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	48
Benign Prostatic Hyperplasia	19
Pulmonary Arterial Hypertension	14
Impotence	11

Condition MeSH

Condition MeSH for TADALAFIL
Intervention	Trials
Erectile Dysfunction	63
Hypertension	35
Prostatic Hyperplasia	27
Hyperplasia	27

Clinical Trial Locations for TADALAFIL

Trials by Country

Trials by Country for TADALAFIL
Location	Trials
United States	505
Canada	63
Germany	54
Italy	35
United Kingdom	32

Trials by US State

Trials by US State for TADALAFIL
Location	Trials
California	33
Florida	27
Texas	23
Ohio	20
Maryland	19

Clinical Trial Progress for TADALAFIL

Clinical Trial Phase

Clinical Trial Phase for TADALAFIL
Clinical Trial Phase	Trials
Phase 4	49
Phase 3	57
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for TADALAFIL
Clinical Trial Phase	Trials
Completed	130
Not yet recruiting	25
Recruiting	17

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	171
Industry	144
NIH	17

TADALAFIL Market Analysis and Financial Projection

Tadalafil: Clinical Trials, Market Analysis, and Projections

Introduction to Tadalafil

Tadalafil, commonly known by the brand name Cialis, is a selective and potent inhibitor of phosphodiesterase type 5 (PDE5) approved for the treatment of erectile dysfunction (ED) and other conditions such as pulmonary arterial hypertension and benign prostatic hyperplasia (BPH)[1].

Clinical Trials and Efficacy

Efficacy in Erectile Dysfunction

Clinical trials have consistently shown that tadalafil is highly effective in treating ED. A multicenter, randomized, double-blind, placebo-controlled study demonstrated that both 10- and 20-mg doses of tadalafil significantly improved erectile function up to 36 hours post-dosing. The study used the International Index of Erectile Function (IIEF) and the Sexual Encounter Profile (SEP) to assess efficacy, showing robust improvements over placebo[1].

Long-Acting Profile

Tadalafil's unique pharmacokinetic profile, with a mean terminal half-life of 17.5 hours, allows it to remain effective for a longer period compared to other PDE5 inhibitors. This extended duration of action makes it a preferred option for many patients[1].

Ongoing Research and Combination Therapies

For patients who do not respond to PDE5 inhibitors like tadalafil, new clinical trials are exploring combination therapies. For example, a Phase 2 clinical study initiated by Palatin Technologies will investigate the co-administration of bremelanotide with a PDE5 inhibitor to treat ED in non-responders. This study aims to assess the safety and efficacy of this combination and is expected to start in the first half of 2025[4].

Market Analysis

Current Market Size and Growth

The global tadalafil market was valued at $2.59 billion in 2023 and is projected to reach $4.61 billion by 2031, growing at a CAGR of 7.6% during the forecast period 2024-2031. This growth is driven by an increasing prevalence of ED, aging populations, and ongoing research expanding tadalafil's therapeutic range[3].

Tadalafil API Market

The tadalafil API market, which involves the active pharmaceutical ingredient used in tadalafil formulations, was valued at $736 million in 2023 and is expected to reach $1.096 billion by 2030, with a CAGR of 5.9% during the forecast period 2024-2030. Key players in this market include Rakshit Drugs, Glenmark Pharmaceuticals, and Zhejiang Huahai Pharmaceutical, among others[2].

Market Drivers

Growing Prevalence of Erectile Dysfunction

The increasing prevalence of ED, fueled by factors such as aging populations, altered lifestyles, and the rise in chronic illnesses like diabetes and cardiovascular diseases, is a major driver of the tadalafil market. As awareness and destigmatization of ED grow, more patients are seeking treatment, expanding the market for tadalafil and other ED therapies[3].

Advances in Pharmaceutical Research

Ongoing research and development in pharmaceuticals are expanding tadalafil's therapeutic range, including its use in treating pulmonary arterial hypertension and BPH. These advancements make tadalafil more attractive for funding and investment, leading to new formulations and delivery systems that help the drug compete with newer and generic alternatives[3].

Market Challenges

Regulatory Difficulties

The tadalafil market faces significant regulatory challenges, including strict legal restrictions for product approval, production, and marketing. Extensive clinical trials are required to comply with FDA and EMA standards, which can be expensive and time-consuming. Changes in regulations can also impact the commercial viability of existing products and create a fragmented market environment[3].

Competition from Alternatives

The market for tadalafil is also challenged by the presence of alternative treatments, including other PDE5 inhibitors like sildenafil (Viagra) and emerging therapies such as testosterone replacement therapies (TRT). Additionally, the rise in demand for generic ED drugs, especially in emerging markets, poses a competitive threat to branded tadalafil products[5].

Regional Market Trends

Asia-Pacific Region

The Asia-Pacific region is expected to contribute significantly to the global erectile dysfunction drug market, driven by a large and aging male population, increasing awareness of ED treatments, and economic growth in countries like China and India. Improved healthcare access and rising disposable incomes in these regions are driving the demand for affordable ED therapies[5].

Key Takeaways

• Efficacy and Duration: Tadalafil is highly effective in treating ED, with a long-acting profile that allows it to remain effective up to 36 hours post-dosing.
• Market Growth: The global tadalafil market is projected to grow at a CAGR of 7.6% from 2024 to 2031, driven by increasing ED prevalence and ongoing research.
• API Market: The tadalafil API market is expected to grow at a CAGR of 5.9% from 2024 to 2030.
• Regulatory Challenges: The market faces regulatory hurdles, including strict approval processes and potential changes in regulations.
• Regional Trends: The Asia-Pacific region is expected to be a significant contributor to the global ED drug market due to demographic and economic factors.

FAQs

What is the current market size of the tadalafil market?

The tadalafil market was valued at $2.59 billion in 2023[3].

What is the projected growth rate of the tadalafil market?

The tadalafil market is projected to grow at a CAGR of 7.6% from 2024 to 2031[3].

What are the main drivers of the tadalafil market?

The main drivers include the growing prevalence of ED, advances in pharmaceutical research, and increasing awareness and destigmatization of ED[3].

What are the key challenges facing the tadalafil market?

Key challenges include regulatory difficulties, competition from alternative treatments, and the rise in demand for generic ED drugs[3].

Which region is expected to contribute significantly to the global ED drug market?

The Asia-Pacific region is expected to be a significant contributor due to its large and aging male population and economic growth[5].

Sources

1. Patterson, B. E., et al. "Tadalafil Improved Erectile Function at Twenty‐Four and Thirty‐Six Hours Postdosing in Men with ED of Varied Severity." Journal of Andrology, vol. 34, no. 1, 2013, doi: 10.2164/jandrol.04126.
2. Global Tadalafil API Market Research Report 2024. Valuates Reports.
3. Tadalafil Market Size, Scope, Growth, Trends and Forecast. Verified Market Research.
4. Palatin Announces the Initiation of a Phase 2 Clinical Study of Bremelanotide Co-administered with a PDE5i for the Treatment of Erectile Dysfunction (ED). Palatin Technologies.
5. Erectile Dysfunction Drug Market Size and Share 2025-2035. MetaTech Insights.