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Altace (RAMIPRIL)
Altace works by blocking the action of angiotensin-converting enzyme, a key player in the renin-angiotensin-aldosterone system that regulates blood pressure.
At a glance
| Generic name | RAMIPRIL |
|---|---|
| Sponsor | King Pfizer |
| Drug class | Angiotensin Converting Enzyme Inhibitor [EPC] |
| Target | Angiotensin-converting enzyme |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1991 |
Mechanism of action
Mechanism of Action. Ramipril and ramiprilat inhibit angiotensin-converting enzyme (ACE) in human subjects and animals. ACE is peptidyl dipeptidase that catalyzes the conversion of angiotensin to the vasoconstrictor substance, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. Inhibition of ACE results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and to decreased aldosterone secretion. The latter decrease may result in small increase of serum potassium. In hypertensive patients with normal renal function treated with ramipril alone for up to 56 weeks, approximately 4% of patients during the trial had an abnormally high serum potassium and an increase from baseline greater than 0.75 mEq/L, and none of the patients had an abnormally low potassium and decrease from baseline greater than 0.75 mEq/L. In the same study, approximately 2% of patients treated with ramipril and hydrochlorothiazide for up to 56 weeks ha
Approved indications
- Cerebrovascular accident
- Chronic heart failure
- Hypertensive disorder
- Left ventricular cardiac dysfunction
- Myocardial Infarction Prevention
Boxed warnings
- 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 ).
Common side effects
- Cough
- Asthenia (Fatigue)
- Upper respiratory infection
- Flu syndrome
- Anaphylactoid reactions
- Symptomatic hypotension
- Syncope
- Palpitations
- Pancytopenia
- Hemolytic anemia
- Thrombocytopenia
- Acute renal failure
Drug interactions
- spironolactone
- triamterene
Key clinical trials
- Blood Flow Restricted Resistance Exercises Versus Low Level Laser on Cardiac Functions in Patients With Chronic Heart Failure (NA)
- Testing Ramipril to Prevent Memory Loss in People With Glioblastoma (PHASE2)
- Short-Term Effects of Antihypertensive Drugs on Postural Balance and Fall Risk (NA)
- The COVID-RASi Trial (COVID-19) (PHASE3)
- Pentoxifylline on Inflammatory Markers in Non-Diabetic Chronic Kidney Disease Patients (NA)
- Clinical and Cost Effectiveness of ACE Inhibitor, Ramipril, in Intermittent Claudicants (PHASE4)
- Single and Twice-daily Dosing of Ramipril on Renal Function in Chronic Kidney Disease Patients With Reduced Ejection Fraction Heart Failure (PHASE4)
- Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment II Study (SMAART II) (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 12343338 | 2039-08-16 | Formulation |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Altace CI brief — competitive landscape report
- Altace updates RSS · CI watch RSS
- King Pfizer portfolio CI