QBRELIS (lisinopril)
QBRELIS is indicated for the treatment of Hypertension; Heart Failure; Myocardial Infarction.
How QBRELIS Works
Lisinopril is an angiotensin-converting enzyme (ACE) inhibitor. It works by inhibiting the peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the potent vasoconstrictor angiotensin II. Reduction in angiotensin II leads to decreased vasopressor activity and decreased aldosterone secretion. Additionally, lisinopril inhibits the degradation of bradykinin (a vasodilatory peptide) because ACE is identical to kininase II, the enzyme responsible for bradykinin breakdown. These actions result in systemic vasodilation and a reduction in blood pressure.
Details
- Status
- Prescription
- First Approved
- 2016-07-29
- Patent Cliff
- 2035
- Routes
- ORAL
- Dosage Forms
- SOLUTION
QBRELIS Approval History
What QBRELIS Treats
3 indicationsQBRELIS is approved for 3 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
- Heart Failure
- Myocardial Infarction
QBRELIS Boxed Warning
FETAL TOXICITY When pregnancy is detected, discontinue QBRELIS as soon as possible [see Warnings and Precautions ( 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 QBRELIS as soon as possible ( 5.1 ). Drugs that act directly on the renin-angiotensin system can cause ...
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue QBRELIS as soon as possible [see Warnings and Precautions ( 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 QBRELIS 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 ).
QBRELIS 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 QBRELIS's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications QBRELIS treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to QBRELIS
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
27 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) |
| NCT04550481 | NCI-2020-06905 NCI-2020-06905, NCI20-01-03 | Ph 2 | active not recruiting | Role of Lisinopril in Preventing the Progression of Non-Alcoholic Fatty Liver Disease, RELIEF-NAFLD Study |
| NCT05056727 STABILIZE-CKD results posted | D9488C00001 2021-001911-96 | Ph 3 | terminated | A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia |
| NCT02847338 AIMHY-INFORM | AO94005 | Ph 4 | completed | Comparison of Optimal Hypertension Regimens |
| NCT03201939 R3 results posted | Vanderbilt_University MC U01DK112271 | Ph 2 | terminated | Optimal Management of HIV Infected Adults at Risk for Kidney Complications in Nigeria |
| NCT06772779 | 0616-026 MK-0616-026 | Ph 1 | completed | A Study of Enlicitide Decanoate (MK-0616), Warfarin, and Lisinopril in Healthy Adult Participants (MK-0616-026) |
| NCT03392740 | GHIGHCI2018 | Ph 4 | withdrawn | Prophylactic Lisinopril to Prevent Anthracycline Cardiomyopathy. |
| NCT04190433 | 19-007547 NCI-2021-13928 | Ph 2 | withdrawn | Autophagy Activation for the Alleviation of Cardiomyopathy Symptoms After Anthracycline Treatment, ATACAR Trial |
| NCT03461003 NICHE results posted | HSC-MS-17-1014 UL1TR003167 | Ph 4 | completed | N-of-1 Trials In Children With Hypertension |
| NCT01009918 results posted | SCUSF 0806 SCUSF-0806, 5U10CA081920-11 | Ph 2 | completed | Lisinopril or Coreg CR® in Reducing Side Effects in Women With Breast Cancer Receiving Trastuzumab |
| NCT01984164 CALIBREX results posted | IRB00070087 R01AG042127 | Ph 2 | completed | CAndesartan vs LIsinopril Effects on the BRain |
| NCT00874432 results posted | H-2008-0221 A534280, SMPH/MEDICINE/NEPHROLOGY | Ph 2 | completed | Effect of ACE-inhibitors on Aortic Stiffness in Elderly Patients With Chronic Kidney Disease |
| NCT01837069 OPTMIZE-OS results posted | 12-02407 | Ph 4 | terminated | Risk Factor Control Before Orthopedic Surgery |
| NCT02070510 | NN9924-4065 2013-001087-39, U1111-1140-3741 | Ph 1 | completed | A Trial Investigating the Influence of Oral Semaglutide on the Pharmacokinetics of Lisinopril and Warfarin in Healthy Subjects |
| NCT01880528 results posted | MC1221 NCI-2013-01139, 12-008062 | Ph 2 | completed | Lisinopril in Reducing Shortness of Breath Caused by Radiation Therapy in Patients With Lung Cancer |
| 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 |
| NCT01066572 PIL-FAST | RP-PG-0606-1241 | Ph 1 | completed | Paramedic Initiated Lisinopril For Acute Stroke Treatment |
| NCT02641899 | ITCA 650-CLP-115 | Ph 1 | completed | Study of the Effects of ITCA 650 on Gastric Emptying and Interaction of ITCA 650 on 4 Commonly Studied Drugs |
| NCT01398267 | BP25328 | Ph 1 | completed | A Pharmacodynamic/Pharmacokinetic Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus on Treatment With Lisinopril |
| NCT01535235 results posted | 11-08132 | Ph 4 | completed | ACE Inhibitors to Decrease Lymphoid Fibrosis in Antiretroviral-Treated, HIV-infected Patients: A Pilot Study |
| NCT01491919 PTN_LISINO results posted | Pro00029537 HHSN275201000003I | Ph 1 | completed | Safety Study of Lisinopril in Children and Adolescents With a Kidney Transplant |
| NCT00555217 VA NEPHRON-D results posted | 565 | Ph 3 | terminated | VA NEPHRON-D: Diabetes iN Nephropathy Study |
| NCT02232308 | 14-004137 UL1RR024150, P01DK068055 | Ph 1 | completed | Modulation of Heme Oxygenase 1 by Nizatidine and Lisinopril in Healthy Subjects |
| NCT01324388 results posted | 11552 H9X-MC-GBCO | Ph 1 | completed | A Study of the Effect of LY2189265 on Two Blood Pressure Drugs |
| NCT00605072 AVEC results posted | IA0127 K23AG030057 | Ph 2 | completed | The Antihypertensives and Vascular, Endothelial and Cognitive Function Trial |
| NCT01735344 | Ipca/ARL-10/385 | Ph 1 | completed | Bioequivalence Study of Lisinopril Tablets 40 mg Under Fed Condition |
| NCT01735318 | Ipca/ARL-10/384 | Ph 1 | completed | Bioequivalence Study of Lisinopril Tablets 40 mg Under Fasting Condition |
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.
QBRELIS FDA Label Details
Indications & Usage
FDA Label (PDF)QBRELIS is indicated for the treatment of Hypertension; Heart Failure; Myocardial Infarction.
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue QBRELIS as soon as possible [see Warnings and Precautions ( 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 TOXI...
QBRELIS Patents & Exclusivity
Patents (12 active)
Pro Intelligence Preview
Deep insights for QBRELIS
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2035
- • 32 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.