VOSTALLY (ramipril)
Vostally helps adults manage high blood pressure, which reduces the risk of experiencing strokes or heart attacks. It is also used for patients 55 and older who are at high risk for major cardiovascular events to help prevent death or myocardial infarction. Additionally, the medication helps patients with heart failure following a heart attack by reducing the likelihood of hospitalization and cardiovascular death.
How VOSTALLY Works
This medication works by blocking the enzyme that converts angiotensin I into angiotensin II, a substance that constricts blood vessels. By lowering angiotensin II levels, the drug reduces blood vessel tension and decreases the secretion of aldosterone. These actions help lower blood pressure and improve cardiovascular outcomes.
Development Insights
Details
- Status
- Discontinued
- First Approved
- 2025-07-23
- Patent Cliff
- 2039
- Routes
- ORAL
- Dosage Forms
- SOLUTION
VOSTALLY Approval History
What VOSTALLY Treats
4 indicationsVOSTALLY is approved for 4 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
- Myocardial Infarction
- Stroke
- Heart Failure
VOSTALLY Boxed Warning
FETAL TOXICITY When pregnancy is detected, discontinue VOSTALLY 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 VOSTALLY as soon as possible (5.1) . Drugs that act directly on the renin-angiotensin system can cause in...
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue VOSTALLY 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 VOSTALLY 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) .
VOSTALLY 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.
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 VOSTALLY's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications VOSTALLY treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to VOSTALLY
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
VOSTALLY FDA Label Details
Indications & Usage
FDA Label (PDF)VOSTALLY is indicated for the treatment of Hypertension; Myocardial Infarction; Stroke; Heart Failure.
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue VOSTALLY 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 TOXIC...
VOSTALLY Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for VOSTALLY
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2039
- • 1 active patents
Trial Analysis
- • 44 total trials
- • Stage: Mature
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.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment