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.

Clinical Trial Conditions for TADALAFIL

Condition Name

Condition Name for TADALAFIL
Intervention	Trials
Erectile Dysfunction	54
Benign Prostatic Hyperplasia	19
Pulmonary Arterial Hypertension	14
Pulmonary Hypertension	11

Condition MeSH

Condition MeSH for TADALAFIL
Intervention	Trials
Erectile Dysfunction	71
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	7
PHASE2	6

Clinical Trial Status

Clinical Trial Status for TADALAFIL
Clinical Trial Phase	Trials
Completed	140
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
Bayer	6

Sponsor Type

Sponsor Type for TADALAFIL
Sponsor	Trials
Other	200
Industry	149
NIH	18

Tadalafil (Tadalafil) Clinical Trials Update, Market Analysis, and Projection

Last updated: April 26, 2026

What is tadalafil and how is it positioned clinically?

Tadalafil is an oral phosphodiesterase-5 (PDE5) inhibitor approved for erectile dysfunction (ED) and benign prostatic hyperplasia (BPH) with lower urinary tract symptoms (LUTS). Across major jurisdictions, tadalafil’s commercial footprint is driven by broad label coverage for ED and LUTS/BPH and by a mature, generic-heavy supply chain. The drug’s clinical value proposition centers on once-daily dosing options (notably for ED), as well as on-demand dosing.

Key approved indications (label-level scope)

• Erectile dysfunction (ED)
• BPH with LUTS (often co-labeled with ED depending on jurisdiction/brand)

Source: FDA label for Cialis (tadalafil) describes PDE5 inhibition and approved indications including ED and BPH-related LUTS. [1]

What do the most visible clinical-development signals show?

Tadalafil is a mature molecule with extensive off-patent penetration in most markets. Current clinical activity is typically oriented toward:

• Bioequivalence and formulation optimization for generic entrants
• New combinations (limited by regulatory and commercial incentives versus generics)
• Expanded use-cases that are often incremental rather than platform-defining

Because tadalafil is widely approved, the highest signal tends to come from:

• Regulatory filings tied to formulations (bioequivalence studies)
• Trials focused on specific patient subsets (comorbidity-adjusted outcomes)
• Combination or alternative dosing schedules

Source anchor (molecule-level and protocol references): U.S. prescribing and clinical use context are captured by the FDA label and associated safety/efficacy framing. [1]

Where do clinical trials concentrate (trial types and endpoints)?

Across tadalafil’s modern trial landscape, the dominant trial classes are:

1) Bioequivalence (BE) and formulation studies

• Oral solid dose comparisons against reference-listed products
• Endpoints typically centered on pharmacokinetic measures (AUC, Cmax, Tmax), with tolerability

2) Symptom and responder endpoint studies (ED and LUTS/BPH)

• Erectile function response endpoints (commonly questionnaire-based in ED)
• LUTS symptom endpoints in BPH populations

3) Studies in patient subgroups and comorbidity-adjusted populations

• Cardiovascular comorbidity risk management and exercise-related or safety monitoring
• Medication interaction safety characterization (PDE5-related risk in nitrate exposure contexts)

Source: FDA labeling provides the clinical safety framework that drives inclusion/exclusion criteria and safety monitoring in trials. [1]

Market relevance note: when a molecule is broadly generic, the clinical pipeline tends to optimize “access and differentiation” rather than re-define efficacy.

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How does tadalafil’s market work commercially?

Tadalafil’s market is best understood as a large, high-volume ED and LUTS segment served by:

• Multiple originator and long-standing branded products (historically)
• Broad generic competition (ongoing)
• Regional pricing pressure that shifts differentiation toward pack size, dosing convenience, and channel access

Pricing and access dynamics

• In the majority of high-income markets, tadalafil is priced at a level consistent with generic penetration.
• Value capture shifts to:
  • Daily-dosing convenience
  • Availability through multiple manufacturers
  • Distinct pack/dose formats (e.g., 5 mg daily in ED/BPH contexts, where approved)

Competitive set (practical substitutes)

• Other PDE5 inhibitors with overlapping use (e.g., sildenafil, vardenafil, other branded generics by geography)
• Brand loyalty exists but is diluted by generic availability and guideline-driven switching

Source: FDA labeling and established use-case context for PDE5 inhibitors in ED and LUTS. [1]

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What market projections are supported by the current demand base?

Tadalafil’s demand is driven by a persistent, chronic prevalence pool for:

• ED
• BPH/LUTS

The commercially relevant projection for tadalafil is typically “share of PDE5 inhibitors” rather than “absolute molecule growth from novel indications,” given the lack of patent-backed exclusivity in many markets.

Projection logic used for tadalafil (molecule-level)

A pragmatic projection for tadalafil market outlook can be structured as:

1. Total addressable demand growth from aging demographics and diagnosis/treatment rates
2. Competitive intensity from generic entrants and price competition
3. Switching dynamics within PDE5 class based on tolerability, dosing preference, and availability
4. Formulation differentiation (once-daily convenience, pack strategies)

This yields an outlook where:

• Growth is incremental and share-dependent
• Revenue headwinds from pricing are partially offset by volume

Source: FDA-approved indications define the addressable clinical population base. [1]

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What is the regulatory and safety constraint that shapes clinical and market strategy?

Tadalafil’s label includes warnings and contraindication logic that shapes both trial eligibility and commercialization messaging:

• Nitrate contraindication due to PDE5-mediated blood pressure effects
• Caution with certain antihypertensives and cardiovascular risk contexts

These constraints influence:

• Trial recruitment and monitoring requirements
• Real-world prescribing patterns and payer policies

Source: Cialis (tadalafil) label safety information. [1]

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Market performance checkpoints you can use now

Because tadalafil is mature and generic-dense, actionable checkpoints are channel and formulation-led:

Demand signals to monitor (business planning)

• Rx volume trends for ED and LUTS/BPH dosing patterns (on-demand vs once daily)
• Generic pricing indexes and payer contract changes
• Channel shifts (retail vs mail order; formularies)
• Portfolios that bundle tadalafil formulations with adherence support (where available)

Source anchor: Label-based dosing use cases drive demand tracking. [1]

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Segmenting tadalafil’s opportunity: where growth is most likely

Even with patent limitations, growth is possible through segment strategy:

1) Once-daily convenience cohorts

• Patients who prefer continuous daily dosing over on-demand schedules

2) BPH with LUTS cohorts (where label-appropriate)

• Patients treated for LUTS symptoms who also have comorbid ED needs

3) Regional access expansion

• Markets where generic penetration is less mature or where distribution coverage is improving

Source: Indication scope in FDA label. [1]

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Key Takeaways

• Tadalafil is a mature PDE5 inhibitor with commercial demand anchored in ED and BPH with LUTS; its market behavior is primarily driven by generic competition and dosing convenience rather than major efficacy redefinition. [1]
• Clinical activity remains dominated by bioequivalence and formulation optimization with incremental subgroup or endpoint refinements. [1]
• Forward-looking market performance should be projected using (a) aging-driven prevalence, (b) price competition intensity, and (c) share-of-class dynamics among PDE5 inhibitors. [1]

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FAQs

1) Is tadalafil still seeing meaningful clinical trial activity?

Most contemporary trials for tadalafil concentrate on formulation and pharmacokinetic equivalence, plus label-aligned symptom studies in ED and BPH/LUTS populations. [1]

2) What drives tadalafil’s real-world demand most?

Demand is primarily tied to treated prevalence of ED and LUTS/BPH and to patient preference for dosing convenience within the PDE5 class. [1]

3) How do safety constraints affect tadalafil development and prescribing?

Nitrate contraindication and blood pressure related risk management constrain eligibility in trials and direct prescribing in real-world settings. [1]

4) What competitive pressure matters most for tadalafil revenues?

Generic pricing pressure and substitution among PDE5 inhibitors are the dominant forces shaping revenue growth or decline. [1]

5) What is the best way to model tadalafil market growth?

Model share-of-class and pricing elasticity, anchored to the drug’s label-defined addressable population for ED and BPH/LUTS. [1]

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References

[1] U.S. Food and Drug Administration. (n.d.). Cialis (tadalafil) prescribing information. FDA. https://www.accessdata.fda.gov/