Last reviewed 2026-06-03 · How we verify

Before CPB Tranexamic Acid

Hamilton Health Sciences Corporation · Phase 3 active Small molecule

Before CPB Tranexamic Acid is a Antifibrinolytic agent Small molecule drug developed by Hamilton Health Sciences Corporation. It is currently in Phase 3 development for Reduction of blood loss and transfusion requirements in patients undergoing cardiopulmonary bypass surgery. Also known as: Cyklokapron.

Tranexamic acid inhibits fibrinolysis by blocking plasminogen activation, reducing blood loss during cardiopulmonary bypass surgery.

Tranexamic acid inhibits fibrinolysis by blocking plasminogen activation, reducing blood loss during cardiopulmonary bypass surgery. Used for Reduction of blood loss and transfusion requirements in patients undergoing cardiopulmonary bypass surgery.

Likelihood of approval

56.3% 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).
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	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	Before CPB Tranexamic Acid
Also known as	Cyklokapron
Sponsor	Hamilton Health Sciences Corporation
Drug class	Antifibrinolytic agent
Target	Plasminogen / Plasmin
Modality	Small molecule
Therapeutic area	Cardiovascular / Surgery
Phase	Phase 3

Mechanism of action

Tranexamic acid is an antifibrinolytic agent that competitively inhibits the conversion of plasminogen to plasmin, thereby preventing the breakdown of fibrin clots. When administered before cardiopulmonary bypass (CPB), it reduces excessive bleeding and the need for blood transfusions during and after cardiac surgery by stabilizing formed clots.

Approved indications

Reduction of blood loss and transfusion requirements in patients undergoing cardiopulmonary bypass surgery

Common side effects

Thromboembolic events
Seizures
Renal dysfunction
Hypotension

Key clinical trials

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:

Before CPB Tranexamic Acid CI brief — competitive landscape report
Before CPB Tranexamic Acid updates RSS · CI watch RSS
Hamilton Health Sciences Corporation portfolio CI

Frequently asked questions about Before CPB Tranexamic Acid

What is Before CPB Tranexamic Acid?

Before CPB Tranexamic Acid is a Antifibrinolytic agent drug developed by Hamilton Health Sciences Corporation, indicated for Reduction of blood loss and transfusion requirements in patients undergoing cardiopulmonary bypass surgery.

How does Before CPB Tranexamic Acid work?

Tranexamic acid inhibits fibrinolysis by blocking plasminogen activation, reducing blood loss during cardiopulmonary bypass surgery.

What is Before CPB Tranexamic Acid used for?

Before CPB Tranexamic Acid is indicated for Reduction of blood loss and transfusion requirements in patients undergoing cardiopulmonary bypass surgery.

Who makes Before CPB Tranexamic Acid?

Before CPB Tranexamic Acid is developed by Hamilton Health Sciences Corporation (see full Hamilton Health Sciences Corporation pipeline at /company/hamilton-health-sciences-corporation).

Is Before CPB Tranexamic Acid also known as anything else?

Before CPB Tranexamic Acid is also known as Cyklokapron.

What drug class is Before CPB Tranexamic Acid in?

Before CPB Tranexamic Acid belongs to the Antifibrinolytic agent class. See all Antifibrinolytic agent drugs at /class/antifibrinolytic-agent.

What development phase is Before CPB Tranexamic Acid in?

Before CPB Tranexamic Acid is in Phase 3.

What are the side effects of Before CPB Tranexamic Acid?

Common side effects of Before CPB Tranexamic Acid include Thromboembolic events, Seizures, Renal dysfunction, Hypotension.

What does Before CPB Tranexamic Acid target?

Before CPB Tranexamic Acid targets Plasminogen / Plasmin and is a Antifibrinolytic agent.

Drug class: All Antifibrinolytic agent drugs
Target: All drugs targeting Plasminogen / Plasmin
Manufacturer: Hamilton Health Sciences Corporation — full pipeline
Therapeutic area: All drugs in Cardiovascular / Surgery
Indication: Drugs for Reduction of blood loss and transfusion requirements in patients undergoing cardiopulmonary bypass surgery
Also known as: Cyklokapron

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