TROGARZO

(Ibalizumab)

PreclinicalMonoclonal antibody

TTheratechnologies

TROGARZO is one of 45 small molecule programs targeting HIV infection. It is currently in Preclinical.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

HIV InfectionActive, not recruiting

HIV InfectionPreclinical

Active, not recruiting

Competition

Competitive Landscape

326 competitors in HIV Infection

#DrugCompanyPhaseTrials

Leukine

Sanofi

Phase 3

2 2

Hivid

CConrado Roberto Hoffmann Filho

Phase 3

9 3

Intron a

Merck & Co.

Phase 3

1 4

Sunlenca

Gilead

Phase 3

1 5

Praluent

Regeneron

Phase 3

1 6

PEG-Intron

Megace

Betaseron

Isentress

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Phase 3

3 10

Proleukin

IIovance Biotherapeutics, Inc.

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

HIV infection1 trial

Compassionate Use of Ibalizumab for the Treatment of HIV Infection

No longer available·UUniversity of Colorado, Denver··NCT02028819

Drug1 trial

Ibalizumab Plus Optimized Background Regimen in Patient With Multi-Drug Resistant HIV

Completed·TTaiMed Biologics Inc.·Phase 3·NCT02475629·40 enrolled

Treatment1 trial

Ibalizumab Plus Optimized Background Regimen in Treatment-Experienced Patients With Multi-Drug Resistant HIV-1

Completed·TTaiMed Biologics Inc.·Phase 3·NCT02707861·79 enrolled

Monoclonal1 trial

Dose-Response Study of Ibalizumab (Monoclonal Antibody) Plus Optimized Background Regimen in Patients With HIV-1

Completed·TTaiMed Biologics Inc.·Phase 2·NCT00784147·113 enrolled

Trial1 trial

External Comparison of Ibalizumab in Trials vs. Other Regimens in OPERA

Completed·EEpividian··NCT05495204·141 enrolled

Regulatory

FDA Approval Timeline[4]

Mar 6, 2018

TROGARZO

BLA BLA761065

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for Ibalizumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ibalizumab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Ibalizumab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761065). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Theratechnologies company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Monoclonal antibody[2]
Highest Phase: Preclinical[1]
Company: TTheratechnologies

TROGARZO

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

HIV infection1 trial

Drug1 trial

Treatment1 trial

Monoclonal1 trial

Trial1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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