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: C_₂₂H_₁₉N_₃O_₄

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: -

Clinical Trials

Multinational Study to Evaluate Tadalafil in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia

Phase 3

Completed

Conditions: Benign Prostatic Hyperplasia

Interventions: Drug: Placebo
Drug: Tadalafil
Drug: Tamsulosin

First Posted Date: 2009-03-13

Last Posted Date: 2011-06-28

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 612

Registration Number: NCT00861757

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., Tao-Yuan, Taiwan

A Study in the Treatment of Erectile Dysfunction and Benign Prostate Hyperplasia

Phase 3

Completed

Conditions: Erectile Dysfunction
Benign Prostatic Hyperplasia

Interventions: Drug: Placebo
Drug: Tadalafil

First Posted Date: 2009-03-04

Last Posted Date: 2011-07-28

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 606

Registration Number: NCT00855582

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., Rostov-On-Don, Russian Federation

A Study of Tadalafil in Men With Benign Prostatic Hyperplasia Symptoms Who Are Being Treated With Alpha Blockers

Phase 3

Completed

Conditions: Benign Prostatic Hyperplasia

Interventions: Drug: Placebo
Drug: Tadalafil

First Posted Date: 2009-02-20

Last Posted Date: 2010-09-14

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 318

Registration Number: NCT00848081

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., Santurce, Puerto Rico

Tadalafil in Treating Patients Undergoing Surgery for Cancer of the Oral Cavity or Oropharynx

Not Applicable

Completed

Conditions: Head and Neck Cancer

Interventions: Other: Placebo
Drug: Tadalafil

First Posted Date: 2009-02-13

Last Posted Date: 2015-10-19

Lead Sponsor: Donald T. Weed

Target Recruit Count: 35

Registration Number: NCT00843635

Locations: 🇺🇸
University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami, Florida, United States

Effect of Tadalafil Once a Day in Men With Erectile Dysfunction

Phase 3

Completed

Conditions: Erectile Dysfunction

Interventions: Drug: placebo
Drug: tadalafil

First Posted Date: 2009-02-04

Last Posted Date: 2011-01-04

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 217

Registration Number: NCT00836693

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., Majadahonda, Spain

A Study in Erectile Dysfunction

Phase 4

Completed

Conditions: Erectile Dysfunction

Interventions: Drug: Placebo
Drug: Tadalafil

First Posted Date: 2009-02-02

Last Posted Date: 2010-08-24

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 372

Registration Number: NCT00833638

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., Indianapolis, Indiana, United States

Study to Treat Patients Who Have Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) With Tadalafil Daily

Phase 3

Completed

Conditions: Benign Prostatic Hyperplasia

Interventions: Drug: Placebo
Drug: tadalafil

First Posted Date: 2009-01-22

Last Posted Date: 2010-11-17

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 325

Registration Number: NCT00827242

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., Zapopan, Mexico