TheraRadar
Data updated: May 26, 2026

TIROFIBAN HYDROCHLORIDE

Cardiovascular Approved 2021-04-08

Tirofiban hydrochloride

Source: FDA Label • NEXUS

How TIROFIBAN HYDROCHLORIDE Works

This drug works by blocking fibrinogen from binding to the GP IIb/IIIa receptor, which is the primary receptor on the surface of platelets responsible for clumping. By interfering with this binding process, the medication inhibits platelet aggregation in a way that depends on the dose and concentration. The effect is reversible, meaning platelet function returns to normal once the infusion is stopped.

Source: FDA Label
4
Indications
--
Phase 3 Trials
5
Years on Market

Details

Status
Prescription
First Approved
2021-04-08
Routes
INTRAVENOUS
Dosage Forms
SOLUTION

TIROFIBAN HYDROCHLORIDE Approval History

2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
7 FDA actions from 2021 to 2023
Jul 2023 ORIGINAL
Update
May 2023 ORIGINAL
Update
Feb 2023 ORIGINAL
Update

What TIROFIBAN HYDROCHLORIDE Treats

1 indications

TIROFIBAN HYDROCHLORIDE is approved for 1 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Acute Coronary Syndrome
Source: FDA Label

TIROFIBAN HYDROCHLORIDE Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Unlock 8 more competitors across all three rings.
Upgrade to Pro

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to TIROFIBAN HYDROCHLORIDE

3 of 8

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

AGGRASTAT
TIROFIBAN HYDROCHLORIDE
1 shared
MEDICURE
Shared indications:
Acute Coronary Syndrome
BRILINTA
TICAGRELOR
1 shared
AstraZeneca
Shared indications:
Acute Coronary Syndrome
EFFIENT
PRASUGREL HYDROCHLORIDE
1 shared
COSETTE
Shared indications:
Acute Coronary Syndrome
📋

Clinical Trial Registry

3 trials
Trial Sponsor ID Phase Status Title
NCT05604638 INSTANT SecondAHGuangxiMU Ph 3 recruiting Early Administration of Tirofiban in Patients Treated With Tenecteplase for Acute Ischemic Stroke
NCT06587347 TREND-2 TREND-2 Ph 2, Ph 3 not yet recruiting Tirofiban for the Prevention of Early Neurological Deterioration After Intravenous Thrombolysis in Acute Ischemic Stroke
NCT04818944 iTREMT 202010341 Ph 1, Ph 2 withdrawn Clinical Trial to Evaluate the Safety of Continuous IV Tirofiban in Acute Ischemic Stroke
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

Full development history with FDA approval milestones

|
Loading...
Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

TIROFIBAN HYDROCHLORIDE FDA Label Details

Indications & Usage

TIROFIBAN HYDROCHLORIDE is indicated for the treatment of Acute Coronary Syndrome.

Looking for the branded version?

AGGRASTAT

Full clinical data, patents, trials, and competitive landscape for tirofiban hydrochloride.

See AGGRASTAT

Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.