RAMIPRIL
Ramipril is a medication used to manage high blood pressure, either as a standalone therapy or in combination with thiazide diuretics. It also helps stable patients who develop signs of congestive heart failure within the first few days after a heart attack. By managing these conditions, the drug helps reduce the risk of cardiovascular death and prevents the progression to more severe heart failure. HOW
Details
- Status
- Discontinued
- First Approved
- 2005-10-24
- Routes
- ORAL
- Dosage Forms
- TABLET, CAPSULE
Companies
RAMIPRIL Approval History
What RAMIPRIL Treats
12 FDA approvalsOriginally approved for its first indication in 2005 . Covers 12 distinct patient populations.
- Other (12)
Other
(12 approvals)- • Approved indication (Oct 2005)Letter
- • Approved indication (Jun 2008)Letter
- • Approved indication (Jun 2008)
- • Approved indication (Jun 2008)
- • Approved indication (Aug 2008)
- • Approved indication (Sep 2008)
- • Approved indication (Mar 2009)
- • Approved indication (Sep 2009)
- • Approved indication (Jun 2011)
- • Approved indication (Jun 2011)
- • Approved indication (Apr 2014)
- • Approved indication (Dec 2015)
RAMIPRIL Boxed Warning
FETAL TOXICITY See full prescribing information for complete boxed warning • When pregnancy is detected, discontinue ramipril as soon as possible ( 5.6 ). • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.6 ). WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue ramipril as soon as possible ( 5.6 ). • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.6 )....
WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning • When pregnancy is detected, discontinue ramipril as soon as possible ( 5.6 ). • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.6 ). WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue ramipril as soon as possible ( 5.6 ). • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.6 ).
RAMIPRIL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
39 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03475186 results posted | IRB00053531 3UG1CA189824-04S1, NCI-2018-01807 | Ph 2 | completed | Testing Ramipril to Prevent Memory Loss in People With Glioblastoma |
| NCT01037530 results posted | 05102009 2009-016600-23 | Ph 4 | completed | Clinical and Cost Effectiveness of ACE Inhibitor, Ramipril, in Intermittent Claudicants |
| NCT07259512 | 041/UN27.46/TA.04.19/KEP/EC/20 | Ph 4 | recruiting | Single and Twice-daily Dosing of Ramipril on Renal Function in Chronic Kidney Disease Patients With Reduced Ejection Fraction Heart Failure |
| NCT02842424 | 0139-16-ET 00991 | Ph 4 | recruiting | Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis |
| NCT02901977 DoRa | 2007-000631-25 | Ph 4 | completed | Doxazosin and Ramipril in Hypertension |
| NCT00933231 | FKC-014 | Ph 3 | completed | Comparison of Standard Versus Low Dose Advagraf® With or Without Angiotensin-converting Enzyme Inhibitor (ACEi)/Angiotensin Receptor Blocker (ARB) on Histology and Function of Renal Allografts |
| NCT05508035 CRACOVIA-HF | DW.0701.005.2020P | Ph 3 | recruiting | The Effect of Sacubitril/valsartan Versus Ramipril on Left Ventricular Function and Remodeling in Patients with Ischemic Heart Failure with Mid-range Ejection Fraction |
| NCT02008786 SAFER-SCAD | SAFER-SCAD | Ph 4 | terminated | Statin and Angiotensin-converting Enzyme Inhibitor on Symptoms in Patients With SCAD |
| NCT02924727 PARADISE-MI results posted | CLCZ696G2301 2016-002154-20 | Ph 3 | completed | Prospective ARNI vs ACE Inhibitor Trial to DetermIne Superiority in Reducing Heart Failure Events After MI |
| NCT03715998 QUORUM results posted | QGC001-2QG4 | Ph 2 | completed | Firibastat or Ramipril After Acute Myocardial Infarction for Prevention of Left Ventricular Dysfunction |
| NCT03414723 | INT14935 2017-002650-37, U1111-1196-5355 | Ph 1 | completed | A Drug-Drug Interaction Study Between Sotagliflozin and Ramipril |
| NCT02499822 REVERENT | 09F401 | Ph 4 | completed | REducing Blood Pressure Variability in Essential Hypertension With RAmipril vErsus Nifedipine GITS Trial |
| NCT04582097 | PHCL 65 | Ph 2, Ph 3 | completed | Ramipril in Pediatric Patients on Hemodialysis |
| NCT00980785 SEAIRA results posted | 2014-1353 H-2009-0036, A534255 | Ph 4 | completed | Studying the Effects of Antihypertensives on Individuals at Risk for Alzheimer's |
| NCT02632747 results posted | 1245.100 | Ph 2 | completed | Empagliflozin and ACEi- Effects on Hyperfiltration: BETWEEN Study |
| NCT01485978 | EARLY_PRO-TECT_ALPORT | Ph 3 | completed | Efficacy and Safety Study to Delay Renal Failure in Children With Alport Syndrome |
| NCT03979976 | Ramipril.unifesp | Ph 2, Ph 3 | completed | Ramipril, Endothelial Function and Endothelial Progenitor Cells in Patients With Systemic Lupus Erythematosus |
| NCT02832973 ResHypOT | SaoJoseRPU | Ph 4 | completed | Sequential Nephron Blockade vs. Dual Blockade Renin-angiotensin System + Bisoprolol in Resistant Arterial Hypertension |
| NCT03770936 | liver fibrosis | Ph 3 | recruiting | Effect of Some Drugs on Liver Fibrosis |
| 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 |
| NCT02729441 ENDURE | 053-2010 | Ph 3 | completed | Perindopril vs Ramipril for Persistence in MAU Reduction Study |
| NCT00736294 PREFACE | 0608066 2006-007032-10 | Ph 3 | terminated | Prevention of Atrial Fibrillation by Inhibition Conversion Enzyme (ICE) After Radiofrequency Ablation of Atrial Flutter |
| NCT01922141 ASSESS | CSPP100A2370 2013-001562-42 | Ph 4 | withdrawn | Aliskiren Study of Safety and Efficacy in Senior Hypertensives |
| NCT00729365 PREVENTKD results posted | 1U01DK071733-01A1 1U01DK071733-01A1 | Ph 3 | terminated | PREVENTKD (Prevent Risks by Early interVEntion at Nighttime in Type 1 Diabetes for Kidney Disease) |
| NCT01284621 results posted | 1245.45 2010-022717-25 | Ph 1 | completed | Relative Bioavailability of Empagliflozin (BI 10773) and Ramipril Administered Together Compared to Empagliflozin (BI 10773) and Ramipril Alone in Healthy Volunteers |
| NCT00732069 results posted | Fibrinolysis in Dialysis R01HL065193-08A2 | Ph 2 | completed | Study of Inflammation and Oxidative Stress in Persons Undergoing Dialysis |
| NCT01302899 ARIA results posted | CSPP100A2260 2009-012196-10 | Ph 2 | terminated | To Study the Effects of Aliskiren on Albuminuria and Various Biomarkers in Patients With Nephropathy |
| NCT00760214 results posted | 01-06-TL-491-020 2007-002583-10, U1111-1113-8982 | Ph 3 | completed | Efficacy and Safety Study of Azilsartan Medoxomil Compared to Ramipril for Treating Essential Hypertension |
| NCT01703234 | GATARAMFGF232012 | Ph 4 | completed | FGF-23 and Endothelial Dysfunction in Diabetic Proteinuric Patients |
| NCT01005290 results posted | P-080646-01 | Ph 2 | terminated | A Pharmacodynamic Study to Evaluate the Effect of a Fixed Dose Combination Pill on Blood Pressure |
| NCT00923156 ESCAPE-SHF results posted | CSPP100A2252 EudraCT 2008-001035-35 | Ph 2 | completed | Effects of Aliskiren, Ramipril, and the Combination on Levels of Angiotensin II in Patients With Decompensated Systolic Heart Failure |
| NCT01180413 Vasomore | 26169 | Ph 4 | completed | Intensive Vasodilator Therapy in Patients With Essential Hypertension |
| NCT01042392 ALIAS results posted | CSPP100AFR01 2009-011296-80 | Ph 4 | completed | Efficacy of Aliskiren Compared to Ramipril in the Treatment of Moderate Systolic Hypertensive Patients |
| NCT00657865 | Ram_Gep_1 2007-007276-41 | Ph 4 | completed | Gene Expression Profiling in Skeletal Muscle of Healthy Subjects Treated With Ramipril |
| NCT00631917 results posted | CSPP100A2404 | Ph 4 | completed | A Study Evaluating the Gastrointestinal (GI) Safety and Tolerability of Aliskiren Compared to Ramipril in Essential Hypertension |
| NCT00542269 ALTO results posted | CSPP100AGB01 | Ph 4 | terminated | Efficacy and Safety of Aliskiren/Ramipril/Amlodipine Compared With Ramipril/Amlodipine and Aliskiren/Amlodipine in Patients With Metabolic Syndrome |
| NCT00772577 ATTAIN results posted | CSPP100AUS07 | Ph 4 | completed | Study of the Efficacy and Safety of Aliskiren HCTZ vs Ramipril in Obese Patients (BMI ≥ 30) With Stage 2 Hypertension |
| NCT00841880 | RAMFE_L_03420 | Ph 4 | completed | China Medical University Hospital (CMUH) Triapin Listing |
| NCT00893425 | GATARAMCD9509 | Ph 4 | completed | Effect of Renin Angiotensin System Blockade on the Fas Antigen (CD95) and Asymmetric Dimethylarginine (ADMA) Levels in Type-2 Diabetic Patients With Proteinuria |
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.
RAMIPRIL FDA Label Details
Indications & Usage
• Ramipril capsules USP are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. . • Ramipril capsules USP are indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction . 1.1 Hypertension Ramipril capsules USP are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. 1.3 Heart Failure Post-Myocardial Infarction Ramipril capsules USP are indicated in stable patients who have demonstrated clinical signs of congestive heart f...
WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning • When pregnancy is detected, discontinue ramipril as soon as possible ( 5.6 ). • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.6 ). WARNING: FETAL TOX...
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Full clinical data, patents, trials, and competitive landscape for ramipril.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.