CLINICAL TRIALS PROFILE FOR VIAGRA

All Clinical Trials for Viagra

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00056433 ↗	Evaluation of Hydroxyurea Plus L-arginine or Sildenafil to Treat Sickle Cell Anemia	Completed	National Institutes of Health Clinical Center (CC)	Phase 1	2003-03-10	Patients with sickle cell disease have abnormal hemoglobin (the protein in red blood cells that carries oxygen to the body). This abnormality causes red blood cells to take on a sickle shape, producing disease symptoms. Fetal hemoglobin, a type of hemoglobin present in fetuses and babies, can prevent red cells from sickling. The drug hydroxyurea increases fetal hemoglobin production in patients with sickle cell disease by making a molecule called nitric oxide. The drugs L-arginine and Sildenafil (Viagra) increase the amount or the effect of nitric oxide. This study will evaluate: - The safety of giving L-arginine or Sildenafil together with hydroxyurea in patients with sickle cell disease; - The effectiveness of L-arginine plus hydroxyurea or Sildenafil plus hydroxyurea in increasing fetal hemoglobin in patients with sickle cell disease; and - The effectiveness of L-arginine plus hydroxyurea or Sildenafil and hydroxyurea in lowering blood pressure in the lungs of patients with sickle cell disease. (Pulmonary blood pressure is elevated in about one-third of patients with sickle cell disease, and this condition increases the risk of dying from the disease.) Patients with hemoglobin S-only, S-beta-thalassemia, or other sickle cell disease genotype may be eligible for this study. Before starting treatment, patients will have a complete medical history and physical examination. All patients will take hydroxyurea once a day every day by mouth for at least 2 months. They will be admitted to the NIH Clinical Center to take their first dose of hydroxyurea, and will have blood drawn through a catheter (plastic tube placed in a vein) every hour for 6 hours for tests to determine nitric oxide levels. After discharge, they will return to the clinic once every 2 weeks to check for treatment side effects and for blood tests to monitor hemoglobin and fetal hemoglobin levels. After fetal hemoglobin levels have been stable for 2 months, patients will be admitted to the Clinical Center for their first dose of L-arginine (for men) or Sildenafil (for women). Again, blood samples will be collected through a catheter once an hour for 6 hours. If there are no complications, patients will be discharged and will continue taking hydroxyurea once a day and L-arginine or Sildenafil three times a day for at least 3 months until fetal hemoglobin levels have been stable for at least 2 months. Patients will return to the clinic for blood tests every week for 2 weeks and then every 2 weeks to monitor hemoglobin and fetal hemoglobin levels and to check for treatment side effects. Patients will have eye examinations before and during treatment. Some patients with sickle cell disease develop abnormalities in the blood vessels of the eye. Also, Sildenafil can cause temporary changes in color vision. Rarely, more serious eye problems can occur, such as bleeding from the eye blood vessels or damage to the retina a layer of tissue that lines the back of the eye. Patients will also have an echocardiogram (ultrasound of the heart) before beginning treatment, after hydroxyurea treatment, and after 1 and 3 months of combined treatment with hydroxyurea and L-arginine or Sildenafil to help measure blood pressure in the lungs. Patients who develop complications from L-arginine or Sildenafil may continue in the study on hydroxyurea alone. Patients whose fetal hemoglobin levels increase with the combination therapy of hydroxyurea and L-arginine or Sildenafil may continue to take them.
NCT00080808 ↗	Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2001-08-01	RATIONALE: Nerve-sparing radical prostatectomy with nerve grafting followed by standard therapies for erectile dysfunction may be effective in helping patients with prostate cancer improve sexual satisfaction and quality of life. It is not yet known whether erectile dysfunction therapy and nerve-sparing prostatectomy are more effective with or without nerve grafting. PURPOSE: This randomized phase II trial is studying nerve grafting and standard therapy to see how well they work compared to standard therapy alone in treating erectile dysfunction in patients undergoing nerve-sparing radical prostatectomy for localized prostate cancer.
NCT00080808 ↗	Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer	Completed	M.D. Anderson Cancer Center	Phase 2	2001-08-01	RATIONALE: Nerve-sparing radical prostatectomy with nerve grafting followed by standard therapies for erectile dysfunction may be effective in helping patients with prostate cancer improve sexual satisfaction and quality of life. It is not yet known whether erectile dysfunction therapy and nerve-sparing prostatectomy are more effective with or without nerve grafting. PURPOSE: This randomized phase II trial is studying nerve grafting and standard therapy to see how well they work compared to standard therapy alone in treating erectile dysfunction in patients undergoing nerve-sparing radical prostatectomy for localized prostate cancer.
NCT00090376 ↗	Evaluate the Effects of GPI 1485 on Erectile Function Following Bilateral Nerve-Sparing Prostatectomy	Completed	Symphony Neuro Development Company	Phase 2	2003-12-01	In this phase II study, an investigative (not approved by the FDA) drug called GPI 1485 is being assessed to see if it can help preserve erectile function after prostatectomy.
NCT00090376 ↗	Evaluate the Effects of GPI 1485 on Erectile Function Following Bilateral Nerve-Sparing Prostatectomy	Completed	Eisai Inc.	Phase 2	2003-12-01	In this phase II study, an investigative (not approved by the FDA) drug called GPI 1485 is being assessed to see if it can help preserve erectile function after prostatectomy.

Clinical Trial Conditions for Viagra

Condition Name

Condition Name for Viagra
Intervention	Trials
Erectile Dysfunction	30
Impotence	17
Prostate Cancer	7
Pulmonary Arterial Hypertension	6

Condition MeSH

Condition MeSH for Viagra
Intervention	Trials
Erectile Dysfunction	49
Hypertension	27
Hypertension, Pulmonary	16
Pulmonary Arterial Hypertension	7

Clinical Trial Locations for Viagra

Trials by Country

Trials by Country for Viagra
Location	Trials
United States	204
Canada	17
United Kingdom	13
Australia	10
Denmark	9

Trials by US State

Trials by US State for Viagra
Location	Trials
California	17
Texas	17
New York	14
Maryland	10
Ohio	10

Clinical Trial Progress for Viagra

Clinical Trial Phase

Clinical Trial Phase for Viagra
Clinical Trial Phase	Trials
Phase 4	50
Phase 3	14
Phase 2/Phase 3	5

Clinical Trial Status

Clinical Trial Status for Viagra
Clinical Trial Phase	Trials
Completed	98
Unknown status	21
Terminated	18

Clinical Trial Sponsors for Viagra

Sponsor Name

Sponsor Name for Viagra
Sponsor	Trials
Pfizer	34
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	23
Duke University	5

Sponsor Type

Sponsor Type for Viagra
Sponsor	Trials
Other	172
Industry	85
NIH	17

Viagra: Clinical Trials, Market Analysis, and Projections

Introduction to Viagra

Viagra, known generically as sildenafil citrate, is one of the most recognized and widely used treatments for erectile dysfunction (ED). Developed by Pfizer Inc., it has been a cornerstone in the treatment of ED since its approval in 1998.

Current Clinical Trials and Developments

Bremelanotide and PDE5i Combination

While Viagra (sildenafil) is effective for many, approximately 30-40% of ED patients do not respond adequately to PDE5i monotherapy. To address this, Palatin Technologies has initiated a Phase 2 clinical study combining bremelanotide with a PDE5i. This study aims to assess the safety and efficacy of this combination in men who are non-responders to PDE5i monotherapy. The trial is expected to enroll around 50 patients and will be conducted under FDA clearance and IRB approval. Data from this study is anticipated by the end of 2024, with potential Phase 3 trials starting in the first half of 2025[1].

Sildenafil Cream for Female Sexual Arousal Disorder (FSAD)

Although not directly related to Viagra's traditional use, Daré Bioscience is conducting Phase 3 trials for a sildenafil cream aimed at treating Female Sexual Arousal Disorder (FSAD). This cream, if approved, would be the first FDA-approved treatment for FSAD. The trial design and statistical analysis plan are being finalized in collaboration with the FDA, with the study expected to commence in mid-2025[4].

Market Analysis

Market Size and Growth

The erectile dysfunction drugs market, led by Viagra, is projected to experience significant growth. In North America, the market is expected to reach $2,363.7 million by 2030, growing at a compound annual growth rate (CAGR) of 8% from 2023 to 2030[2].

Globally, the sildenafil citrate market is estimated to reach $2.3 billion by 2030, growing at a CAGR of 5.5% during the forecast period 2024-2030. The North American region accounted for the highest revenue share in 2023 and is expected to continue dominating the market[3].

Market Segmentation

The market is segmented by product type, including 25 mg, 50 mg, and 100 mg tablets, as well as other forms like capsules, injections, and oral jellies. The medical uses segment, which includes the treatment of ED and pulmonary arterial hypertension, holds the largest market share and is expected to grow with the fastest CAGR during the forecast period[3].

Geographical Distribution

North America remains the largest market for erectile dysfunction drugs, driven by the increasing prevalence of ED and the high adoption rate of PDE5 inhibitors like Viagra. However, the Asia-Pacific region is expected to be the fastest-growing market due to the expanding elderly population and increasing awareness of ED treatments[3][5].

Key Market Players

Pfizer Inc., the manufacturer of Viagra, is one of the key players in the erectile dysfunction drugs market. Other major players include Eli Lilly and Co, Teva Pharmaceutical Industries Ltd, Sanofi SA, and Bayer AG. These companies play a crucial role in shaping the market through innovative products and strategic marketing[2][5].

Market Projections

Revenue Projections

The global erectile dysfunction drugs market is projected to reach $6.81 billion by 2030, growing at a CAGR of 7.06% from 2025 to 2030. The sildenafil citrate market specifically is expected to reach $2.3 billion by 2030[3][5].

Growth Drivers

The growth of the Viagra market is driven by several factors, including:

• Increasing Prevalence of ED: Rising cases of ED due to factors like diabetes, hypertension, and an inactive lifestyle.
• Government and NGO Initiatives: Increased awareness campaigns by governments and non-governmental organizations.
• Aging Population: The growing elderly population, which is more prone to ED.
• Innovative Products: Continuous innovation in medical applications, such as the development of new formulations and delivery methods[3][5].

Challenges

Despite the positive growth projections, the market faces several challenges:

• Misuse and Dependence: The misuse of PDE5 inhibitors for recreational purposes can lead to psychological dependence.
• Generic Competition: The presence of generic medications can reduce the market share of branded products like Viagra.
• Social Stigma: The social stigma associated with ED can affect the adoption rate of treatments[3].

Key Takeaways

• Clinical Trials: Ongoing and planned clinical trials, such as the combination of bremelanotide with PDE5i and sildenafil cream for FSAD, are expanding the therapeutic landscape for ED and related conditions.
• Market Growth: The erectile dysfunction drugs market, led by Viagra, is expected to grow significantly, driven by increasing prevalence, government initiatives, and an aging population.
• Geographical Trends: North America remains the largest market, but the Asia-Pacific region is expected to be the fastest-growing due to demographic and awareness factors.
• Challenges: The market faces challenges such as misuse, generic competition, and social stigma, which need to be addressed through strategic marketing and public awareness campaigns.

FAQs

What is the current status of clinical trials for new ED treatments involving Viagra?

• Palatin Technologies is conducting a Phase 2 clinical study combining bremelanotide with a PDE5i for ED patients who do not respond to PDE5i monotherapy. Data is expected by the end of 2024, with potential Phase 3 trials in 2025[1].

How is the market for Viagra expected to grow in the coming years?

• The global erectile dysfunction drugs market, led by Viagra, is projected to reach $6.81 billion by 2030, growing at a CAGR of 7.06% from 2025 to 2030[5].

What are the main drivers of the growth in the Viagra market?

• The growth is driven by the increasing prevalence of ED, government and NGO initiatives, an aging population, and continuous innovation in medical applications[3].

What challenges does the Viagra market face?

• The market faces challenges such as misuse and dependence on PDE5 inhibitors, generic competition, and social stigma associated with ED[3].

Are there any new formulations or delivery methods being developed for Viagra?

• Yes, Daré Bioscience is developing a sildenafil cream for the treatment of Female Sexual Arousal Disorder (FSAD), and Palatin is working on a co-formulation of bremelanotide and a PDE5i for ED treatment[1][4].

Which region is expected to be the fastest-growing market for Viagra?

• The Asia-Pacific region is expected to be the fastest-growing market due to the expanding elderly population and increasing awareness of ED treatments[3][5].

Last updated: 2025-01-13