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

Tadalafil and Nesiritide as Therapy in Pre-clinical Heart Failure

Phase 1

Completed

Conditions: Congestive Heart Failure

Interventions: Drug: Nesiritide
Drug: Tadalafil
Drug: Placebo
Drug: Saline load

First Posted Date: 2012-03-06

Last Posted Date: 2018-03-22

Lead Sponsor: Mayo Clinic

Target Recruit Count: 43

Registration Number: NCT01544998

Locations: 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States

Phase 3 Study of Tadalafil Once-Daily in Asian Men With Benign Prostatic Hyperplasia (BPH)

Phase 3

Completed

Conditions: Benign Prostatic Hyperplasia

Interventions: Drug: Placebo
Drug: Tadalafil

First Posted Date: 2011-10-26

Last Posted Date: 2013-09-25

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 610

Registration Number: NCT01460342

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., Seoul, Korea, Republic of

A Trial of Tadalafil and Glycemic Traits

Phase 3

Completed

Conditions: Cardiovascular Disease
Obesity
Insulin Resistance
Glucose Intolerance

Interventions: Drug: Tadalafil
Drug: Placebo

First Posted Date: 2011-10-03

Last Posted Date: 2017-01-30

Lead Sponsor: Thomas J. Wang, MD

Target Recruit Count: 73

Registration Number: NCT01444651

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

A Bioavailability Study of LY2452473 and Tadalafil

Phase 1

Completed

Conditions: Erectile Dysfunction

Interventions: Drug: LY2452473
Drug: LY900010
Drug: Tadalafil

First Posted Date: 2011-07-25

Last Posted Date: 2019-06-14

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 24

Registration Number: NCT01401543

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., Madison, Wisconsin, United States

Administration of Tadalafil in Conjunction With Lenalidomide and Dexamethasone in Patients With Multiple Myeloma

Phase 2

Terminated

Conditions: Multiple Myeloma

Interventions: Drug: Tadalafil
Drug: Lenalidomide
Drug: Dexamethasone
Drug: Clarithromycin

First Posted Date: 2011-06-15

Last Posted Date: 2018-12-10

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 14

Registration Number: NCT01374217

Locations: 🇺🇸
Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States

Tadalafil and Sildenafil for Duchenne Muscular Dystrophy

Early Phase 1

Completed

Conditions: Duchenne Muscular Dystrophy

Interventions: Drug: Tadalafil
Drug: Sildenafil

First Posted Date: 2011-05-25

Last Posted Date: 2020-01-14

Lead Sponsor: Cedars-Sinai Medical Center

Target Recruit Count: 30

Registration Number: NCT01359670

Locations: 🇺🇸
Cedars-Sinai Medical Center, Los Angeles, California, United States

A Study of Tadalafil and Sildenafil in Men With Erectile Dysfunction in China

Phase 4

Completed

Conditions: Erectile Dysfunction

Interventions: Drug: Tadalafil
Drug: Sildenafil

First Posted Date: 2011-05-12

Last Posted Date: 2013-04-26

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 383

Registration Number: NCT01352507

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., Xi'An, China

Daily Tadalafil and Gastric Emptying Time in Diabetic Gastroparesis

Phase 4

Withdrawn

Conditions: Gastroparesis
Diabetic Gastroparesis
Nausea
Vomiting

Interventions: Drug: tadalafil

First Posted Date: 2011-03-30

Last Posted Date: 2014-07-29

Lead Sponsor: Mark Feinglos

Registration Number: NCT01326117

Locations: 🇺🇸
Duke University Medical Center, Durham, North Carolina, United States

Tadalafil for Sarcoidosis Associated Pulmonary Hypertension

Phase 2

Completed

Conditions: Pulmonary Hypertension

Interventions: Drug: Tadalafil

First Posted Date: 2011-03-29

Last Posted Date: 2017-07-24

Lead Sponsor: University of North Carolina, Chapel Hill

Target Recruit Count: 12

Registration Number: NCT01324999

Locations: 🇺🇸
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
🇺🇸
University of Cincinnati, Cincinnati, Ohio, United States

A 48-week Study of the Effect of Dual Therapy (Inhaled Treprostinil and Tadafafil) Versus Monotherapy (Tadalafil).

Phase 4

Completed

Conditions: Hypertension, Pulmonary

Interventions: Drug: treprostinil inhalations
Drug: tadalafil

First Posted Date: 2011-02-28

Last Posted Date: 2017-06-02

Lead Sponsor: Stanford University

Target Recruit Count: 21

Registration Number: NCT01305252

Locations: 🇺🇸
Stanford University School of Medicine, Stanford, California, United States
🇺🇸
Northwestern University, Chicago, Illinois, United States

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy