- Raw materials
- Antihypertensive agents
- Vasodilators
- Nitric Oxide
Filters
Custom request?
Type
Production region
Qualifications
Country of origin
Nitric Oxide API Manufacturers & Suppliers
2 verified results
Commercial-scale Suppliers
All certificates
All certificates
Total market transparency
Supplier trade data access
Buyer / supplier flow comparison
Nitric Oxide | CAS No: 10102-43-9 | GMP-certified suppliers
A medication that treats hypoxic respiratory failure in term and near-term neonates by selectively dilating pulmonary vessels to improve oxygenation and reduce pulmonary hypertension.
Therapeutic categories
Primary indications
- For the treatment of term and near-term (>
- 34 weeks) neonates with hypoxic respiratory failure
Product Snapshot
- Nitric Oxide is available as a gas for inhalation and various liquid and solid formulations for topical and respiratory use
- It is primarily indicated for the treatment of hypoxic respiratory failure in term and near-term neonates
- The product is approved for use in key regulated markets including the US, Canada, and the EU
Clinical Overview
PPHN is characterized by abnormally elevated pulmonary vascular resistance (PVR), which leads to right-to-left shunting of blood through fetal circulatory pathways such as the patent ductus arteriosus and foramen ovale. This shunting causes hypoxemia despite adequate ventilation. Nitric oxide administration selectively dilates pulmonary vessels in well-ventilated lung regions. The vasodilatory effect improves ventilation/perfusion matching by redirecting blood flow from poorly ventilated to better ventilated alveoli, resulting in significant increases in arterial oxygen partial pressure (PaO2).
Pharmacologically, nitric oxide acts by diffusing into vascular smooth muscle cells where it binds to the heme group of cytosolic guanylate cyclase. This interaction activates guanylate cyclase, increasing intracellular cyclic guanosine 3’,5’-monophosphate (cGMP) levels. Elevated cGMP induces smooth muscle relaxation and vasodilation. When inhaled, this mechanism produces selective pulmonary vasodilation without causing systemic hypotension.
Nitric oxide is a reactive free radical gas, which contributes to its short biological half-life and high local reactivity. It is rapidly inactivated by binding to hemoglobin and is metabolized primarily by conversion to nitrate and nitrite. Given its gaseous nature and reactivity, dosing systems require precise control. Safety considerations include monitoring for methemoglobinemia and nitrogen dioxide generation, as NO reacts with oxygen under certain conditions to form nitrogen dioxide (NO2), a pulmonary irritant and toxic pollutant.
Notable clinical formulations include calibrated nitric oxide gas mixtures for inhalation administered via mechanical ventilation circuits in neonatal intensive care units. Its use is regulated globally, with established protocols to manage dosing and minimize exposure risks.
For API procurement and formulation purposes, quality control must focus on gas purity, absence of nitrogen dioxide contamination, and residual impurities. Manufacturing and storage conditions require strict monitoring to prevent degradation and ensure consistent pharmacological efficacy. Analytical methods should verify concentration and stability to comply with regulatory standards for medicinal gases.
Identification & chemistry
| Generic name | Nitric Oxide |
|---|---|
| Molecule type | Small molecule |
| CAS | 10102-43-9 |
| UNII | 31C4KY9ESH |
| DrugBank ID | DB00435 |
Pharmacology
| Summary | Nitric oxide acts by activating soluble guanylate cyclase in vascular smooth muscle cells, increasing cyclic GMP levels and inducing vasodilation. When inhaled, it selectively dilates pulmonary vessels in well-ventilated lung regions, reducing pulmonary vascular resistance and improving oxygenation. This mechanism is utilized therapeutically to manage hypoxic respiratory failure in term and near-term neonates by addressing elevated pulmonary vascular resistance. |
|---|---|
| Mechanism of action | Nitric oxide is a compound produced by many cells of the body. It relaxes vascular smooth muscle by binding to the heme moiety of cytosolic guanylate cyclase, activating guanylate cyclase and increasing intracellular levels of cyclic guanosine 3',5'-monophosphate, which then leads to vasodilation. When inhaled, nitric oxide produces pulmonary vasodilation. |
| Pharmacodynamics | Persistent pulmonary hypertension of the newborn (PPHN) occurs as a primary developmental defect or as a condition secondary to other diseases such as meconium aspiration syndrome (MAS), pneumonia, sepsis, hyaline membrane disease, congenital diaphragmatic hernia (CDH), and pulmonary hypoplasia. In these states, pulmonary vascular resistance (PVR) is high, which results in hypoxemia secondary to right-to-left shunting of blood through the patent ductus arteriosus and foramen ovale. In neonates with PPHN, Nitric oxide improves oxygenation (as indicated by significant increases in PaO2). Nitric oxide appears to increase the partial pressure of arterial oxygen (PaO2) by dilating pulmonary vessels in better entilated areas of the lung, redistributing pulmonary blood flow away from lung regions with low ventilation/perfusion (V/Q) ratios toward regions with normal ratios. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Guanylate cyclase soluble subunit alpha-2 | Humans | inducer |
| Metallothionein-1A | Humans | |
| Indoleamine 2,3-dioxygenase 1 | Humans |
ADME / PK
| Absorption | Nitric oxide is absorbed systemically after inhalation. |
|---|---|
| Half-life | 2–6 seconds |
| Metabolism | via pulmonary capillary bed |
| Route of elimination | Nitrate has been identified as the predominant nitric oxide metabolite excreted in the urine, accounting for >70% of the nitric oxide dose inhaled. |
Formulation & handling
- Nitric oxide is administered primarily via respiratory inhalation, endotracheal, or topical routes, not suitable for oral formulations.
- Being a small inorganic gaseous molecule, it requires specialized containment and delivery systems to maintain stability and dosing accuracy.
- Handling should consider the gas's reactivity and ensure controlled environment conditions to prevent degradation or hazardous exposure.
Regulatory status
| Lifecycle | The API is marketed in the US, Canada, and EU, with key patents in the US expiring between 2013 and 2017, while a later patent extends protection in the US until 2029. This places the product in different stages of market maturity across regions, with mature markets in Canada and earlier-expiring US patents, and ongoing patent protection in the US until 2029. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | The manufacturing and supply landscape for Nitric Oxide is primarily driven by a single originator company, Ino Therapeutics Inc., which also handles packaging alongside Pulmonox Gas Corporation. Branded products are marketed in the US, Canada, and the EU, with several formulations targeting brain health, joint pain, and menopause. Patent data indicates active intellectual property protection extending to 2029 in the US, suggesting limited immediate generic competition. |
|---|
Nitric Oxide is a type of Vasodilators
Vasodilators are a crucial subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs) that play a significant role in the management of various cardiovascular conditions. These medications work by widening the blood vessels, promoting increased blood flow and reducing peripheral resistance.
Vasodilators are commonly prescribed to treat hypertension (high blood pressure), angina (chest pain), and heart failure. They are designed to relax and dilate the smooth muscle cells in the walls of blood vessels, leading to improved circulation and reduced strain on the heart.
One widely used class of vasodilators is calcium channel blockers, which prevent calcium from entering the muscle cells of blood vessels. This action inhibits muscle contraction, resulting in widened arteries and enhanced blood flow. Another class is nitric oxide (NO) donors, which release NO, a potent vasodilator, to promote relaxation of vascular smooth muscles.
The therapeutic benefits of vasodilators extend beyond cardiovascular disorders. Some vasodilators, such as minoxidil, have been repurposed for treating male pattern baldness. These medications stimulate hair growth by dilating blood vessels around hair follicles, enhancing nutrient and oxygen delivery.
As with any pharmaceutical API, vasodilators must meet strict quality standards and regulatory guidelines to ensure safety and efficacy. Manufacturers employ sophisticated production processes and stringent quality control measures to guarantee the purity, potency, and stability of these APIs.
In conclusion, vasodilators are a vital subcategory of pharmaceutical APIs used to manage cardiovascular conditions. By expanding blood vessels and enhancing blood flow, vasodilators contribute to improved patient outcomes and play a critical role in the treatment of hypertension, angina, heart failure, and even hair loss.
Nitric Oxide (Vasodilators), 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.
Nitric Oxide API manufacturers & distributors
Compare qualified Nitric Oxide API suppliers worldwide. We currently have 2 companies offering Nitric Oxide API, with manufacturing taking place in 2 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 |
|---|---|---|---|---|---|
| Air Liquide | Producer | France | France | CoA, GMP | 4 products |
| Sol S.P.A. | Producer | Italy | Italy | CEP, CoA, GMP | 4 products |
When sending a request, specify which Nitric Oxide 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.).
Use the list above to find high-quality Nitric Oxide API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
