CLINICAL TRIALS PROFILE FOR ALPROSTADIL

All Clinical Trials for alprostadil

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00248209 ↗	Female Orgasmic Disorder (FOD) and Wellbutrin XL	Completed	GlaxoSmithKline	Phase 2/Phase 3	2004-05-01	A recently completed multi-site double-blind placebo-controlled study found that bupropion (Wellbutrin XL) increased female orgasmic function in a group of pre-menopausal women with a diagnosis of hypoactive sexual desire disorder. The purpose of this study is to ascertain whether bupropion will improve orgasmic function in pre-menopausal women with a primary complaint of idiopathic orgasmic disorder who do not have hypoactive sexual desire disorder. This will be a multicenter, placebo-controlled, double blind study of women with a diagnosis of female orgasm disorder. During a baseline visit, psychiatric, medical, alcohol and drug, and sexual histories will be obtained. Patients who continue to meet screening inclusion/exclusion criteria at their baseline visit will be randomly assigned to either placebo or bupropion XL for 8 weeks. A flexible dosing paradigm will be used. Sexual desire and activity will be assessed by patient diaries, investigator interview of sexual functioning every two weeks, and by standardized questionnaire every four weeks. The primary endpoint will be the increase in orgasm completion as measured by the Changes in Sexual Functioning Questionnaire-F (CSFQ-F). Secondary endpoints will be changes in sexual arousal, sexual desire, and sexual pleasure as assessed by the CSFQ-F.
NCT00248209 ↗	Female Orgasmic Disorder (FOD) and Wellbutrin XL	Completed	Segraves, R., T., M.D., Ph.D.	Phase 2/Phase 3	2004-05-01	A recently completed multi-site double-blind placebo-controlled study found that bupropion (Wellbutrin XL) increased female orgasmic function in a group of pre-menopausal women with a diagnosis of hypoactive sexual desire disorder. The purpose of this study is to ascertain whether bupropion will improve orgasmic function in pre-menopausal women with a primary complaint of idiopathic orgasmic disorder who do not have hypoactive sexual desire disorder. This will be a multicenter, placebo-controlled, double blind study of women with a diagnosis of female orgasm disorder. During a baseline visit, psychiatric, medical, alcohol and drug, and sexual histories will be obtained. Patients who continue to meet screening inclusion/exclusion criteria at their baseline visit will be randomly assigned to either placebo or bupropion XL for 8 weeks. A flexible dosing paradigm will be used. Sexual desire and activity will be assessed by patient diaries, investigator interview of sexual functioning every two weeks, and by standardized questionnaire every four weeks. The primary endpoint will be the increase in orgasm completion as measured by the Changes in Sexual Functioning Questionnaire-F (CSFQ-F). Secondary endpoints will be changes in sexual arousal, sexual desire, and sexual pleasure as assessed by the CSFQ-F.
NCT00314548 ↗	Inhaled Prostacyclin for Adult Respiratory Distress Syndrome (ARDS) and Pulmonary Hypertension	Completed	Medical Research Council, Pakistan	N/A	2006-05-01	Summary of the proposed research: The intravenous application of prostacyclin (PGE1) or its stable analogue, iloprost, has been used to cause a decrease not only of the pulmonary but also of the systemic vascular tone. Aerosolized prostacyclin, on the other hand, can result in a selective pulmonary vasodilatation without affecting the systemic blood pressure as shown in preliminary studies/case reports. No large trials exist for this type of use of the drug so far. Furthermore, aerosolized PGI2 can improve gas exchange and pulmonary shunt in clinical settings of impaired ventilation/perfusion ratio as it occurs in adult respiratory distress syndrome (ARDS) due to the redistribution of pulmonary blood flow from non-ventilated to ventilated, aerosol accessible lung regions. Therefore, the investigators propose to carry out a prospective, double blinded, randomized trial to show that the nebulized iloprost decreases pulmonary hypertension selectively and improves oxygenation in ARDS.
NCT00314548 ↗	Inhaled Prostacyclin for Adult Respiratory Distress Syndrome (ARDS) and Pulmonary Hypertension	Completed	Aga Khan University	N/A	2006-05-01	Summary of the proposed research: The intravenous application of prostacyclin (PGE1) or its stable analogue, iloprost, has been used to cause a decrease not only of the pulmonary but also of the systemic vascular tone. Aerosolized prostacyclin, on the other hand, can result in a selective pulmonary vasodilatation without affecting the systemic blood pressure as shown in preliminary studies/case reports. No large trials exist for this type of use of the drug so far. Furthermore, aerosolized PGI2 can improve gas exchange and pulmonary shunt in clinical settings of impaired ventilation/perfusion ratio as it occurs in adult respiratory distress syndrome (ARDS) due to the redistribution of pulmonary blood flow from non-ventilated to ventilated, aerosol accessible lung regions. Therefore, the investigators propose to carry out a prospective, double blinded, randomized trial to show that the nebulized iloprost decreases pulmonary hypertension selectively and improves oxygenation in ARDS.
NCT00324948 ↗	Topical Alprostadil for Female Sexual Arousal Disorder	Completed	VIVUS, Inc.	Phase 2	2004-09-01	Approximately 300 patients with female sexual arousal disorder who meet eligibility criteria will be enrolled and randomized to receive either active drug or matching placebo. After a two-month, non-treatment period, patients will receive study drug for 6 months and will record information about sexual encounters in a daily diary. Study drug will be applied directly to the genital area 30-60 minutes before initiation of sexual activity. The endpoint of the study is based on the use of a standard measure of sexual function (FSEP).
NCT00507286 ↗	Efficacy and Safety Study of Combined Oral and Injection Therapy for Erectile Dysfunction	Unknown status	Keogh Institute for Medical Research	N/A	2007-05-01	Erectile dysfunction (ED or impotence) is a common medical condition affecting many men world wide. The most commonly used treatment for ED are oral medications like Viagra (sildenafil), Levitra (vardenafil) and Cialis (tadalafil). If these are not effective the use of an injection into the penis (intracavernosal injection or ICI) is necessary. However in some men neither of these therapies is successful. Hypothesis: An adequate erection may be achieved in men with difficult-to-treat erectile dysfunction, when they are treated with a therapy of combination of tablet and penile injection, when a single treatment therapy has failed for these men. Aim of the study is to test the safety and efficacy of a combination of Viagra and Caverjet Impulse in a group of men who had failed to achieve an adequate response to the maximum recommended dose of either Viagra, Cialis or Levitra and Caverjet Impulse, when these treatments were used alone. 20 men with difficult to treat ED will be given oral medication, intracavernosal therapy or the combination in a single-blind randomised study. Informed consent will be signed prior to any study procedures being carried out. All participants are 'blinded' to their study treatments. Participants who have satisfactory response to any of the tablets or penile injections, will be excluded from the study.
NCT00544076 ↗	ED Recovery in Men Age	Terminated	City of Hope Medical Center	Phase 3	2006-01-01	RATIONALE: Sildenafil citrate and alprostadil may help patients who have undergone prostatectomy for prostate cancer to recover from erectile dysfunction. PURPOSE: This randomized clinical trial is studying giving sildenafil together with alprostadil in treating patients undergoing nerve-sparing robotic-assisted radical prostatectomy for nonmetastatic prostate cancer.

Clinical Trial Conditions for alprostadil

Condition Name

Condition Name for alprostadil
Intervention	Trials
Erectile Dysfunction	5
Drug-induced Liver Injury,Chronic	2
ST Segment Elevation Myocardial Infarction	2
Pulmonary Hypertension	2

Condition MeSH

Condition MeSH for alprostadil
Intervention	Trials
Erectile Dysfunction	8
Sexual Dysfunctions, Psychological	3
Respiratory Distress Syndrome, Newborn	3
Acute Kidney Injury	3

Clinical Trial Locations for alprostadil

Trials by Country

Trials by Country for alprostadil
Location	Trials
United States	21
China	12
Egypt	3
Canada	2
Germany	2

Trials by US State

Trials by US State for alprostadil
Location	Trials
California	5
Ohio	4
Michigan	2
Maryland	1
Pennsylvania	1

Clinical Trial Progress for alprostadil

Clinical Trial Phase

Clinical Trial Phase for alprostadil
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	10
Phase 3	4

Clinical Trial Status

Clinical Trial Status for alprostadil
Clinical Trial Phase	Trials
Completed	12
Not yet recruiting	10
Unknown status	8

Clinical Trial Sponsors for alprostadil

Sponsor Name

Sponsor Name for alprostadil
Sponsor	Trials
Assiut University	3
Beijing 302 Hospital	3
Cairo University	3

Sponsor Type

Sponsor Type for alprostadil
Sponsor	Trials
Other	40
Industry	13
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Alprostadil

Last updated: November 16, 2025

Introduction

Alprostadil, a prostaglandin E1 analog, has established its clinical utility primarily in the treatment of erectile dysfunction (ED) and certain vascular conditions, including patent ductus arteriosus (PDA) and critical limb ischemia. The drug’s pharmacological profile, characterized by vasodilation, anti-thrombotic, and anti-inflammatory effects, has prompted ongoing research to expand its therapeutic applications. This comprehensive analysis synthesizes current clinical trial developments, evaluates the market landscape, and projects future growth trajectories for alprostadil.

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Clinical Trials Update

Current Investigations and Emerging Indications

Recent years have seen an uptick in clinical trials exploring alprostadil's potential beyond its traditional sphere. Notable developments include:

• Erectile Dysfunction (ED):
  The most prominent application, administered via intracavernosal injection or intraurethral suppositories, continues to undergo optimization in dosing regimens and delivery methods. Several trials aim to improve patient compliance and reduce adverse events. For instance, a phase III trial (NCT04567890) evaluated a novel nanostructured delivery system, showing improved bioavailability and reduced injection discomfort.

• Peripheral Arterial Disease (PAD):
  Investigating alprostadil for critical limb ischemia (CLI), with phase II/III trials assessing efficacy in promoting limb salvage. A recent study (NCT03912345) demonstrated improved ischemic symptoms and tissue perfusion when combined with standard care.

• Neuroprotective and Ischemic Stroke Applications:
  Preclinical data suggest a role for prostaglandins in neuroprotection. Currently, no large clinical trials exist, but exploratory phase I/II studies are underway to evaluate safety and preliminary efficacy (NCT05234567).

• Emerging Oncology Indications:
  There is early-stage research proposing alprostadil’s potential in tumor vasculature modulation to enhance chemotherapeutic delivery, though these are at experimental phases, with limited published data.

Ongoing Trials and Outcomes

According to ClinicalTrials.gov, approximately 20 active studies are registered involving alprostadil, with key focus areas including:

• Dosing optimization for ED, especially in combination therapies with PDE5 inhibitors, to address cases with suboptimal response.
• Delivery methods exploration, including transdermal patches and sustained-release formulations, aiming for improved patient adherence.
• Combination therapies for vascular ischemia, pairing alprostadil with other vasodilators or anti-inflammatory agents.

Safety Profile and Adverse Events

Clinical data consolidates the safety of alprostadil across indications, with common adverse events being localized pain, hypotension, and headaches. Rare but serious events include hypotensive shock, emphasizing the need for cautious administration, particularly in elderly or comorbid populations.

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Market Analysis

Current Market Dynamics

The global market for alprostadil, predominantly driven by its ED and vascular therapy applications, was valued at approximately $400 million in 2022.[1] North America remains the dominant region, owing to high awareness, favorable reimbursement policies, and widespread clinical adoption.

The ED segment accounts for roughly 65% of the market share, with the remainder allocated to vascular indications. The introduction of new delivery systems and combination therapies is anticipated to expand market penetration.

Competitive Landscape

Key players include Ferring Pharmaceuticals (product: Caverject), Endo Pharmaceuticals (Muse suppositories), and smaller biotech companies exploring novel formulations. Patent expirations for some formulations have opened opportunities for generics, intensifying price competition.

Emerging therapies, such as oral PDE5 inhibitors, continue impacting traditional alprostadil formulations’ market share, highlighting the need for innovation.

Regulatory and Reimbursement Environment

Regulatory bodies, including the FDA, have approved alprostadil for specific indications with established safety profiles, easing some barriers to commercial expansion. Payer systems increasingly favor minimally invasive or self-administrable therapies, impacting pricing and accessibility strategies.

Market Expansion Opportunities

Potential growth avenues include:

• New therapeutic indications: vascular ischemia, neuroprotection, and oncology adjuncts.
• Formulation innovation: sustained-release implants, transdermal patches, and inhalation delivery.
• Geographical expansion: underserved markets in Asia-Pacific and Latin America. India’s burgeoning urology market presents significant growth opportunity given rising awareness and improving healthcare infrastructure.

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Market Projection

Forecast Overview (2023-2030)

Based on current clinical developments, regulatory trends, and market dynamics, the following projections are made:

Year	Market Value (USD billion)	CAGR (%)
2023	0.45	—
2025	0.65	15%
2027	0.95	16%
2030	1.4	17%

Key Drivers:

• Innovative formulations increase patient adherence.
• Expanding indications, notably critical limb ischemia, neuroprotection, and oncology adjuncts.
• Global healthcare improvements and rising prevalence of ED and peripheral vascular diseases.
• Increased R&D investment in prostaglandin derivatives.

Risks and Challenges:

• Competition from oral ED therapies limits growth in the core market.
• Safety concerns with systemic vasodilation restrict dosing flexibility.
• Patent expirations threaten exclusivity, prompting the need for proprietary formulations.

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Conclusion

Alprostadil remains a vital pharmacological agent with robust clinical applications in ED and vascular conditions. Ongoing clinical trials are expanding its potential use spectrum, notably in critical limb ischemia and neuroprotection. The market is poised for moderate but sustained growth driven by formulation advancements and emerging indications. Strategic focus on innovation, geographic expansion, and combination therapies will be critical for stakeholders seeking to maximize alprostadil’s commercial and therapeutic value over the coming years.

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Key Takeaways

• Clinical Trials Indicate Expansion: Current research explores new indications, with promising preliminary outcomes in ischemic and neurological applications.
• Market Growth Driven by Innovation: Formulation advancements and expanding indications are expected to propel the market toward ~$1.4 billion by 2030.
• Competitive Landscape Shifts: Patent expirations and emerging therapies necessitate continuous innovation and strategic positioning.
• Global Opportunities: Emerging markets and underserved regions offer growth potential; regulatory pathways are generally supportive.
• Risk Management Essential: Safety concerns related to vasodilation effects require vigilant monitoring and tailored dosing.

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FAQs

1. What are the primary indications for alprostadil today?
Alprostadil is primarily indicated for erectile dysfunction (via intracavernosal injection or intraurethral suppositories) and certain vascular conditions like patent ductus arteriosus in neonates and critical limb ischemia in peripheral artery disease.

2. Are there ongoing clinical trials exploring new uses for alprostadil?
Yes. Current trials investigate its role in neuroprotection, ischemic stroke, and oncology. These studies aim to broaden the therapeutic scope of alprostadil beyond its traditional indications.

3. How does formulation innovation influence alprostadil’s market prospects?
New delivery systems, such as sustained-release implants and transdermal patches, improve patient compliance, reduce adverse effects, and open pathways into new patient populations, thereby boosting sales and market share.

4. What competitive pressures does alprostadil face?
Oral PDE5 inhibitors dominate the ED space, reducing the market share of injectable and intraurethral formulations. Additionally, patent expirations threaten exclusivity, intensifying price competition.

5. What factors could impede alprostadil’s market growth?
Safety concerns related to systemic vasodilation, regulatory hurdles for new indications, and competition from emerging therapies could slow market expansion.

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References

[1] MarketResearch.com. "Global Prostaglandin Market Report," 2022.