BENAZEPRIL HYDROCHLORIDE · HERITAGE PHARMA
Benazepril hydrochloride tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs.
Details
- Status
- Prescription
- First Approved
- 1991-06-25
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
BENAZEPRIL HYDROCHLORIDE Approval History
What BENAZEPRIL HYDROCHLORIDE Treats
1 indicationsBENAZEPRIL HYDROCHLORIDE is approved for 1 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
BENAZEPRIL HYDROCHLORIDE Boxed Warning
FETAL TOXICITY When pregnancy is detected, discontinue benazepril hydrochloride tablets as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions ( 5.1 )]. WARNING-FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue benazepril hydrochloride tablets as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin s...
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue benazepril hydrochloride tablets as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions ( 5.1 )]. WARNING-FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue benazepril hydrochloride tablets as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 )
BENAZEPRIL HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in BENAZEPRIL HYDROCHLORIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications BENAZEPRIL HYDROCHLORIDE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to BENAZEPRIL HYDROCHLORIDE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01234922 results posted | IRB00014933 NCI-2010-02043, IRB00014933 | Ph 2 | terminated | Benazepril Hydrochloride, Lisinopril, Ramipril, or Losartan Potassium in Treating Hypertension in Patients With Solid Tumors |
| NCT01095939 RPPEC | 09-136 | Ph 3 | completed | Post-preeclampsia Renal Project: Study of Nephroprotection in Women Having Suffered Preeclampsia |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
BENAZEPRIL HYDROCHLORIDE FDA Label Details
Indications & Usage
Benazepril hydrochloride tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therap...
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue benazepril hydrochloride tablets as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions ( 5.1 )]. WARNING-FETAL TOXICITY See ...
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LOTENSIN
Full clinical data, patents, trials, and competitive landscape for benazepril hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.