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Lotensin (BENAZEPRIL)
Lotensin (BENAZEPRIL) is an Angiotensin Converting Enzyme Inhibitor (ACE inhibitor) small molecule developed by US PHARMS HOLDINGS I and currently owned by Validus Pharms. It targets the angiotensin-converting enzyme to treat hypertensive disorders. Lotensin was FDA approved in 1991 and is now off-patent with 12 generic manufacturers. As an ACE inhibitor, it works by blocking the conversion of angiotensin I to angiotensin II, a potent vasoconstrictor, thereby lowering blood pressure. It has a bioavailability of 18%.
At a glance
| Generic name | BENAZEPRIL |
|---|---|
| Sponsor | Validus Pharms |
| Drug class | Angiotensin Converting Enzyme Inhibitor |
| Target | Angiotensin-converting enzyme |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1991 |
Approved indications
- Hypertensive disorder
Boxed warnings
- 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 )
Common side effects
- headache
- dizziness
- somnolence
- nausea
- pancreatitis
- constipation
- gastritis
- vomiting
- melena
- thrombocytopenia
- hemolytic anemia
- anxiety
Drug interactions
- bumetanide
- ethacrynic acid
- furosemide
- indomethacin
- lithium
- potassium acetate
- potassium chloride
- potassium citrate
- potassium gluconate
- potassium hydrogencarbonate
- spironolactone
- triamterene
Key clinical trials
- Bioequivalence Study of Sacubitril Alisartan Amlodipine Tablets (PHASE1)
- Study of Hydroxychloroquine in Patients With X-linked Alport Syndrome in China (CHXLAS) (PHASE2)
- Association of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Post-Stroke Pneumonia: A Real-World Retrospective Cohort Study
- Centrally Acting ACE Inhibition in SLE (PHASE2)
- Effect of Sacubitril/Valsartan on Cardiac Function in Hypertensive Patients Stratified by BMI: A Real World Study
- Amlodipine-Benazepril 10mg-20mg Capsules in Healthy Subjects Under Fasting Conditions (PHASE1)
- Amlodipine-Benazepril 10mg-20mg Capsules in Healthy Subjects Under Fed Conditions (PHASE1)
- Benazepril HCl 40 mg Tablets, Fasting (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Lotensin CI brief — competitive landscape report
- Lotensin updates RSS · CI watch RSS
- Validus Pharms portfolio CI