LOTENSIN (benazepril hydrochloride)
Lotensin treats high blood pressure, which helps patients reduce their risk of suffering from strokes or heart attacks. It is used as part of a comprehensive approach to cardiovascular health that may also include managing cholesterol and diabetes. By lowering blood pressure, this medication helps prevent fatal and nonfatal cardiovascular events.
How LOTENSIN Works
Lotensin works by inhibiting the enzyme that converts angiotensin I into angiotensin II, a substance that normally narrows blood vessels. By reducing the amount of angiotensin II, the drug decreases vessel constriction and lowers the secretion of aldosterone. This process helps lower blood pressure, even in patients who have low levels of renin.
Details
- Status
- Prescription
- First Approved
- 1991-06-25
- Routes
- ORAL
- Dosage Forms
- TABLET
LOTENSIN Approval History
What LOTENSIN Treats
1 indicationsLOTENSIN is approved for 1 conditions since its original approval in 1991. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
LOTENSIN Boxed Warning
FETAL TOXICITY When pregnancy is detected, discontinueLotensin as soon as possible. Drugs thatactdirectlyon the renin-angiotensin system can causeinjury and death to the developing fetus [see Warnings and Precautions (5.1) ] . WARNING-FETAL TOXICITY See full prescribinginformation forcomplete boxed warning. When pregnancyis detected, discontinue Lotensin 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 ...
WARNING: FETAL TOXICITY When pregnancy is detected, discontinueLotensin as soon as possible. Drugs thatactdirectlyon the renin-angiotensin system can causeinjury and death to the developing fetus [see Warnings and Precautions (5.1) ] . WARNING-FETAL TOXICITY See full prescribinginformation forcomplete boxed warning. When pregnancyis detected, discontinue Lotensin 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 )
LOTENSIN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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 LOTENSIN's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications LOTENSIN treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to LOTENSIN
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07547878 RAPID-CKD | 026-271 | Ph 4 | not yet recruiting | Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD) |
| 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.
LOTENSIN FDA Label Details
Indications & Usage
FDA Label (PDF)LOTENSIN is indicated for the treatment of Hypertension.
WARNING: FETAL TOXICITY When pregnancy is detected, discontinueLotensin as soon as possible. Drugs thatactdirectlyon the renin-angiotensin system can causeinjury and death to the developing fetus [see Warnings and Precautions (5.1) ] . WARNING-FETAL TOXICITY See full prescribinginformation forcomple...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.