Tadalafil

Generic Name
Tadalafil
Brand Names
Adcirca, Alyq, Cialis, Entadfi, Tadliq, Talmanco (previously Tadalafil Generics), Tadalafil Mylan, Tadalafil Lilly, Adcirca (previously Tadalafil Lilly)
Drug Type
Small Molecule
Chemical Formula
C22H19N3O4
CAS Number
171596-29-5
Unique Ingredient Identifier
742SXX0ICT
Background

Tadalafil is a selective phosphodiesterase-5 inhibitor that is used in the treatment of erectile dysfunction (ED), pulmonary arterial hypertension (PAH), and benign prostatic hypertrophy. It was first approved in 2003 by the FDA for use in ED and later in 2009 for PAH. In contrast to other PDE5 inhibitors like sildenafil, tadalafil has greater selectivity for PDE5 and a longer half-life which has made it a more suitable option for chronic once-daily dosing in the treatment of PAH.

Indication

Tadalafil is indicated for the treatment of erectile dysfunction (ED) and either alone or in combination with finasteride for the treatment of benign prostatic hypertrophy (BPH). It is also indicated for the treatment of pulmonary arterial hypertension (PAH) both alone and in combination with macitentan or other endothelin-1 antagonists.

Associated Conditions
Benign Prostatic Hyperplasia (BPH), Erectile Dysfunction, Pulmonary Arterial Hypertension (PAH)
Associated Therapies
-

Treprostinil Combined With Tadalafil for Pulmonary Hypertension

Phase 4
Terminated
Conditions
Interventions
First Posted Date
2011-02-24
Last Posted Date
2013-07-26
Lead Sponsor
Rhode Island Hospital
Target Recruit Count
1
Registration Number
NCT01302444
Locations
🇺🇸

Weill Cornell Medical Center, New York, New York, United States

🇺🇸

Brigham & Womens Hospital, Boston, Massachusetts, United States

🇺🇸

Saint Barnabas Health Care System, Newark Beth Israel Medical Center, Newark, New Jersey, United States

and more 6 locations

Aortic Stenosis and PhosphodiEsterase Type 5 iNhibition (ASPEN): A Pilot Study

First Posted Date
2011-01-12
Last Posted Date
2019-04-17
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
10
Registration Number
NCT01275339
Locations
🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

Aortic Stenosis and PhosphodiEsterase iNhibition With Aortic Valve Replacement (ASPEN-AVR): A Pilot Study

Phase 4
Terminated
Conditions
Interventions
First Posted Date
2011-01-07
Last Posted Date
2018-09-12
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
1
Registration Number
NCT01272388
Locations
🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

A Pharmacokinetic Drug-Drug Interaction (DDI) Study Between Sitaxsentan And Sildenafil, And Between Sitaxsentan And Tadalafil After Multiple Doses

First Posted Date
2010-11-19
Last Posted Date
2012-02-22
Lead Sponsor
Pfizer
Target Recruit Count
16
Registration Number
NCT01244620
Locations
🇸🇬

Pfizer Investigational Site, Singapore, Singapore

Effects of PDE-5 Inhibition on Postprandial Hyperglycemia in Type 2 Diabetes

Phase 1
Terminated
Conditions
Interventions
First Posted Date
2010-11-10
Last Posted Date
2020-02-12
Lead Sponsor
Vastra Gotaland Region
Target Recruit Count
22
Registration Number
NCT01238224
Locations
🇸🇪

The Wallenberg Laboratory, Dept of Molecular and Clinical Medicine, Sahlgrenska University Hospital, Bruna stråket 16,, Göteborg, Sweden

Do Phosphodiesterase 5A Inhibitors Improve Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Pulmonary Hypertension?

First Posted Date
2010-09-09
Last Posted Date
2012-11-06
Lead Sponsor
University of Dundee
Target Recruit Count
120
Registration Number
NCT01197469
Locations
🇬🇧

University of Dundee, Dundee, Tayside, United Kingdom

A Study of Tadalafil in Benign Prostatic Hyperplasia

Phase 1
Completed
Conditions
Interventions
First Posted Date
2010-08-17
Last Posted Date
2012-05-16
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
24
Registration Number
NCT01183650
Locations
🇩🇪

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Munich, Germany

A Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)

Phase 3
Completed
Conditions
Interventions
First Posted Date
2010-08-09
Last Posted Date
2017-09-13
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
610
Registration Number
NCT01178073
Locations
🇬🇧

GSK Investigational Site, Sheffield, United Kingdom

A Study of LY900010 in Erectile Dysfunction

First Posted Date
2010-07-12
Last Posted Date
2019-04-09
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
410
Registration Number
NCT01160289
Locations
🇺🇸

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Spokane, Washington, United States

A Study in Benign Prostatic Hyperplasia

Phase 3
Completed
Conditions
Interventions
First Posted Date
2010-06-29
Last Posted Date
2013-05-20
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
97
Registration Number
NCT01152190
Locations
🇮🇹

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Bergamo, Italy

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