiple clotting factor deficiencies
Indication: Drugs for Perioperative hemostatic support

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