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Lisinopril | CAS No: 76547-98-3 | GMP-certified suppliers
A medication that treats hypertension, heart failure, and acute myocardial infarction, offering vasodilation and reduced cardiac workload for improved cardiovascular outcomes.
Therapeutic categories
Primary indications
- Lisinopril is indicated for the treatment of acute myocardial infarction, hypertension in patients ≥6 years, and as an adjunct therapy for heart failure
- A combination product with hydrochlorothiazide is indicated for the treatment of hypertension
Product Snapshot
- Lisinopril is an oral small molecule formulation available primarily as tablets and film-coated tablets
- It is used for the treatment of acute myocardial infarction, hypertension, and as adjunct therapy for heart failure
- The product is approved for use in major regulatory markets including the United States and Canada
Clinical Overview
Pharmacologically, lisinopril exerts its effects by inhibiting the angiotensin converting enzyme, thereby preventing the conversion of angiotensin I to angiotensin II, a potent vasoconstrictor. This inhibition results in vasodilation, decreased aldosterone secretion, and reduced sodium and water retention. Additionally, lisinopril attenuates the renin-angiotensin-aldosterone system (RAAS) upstream by inhibiting renin-mediated conversion of angiotensinogen to angiotensin I. Elevated bradykinin levels secondary to ACE inhibition contribute further to vasodilation. These combined actions reduce vascular resistance and cardiac workload, which is therapeutically relevant in hypertension and heart failure management.
Key pharmacokinetic parameters include oral bioavailability and a reliance on renal elimination, as lisinopril is not significantly metabolized hepatically but primarily excreted unchanged via the kidneys. This necessitates careful dose adjustment in patients with renal impairment to minimize toxicity. The drug demonstrates a wide therapeutic index with typical daily doses ranging from 10 to 80 mg.
Safety considerations include risks of hyperkalemia, hypotension, and angioedema, consistent with ACEI class effects. Caution is advised in patients with a history of angioedema or significant renal artery stenosis. Lisinopril’s photosensitizing potential is a noted, although infrequent, adverse effect.
Lisinopril is available as a single entity or in combination with hydrochlorothiazide for enhanced antihypertensive efficacy. When sourcing API, quality control focus should include confirmation of chemical identity (CAS 76547-98-3), purity, impurity profiling, and compliance with pharmacopeial standards due to its widespread clinical use and narrow margin for adverse events in vulnerable populations.
Identification & chemistry
| Generic name | Lisinopril |
|---|---|
| Molecule type | Small molecule |
| CAS | 76547-98-3 |
| UNII | 7Q3P4BS2FD |
| DrugBank ID | DB00722 |
Pharmacology
| Summary | Lisinopril is an angiotensin-converting enzyme inhibitor that reduces the formation of angiotensin II, a peptide that induces vasoconstriction and promotes cardiac and vascular remodeling. By inhibiting both angiotensin-converting enzyme and renin activity, lisinopril decreases vascular resistance and mitigates myocyte hypertrophy and smooth muscle proliferation. Additionally, elevated bradykinin levels contribute to vasodilation, supporting its therapeutic use in hypertension, heart failure, and myocardial infarction. |
|---|---|
| Mechanism of action | Angiotensin II constricts coronary blood vessels and is positively inotropic, which under normal circumstances, would increase vascular resistance and oxygen consumption. This action can eventually lead to myocyte hypertrophy and vascular smooth muscle cell proliferation. Lisinopril is an angiotensin converting enzyme inhibitor (ACEI), preventing the conversion of angiotensin I to angiotensin II. This action prevents myocyte hypertrophy and vascular smooth muscle cell proliferation seen in untreated patients. Increased levels of bradykinin also exhibit vasodilating effects for patients taking ACEIs. Lisinopril also inhibits renin's conversion of angiotensin to angiotensin I. |
| Pharmacodynamics | Lisinopril is an angiotensin converting enzyme inhibitor used to treat hypertension, heart failure, and myocardial infarction. Lisinopril is not a prodrug, and functions by inhibition of angiotensin converting enzyme as well as the renin angiotensin aldosterone system. It has a wide therapeutic index and a long duration of action as patients are generally given 10-80mg daily. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Angiotensin-converting enzyme | Humans | inhibitor |
| Renin | Humans | inhibitor |
ADME / PK
| Absorption | Lisinopril is 6-60% orally bioavailable with an average of 25% bioavailability. Lisinopril reaches a C<sub>max</sub> of 58ng/mL with a T<sub>max</sub> of 6-8h. Lisinopril's absorption is not affected by food. |
|---|---|
| Half-life | Lisinopril has an effective half life of accumulation of 12.6h and a terminal half life of 46.7h. |
| Protein binding | Lisinopril has not been demonstrated to bind to serum proteins. |
| Metabolism | Lisinopril is not metabolized and is excreted as the unchanged drug. |
| Route of elimination | Lisinopril is entirely eliminated exclusively in the urine. |
| Volume of distribution | The apparent volume of distribution of lisinopril is 124L. |
| Clearance | A 30kg child has a typical clearance of 10L/h, which increases with renal function. The mean renal clearance of lisinopril in healthy adult males is 121mL/min. |
Formulation & handling
- Lisinopril is a small molecule dipeptide administered orally primarily as tablets or oral solutions.
- This API is water-soluble with a low logP, indicating hydrophilic properties suitable for oral absorption.
- Food does not affect its absorption, but concurrent intake of potassium-containing products or hypertensive herbs should be avoided.
Regulatory status
| Lifecycle | The API is currently protected by multiple patents in the United States with expiration dates in November 2035, indicating limited generic competition in the US and Canadian markets until patent expiry. Market maturity is expected post-2035 as patent protections lapse. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | The manufacturing landscape for Lisinopril includes multiple originator and generic companies, with both branded and generic versions produced by firms such as Merck Research Laboratories and AstraZeneca UK Ltd alongside several generic manufacturers. Branded products are primarily present in the US and Canadian markets. Existing patents covering Lisinopril extend through 2035, indicating that generic competition is currently limited but may emerge after patent expiry. |
|---|
Safety
| Toxicity | The oral and subcutaneous LD<sub>50</sub> in rats is >8500mg/kg and in mice is >9100mg/kg. The oral LDLO in women is 1200µg/kg/16D and in men is 43mg/kg/43W. Patients experiencing an overdose of lisinopril may present with hypotension. Patients should be treated with intravenous saline to restore blood pressure. Lisinopril can be removed from the blood by hemodialysis due to it not being protein bound. |
|---|
- Oral and subcutaneous LD50 values exceed 8500 mg/kg in rats and 9100 mg/kg in mice, indicating low acute toxicity
- In cases of overdose, hypotension may occur
- Lisinopril is dialyzable due to low protein binding
Lisinopril is a type of ACE inhibitors
ACE inhibitors, or angiotensin-converting enzyme inhibitors, are a subcategory of pharmaceutical APIs (active pharmaceutical ingredients) commonly used in the treatment of various cardiovascular conditions. These medications work by inhibiting the activity of the angiotensin-converting enzyme, which plays a crucial role in the regulation of blood pressure and fluid balance.
By blocking the action of this enzyme, ACE inhibitors help relax and widen the blood vessels, reducing peripheral resistance and ultimately lowering blood pressure. This mechanism of action makes ACE inhibitors highly effective in treating hypertension (high blood pressure) and congestive heart failure.
Additionally, ACE inhibitors have been found to be beneficial for patients with certain kidney disorders and diabetic nephropathy. By dilating the renal blood vessels, they can help improve renal function and reduce proteinuria.
Some commonly prescribed ACE inhibitors include lisinopril, enalapril, and ramipril. These medications are typically administered orally and are available in various dosage forms, including tablets and capsules.
It's worth noting that ACE inhibitors may have certain side effects, such as dry cough, dizziness, and hyperkalemia (high potassium levels). However, these side effects are generally mild and well-tolerated by most patients.
In summary, ACE inhibitors are a vital subcategory of pharmaceutical APIs used in the management of hypertension, heart failure, and certain renal disorders. Their ability to lower blood pressure and improve renal function makes them an essential tool in the treatment of cardiovascular diseases.
Lisinopril (ACE inhibitors), classified under Antihypertensive agents
Antihypertensive agents are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) used to treat high blood pressure, also known as hypertension. These medications are designed to lower blood pressure and reduce the risk of associated cardiovascular complications.
Antihypertensive agents function by targeting various mechanisms involved in blood pressure regulation. Some common classes of antihypertensive agents include angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), beta-blockers, calcium channel blockers (CCBs), and diuretics.
ACE inhibitors work by inhibiting the enzyme responsible for converting angiotensin I to angiotensin II, a hormone that constricts blood vessels. ARBs, on the other hand, block the receptors to which angiotensin II binds, thereby preventing its vasoconstrictive effects.
Beta-blockers reduce blood pressure by blocking the effects of adrenaline and noradrenaline, which are responsible for increasing heart rate and constricting blood vessels. CCBs inhibit calcium from entering the smooth muscles of blood vessels, resulting in relaxation and vasodilation. Diuretics promote the elimination of excess fluid and sodium from the body, reducing blood volume and thereby lowering blood pressure.
Antihypertensive agents are typically prescribed based on the individual patient's condition and specific needs. They can be used alone or in combination to achieve optimal blood pressure control. It is important to note that antihypertensive agents should be taken regularly as prescribed by a healthcare professional and may require periodic monitoring to ensure their effectiveness and manage any potential side effects.
In summary, antihypertensive agents play a vital role in the management of hypertension by targeting various mechanisms involved in blood pressure regulation. These medications offer significant benefits in reducing the risk of cardiovascular complications associated with high blood pressure.
Lisinopril API manufacturers & distributors
Compare qualified Lisinopril API suppliers worldwide. We currently have 9 companies offering Lisinopril API, with manufacturing taking place in 5 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| Arshine Pharmaceutical Co... | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, MSDS, USDMF | 176 products |
| Azelis | Producer | Germany | Germany | CEP, CoA, GMP | 4 products |
| Evonik TC | Producer | Germany | Germany | CEP, CoA, FDA, GMP, USDMF | 7 products |
| Gedeon Richter | Producer | Hungary | Unknown | CoA, JDMF | 48 products |
| Hetero Drugs | Producer | India | Unknown | CEP, CoA, FDA, GMP, JDMF, USDMF, WC | 98 products |
| Lupin | Producer | India | India | CEP, CoA, FDA, GMP, JDMF, USDMF, WC | 155 products |
| Mylan | Producer | India | India | CEP, CoA, USDMF, WC | 201 products |
| Zhejiang Changming | Producer | China | China | CEP, CoA, FDA, GMP, USDMF, WC | 19 products |
When sending a request, specify which Lisinopril API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
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