CLINICAL TRIALS PROFILE FOR SILDENAFIL CITRATE

All Clinical Trials for Sildenafil Citrate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00057759 ↗	Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer	Completed	National Cancer Institute (NCI)	N/A	2003-01-01	RATIONALE: Sildenafil may be effective in helping patients who have undergone treatment for prostate cancer to have an erection for sexual activity and may improve sexual satisfaction and quality of life. PURPOSE: Randomized clinical trial to study the effectiveness of sildenafil in treating erectile dysfunction in patients who have undergone radiation therapy and hormone therapy for prostate cancer in clinical trial RTOG-9910.
NCT00057759 ↗	Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer	Completed	Radiation Therapy Oncology Group	N/A	2003-01-01	RATIONALE: Sildenafil may be effective in helping patients who have undergone treatment for prostate cancer to have an erection for sexual activity and may improve sexual satisfaction and quality of life. PURPOSE: Randomized clinical trial to study the effectiveness of sildenafil in treating erectile dysfunction in patients who have undergone radiation therapy and hormone therapy for prostate cancer in clinical trial RTOG-9910.
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.
NCT00104637 ↗	Sildenafil for Chronic Obstructive Pulmonary Disease	Completed	Pfizer	Phase 2	2005-02-01	The purpose of this study is to determine if sildenafil improves the exercise capacity and lung function of patients with chronic obstructive pulmonary disease.
NCT00104637 ↗	Sildenafil for Chronic Obstructive Pulmonary Disease	Completed	Kawut, Steven, MD	Phase 2	2005-02-01	The purpose of this study is to determine if sildenafil improves the exercise capacity and lung function of patients with chronic obstructive pulmonary disease.

Clinical Trial Conditions for Sildenafil Citrate

Condition Name

Condition Name for Sildenafil Citrate
Intervention	Trials
Erectile Dysfunction	19
Impotence	12
Pulmonary Arterial Hypertension	10
Pulmonary Hypertension	9

Condition MeSH

Condition MeSH for Sildenafil Citrate
Intervention	Trials
Erectile Dysfunction	34
Hypertension	27
Hypertension, Pulmonary	16
Pulmonary Arterial Hypertension	14

Clinical Trial Locations for Sildenafil Citrate

Trials by Country

Trials by Country for Sildenafil Citrate
Location	Trials
United States	207
United Kingdom	37
Egypt	22
Mexico	21
Canada	20

Trials by US State

Trials by US State for Sildenafil Citrate
Location	Trials
Texas	15
California	14
New York	12
Massachusetts	11
Ohio	10

Clinical Trial Progress for Sildenafil Citrate

Clinical Trial Phase

Clinical Trial Phase for Sildenafil Citrate
Clinical Trial Phase	Trials
Phase 4	42
Phase 3	24
Phase 2/Phase 3	6

Clinical Trial Status

Clinical Trial Status for Sildenafil Citrate
Clinical Trial Phase	Trials
Completed	81
Unknown status	18
Terminated	12

Clinical Trial Sponsors for Sildenafil Citrate

Sponsor Name

Sponsor Name for Sildenafil Citrate
Sponsor	Trials
Pfizer	45
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	32
Ain Shams University	8

Sponsor Type

Sponsor Type for Sildenafil Citrate
Sponsor	Trials
Other	117
Industry	92
NIH	8

Sildenafil Citrate: Clinical Trials, Market Analysis, and Projections

Last updated: January 1, 2025

Introduction

Sildenafil citrate, widely known by its brand name Viagra, is a phosphodiesterase 5 (PDE5) inhibitor used primarily to treat erectile dysfunction (ED) and pulmonary arterial hypertension. Here, we will delve into recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

SIOVAC Trial: Sildenafil in Valvular Heart Disease

A significant clinical trial that has shed light on the use of sildenafil in a specific patient group is the SIOVAC trial. This trial investigated the use of sildenafil in patients with residual pulmonary hypertension after the correction of valvular heart disease. The results were surprising and cautionary: sildenafil led to worse clinical outcomes, including a doubled risk of hospitalization compared to placebo. The study concluded that long-term use of sildenafil for treating residual pulmonary hypertension in patients with valvular heart disease should be avoided[1].

Phase 2 Clinical Study: Bremelanotide Co-administered with PDE5i

Another ongoing clinical study of interest involves the co-administration of bremelanotide with a PDE5 inhibitor (such as sildenafil) for the treatment of erectile dysfunction in patients who do not respond to PDE5i monotherapy. This Phase 2 clinical trial, initiated by Palatin, aims to assess the safety and efficacy of this combination in approximately 50 patients. The study is expected to provide data by the end of 2024 and may lead to a Phase 3 trial in 2025[4].

Market Analysis

Market Size and Growth

The sildenafil citrate market is projected to experience significant growth over the forecast period of 2024-2030. According to IndustryARC, the market size is estimated to reach $2.3 billion by 2030, growing at a CAGR of 5.5%[3].

Segmentation by Product Type

The market can be segmented by product type, including 25 mg, 50 mg, and 100 mg tablets, capsules, injections, oral jellies, oral sprays, and tropical gels. The tablet forms, particularly the 50 mg and 100 mg doses, remain the most popular due to their ease of use and established efficacy[2][3].

Segmentation by Application Type

Sildenafil citrate is primarily used for two medical applications: erectile dysfunction and pulmonary arterial hypertension. The erectile dysfunction segment holds the largest market share due to the increasing prevalence of ED worldwide. However, the pulmonary hypertension segment is expected to grow with a CAGR of 6.3% during the forecast period, driven by the extensive use of sildenafil in treating pulmonary arterial hypertension[2][3].

Geographical Segmentation

North America dominates the sildenafil citrate market, accounting for the highest revenue share in 2023. This is due to the high prevalence of erectile dysfunction, superior healthcare infrastructure, and significant R&D initiatives in the region. The Asia-Pacific region is expected to grow at the fastest CAGR over the forecast period, driven by the expanding elderly population and increasing awareness of ED treatments[2][3].

Market Drivers

Increasing Prevalence of Erectile Dysfunction

The rising prevalence of erectile dysfunction, fueled by factors such as diabetes, hypertension, smoking, and an inactive lifestyle, is a major driver of the sildenafil citrate market. Increased awareness and reduced social stigma around ED have led to higher demand for treatments like sildenafil[2][3].

Advancements in Drug Formulations

Advancements in drug formulations, including the introduction of generic alternatives and innovative delivery methods like oral jellies and sprays, enhance accessibility and patient adherence. These innovations are expected to continue driving market growth[3].

Government and NGO Initiatives

Government and non-governmental organization initiatives to boost awareness about erectile dysfunction and other conditions treatable with sildenafil citrate are also significant drivers. Observances like "National Impotence Day" and "Men’s Health Month" contribute to increased awareness and demand for ED treatments[2].

Market Challenges

Misutilization and Psychological Dependence

One of the major challenges facing the sildenafil citrate market is the misutilization of the drug for recreational purposes, leading to psychological dependence. This issue hampers the growth of the market by diverting the drug from its intended medical use[2].

Future Projections

Continued Growth in ED Treatment

The market for sildenafil citrate is poised for continued expansion, driven by evolving consumer attitudes and innovative product offerings. As more men seek effective solutions for erectile dysfunction, the demand for sildenafil is expected to rise[3].

Expanding Therapeutic Applications

Research into the therapeutic applications of sildenafil beyond ED, such as pulmonary arterial hypertension, mountain sickness, and Raynaud’s phenomenon, is expected to further propel the market. These additional uses highlight the versatility of sildenafil and its potential for growth in various medical segments[2][3].

Key Takeaways

• Clinical Trials: The SIOVAC trial highlights the need to avoid sildenafil in patients with residual pulmonary hypertension after valvular heart disease correction. Ongoing trials like the co-administration of bremelanotide with PDE5i show promise for treating ED in non-responders.
• Market Growth: The sildenafil citrate market is projected to reach $2.3 billion by 2030, growing at a CAGR of 5.5%.
• Segmentation: The market is segmented by product type, application type, and geography, with North America dominating and the Asia-Pacific region showing the fastest growth.
• Drivers: Increasing prevalence of ED, advancements in drug formulations, and government/NGO initiatives drive the market.
• Challenges: Misutilization and psychological dependence are significant challenges.

FAQs

What was the outcome of the SIOVAC trial regarding sildenafil use in valvular heart disease?

The SIOVAC trial found that sildenafil should be avoided in patients with residual pulmonary hypertension after the correction of valvular heart disease, as it led to worse clinical outcomes and a doubled risk of hospitalization compared to placebo[1].

What is the current market size and growth projection for sildenafil citrate?

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[3].

Which segment holds the largest market share in the sildenafil citrate market?

The erectile dysfunction segment holds the largest market share due to the increasing prevalence of ED worldwide[2][3].

What are the major drivers of the sildenafil citrate market?

The major drivers include the increasing prevalence of erectile dysfunction, advancements in drug formulations, and government and NGO initiatives to boost awareness about ED treatments[2][3].

What challenges does the sildenafil citrate market face?

One of the major challenges is the misutilization of the drug for recreational purposes, leading to psychological dependence, which hampers the growth of the market[2].

Sources

1. European Society of Cardiology. "Sildenafil should be avoided in valve disease with residual pulmonary hypertension - SIOVAC." Press Release, 28 August 2017.
2. IndustryARC. "Sildenafil Citrate Market - Forecast(2024 - 2030)." Report, 2024.
3. IndustryARC. "Sildenafil Citrate Market - Forecast(2024 - 2030) - IndustryARC." Press Release, 18 November 2024.
4. Palatin Technologies, Inc. "Palatin Announces the Initiation of a Phase 2 Clinical Study of Bremelanotide Co-administered with a PDE5i for the Treatment of Erectile Dysfunction (ED)." Press Release, 20 June 2024.