New ED treatments in 2026, in brief: pills (PDE5 inhibitors) are still first-line. The newest FDA-authorized option is a drug-free gel, authorized for over-the-counter use in June 2023. Shockwave therapy and PRP injections are offered by some clinics, but the American Urological Association calls them investigational and experimental. Stem cells remain in trials.
Written by Jen Adams, BSN, RN
Medically reviewed by Dr. Josh Allen, D.O., Medical Director, October 23, 2026
Disclaimer: This article is general education, not medical advice. Results vary with the cause of ED, your health and how you respond to treatment, so talk with a licensed provider before starting anything.
The American Urological Association guideline says men should be counseled that ED is a risk marker for underlying cardiovascular disease. NIDDK puts it simply: ED may be a symptom of another health problem, such as heart and blood vessel disease, high blood pressure, diabetes or low testosterone.
So before choosing any new treatment, start with a full medical history, an exam and, where needed, lab work from a licensed provider. The AUA guideline also recommends measuring morning testosterone in men with ED. Treating the cause can change which option makes sense, and it can catch a health problem that matters more than the erection itself.
PDE5 inhibitors such as sildenafil (Viagra) and tadalafil (Cialis) help increase blood flow to the penis during sexual arousal. They must not be taken with nitrate medicines for chest pain, because the combination can cause a dangerous drop in blood pressure (see the tadalafil prescribing information). Your provider sets the dose.
PDE5 inhibitors work well for many men. But they have real limitations:
| Limitation | Impact |
|---|---|
| Temporary effect only | Works for a limited window after each dose |
| Must plan ahead | Usually taken before sexual activity |
| Common side effects | Headaches, flushing, nasal congestion |
| Doesn’t work for everyone | Some men do not respond, especially with diabetes-related nerve damage or after prostate surgery |
| Doesn’t address root causes | Manages symptoms, not underlying issues |
| Drug interactions | Must not be combined with nitrates for chest pain |
| Performance anxiety | Pressure of “will it work this time” |
A 2021 review of emerging ED therapies notes that a real share of men do not respond to pills, which drives research into newer options.
In June 2023, the FDA authorized the first over-the-counter gel to treat erectile dysfunction, a product called Eroxon. It is a non-medicated gel for adult men aged 22 and over. As the alcohol and water in it evaporate, it creates a quick cooling sensation on the head of the penis, then a slower warming one, which the FDA says stimulates nerve endings that lead to an erection.
It was granted marketing authorization as a new device through the FDA De Novo pathway (decision DEN220078, June 9, 2023), not approved as a drug. In the 24-week home-use study summarized in the FDA decision summary, 62% of men using the gel improved their erectile function score by more than the minimum meaningful amount. That study was open-label and was not designed to compare the gel with pills, so results vary and it is not a replacement for an evaluation.
Here is how the main options compare:
| Treatment | FDA status | How it works | Typically considered for | AUA guideline view | How long it lasts |
|---|---|---|---|---|---|
| PDE5 inhibitors (sildenafil, tadalafil) | FDA approved for ED | Increases blood flow during arousal | Most men with ED (first-line) | Standard option | Per dose |
| Drug-free topical gel | FDA-authorized device (De Novo, 2023), over the counter | Cooling then warming effect on nerve endings | Men 22 and over | Not covered (authorized after the 2018 guideline) | Per use |
| Vacuum devices | FDA-regulated device (Class II) | Pulls blood into the penis | Men who prefer a drug-free device | Standard option | Per use |
| Penile injections (alprostadil) | FDA approved for ED | Medicine injected into the penis relaxes blood vessels | Men who do not respond to pills | Standard option | Per use |
| Penile implants | FDA approved (premarket approval) | Mechanical erection | Severe, treatment-resistant ED | Standard option | Long-term device |
| Testosterone therapy | FDA approved for low testosterone | Hormone replacement | ED with lab-confirmed low testosterone | Measure testosterone first | Ongoing while treated |
| Shockwave therapy | Not FDA-approved for ED | Sound waves aimed at penile tissue | Vasculogenic ED, in clinic or research settings | Investigational | Not established |
| PRP injections | Not FDA-approved for ED | Platelet concentrate from your own blood | Clinic or research settings | Experimental | Not established |
| Stem cell therapy | Not approved for ED | Proposed tissue regeneration | Clinical trials only | Investigational | Not established |
Low-intensity extracorporeal shockwave therapy (Li-ESWT) has drawn a lot of interest as a non-drug ED treatment.
Shockwave therapy uses acoustic sound waves applied to penile tissue. The proposed mechanism:
Shockwave therapy is not FDA-approved for ED, and the American Urological Association guideline says low-intensity shockwave therapy for ED should be considered investigational. The 2021 review reported promising results in men with vasculogenic ED (ED caused by blood flow problems) but said most emerging therapies still need validation in well-designed clinical trials. Ask your provider what results are realistic for you, and learn more about shockwave therapy for ED at InjectCo.
A licensed nurse walks you through what the evidence shows for your situation.
Some clinics offer PRP injections as a regenerative ED treatment, but the evidence is still early.
PRP uses platelet-rich plasma drawn from your own blood. A small blood sample is spun in a centrifuge to concentrate the platelets, and the PRP is injected into the penis. The idea is that growth factors in platelets may support tissue repair and blood flow, but this has not been proven: the AUA guideline says platelet-rich plasma therapy for ED should be considered experimental, and PRP is not FDA-approved for ED.
At InjectCo, men’s PRP injections are $1,799. Because the evidence is still early, your nurse will explain what PRP can and cannot be expected to do before you decide. For a side-by-side look, see PRP vs shockwave for ED.
Hormones play a real but often misunderstood role in erectile function, which is why the AUA guideline recommends checking morning testosterone levels in men with ED.
| Factor | Truth |
|---|---|
| Low T causes ED | Can contribute, but often not the sole cause |
| Normal T guarantees function | No. ED occurs at all testosterone levels |
| TRT fixes ED | Only helps if low T was a contributing factor |
| All men with ED need TRT | No. Only those with documented deficiency |
Testosterone therapy may help ED when:
It is less likely to help if testosterone levels are normal, vascular disease is significant, nerve damage is present or psychological factors dominate. For borderline levels, better sleep, weight management, exercise and less alcohol are reasonable places to start.
Stem cell therapy for ED is still experimental: the AUA guideline says it should be considered investigational. The 2021 review reported favorable early data in some groups, such as men with diabetes-related ED or ED after prostate surgery, but larger, well-designed trials are still needed. The same review describes new medicines being studied that act on nerve and blood vessel signaling, such as guanylate cyclase activators and nitric oxide donors, alone or alongside pills.
| Aspect | Reality |
|---|---|
| FDA approval | Stem cells not approved for ED |
| Clinical trials | Ongoing, mostly early phase |
| Availability | Should be limited to research settings |
| Standardization | Lacks consistent protocols; small studies, varied cell sources |
| Long-term outcomes | Unknown |
The FDA warns that unapproved regenerative medicine products are often illegally marketed as safe and effective, and that it has received reports of blindness, tumor formation and infections. It also says that if you are being charged for these products outside a clinical trial, you are likely being deceived. Men considering this path should:
Stem cell therapy for ED is promising but premature as a mainstream treatment. Watch this space, but do not pay for unproven protocols outside a clinical trial.
“Natural Viagra” pills are often ineffective, and many supplements sold for ED or sexual enhancement have been found to contain hidden drug ingredients that are not on the label and may interact dangerously with nitrate medicines. NCCIH says there is no definite evidence that any herbal product is effective or safe for ED. For yohimbe, NCCIH notes there is not enough research to say it helps, and a component of it has been linked to irregular heartbeat, blood pressure problems, heart attacks and seizures.
| Your situation | Options to discuss with a provider |
|---|---|
| New ED, no evaluation yet | A medical evaluation first, including heart and blood vessel risk |
| Mild to moderate ED, no nitrate use | PDE5 inhibitor pills (first-line) |
| Prefer a drug-free, over-the-counter option | The FDA-authorized topical gel |
| Pills not suitable or not enough | Vacuum devices, injections or implants, chosen with a urologist |
| Interested in shockwave or PRP | Investigational or experimental options, with realistic expectations |
| Symptoms of low testosterone | Blood tests first; treatment only if deficiency is confirmed |
For a deeper look at the established options, see ED treatments compared by the evidence. If you plan to pay from a health account, read about using an HSA or FSA for ED treatment.
The newest FDA-authorized option is a drug-free, over-the-counter topical gel, authorized through the FDA De Novo pathway in June 2023 for men 22 and over. Shockwave therapy and PRP injections are offered by some clinics but are not FDA-approved for ED. Stem cell therapy and new drug targets remain in clinical research, so pills are still where most men start.
No. Shockwave therapy is not FDA-approved for treating ED, so clinics that offer it are using it outside an approved indication. The American Urological Association guideline says low-intensity shockwave therapy for ED should be considered investigational. Some studies show promise in men with blood-flow-related ED, but ask any provider what results are realistic for you and how they will measure them.
It is not proven. The AUA guideline says platelet-rich plasma therapy for ED should be considered experimental, PRP is not FDA-approved for ED, and larger, well-controlled trials are still needed. If you are considering PRP, ask what the evidence shows for your type of ED and treat it as an option to discuss, not a substitute for a medical evaluation.
Research is looking at stem cell therapy, which showed favorable early data in men with diabetes-related ED or ED after prostate surgery, and at new medicines that act on nerve and blood vessel signaling, such as guanylate cyclase activators and nitric oxide donors. Most are still in early phases. The FDA warns against paying for unapproved stem cell products outside a clinical trial.
It was not approved as a drug. The FDA granted it marketing authorization as a new medical device through the De Novo pathway in June 2023. It contains no medicine: it works through a cooling and then warming effect on nerve endings. It is authorized for adult men aged 22 and over, and it is worth getting evaluated first if your ED is new.
“Better” depends on your situation and health history. Some men prefer tadalafil because each dose lasts longer. A drug-free gel is available over the counter. Vacuum devices and penile injections help some men who do not respond to pills, and implants may be considered for severe ED. Most men still start with PDE5 inhibitors because they work well for many.
Regenerative treatments such as PRP and stem cells are still experimental or investigational for ED, so lasting benefit has not been shown. What can improve ED for some men is treating the underlying cause, such as heart and blood vessel disease, diabetes, low testosterone or medication side effects. That is one more reason to start with a full evaluation rather than a new treatment.
Yes. The American Urological Association guideline says men should be counseled that ED is a risk marker for underlying cardiovascular disease, and NIDDK lists heart and blood vessel disease, high blood pressure and diabetes among its causes. If ED is new for you, tell your provider about chest pain, shortness of breath or a family history of heart disease.
Not every new ED treatment has strong data behind it, so start with an evaluation and choose based on evidence rather than marketing. At InjectCo, licensed nurses offer PRP injections and ED shockwave therapy in a private setting with physician oversight, and we will tell you plainly what the evidence does and does not show.
A licensed nurse, a private room and a straight answer about your options.
Men’s PRP injections (platelet-rich plasma): $1,799
