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Drug

Ramipril

Regulatory activity · FDA
Emerging researchLate-stage development

Also known as Altace, Vostally, (2S-(1(R*(R*)),2alpha,3abeta,6abeta))-1-(2-((1-(Ethoxycarbonyl)-3-phenylpropyl)amino)-1-oxopropyl)octahydrocyclopenta(b)pyrrole-2-carboxylic acid, Ramiprilum.

RxNorm35296ChEMBLCHEMBL1168UNIIL35JN3I7SJ
1
Research papers
7
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis

Clinical trial2026-06-01Primary completion · ClinicalTrials.gov

A Pilot Randomized Clinical Trial to Assess Feasibility, Safety, and Efficacy of Rapid, Simultaneous Therapy Initiation in Chronic Kidney Disease and Type 2 Diabetes: RAPID-CKD

Clinical trial2026-05-08Results expected Q1 2029 · ClinicalTrials.gov

A Single Arm, Pilot Study of Ramipril for Preventing Radiation-Induced Cognitive Decline in Glioblastoma (GBM) Patients Receiving Brain Radiotherapy

Clinical trial2026-03-13Results posted · ClinicalTrials.gov

Comparative Effects of Single Versus Twice-Daily Ramipril Dosing on Renal Function in Patients With Chronic Kidney Disease and Heart Failure With Reduced Ejection Fraction: Evaluation of Plasma Renin Activity, Malondialdehyde, Interleukin-6, Albuminuria, and Cystatin C

Clinical trial2025-12-31Primary completion · ClinicalTrials.gov

Explorative Study for Treating Persistent Developmental Stuttering With Ramipril

Clinical trial2025-12-30Primary completion · ClinicalTrials.gov

A Double Blind, Randomised, Placebo Controlled Trial to Study the Clinical and Cost Effectiveness of the Angiotensin Converting Enzyme Inhibitor, Ramipril, in Intermittent Claudicants

Clinical trial2025-12-18Results posted · ClinicalTrials.gov

Colchicine Versus Beta-blockers, Angiotensin-converting Enzyme Inhibitors, and Statins for Prevention of Chemotherapy-Induced Cardiomyopathy

Clinical trial2025-05-01Primary completion · ClinicalTrials.gov

Comparative Assessment of Efficacy & Safety of Sacubitril/Valsartan Versus Ramipril in Patients With Renal Dysfunction Hospitalized With Acute Decompensated Heart Failure - CAESAR (a Randomized Controlled Trial)

Clinical trial2025-02-28Completed · ClinicalTrials.gov

Safety and Efficacy of Early Angiotensin-converting Enzyme Inhibition in Patients With Alport Syndrome Carrying Pathogenic Heterozygous COL4A3,COL4A4 or COL4A5 Mutations

Clinical trial2024-12-31Primary completion · ClinicalTrials.gov

The Effect of Sacubitril/valsartan Versus Ramipril on Left Ventricular Function and Remodeling in Patients with Ischemic Heart Failure with Mid-range Ejection Fraction

Clinical trial2024-10-31Results expected Q1 2027 · ClinicalTrials.gov

Recall (Class II): RAMIPRIL

Regulatory2024-10-23FDA

Randomized clinical trial of angiotensin-converting enzyme inhibitor, ramipril, in patients with intermittent claudication.

Research2013-08-01The British journal of surgery

Evidence confidence

1 claim

How strongly the incorporated evidence supports specific clinical claims about this treatment. A confidence figure is a current summary of evidence strength, not a permanent verdict.

Lowers systolic blood pressure in hypertension
63%Moderate confidence
Uncertainty ±17%Evidence coverage: HighUpdated 27 November 2024

High point estimate, but substantial uncertainty remains.

Confidence has a moderate point estimate but a wide uncertainty band — the evidence base is still thin.

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Ramipril
Aliases & brands
AltaceVostally(2S-(1(R*(R*)),2alpha,3abeta,6abeta))-1-(2-((1-(Ethoxycarbonyl)-3-phenylpropyl)amino)-1-oxopropyl)octahydrocyclopenta(b)pyrrole-2-carboxylic acidRamiprilum
RxNorm CUI
35296
ChEMBL ID
CHEMBL1168
UNII
L35JN3I7SJ
Regulatory jurisdictions
fda

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities
FDA
Total events
1
fdaU.S. Food and Drug Administration· 1 event
2024-10-23RecallSafety
Recall (Class II): RAMIPRIL
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

113 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
113
registered trials across all phases
LATEST COMPLETION 2025
7
Active studies
6
Recruiting
84
Late-stage (III+)
80
Completed
26
Discontinued
PHASE DISTRIBUTIONn = 113
Early Phase 11Phase 114Phase 214Phase 2 / 36Phase 326Phase 443Phase N / A9

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Pilot Randomized Clinical Trial to Assess Feasibility, Safety, and Efficacy of Rapid, Simultaneous Therapy Initiation in Chronic Kidney Disease and Type 2 Diabetes: RAPID-CKD

Not yet recruitingPH IVBaylor Research Instituten=642029

Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis

RecruitingPH IVUniversity of Nebraskan=702026

Comparative Effects of Single Versus Twice-Daily Ramipril Dosing on Renal Function in Patients With Chronic Kidney Disease and Heart Failure With Reduced Ejection Fraction: Evaluation of Plasma Renin Activity, Malondialdehyde, Interleukin-6, Albuminuria, and Cystatin C

RecruitingPH IVEvi Liliek Wulandarin=802026

Beneficio Del Bloqueo Del Sistema Renina-angiotensina Sobre la evolución clínica y el Remodelado Ventricular Tras la colocación de Una prótesis percutánea aórtica (RASTAVI)

Unknown statusPH IVHospital Clínico Universitario de Valladolidn=1942023

Short - Medium and Long Term Blood Pressure Variability in Essential Hypertensive Patients Treated With Nifedipine GITS or Ramipril - a Randomized Trial

CompletedPH IVIstituto Auxologico Italianon=1682020

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Single Arm, Pilot Study of Ramipril for Preventing Radiation-Induced Cognitive Decline in Glioblastoma (GBM) Patients Receiving Brain Radiotherapy

CompletedPH IIWake Forest University Health Sciencesn=752025

Comparative Assessment of Efficacy & Safety of Sacubitril/Valsartan Versus Ramipril in Patients With Renal Dysfunction Hospitalized With Acute Decompensated Heart Failure - CAESAR (a Randomized Controlled Trial)

CompletedPH II/IIINational Heart Institute, Egyptn=5152025

Open-label Randomized Crossover Two Period Single Dose Bioequivalence Study of Two Formulations Ramipril Tablets 10 mg (Pharmtechnology LLC, Republic of Belarus) and Tritace® Tablets 10 mg (Sanofi-Aventis Deutschland GmbH, Germany) in Healthy Volunteers Under Fasting Conditions

CompletedPH IPharmtechnology LLCn=502022

A Phase 2, Double-blind, Active-controlled, Dose-titrating Efficacy and Safety Study of Firibastat Compared to Ramipril Administered Orally, Twice Daily, Over 12 Weeks to Prevent Left Ventricular Dysfunction After Acute MI

CompletedPH IIQuantum Genomics SAn=2952021

A Randomized, Double-blind, Placebo-Controlled Trial to Evaluate the Efficacy of Ramipril to Prevent ICU Admission, Need for Mechanical Ventilation or Death in Persons With COVID-19

CompletedPH IIUniversity of California, San Diegon=1602021

A Multi-center, Randomized, Double-blind, Active-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Ramipril on Morbidity and Mortality in High Risk Patients Following an Acute Myocardial Infarction (AMI)

CompletedPH IIIKey trialNovartis Pharmaceuticalsn=5,6692021

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Journals, researchers & institutions
Top journals
  • The British journal of surgery1
Leading researchers
  • Chetter IC1
  • Cockcroft JR1
  • Shahin Y1
Leading institutions
free-text, unnormalised
  • Hull York Medical School and University of Hull1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.