LOTREL (amlodipine besylate)
Lotrel is a combination capsule used for patients with high blood pressure that is not well-managed by a single medication alone. It helps patients by combining two different types of blood pressure-lowering agents into one treatment. This medication is specifically used when monotherapy with either amlodipine or benazepril does not provide adequate control of a patient's hypertension.
How LOTREL Works
This medication works by blocking the enzyme that creates angiotensin II, a substance that narrows blood vessels, while also preventing calcium from entering muscle cells in the heart and blood vessels. These combined actions lead to relaxed blood vessels and decreased secretion of aldosterone, which helps lower overall blood pressure.
Details
- Status
- Prescription
- First Approved
- 1995-03-03
- Routes
- ORAL
- Dosage Forms
- CAPSULE
LOTREL Approval History
What LOTREL Treats
1 indicationsLOTREL is approved for 1 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
LOTREL Boxed Warning
FETAL TOXICITY When pregnancy is detected, discontinue Lotrel as soon as possible ( 5.1 ). Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus ( 5.1 ). WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue Lotrel as soon as possible ( 5.1 ). Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus ( 5.1 )....
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue Lotrel as soon as possible ( 5.1 ). Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus ( 5.1 ). WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue Lotrel as soon as possible ( 5.1 ). Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus ( 5.1 ).
LOTREL 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 LOTREL's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications LOTREL treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to LOTREL
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04434664 BLOCK HFpEF results posted | 833517 | Ph 4 | completed | BLOCKade of Calcium Channels and Beta Adrenergic Receptors for the Treatment of Hypertension in HFpEF |
| NCT04974138 CSPPT2-CC/CT | CSPPT2-CC/CT_2020 | Ph 4 | recruiting | China Stroke Primary Prevention Trial 2 for Participants With H-type Hypertension and MTHFR 677 CC/CT Genotype (CSPPT2-CC/CT) |
| NCT04974151 CSPPT2-TT | CSPPT2-TT_2020 | Ph 4 | recruiting | China Stroke Primary Prevention Trial 2 for Participants With Hypertension and MTHFR 677 TT Genotype |
| NCT05275907 | STU00215781 1R56HL155093-01 | Ph 4 | withdrawn | Mechanism of Hypertension Treatments in Liver Transplant Recipients (BLOCK LTR-HTN) |
| NCT02940548 NARRAS | 2016PHB013-02 | Ph 4 | terminated | Nifedipine GITS and Amlodipine Besylate on Recovery of Blood Pressure Rhythm and Arterial Stiffness |
| NCT01302691 results posted | 0954E-357 | Ph 3 | completed | MK-0954E Study in Participants With Hypertension (MK-0954E-357) |
| NCT02353806 results posted | 042014-059 UL1TR001105 | Ph 4 | completed | Pharmacokinetics of Amlodipine Besylate at Delivery and During Lactation |
| NCT01556997 PATH results posted | X985400 | Ph 3 | completed | Perindopril Amlodipine for the Treatment of Hypertension |
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.
LOTREL FDA Label Details
Indications & Usage
FDA Label (PDF)LOTREL is indicated for the treatment of Hypertension.
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue Lotrel as soon as possible ( 5.1 ). Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus ( 5.1 ). WARNING: FETAL TOXICITY See full prescribing information for complete boxed wa...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.