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

Phosphodiesterase Type 5 Inhibition With Tadalafil Changes Outcomes in Heart Failure

Phase 3

Terminated

Conditions: Heart Failure
Pulmonary Hypertension

Interventions: Drug: Placebo for tadalafil
Drug: Tadalafil

First Posted Date: 2013-07-29

Last Posted Date: 2015-05-04

Lead Sponsor: Carelon Research

Target Recruit Count: 23

Registration Number: NCT01910389

Locations: 🇺🇸
Northwestern University, Chicago, Illinois, United States
🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States
🇺🇸
Miller School of Medicine University of Miami, Miami, Florida, United States

and more 60 locations

Chemoimmunotherapy and Radiation in Pancreatic Cancer

Phase 1

Completed

Conditions: Locally Advanced Malignant Neoplasm

Interventions: Drug: Tadalafil
Drug: Gemcitabine
Radiation: Radiation
Procedure: Pancreaticoduodenectomy

First Posted Date: 2013-07-19

Last Posted Date: 2018-02-01

Lead Sponsor: Providence Health & Services

Target Recruit Count: 10

Registration Number: NCT01903083

Locations: 🇺🇸
Portland Providence Medical Center, Portland, Oregon, United States

A Study of Tadalafil for Duchenne Muscular Dystrophy

Phase 3

Terminated

Conditions: Muscular Dystrophy, Duchenne

Interventions: Drug: Placebo
Drug: Tadalafil

First Posted Date: 2013-05-30

Last Posted Date: 2019-10-09

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 331

Registration Number: NCT01865084

Locations: 🇵🇷
University of Puerto Rico, Medical Sciences Campus, San Juan, Puerto Rico
🇺🇸
University of California, Davis - Health Systems, Sacramento, California, United States
🇺🇸
Children's Hospital, Aurora, Colorado, United States

and more 22 locations

Tadalafil for Pulmonary Hypertension Due to Chronic Lung Disease

Phase 2

Completed

Conditions: Pulmonary Hypertension
Chronic Obstructive Pulmonary Disease (COPD)

Interventions: Drug: placebo
Drug: Tadalafil

First Posted Date: 2013-05-24

Last Posted Date: 2021-03-09

Lead Sponsor: VA Office of Research and Development

Target Recruit Count: 44

Registration Number: NCT01862536

Locations: 🇺🇸
Atlanta VA Medical and Rehab Center, Decatur, GA, Decatur, Georgia, United States
🇺🇸
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA, Boston, Massachusetts, United States
🇺🇸
VA Greater Los Angeles Healthcare System, West Los Angeles, CA, West Los Angeles, California, United States

and more 2 locations

A Study of Tadalafil in Pediatric Participants With Pulmonary Arterial Hypertension (PAH)

Phase 3

Completed

Conditions: Hypertension, Pulmonary

Interventions: Drug: Placebo
Drug: Tadalafil
Drug: ERA as specific PAH treatment

First Posted Date: 2013-04-04

Last Posted Date: 2021-11-05

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 35

Registration Number: NCT01824290

Locations: 🇧🇷
Irmandade da Santa Casa de Misericordia de Porto Alegre, Porto Alegre, Rio Grande Do Sul, Brazil
🇵🇱
Uniwersytecki Szpital Dzieciecy w Krakowie-Prokocimiu, Krakow, Poland
🇩🇪
Universitätsklinikum Heidelberg, Heidelberg, Baden-Württemberg, Germany

and more 40 locations