Last reviewed 2026-05-29 · How we verify

Topical tranexamic acid

Topical tranexamic acid is a Antifibrinolytic agent Small molecule drug developed by Aswan University Hospital. It is currently FDA-approved for Topical hemostasis and reduction of bleeding in dermatological procedures, Melasma and post-inflammatory hyperpigmentation (off-label use), Rosacea and vascular lesions (investigational). Also known as: active comparator, Active Comparator, experimental, TXA group.

Topical tranexamic acid inhibits fibrinolysis by blocking plasminogen activation, reducing bleeding and promoting hemostasis at the site of application.

Topical tranexamic acid has been studied as a treatment for various conditions, including postoperative blood loss, hematoma, and venous thromboembolism, as well as for cosmetic conditions such as melasma and skin hyperpigmentation after total hip arthroplasty. It has been tested in clinical trials using different formulations, including 3% topical tranexamic acid, compared to placebo or other interventions.

At a glance

Mechanism of action

Tranexamic acid is an antifibrinolytic agent that competitively inhibits the conversion of plasminogen to plasmin, thereby reducing fibrin degradation and clot breakdown. When applied topically, it localizes to the wound or affected tissue surface, reducing bleeding and oozing. This mechanism is particularly useful in dermatology for conditions involving abnormal bleeding, vascular lesions, or post-procedural hemostasis.

Approved indications

• Topical hemostasis and reduction of bleeding in dermatological procedures
• Melasma and post-inflammatory hyperpigmentation (off-label use)
• Rosacea and vascular lesions (investigational)

Common side effects

• Local irritation or erythema
• Allergic contact dermatitis
• Minimal systemic absorption with topical application

Key clinical trials

• Comparative Evaluation of Topical Metformin and Topical Tranexamic Acid in Melasma (NA)
• A Trial of Intraoperative Fibrin Sealant on Postoperative Recovery After Total Knee Replacement (PHASE4)
• Evaluation of the Efficacy of Oral Tranexamic Acid and Glutathione-assisted Microneedling in Treatment of Melasma (PHASE2, PHASE3)
• "Topical Tranexamic Acid With Flap Fixation: A Novel Approach to Minimize Post-operative Drainage and Surgical Site Infection in Patients Undergoing Modified Radical Mastectomy" (NA)
• Topical Tranexamic Acid to Reduce Blood Loss During Cesarean Delivery (EARLY_PHASE1)
• Effect of Intravenous and Topical Tranexamic Acid on Drain Output in Breast Reduction Surgery (PHASE4)
• Protest Trial: TXA vs Saline (PHASE3)
• A Randomized Control Trial Assessing the Effect of Topical Tranexamic Acid on Risk of Hematoma in Breast Surgery (PHASE4)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Topical tranexamic acid CI brief — competitive landscape report
• Topical tranexamic acid updates RSS · CI watch RSS
• Aswan University Hospital portfolio CI

Frequently asked questions about Topical tranexamic acid

Related

• Drug class: All Antifibrinolytic agent drugs
• Target: All drugs targeting Plasminogen / Plasmin
• Manufacturer: Aswan University Hospital — full pipeline
• Therapeutic area: All drugs in Dermatology
• Indication: Drugs for Topical hemostasis and reduction of bleeding in dermatological procedures
• Indication: Drugs for Melasma and post-inflammatory hyperpigmentation (off-label use)
• Indication: Drugs for Rosacea and vascular lesions (investigational)
• Also known as: active comparator, Active Comparator, experimental, TXA group, Topical transamine

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