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
-

Assessment of Efficacy of Vardenafil in Subjects With Erectile Dysfunction and Diabetes, Hypertension or Hyperlipidemia

First Posted Date
2008-04-28
Last Posted Date
2014-12-23
Lead Sponsor
Bayer
Target Recruit Count
614
Registration Number
NCT00668109

Evaluating the Efficacy Vardenafil 10 mg vs Tadalafil 10 mg in in Subjects With Erectile Dysfunction (ED)

First Posted Date
2008-04-22
Last Posted Date
2013-10-11
Lead Sponsor
Bayer
Target Recruit Count
759
Registration Number
NCT00663130

A Randomized, Open-Label, Crossover, Multicenter, Single Dose Comparator Study Evaluating Onset Of Penile Rigidity In Men With Erectile Dysfunction Who Are Treated With Sildenafil And Tadalafil

Phase 4
Completed
Conditions
Interventions
First Posted Date
2008-03-27
Last Posted Date
2021-02-01
Lead Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Target Recruit Count
56
Registration Number
NCT00644956
Locations
๐Ÿ‡ฌ๐Ÿ‡ง

Pfizer Investigational Site, Leeds, United Kingdom

Randomised Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma

Phase 3
Completed
Conditions
Interventions
First Posted Date
2008-02-29
Last Posted Date
2013-03-22
Lead Sponsor
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Target Recruit Count
25
Registration Number
NCT00626665

Study of Add-on Ambrisentan Therapy to Background Phosphodiesterase Type-5 Inhibitor (PDE5i) Therapy in Pulmonary Arterial Hypertension (ATHENA-1)

First Posted Date
2008-02-18
Last Posted Date
2012-07-30
Lead Sponsor
Gilead Sciences
Target Recruit Count
38
Registration Number
NCT00617305
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Scott & White Memorial Hospital, Temple, Texas, United States

๐Ÿ‡บ๐Ÿ‡ธ

University of Iowa, Iowa City, Iowa, United States

๐Ÿ‡บ๐Ÿ‡ธ

Emory University, Atlanta, Georgia, United States

and more 27 locations

Study the Safety and Effectiveness of Tadalafil on High Blood Pressure in the Blood Vessel Going From the Heart to the Lungs

Phase 3
Completed
Conditions
Interventions
First Posted Date
2007-10-25
Last Posted Date
2013-04-09
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
357
Registration Number
NCT00549302
Locations
๐Ÿ‡ฌ๐Ÿ‡ง

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., London, United Kingdom

Determine Safety and Effectiveness of Tadalafil in Asian Men When Taken as Needed for Getting and Keeping an Erection

Phase 3
Completed
Conditions
Interventions
First Posted Date
2007-10-22
Last Posted Date
2007-10-22
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
367
Registration Number
NCT00547573
Locations
๐Ÿ‡จ๐Ÿ‡ณ

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 to your personal physician., Beijing, China

To Determine Effect and Safety of Tadalafil Taken by Men of Different Races and With Different Diseases When Needed for Erections

Phase 3
Completed
Conditions
Interventions
First Posted Date
2007-10-22
Last Posted Date
2007-10-22
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
1933
Registration Number
NCT00547417
Locations
๐Ÿ‡บ๐Ÿ‡ธ

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., Dallas, Texas, United States

Study to Determine Safety and Effectiveness of Tadalafil on Prostate Related Sex Organ/Urinary Tract Problems

Phase 2
Completed
Conditions
Interventions
First Posted Date
2007-10-22
Last Posted Date
2007-10-22
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
275
Registration Number
NCT00547625
Locations
๐Ÿ‡บ๐Ÿ‡ธ

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., Chicago, Illinois, United States

Study For Which Treatment, Tadalafil or Sildenafil, is Preferred For Problems Getting or Maintaining an Erection

Phase 4
Completed
Conditions
Interventions
First Posted Date
2007-10-22
Last Posted Date
2007-10-22
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
386
Registration Number
NCT00547092
Locations
๐Ÿ‡ฌ๐Ÿ‡ง

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., Plymouth, United Kingdom

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