PERINDOPRIL ERBUMINE · Aurobindo Pharma
Perindopril erbumine is indicated for the treatment of essential hypertension, either as monotherapy or in combination with other antihypertensive classes, particularly thiazide diuretics. It is also indicated for patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction. In managing long-term heart health, it is frequently used alongside conventional treatments such as antiplatelet, antihypertensive, or lipid-lowering therapies.
How PERINDOPRIL ERBUMINE Works
Perindopril erbumine is a pro-drug for perindoprilat, which lowers blood pressure primarily by inhibiting the angiotensin-converting enzyme (ACE). This inhibition prevents the conversion of angiotensin I to angiotensin II, a potent vasoconstrictor. The resulting reduction in angiotensin II levels leads to decreased vasoconstriction and reduced aldosterone secretion, which promotes natriuresis and diuresis. Additionally, perindoprilat inhibits kininase II, the enzyme responsible for breaking down the vasodepressor peptide bradykinin, which may further contribute to its therapeutic effects.
Details
- Status
- Prescription
- First Approved
- 1993-12-30
- Routes
- ORAL
- Dosage Forms
- TABLET
PERINDOPRIL ERBUMINE Approval History
What PERINDOPRIL ERBUMINE Treats
3 indicationsPERINDOPRIL ERBUMINE is approved for 3 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
PERINDOPRIL ERBUMINE Boxed Warning
FETAL TOXICITY When pregnancy is detected, discontinue perindopril erbumine as soon as possible [see Warnings and Precautions (5.4) ]. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.4) ] . WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue perindopril erbumine as soon as possible [see Warnings and Precautions (5.4) ] . Drugs that a...
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue perindopril erbumine as soon as possible [see Warnings and Precautions (5.4) ]. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.4) ] . WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue perindopril erbumine as soon as possible [see Warnings and Precautions (5.4) ] . Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [ see Warnings and Precautions (5.4) ] .
PERINDOPRIL ERBUMINE 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 PERINDOPRIL ERBUMINE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications PERINDOPRIL ERBUMINE treats. First-in-class if their pivotal trials read out positive.
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| 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.
PERINDOPRIL ERBUMINE FDA Label Details
Indications & Usage
Perindopril erbumine tablets are indicated for the treatment of patients with essential hypertension. Perindopril erbumine tablets are indicated for treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction. 1.1 Hypertension Perindopril erbumine tablets are indicated for the treatment of patients with essential hypertension. Perindopril erbumine tablets may be used alone or given with other classes of antihypertensives, especially thiazide diuretics. 1.2 Stable Coronary Artery Disease Perindopril erbumine tablets ...
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue perindopril erbumine as soon as possible [see Warnings and Precautions (5.4) ]. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.4) ] . WARNING: ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.