LOTENSIN HCT (benazepril hydrochloride)
Lotensin HCT is a fixed-dose combination of benazepril, an ACE inhibitor, and hydrochlorothiazide, a thiazide diuretic, indicated for the management of hypertension. It is intended for patients whose blood pressure is not adequately controlled by monotherapy; per FDA labeling, it is not indicated for the initial therapy of hypertension.
How LOTENSIN HCT Works
Benazepril inhibits angiotensin-converting enzyme (ACE), blocking the conversion of angiotensin I to angiotensin II, a potent vasoconstrictor. This inhibition reduces systemic vascular resistance and decreases aldosterone secretion. Hydrochlorothiazide, a thiazide diuretic, inhibits sodium and chloride reabsorption in the distal convoluted tubules, increasing the excretion of sodium and water to reduce plasma volume. These complementary mechanisms lower blood pressure through both vasodilation and volume depletion.
Details
- Status
- Prescription
- First Approved
- 1992-05-19
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
LOTENSIN HCT Approval History
What LOTENSIN HCT Treats
1 indicationsLOTENSIN HCT is approved for 1 conditions since its original approval in 1992. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
LOTENSIN HCT Boxed Warning
FETAL TOXICITY When pregnancy is detected, discontinue Lotensin HCT as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (see WARNINGS: Fetal Toxicity )....
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue Lotensin HCT as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (see WARNINGS: Fetal Toxicity ).
LOTENSIN HCT 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 HCT's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications LOTENSIN HCT treats. First-in-class if their pivotal trials read out positive.
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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.
LOTENSIN HCT FDA Label Details
Indications & Usage
FDA Label (PDF)LOTENSIN HCT is indicated for the treatment of Hypertension.
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue Lotensin HCT as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (see WARNINGS: Fetal Toxicity )....
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.