TROGARZO
PeakmAbibalizumab
BLAINJECTIONINJECTABLEPriority Review
Approved
Mar 2018
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
4/8 — Partial
Priority Review
TROGARZO (ibalizumab) is cd4-directed antibody interactions [moa]. First approved in 2018.
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TROGARZO (ibalizumab) is a monoclonal antibody that functions as a CD4-directed blocking antibody, approved by the FDA on March 6, 2018. It is indicated for treatment-experienced patients with HIV-1 infection and represents a novel mechanism of action by targeting CD4 receptor interactions on immune cells. The drug is administered via injection and is positioned for patients with limited treatment options due to drug resistance or intolerance to existing antiretroviral therapies.
$0.0BPart D
Mechanism of Action
CD4-directed Antibody Interactions
Pharmacologic Class:
CD4-directed Blocking Antibody
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
Study of the Safety of Trogarzo™ Administered as an Undiluted "IV Push" or an Intramuscular Injection
Started May 2019
43 enrolled
HIV-1-infection
Ibalizumab Plus Optimized Background Regimen in Treatment-Experienced Patients With Multi-Drug Resistant HIV-1
Started Mar 2016
79 enrolled
HIV
Ibalizumab Plus Optimized Background Regimen in Patient With Multi-Drug Resistant HIV
Started Aug 2015
40 enrolled
HIV
Compassionate Use of Ibalizumab for the Treatment of HIV Infection
Started Jan 2012
Human Immunodeficiency Virus (HIV)
Safety Study of Ibalizumab Subcutaneous Injection in Healthy Volunteers
Started Feb 2011
25 enrolled
Prevention of Infection With HIV-1
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.