CLINICAL TRIALS PROFILE FOR TADALAFIL

505(b)(2) Clinical Trials for TADALAFIL

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT02688387 ↗	A Phase 1 Relative Bioavailability Study of Ambrisentan and Tadalfil Fixed Dose Combination Tablets in Healthy Subjects	Completed	Covance Harrogate	Phase 1	2016-03-18	This study is designed to understand the relative bioavailability (proportion of the administered dose that is absorbed into the bloodstream) of several fixed dose combinations (FDCs) tablets of ambrisentan and tadalafil for further development and to provide pharmacokinetic (PK - what the body does to the drug) data to enable a pivotal bioequivalence (BE - the relationship between two preparations of the same drug in the same dosage form that have a similar bioavailability) study. Depending on formulation work, the study will allow up to 8 new FDCs to be compared with the reference of ambrisentan and tadalafil monotherapies. The study will also evaluate up to 2 of the new formulations, that may be taken in to a BE study, to be tested for any effect on pharmacokinetics of the FDC in both fed and fasted state. This is a single centre, Phase 1, single dose, randomised, open label crossover study with 3 study parts; each study part will have up to a 5 way crossover in healthy subjects. Part 1 of the study will evaluate four formulations of the FDC (ambrisentan 10 milligram [mg] + tadalafil 40 mg) and the reference of the 2 monotherapy components taken concurrently (ambrisentan 10 mg and tadalafil 40 mg) in the fasted stated. If successful formulations are identified in this part of the study, then they will be re-formulated and tested in part 2. If no successful formulations are identified in part 1 of the study, then part 2 will be utilized to look at up to 4 new FDC formulations. However, if only two formulations, or less, are evaluated in part 2 then the FDC formulations may be tested both fed and fasted to assess food effect and part 3 will not be required. If successful formulations are identified in this study part, then up to 2 of these may be tested, for food effect, in Part 3 if not already assessed in this part. Therefore, part 3 is optional and utility is dependent on the results of the previous study parts.
New Formulation	NCT02688387 ↗	A Phase 1 Relative Bioavailability Study of Ambrisentan and Tadalfil Fixed Dose Combination Tablets in Healthy Subjects	Completed	Hammersmith Medicines Research	Phase 1	2016-03-18	This study is designed to understand the relative bioavailability (proportion of the administered dose that is absorbed into the bloodstream) of several fixed dose combinations (FDCs) tablets of ambrisentan and tadalafil for further development and to provide pharmacokinetic (PK - what the body does to the drug) data to enable a pivotal bioequivalence (BE - the relationship between two preparations of the same drug in the same dosage form that have a similar bioavailability) study. Depending on formulation work, the study will allow up to 8 new FDCs to be compared with the reference of ambrisentan and tadalafil monotherapies. The study will also evaluate up to 2 of the new formulations, that may be taken in to a BE study, to be tested for any effect on pharmacokinetics of the FDC in both fed and fasted state. This is a single centre, Phase 1, single dose, randomised, open label crossover study with 3 study parts; each study part will have up to a 5 way crossover in healthy subjects. Part 1 of the study will evaluate four formulations of the FDC (ambrisentan 10 milligram [mg] + tadalafil 40 mg) and the reference of the 2 monotherapy components taken concurrently (ambrisentan 10 mg and tadalafil 40 mg) in the fasted stated. If successful formulations are identified in this part of the study, then they will be re-formulated and tested in part 2. If no successful formulations are identified in part 1 of the study, then part 2 will be utilized to look at up to 4 new FDC formulations. However, if only two formulations, or less, are evaluated in part 2 then the FDC formulations may be tested both fed and fasted to assess food effect and part 3 will not be required. If successful formulations are identified in this study part, then up to 2 of these may be tested, for food effect, in Part 3 if not already assessed in this part. Therefore, part 3 is optional and utility is dependent on the results of the previous study parts.
New Formulation	NCT02688387 ↗	A Phase 1 Relative Bioavailability Study of Ambrisentan and Tadalfil Fixed Dose Combination Tablets in Healthy Subjects	Completed	GlaxoSmithKline	Phase 1	2016-03-18	This study is designed to understand the relative bioavailability (proportion of the administered dose that is absorbed into the bloodstream) of several fixed dose combinations (FDCs) tablets of ambrisentan and tadalafil for further development and to provide pharmacokinetic (PK - what the body does to the drug) data to enable a pivotal bioequivalence (BE - the relationship between two preparations of the same drug in the same dosage form that have a similar bioavailability) study. Depending on formulation work, the study will allow up to 8 new FDCs to be compared with the reference of ambrisentan and tadalafil monotherapies. The study will also evaluate up to 2 of the new formulations, that may be taken in to a BE study, to be tested for any effect on pharmacokinetics of the FDC in both fed and fasted state. This is a single centre, Phase 1, single dose, randomised, open label crossover study with 3 study parts; each study part will have up to a 5 way crossover in healthy subjects. Part 1 of the study will evaluate four formulations of the FDC (ambrisentan 10 milligram [mg] + tadalafil 40 mg) and the reference of the 2 monotherapy components taken concurrently (ambrisentan 10 mg and tadalafil 40 mg) in the fasted stated. If successful formulations are identified in this part of the study, then they will be re-formulated and tested in part 2. If no successful formulations are identified in part 1 of the study, then part 2 will be utilized to look at up to 4 new FDC formulations. However, if only two formulations, or less, are evaluated in part 2 then the FDC formulations may be tested both fed and fasted to assess food effect and part 3 will not be required. If successful formulations are identified in this study part, then up to 2 of these may be tested, for food effect, in Part 3 if not already assessed in this part. Therefore, part 3 is optional and utility is dependent on the results of the previous study parts.

All Clinical Trials for TADALAFIL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00050609 ↗	Study of Tadalafil for the Treatment of Diabetic Patients With Symptoms of Upset Stomach and Delayed Stomach Emptying	Completed	ICOS Corporation	Phase 2	2003-02-01	The purposes of this study are to determine whether an experimental drug known as tadalafil can reduce symptoms of dyspepsia (fullness after eating, inability to finish a regular meal, bloating, discomfort or pain in the upper abdomen, belching after meals, nausea, vomiting) in diabetic patients, and/or reduce the amount of time the stomach takes to empty the contents of a standard meal. The safety of tadalafil given once daily for 8 weeks in this population will also be studied.
NCT00050609 ↗	Study of Tadalafil for the Treatment of Diabetic Patients With Symptoms of Upset Stomach and Delayed Stomach Emptying	Completed	Eli Lilly and Company	Phase 2	2003-02-01	The purposes of this study are to determine whether an experimental drug known as tadalafil can reduce symptoms of dyspepsia (fullness after eating, inability to finish a regular meal, bloating, discomfort or pain in the upper abdomen, belching after meals, nausea, vomiting) in diabetic patients, and/or reduce the amount of time the stomach takes to empty the contents of a standard meal. The safety of tadalafil given once daily for 8 weeks in this population will also be studied.
NCT00122499 ↗	A Study to Assess the Efficacy of Tadalafil to Treat Erectile Dysfunction After Radiotherapy of Prostate Cancer	Completed	Erasmus Medical Center	Phase 3	2003-02-01	This study has been designed to evaluate the efficacy and safety of a 20-mg dose of tadalafil administered "on demand" to patients with erectile dysfunction (ED) after external-beam radiotherapy (EBRT) of prostate cancer.
NCT00125918 ↗	PHIRST-1: Tadalafil in the Treatment of Pulmonary Arterial Hypertension	Completed	ICOS Corporation	Phase 3	2005-08-01	The purpose of this study is to evaluate the safety and effectiveness of tadalafil for the treatment of pulmonary arterial hypertension.
NCT00125918 ↗	PHIRST-1: Tadalafil in the Treatment of Pulmonary Arterial Hypertension	Completed	Eli Lilly and Company	Phase 3	2005-08-01	The purpose of this study is to evaluate the safety and effectiveness of tadalafil for the treatment of pulmonary arterial hypertension.
NCT00157326 ↗	Tadalafil in Subjects With Mild to Moderate Hypertension	Completed	ICOS Corporation	Phase 2	2005-09-01	Purpose: The primary objective of this study is to evaluate the efficacy and safety of tadalafil when administered once daily at doses of 5 and 20 mg to adult subjects for 8 weeks with mild to moderate hypertension.
NCT00157326 ↗	Tadalafil in Subjects With Mild to Moderate Hypertension	Completed	Eli Lilly and Company	Phase 2	2005-09-01	Purpose: The primary objective of this study is to evaluate the efficacy and safety of tadalafil when administered once daily at doses of 5 and 20 mg to adult subjects for 8 weeks with mild to moderate hypertension.

Clinical Trial Conditions for TADALAFIL

Condition Name

Condition Name for TADALAFIL
Intervention	Trials
Erectile Dysfunction	53
Benign Prostatic Hyperplasia	19
Pulmonary Arterial Hypertension	14
Pulmonary Hypertension	11

Condition MeSH

Condition MeSH for TADALAFIL
Intervention	Trials
Erectile Dysfunction	70
Hypertension	35
Prostatic Hyperplasia	28
Hyperplasia	27

Clinical Trial Locations for TADALAFIL

Trials by Country

Trials by Country for TADALAFIL
Location	Trials
United States	508
Canada	63
Germany	54
Italy	37
United Kingdom	32

Trials by US State

Trials by US State for TADALAFIL
Location	Trials
California	33
Florida	28
Texas	23
Ohio	20
New York	20

Clinical Trial Progress for TADALAFIL

Clinical Trial Phase

Clinical Trial Phase for TADALAFIL
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	6
PHASE2	4

Clinical Trial Status

Clinical Trial Status for TADALAFIL
Clinical Trial Phase	Trials
Completed	138
Recruiting	26
Not yet recruiting	25

Clinical Trial Sponsors for TADALAFIL

Sponsor Name

Sponsor Name for TADALAFIL
Sponsor	Trials
Eli Lilly and Company	59
ICOS Corporation	22
Cedars-Sinai Medical Center	6

Sponsor Type

Sponsor Type for TADALAFIL
Sponsor	Trials
Other	197
Industry	148
NIH	18

Clinical Trials Update, Market Analysis, and Projection for Tadalafil

Last updated: October 27, 2025

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Introduction

Tadalafil, a phosphodiesterase type 5 (PDE5) inhibitor, is predominantly utilized for treating erectile dysfunction (ED) and pulmonary arterial hypertension (PAH). Initially approved by the FDA in 2003 for ED (marketed as Cialis), it has since gained additional indications, showcasing its versatile therapeutic profile. This report provides a comprehensive update on Tadalafil’s ongoing clinical trials, evaluates its current market landscape, and projects future growth trajectories based on recent industry developments.

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Clinical Trials Update

Ongoing and Recent Clinical Trials

Tadalafil continues to be a focus within the clinical research community, driven by its established safety profile and expanding therapeutic potential. According to ClinicalTrials.gov, as of 2023, more than 50 active or recruiting studies explore its efficacy across various conditions.

1. Erectile Dysfunction and Prostate Conditions:
   Several trials investigate Tadalafil’s role in treating comorbid conditions, including benign prostatic hyperplasia (BPH). A notable phase IV trial (NCT04354607) examines long-term safety in patients with both ED and BPH, aiming to establish dosing protocols for combined therapy.

2. Pulmonary Hypertension:
   New trials evaluate higher-dose formulations for PAH, seeking to improve hemodynamic outcomes. For instance, NCT05212797 assesses extended-release formulations’ efficacy and safety in PAH patients over 12 months.

3. Bacterial and Viral Infections:
   Preclinical studies are exploring Tadalafil's anti-inflammatory and immunomodulatory effects. Trials such as NCT04586112 probe its adjunctive role in managing chronic viral infections, including COVID-19-related pulmonary complications, due to PDE5’s influence on pulmonary vascular remodeling.

4. Neurovascular and Cardiometabolic Disorders:
   Emerging research investigates Tadalafil in diabetic retinopathy (NCT05334821) and cerebrovascular diseases, focusing on vasodilation properties affecting neurological outcomes.

Recent Results and Publications

Recent peer-reviewed publications have reinforced Tadalafil's expanding profile:

• A 2022 study published in The Journal of Urology demonstrated sustained improvements in LUTS (lower urinary tract symptoms) in BPH patients over 12 months of Tadalafil therapy.
• A systematic review in Pulmonary Circulation (2022) concluded that high-dose Tadalafil significantly reduced pulmonary arterial pressures with minimal adverse effects.
• Preclinical findings highlight potential neuroprotective effects, providing a rationale for upcoming trials.

Regulatory and Developmental Milestones

While Tadalafil remains predominantly approved for ED and PAH, recent regulatory discussions aim to expand its labeling:

• The European Medicines Agency (EMA) is reviewing data for Tadalafil’s application in sildenafil-resistant pulmonary hypertension.
• Several Phase II/III trials are nearing completion, with top-line results expected by late 2023 or early 2024.

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Market Analysis

Current Market Landscape

As of 2023, the global Tadalafil market is valued at approximately USD 4.2 billion, primarily driven by:

• Erectile Dysfunction: Estimated to account for 65% of revenues, with North America holding the largest market share.
• Pulmonary Hypertension: Accounts for roughly 20%, with significant growth potential in Europe and emerging markets.
• Other Indications: Such as BPH, contribute the remaining share.

Competitive Dynamics

Tadalafil’s primary competitors include sildenafil (Viagra, Revatio) and vardenafil, which operate across overlapping indications.

Key differentiators:

• Longer half-life (17.5 hours) position Tadalafil as a "weekend pill" with prolonged efficacy.
• Favorable side effect profile sustains physician preference, especially among patients requiring convenience.
• Patent protection for Cialis expired in many regions between 2017–2020, opening market opportunities for generics.

Market Drivers

• Increasing Prevalence of ED: Globally, ED affects over 322 million men, with core markets in North America, Europe, and Asia-Pacific.
• Growing Awareness and Acceptance: Societal shifts and reduced stigma are boosting prescription rates.
• Expanding Indications: New clinical evidence supports additional therapeutic uses, diversifying revenue streams.

Market Challenges

• Patent Expiry and Generic Competition: Lower-cost generics have eroded brand dominance since 2017.
• Regulatory Hurdles: Pending approvals for new indications may face delays due to safety assessments.
• Pricing and Reimbursement: Cost containment measures and reimbursement pressures challenge revenue growth.

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Market Projection and Future Outlook

Growth Forecasts

The Tadalafil market is projected to grow at a CAGR of approximately 6.4% from 2023 to 2030, reaching an estimated USD 7.2 billion by the end of the decade.

Drivers of Future Growth

• Enhanced Therapeutic Indications: Successful completion of ongoing trials could facilitate approval for additional indications such as diabetic pulmonary hypertension and neurovascular disorders.
• Geographical Expansion: Emerging markets in Asia-Pacific and Latin America are expected to witness accelerated adoption due to rising awareness and improved healthcare infrastructure.
• Innovative Formulations: Development of injectable, transdermal, or controlled-release formulations could improve patient adherence and expand usage.

Potential Barriers

• Competitive market saturation from generics may limit premium pricing.
• Regulatory delays or adverse trial results could impact expansion plans.
• Cost-effectiveness assessments in new indications will influence reimbursement status.

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Conclusion

Tadalafil continues to exhibit a robust clinical development pipeline with promising results spanning urology, cardiopulmonary, and emerging therapeutic areas. Its long-standing market presence, coupled with ongoing research, positions it well for sustained growth despite generic competition. The next five years will be pivotal, with upcoming regulatory decisions and clinical data dictating its expanded market role. Compound factors such as demographic shifts, technological innovations, and regulatory environment will shape its trajectory, making Tadalafil a key focus for stakeholders in the pharmaceutical and healthcare sectors.

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Key Takeaways

• Clinical pipeline momentum: Multiple ongoing trials explore Tadalafil’s efficacy in novel indications, including BPH, COVID-19 complications, and neurovascular conditions, indicating potential future therapeutic expansion.
• Market maturity and competition: While patent expirations introduced generic competition, brand resilience is maintained through expanded indications and favorable dosing profiles.
• Future growth prospects: With projected CAGR around 6.4%, Tadalafil’s market is poised for steady expansion, especially if new indications gain approval and enter clinical practice.
• Geographical opportunities: Emerging markets present significant growth potential driven by increasing healthcare access and awareness.
• Innovation and regulatory navigation: Continued innovation in formulations and strategic regulatory engagements will be crucial for maintaining market position and capturing new segments.

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FAQs

1. What are the latest clinical trial results for Tadalafil in pulmonary hypertension?
Recent studies have demonstrated that higher-dose Tadalafil formulations significantly reduce pulmonary arterial pressures in PAH patients with minimal adverse effects. Phase III trials are ongoing, with results expected in late 2023.

2. Are there any new indications for Tadalafil currently approved?
Beyond ED and PAH, Tadalafil’s potential for conditions such as BPH and COVID-19-related pulmonary complications is under investigation, with some trials nearing completion, but no new indications have yet obtained regulatory approval.

3. How does patent expiry affect Tadalafil’s market?
Patent expiration has led to increased generic availability, reducing branded Tadalafil’s market share. However, ongoing clinical benefits and new formulations sustain premium segments and brand loyalty among certain patient populations.

4. What are the primary drivers for future growth of Tadalafil?
Key drivers include expanding clinical indications, rising prevalence of ED and pulmonary hypertension, innovation in drug delivery systems, and growth in emerging markets.

5. What challenges could impede Tadalafil’s market expansion?
The main obstacles are intense price competition from generics, regulatory hurdles in new indications, and reimbursement challenges across different healthcare systems.

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References

[1] ClinicalTrials.gov. Tadalafil Clinical Trials.
[2] The Journal of Urology. Long-term efficacy of Tadalafil in BPH. 2022.
[3] Pulmonary Circulation. Efficacy of high-dose Tadalafil in PAH. 2022.
[4] Market research reports by IQVIA and EvaluatePharma. 2023.