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Vericiguat | CAS No: 1350653-20-1 | GMP-certified suppliers
A medication that supports adults with symptomatic chronic heart failure with reduced ejection fraction by lowering the risk of cardiovascular death and recurrent heart‑failure‑related hospitalization.
Therapeutic categories
Primary indications
- Vericiguat is indicated in adults with symptomatic, chronic heart failure and an ejection fraction of <45% to reduce the risk of cardiovascular death and heart failure-related hospitalization following a hospitalization for heart failure or need for outpatient intravenous diuretics
Product Snapshot
- Oral small‑molecule API supplied as film‑coated tablets
- Used for chronic symptomatic heart failure to reduce risk of cardiovascular death and heart‑failure–related hospitalization
- Approved in the US, EU, and Canada, with additional investigational status in some markets
Clinical Overview
Vericiguat targets impaired nitric oxide–sGC–cGMP signaling, a pathway commonly disrupted in systolic heart failure. By binding directly to the beta‑subunit of soluble guanylate cyclase, it stimulates intracellular cGMP generation independently of nitric oxide availability. Increased cGMP supports vascular smooth muscle relaxation, vasodilation, and downstream effects that counteract maladaptive cardiac and vascular remodeling. These actions complement existing guideline-directed heart failure therapy.
Pharmacodynamic properties include sustained elevation of cGMP and associated hemodynamic effects. Vericiguat has a terminal half-life of approximately 30 hours, allowing once-daily oral dosing. Reduced susceptibility to oxidative metabolism contributes to its extended systemic exposure. It is a substrate of transporters such as P‑glycoprotein and BCRP, and undergoes glucuronidation via UGT1A1 and UGT1A9. Absorption increases with food, and elimination occurs through both metabolic and biliary pathways.
Safety considerations include embryo‑fetal toxicity observed in animal studies, with structural cardiovascular defects and pregnancy loss at clinically relevant exposures. Use in pregnancy is contraindicated, and reliable contraception is required during therapy and for one month after discontinuation. Hypotension may occur, particularly in patients with volume depletion or receiving concomitant vasodilators.
For API procurement, suppliers should provide robust impurity characterization, validated analytical methods, and evidence of control of polymorphic form. Consistency in particle size distribution and stability data is important for formulation development, and full regulatory documentation should support global registration needs.
Identification & chemistry
| Generic name | Vericiguat |
|---|---|
| Molecule type | Small molecule |
| CAS | 1350653-20-1 |
| UNII | LV66ADM269 |
| DrugBank ID | DB15456 |
Pharmacology
| Summary | Vericiguat is a soluble guanylate cyclase stimulator that enhances intracellular cGMP production by directly activating the beta‑subunit of the enzyme independent of nitric oxide. This activity supports vascular smooth muscle relaxation and addresses impaired NO–sGC–cGMP signaling associated with chronic heart failure. Its pharmacodynamic effect centers on restoring cGMP-mediated pathways involved in vascular tone and cardiac function. |
|---|---|
| Mechanism of action | Heart failure (HF) involves, amongst other morphologic and physiologic changes, the impaired synthesis of nitric oxide (NO) and decreased activity of soluble guanylate cyclase (sGC). Functioning normally, NO binds to sGC and stimulates the synthesis of intracellular cyclic guanosine monophosphate (cGMP),a second messenger involved in the maintenance of vascular tone, as well as cardiac contractility and remodeling. Defects in this pathway are thought to contribute to the myocardial and vascular dysfunction associated with heart failure and are therefore a desirable target in its treatment. Vericiguat directly stimulates sGC by binding to a target site on its beta-subunit,bypassing the need for NO-mediated activation, and in doing so causes an increase in the production of intracellular cGMP that results in vascular smooth muscle relaxation and vasodilation. |
| Pharmacodynamics | By directly stimulating the increased production of intracellular cyclic guanosine monophosphate (cGMP), vericiguat causes the relaxation of vascular smooth muscle and vasodilation.Vericiguat has a relatively long half-life (~30h) that allows for once-daily dosing. Animal reproduction studies have demonstrated the potential for embryo-fetal toxicity when vericiguat is administered to pregnant females - defects in major vessel and heart formation, as well as spontaneous abortions/resorptions, were observed when vericiguat was administered to pregnant rabbits during organogenesis.The possibility of pregnancy should be excluded prior to beginning therapy with vericiguat, and adequate contraception should be used throughout therapy and for one month following cessation of treatment. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Guanylate cyclase soluble subunit beta-1 | Humans | stimulator |
ADME / PK
| Absorption | Following the administration of 10mg of vericiguat by mouth once daily, the average steady-state C<sub>max</sub> and AUC in patients with heart failure is 350 mcg/L and 6,680 mcg•h/L, respectively, with a T<sub>max</sub> of 1 hour.The absolute bioavailability of orally-administered vericiguat is approximately 93% when taken with food - co-administration with meals has been shown to reduce pharmacokinetic variability, increase T<sub>max</sub> to roughly 4 hours, and increase C<sub>max</sub> and AUC by 41% and 44%, respectively. |
|---|---|
| Half-life | In patients with heart failure, the half-life of vericiguat is 30 hours. |
| Protein binding | Vericiguat is extensively (~98%) protein-bound in plasma, primarily to serum albumin. |
| Metabolism | Vericiguat is primarily metabolized via phase II conjugation reactions, with CYP-mediated oxidative metabolism comprising a small (<5%) portion of its overall biotransformation. The major inactive metabolite, vericiguat N-glucuronide (M1), is formed by UGT1A9 and, to a lesser extent, UGT1A1.Other identified metabolites include a denbenzylated compoundand an M15 metabolite thought to be the result of oxidative metabolism,although these metabolites are poorly characterized. |
| Route of elimination | Following the oral administration of radiolabeled vericiguat, approximately 53% of the administered radioactivity was recovered in the urine and 45% in the feces.A human mass balance study found that the portion recovered in the urine comprised approximately 40.8% N-glucuronide metabolite, 7.7% other metabolites, and 9% unchanged parent drug, while virtually the entire portion recovered in the feces comprised unchanged vericiguat. |
| Volume of distribution | In healthy subjects the steady-state volume of distribution of vericiguat is approximately 44 liters. |
| Clearance | Vericiguat is a low-clearance drug, with an observed plasma clearance of 1.6 L/h in healthy volunteers and 1.3 L/h in patients with systolic heart failure. |
Formulation & handling
- Oral small‑molecule API formulated as film‑coated tablets; moderate lipophilicity (LogP ~3) supports conventional solid‑dose excipient systems.
- Food increases and stabilizes absorption, so formulations should not impede co‑administration with meals.
- Solid-state handling is conventional, with no peptide/biologic sensitivities expected.
Regulatory status
| Lifecycle | The API remains in a mid‑to‑late lifecycle stage, with key U.S. patents expiring between 2031 and 2032. With products already established in the EU, US, and Canada, market presence is mature while exclusivity is expected to continue for several more years. |
|---|
| Markets | EU, US, Canada |
|---|
Supply Chain
| Supply chain summary | Vericiguat is supplied by a single originator group, with branded products available in the US, EU, and Canada, indicating a coordinated global manufacturing and distribution setup. All listed patents extend into 2031–2032 in the United States, suggesting that the compound remains within its primary exclusivity period. As a result, generic competition is unlikely in the near term. |
|---|
Safety
| Toxicity | Data regarding overdosage with vericiguat are unavailable. Doses of up to 15mg once daily (50% greater than the recommended maintenance dose) have been studied and found to be well-tolerated. Symptoms of overdose are likely to be consistent with the adverse effect profile of vericiguat and may therefore involve significant hypotension for which symptomatic and supportive measures should be provided. Dialysis is unlikely to be of benefit in vericiguat overdose given its high degree of protein binding. |
|---|
- High protein binding limits dialyzability
- Extracorporeal removal is not expected to meaningfully reduce systemic exposure
- Overexposure may manifest as marked hypotension, consistent with the agent’s known adverse‑effect profile
Written Confirmation
When an API is imported into the European Union from elsewhere in the world, it should be accompanied by a “written confirmation” (WC). A written confirmation is a document set up by the health authorities of the country where the API was manufactured. After inspections were successfully performed under EU/GMP equivalent standards, the health authorities can provide a WC. These inspections will also have to regularly take place in the future.
Vericiguat is a type of sGC stimulator
The sGC stimulator is a pharmaceutical API (Active Pharmaceutical Ingredient) that falls under the subcategory of soluble guanylate cyclase stimulators. It is an innovative therapeutic agent that has gained significant attention in the field of cardiovascular medicine.
sGC stands for soluble guanylate cyclase, which is an enzyme found in various tissues throughout the body, including blood vessels and the heart. This enzyme plays a crucial role in regulating the production of cyclic guanosine monophosphate (cGMP), a signaling molecule involved in smooth muscle relaxation and vasodilation.
sGC stimulators work by directly activating the sGC enzyme, leading to increased production of cGMP. This, in turn, promotes relaxation of smooth muscles in blood vessels, resulting in vasodilation and improved blood flow. By enhancing the activity of sGC, these stimulators provide a unique mechanism of action for treating cardiovascular diseases, such as pulmonary hypertension and heart failure.
Pharmaceutical companies have been actively researching and developing sGC stimulators as potential therapeutic options. These APIs offer promising benefits, including improved exercise capacity, reduced symptoms, and enhanced quality of life for patients with cardiovascular conditions.
As the pharmaceutical industry continues to advance, sGC stimulators hold great promise for the treatment of various cardiovascular disorders. Their targeted mechanism of action and potential positive impact on patient outcomes make them a valuable addition to the arsenal of medications available to healthcare professionals.
Vericiguat (sGC stimulator), 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.
Vericiguat API manufacturers & distributors
Compare qualified Vericiguat API suppliers worldwide. We currently have 2 companies offering Vericiguat API, with manufacturing taking place in 1 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 |
|---|---|---|---|---|---|
| Apino Pharma Co., Ltd. | Producer | China | China | BSE/TSE, CoA, GMP, MSDS, WC | 229 products |
| Senova Technology Co., Lt... | Producer | China | China | BSE/TSE, CoA, ISO9001, MSDS | 157 products |
When sending a request, specify which Vericiguat 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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Frequently asked questions about Vericiguat API
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