Sildenafil spray approved for erectile dysfunction in Germany, Ireland, and the Netherlands

How effective is Sildenafil Suspension Spray?
12. Sildenafil Oral Suspension - Clinical Pharmacology
How to use Hezkue Sildenafil suspension
Quick Summary
How long will Hezkue take to work?
1. Indications and Usage for Sildenafil Oral Suspension

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases. 10 Mar 2026 Aspargo Laboratories filed application with MHRA to reclassify Sildenafil as Pharmacy (P) medicine status in the United Kingdom 24 Dec 2025 Aspargo Labs plans a phase I pharmacokinetics trial (in voulnteers) in March 2026 (NCT07302698) 24 Dec 2025 Aspargo Laboratories plans a phase II crossover trial for Erectile dysfunction (PO), in April 2026 (NCT07290400) Aspargo plans to file a new drug application with the FDA to support regulatory approval of ASP-001 for erectile dysfunction in the United States. Findings from a recent phase 1 trial show that ASP-001, an investigational sildenafil oral spray for patients with erectile dysfunction, achieved therapeutic levels at a significantly faster rate compared with traditional sildenafil citrate tablets (Viagra), announced Aspargo Labs, the developer of the formulation, in a news release.1 “The rapid and enhanced absorption profile demonstrated by ASP-001 in this phase 1 study highlight its potential to address key unmet needs in the treatment of erectile dysfunction,” said Steven Kaplan, MD, Chief Medical Officer at Aspargo Labs, director of the Men’s Wellness Program at the Mount Sinai Health System, and a professor at the Icahn School of Medicine at Mount Sinai.1 “Many patients struggle with the inconvenience and lack of spontaneity associated with planning ahead to take a tablet and the requirement to fast or time their dosing. An oral spray formulation that achieves therapeutic levels quickly could represent a significant advancement in patient-centric therapy. If approved, ASP-001 would be a welcome addition to the treatment landscape, offering patients and their partners a novel and practical option to enhance their sexual health and overall quality of life.” Overall, data from the phase 1 study showed that ASP-001 achieved initial absorption within 5 minutes of administration.

How effective is Sildenafil Suspension Spray?

Call 999 or attend A&E immediately if you have a prolonged or sometimes painful erection, especially if it lasts for more than 2 hours. Studies carried out by AspargoLabs have stated that Hezkue is as effective as a Sildenafil tablet – or its branded equivalent, Viagra. Clinical trials for Sildenafil showed that a standard dose (50mg) improved erections for 74% of patients that tried it. It is important to note that some erectile dysfunction treatments may not work the first time, and it may take several times on different occasions for Hezkue to take effect. Before you use Hezkue for the first time, make sure you have performed three ‘practice pumps’ away from your mouth to make sure that the dosing pump is working properly. At this time point, the average amount of medication in the bloodstream was 0.615 ng/mL with ASP-001, vs 0 ng/mL with sildenafil tablets. The average level of medication in the bloodstream via mean plasma concentrations remained higher for those who received ASP-001 vs those who received sildenafil tablets for the first 30 minutes following administration. In total, the open-label, single center, 2-way crossover study included 53 healthy, fasted male volunteers. Participants were randomly assigned to receive either 4 mL of ASP-001 or to 100 mg sildenafil tablets.

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All those included in the trial participated in at least a 10-hour fasting period and underwent a total of 24 plasma blood samples over 24 hours.

12. Sildenafil Oral Suspension - Clinical Pharmacology

Our research has demonstrated that ASP-001 exhibits rapid absorption, surpassing the absorption rate of Viagra tablets in the initial minutes after administration. We look forward to collaborating with the FDA to file an NDA for ASP-001 for the treatment of ED under the 505(b)2 regulatory pathway and are enthusiastic about the opportunity to make this drug available to patients in the US.” Aspargo Labs announces data on first oral spray for erectile dysfunction, ASP-001, showing two times faster absorption compared to Viagra tablets. Aspargo announces completion of dosing of all subjects in sildenafil oral suspension bioavailability study and initiation of dosing in companion food-effect study. Hezkue is an oral spray for erectile dysfunction (ED) that can be used as an alternative to a pill like Viagra. It works by increasing blood flow to your penis by relaxing your muscle cells.

Are you currently using Sildenafil (Viagra, Revatio)?

If effective, it allows you to have firmer and longer-lasting erections when you’re sexually aroused. Hezkue is the first and only liquid sildenafil suspension spray for ED. Spray drug delivery provides flexible dosing, allowing you to reduce your dose, if you're having side effects and increase it if the lower dose is not effective enough. Tests have shown that, once applied orally, Hezkue starts absorbing into the bloodstream within five minutes. It's important to remember, Hezkue / sildenafil doesn't create an erection on its own, you still need that spark of interest.

How long does Hezkue spray last?

While the active ingredient stays in your system for a few hours, its effectiveness does taper off. Replace the lid with the pump and nozzle and turn on. Prime the spray bottle with 3 pumps away from your mouth. Once primed, spray required dose directly into your mouth, usually onto your tongue (each spray delivers 12.5mg and your prescriber will advise what dose to take). Remove the pump and nozzle and replace with the lid. In addition to the current phase 1 study, ASP-001 is also being assessed in a companion food-effect trial to compare the amount of active drug in participants’ plasma following an administration of the medication under both fed and fasted conditions.2 In total, the study plans to enroll 38 participants. Sildenafil oral spray is currently approved in Spain, Germany, the Netherlands, Ireland, Mexico and the United Kingdom. Aspargo now plans to file a new drug application with the FDA to support regulatory approval of ASP-001 in the United States. Aspargo is also working on regulatory submissions to support approval of ASP-001 in Japan as well as several countries in the Middle East and South America. “Our innovative oral spray technology has been carefully developed to provide a novel approach for administering medication, simplifying the process of drug consumption,” said Michael Demurjian, CEO of Aspargo Labs, in the news release.1 “The study data provides evidence for the safety and pharmacokinetic profile of our oral spray technology. Our research has demonstrated that ASP-001 exhibits rapid absorption, surpassing the absorption rate of Viagra tablets in the initial minutes after administration. We look forward to collaborating with the FDA to file an NDA for ASP-001 for the treatment of ED under the 505(b)2 regulatory pathway and are enthusiastic about the opportunity to make this drug available to patients in the US.” Aspargo Labs announces data on first oral spray for erectile dysfunction, ASP-001, showing two times faster absorption compared to Viagra tablets. Aspargo announces completion of dosing of all subjects in sildenafil oral suspension bioavailability study and initiation of dosing in companion food-effect study.

Sildenafil spray can enhance male sexual performance.
It is often used when oral pills are not suitable.
The spray allows for targeted delivery to the bloodstream.
Rapid onset makes it suitable for spontaneous encounters.
Use the spray exactly as directed by the healthcare professional.
There is a risk of priapism with overuse.
The spray may cause minor irritation at the application site.
It is advisable to have medical supervision during use.
The spray’s effectiveness depends on individual health.
It is recommended to avoid alcohol for better results.
Regular follow-up visits ensure safe use over time.

Hezkue is an oral spray for erectile dysfunction (ED) that can be used as an alternative to a pill like Viagra. It works by increasing blood flow to your penis by relaxing your muscle cells. If effective, it allows you to have firmer and longer-lasting erections when you’re sexually aroused. Hezkue is the first and only liquid sildenafil suspension spray for ED. Spray drug delivery provides flexible dosing, allowing you to reduce your dose, if you're having side effects and increase it if the lower dose is not effective enough.

How to use Hezkue Sildenafil suspension

3. Prescription ED sprays (PDE5 inhibitor oral sprays, like sildenafil oral spray)

At this time point, the average amount of medication in the bloodstream was 0.615 ng/mL with ASP-001, vs 0 ng/mL with sildenafil tablets. The average level of medication in the bloodstream via mean plasma concentrations remained higher for those who received ASP-001 vs those who received sildenafil tablets for the first 30 minutes following administration. In total, the open-label, single center, 2-way crossover study included 53 healthy, fasted male volunteers. Participants were randomly assigned to receive either 4 mL of ASP-001 or to 100 mg sildenafil tablets. All those included in the trial participated in at least a 10-hour fasting period and underwent a total of 24 plasma blood samples over 24 hours.

5.2 Worsening Pulmonary Vascular Occlusive Disease

In addition to the current phase 1 study, ASP-001 is also being assessed in a companion food-effect trial to compare the amount of active drug in participants’ plasma following an administration of the medication under both fed and fasted conditions.2 In total, the study plans to enroll 38 participants. Sildenafil oral spray is currently approved in Spain, Germany, the Netherlands, Ireland, Mexico and the United Kingdom. Aspargo now plans to file a new drug application with the FDA to support regulatory approval of ASP-001 in the United States. Aspargo is also working on regulatory submissions to support approval of ASP-001 in Japan as well as several countries in the Middle East and South America. “Our innovative oral spray technology has been carefully developed to provide a novel approach for administering medication, simplifying the process of drug consumption,” said Michael Demurjian, CEO of Aspargo Labs, in the news release.1 “The study data provides evidence for the safety and pharmacokinetic profile of our oral spray technology. Tests have shown that, once applied orally, Hezkue starts absorbing into the bloodstream within five minutes.

Sildenafil spray utilizes absorption through oral mucosa.
It provides a discreet alternative for erectile issues.
Use the spray about 10-20 minutes before intimacy.
It generally has fewer gastrointestinal side effects.
The spray must be kept out of reach of children.
Users should avoid alcohol to prevent adverse reactions.
Compatibility with other medications should be checked.
The spray may be part of a comprehensive ED treatment plan.
Discontinue use and consult a doctor if adverse reactions occur.
The spray’s effectiveness can improve confidence in men.
Training on proper application enhances safety and effectiveness.

It's important to remember, Hezkue / sildenafil doesn't create an erection on its own, you still need that spark of interest. While the active ingredient stays in your system for a few hours, its effectiveness does taper off. Replace the lid with the pump and nozzle and turn on. Prime the spray bottle with 3 pumps away from your mouth. Once primed, spray required dose directly into your mouth, usually onto your tongue (each spray delivers 12.5mg and your prescriber will advise what dose to take). Remove the pump and nozzle and replace with the lid. Wash the pump with water and allow to dry completely. Remember to prime and wash after each use.

Quick Summary

Wash the pump with water and allow to dry completely. Remember to prime and wash after each use. Hezkue absorption into the bloodstream begins within 5 minutes of taking it, which is much faster than tablets. However, the effects of treatment can vary in individuals, with most noticing the benefits within 5–20 minutes and lasting up to 4–5 hours. As a spray, this drug offers flexible dosing, allowing you to reduce your dose if you're having side effects and increase if you're not finding the lower dose effective enough.

How long do Hezkue spray side effects last?

The recommended dose is typically 50 mg (4 sprays). If that doesn't work after trying it at least 6 times, clinicians may increase up to a max of 100 mg (8 sprays). If 50mg is too sildenafil citrate tables strong, then the dose can be reduced to 25mg (2 sprays). We recommend always sticking to the prescribed dose. If you think you need to be on a higher dose, speak to your clinician before increasing.

12.1 Sildenafil Oral Suspension Mechanism of Action

The maximum safe daily dosage is 8 sprays (100mg). You are allergic to sildenafil (or any of the ingredients in Hezkue) You are taking medicines like nitrates or Riociguat as this may affect how they work You have had severe issues with your heart or liver Have loss of vision because of non-arteritic ischaemic optic neuropathy (NAION) To find out whether Hezkue may be suitable for you, contact our clinicians through your Account or reach out to our customer care team. Seek medical help right away if you are experiencing any of the above rare/serious side effects. Side effects reported with sildenafil spray were generally mild and consistent with those seen in sildenafil tablets. In clinical studies, the product was generally well-tolerated. Hezkue absorption into the bloodstream begins within 5 minutes of taking it, which is much faster than tablets. However, the effects of treatment can vary in individuals, with most noticing the benefits within 5–20 minutes and lasting up to 4–5 hours. As a spray, this drug offers flexible dosing, allowing you to reduce your dose if you're having side effects and increase if you're not finding the lower dose effective enough. The recommended dose is typically 50 mg (4 sprays). If that doesn't work after trying it at least 6 times, clinicians may increase up to a max of 100 mg (8 sprays). If 50mg is too sildenafil citrate tables strong, then the dose can be reduced to 25mg (2 sprays). We recommend always sticking to the prescribed dose.

Parameter	Value	Notes
Onset of Action	15-30 minutes	Faster than oral tablets
Peak Plasma Levels	30-45 minutes	Rapid absorption
Duration of Effect	Up to 4 hours	Similar to or slightly shorter than oral form

If you think you need to be on a higher dose, speak to your clinician before increasing. The maximum safe daily dosage is 8 sprays (100mg).

Condition	Risk	Recommendation
Use of Nitrates	Severe hypotension	Do not use
Cardiovascular Diseases	Increased risk of adverse effects	Consult a doctor
Allergy to Sildenafil or components	Allergic reaction	Avoid use
Severe Liver or Kidney Impairment	Altered drug metabolism	Medical clearance required

You are allergic to sildenafil (or any of the ingredients in Hezkue) You are taking medicines like nitrates or Riociguat as this may affect how they work You have had severe issues with your heart or liver Have loss of vision because of non-arteritic ischaemic optic neuropathy (NAION) To find out whether Hezkue may be suitable for you, contact our clinicians through your Account or reach out to our customer care team. Seek medical help right away if you are experiencing any of the above rare/serious side effects. Side effects reported with sildenafil spray were generally mild and consistent with those seen in sildenafil tablets. In clinical studies, the product was generally well-tolerated. Always consult your healthcare provider if you have concerns. A full list of side effects will be available via the patient information leaflet within the packet. This will list other uncommon side effects and should be read prior to starting treatment. Can you use a Sildenafil Suspension and Sildenafil tablets at the same time? Who is Sildenafil Suspension Spray suitable for? How to choose between Sildenafil tablets and Sildenafil Suspension Hezkue, known as Bandol in Spain, is a Sildenafil Suspension. This is an oral erectile dysfunction spray you can use in place of a pill like Viagra. Once you have sprayed Hezkue into your mouth, it works like regular sildenafil in increasing blood flow to your penis by relaxing your muscle cells. This lets blood flow increase to your penis. Bear in mind that there are many different reasons you may have erectile dysfunction – Hezkue may not be able to help any psychological or emotional causes. Outline your medical history in our consultation and our clinicians will determine whether Hezkue is suitable for you. Initial tests have shown that, once applied orally, Hezkue was able to begin absorbing into the bloodstream within five minutes. When taken correctly, the effects of a Sildenafil Suspension can last up to five hours after use.

How long will Hezkue take to work?

Always consult your healthcare provider if you have concerns. A full list of side effects will be available via the patient information leaflet within the packet. This will list other uncommon side effects and should be read prior to starting treatment. Can you use a Sildenafil Suspension and Sildenafil tablets at the same time? Who is Sildenafil Suspension Spray suitable for?

Sildenafil Oral Suspension Dosage and Administration

How to choose between Sildenafil tablets and Sildenafil Suspension Hezkue, known as Bandol in Spain, is a Sildenafil Suspension. This is an oral erectile dysfunction spray you can use in place of a pill like Viagra. Once you have sprayed Hezkue into your mouth, it works like regular sildenafil in increasing blood flow to your penis by relaxing your muscle cells. This lets blood flow increase to your penis. Bear in mind that there are many different reasons you may have erectile dysfunction – Hezkue may not be able to help any psychological or emotional causes.

Does Silfin Oral Spray affect fertility?

Outline your medical history in our consultation and our clinicians will determine whether Hezkue is suitable for you. Initial tests have shown that, once applied orally, Hezkue was able to begin absorbing into the bloodstream within five minutes. When taken correctly, the effects of a Sildenafil Suspension can last up to five hours after use. However, this can depend on a number of different factors including: How many pumps of Hezkue you’ve taken How many pumps of Hezkue you’ve taken Please note that the ‘effects’ of a Sildenafil Suspension are the ability to get and maintain an erection. It doesn’t mean that you are likely to have one erection for five hours. However, this can depend on a number of different factors including: How many pumps of Hezkue you’ve taken How many pumps of Hezkue you’ve taken Please note that the ‘effects’ of a Sildenafil Suspension are the ability to get and maintain an erection. It doesn’t mean that you are likely to have one erection for five hours. Call 999 or attend A&E immediately if you have a prolonged or sometimes painful erection, especially if it lasts for more than 2 hours. Studies carried out by AspargoLabs have stated that Hezkue is as effective as a Sildenafil tablet – or its branded equivalent, Viagra. Clinical trials for Sildenafil showed that a standard dose (50mg) improved erections for 74% of patients that tried it. It is important to note that some erectile dysfunction treatments may not work the first time, and it may take several times on different occasions for Hezkue to take effect. Before you use Hezkue for the first time, make sure you have performed three ‘practice pumps’ away from your mouth to make sure that the dosing pump is working properly. Once your pump is ready, do the following: Shake your bottle to help the Suspension mix Shake your bottle to help the Suspension mix Turn the pump to the left (making sure it’s open) Turn the pump to the left (making sure it’s open) Spray directly into the mouth several times – see recommended dosages below Spray directly into the mouth several times – see recommended dosages below Turn the pump back to the right to close Turn the pump back to the right to close This should only be done once on the day you plan to have an erection.

1. Indications and Usage for Sildenafil Oral Suspension

Once your pump is ready, do the following: Shake your bottle to help the Suspension mix Shake your bottle to help the Suspension mix Turn the pump to the left (making sure it’s open) Turn the pump to the left (making sure it’s open) Spray directly into the mouth several times – see recommended dosages below Spray directly into the mouth several times – see recommended dosages below Turn the pump back to the right to close Turn the pump back to the right to close This should only be done once on the day you plan to have an erection.