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)

Clinical Trials

Safety And Efficacy Of L-Arginine Monotherapy Versus Tadalafil Monotherapy Versus Their Combination In Men With Erectile Dysfunction; A Prospective Randomized Study

Phase 4

Completed

Conditions: Erectile Dysfunctions

Interventions: Drug: L-Arginine
Drug: Tadalafil 5 mg

First Posted Date: 2025-04-27

Last Posted Date: 2025-04-27

Lead Sponsor: Fayoum University Hospital

Target Recruit Count: 180

Registration Number: NCT06947265

Locations: 🇪🇬
Mohamed Mahmoud Dogha, Fayoum, Keman Fares, Egypt

Efficacy and Safety of Tadalafil, Tamsulosin, and Their Combinations in Treating Lower Urinary Tract Symptoms in BPH Patients with Prostate Volumes ≤ 40 Ml: a Prospective Comparative Study

Phase 4

Completed

Conditions: BPH with Other Lower Urinary Tract Symptoms

Interventions: Drug: Tamsulosin 0.4 mg
Drug: Tadalafil 5mg
Drug: Tamsulosin and Tadalafil

First Posted Date: 2025-02-05

Last Posted Date: 2025-02-05

Lead Sponsor: Fayoum University Hospital

Target Recruit Count: 95

Registration Number: NCT06809205

Locations: 🇪🇬
Mohamed Mahmoud Dogha, Fayoum, Fayoum Governorate, Egypt

Tadalafil Daily Used Post Turp

Completed

Conditions: Erectile Dysfunction Following Urethral Surgery

Interventions: Drug: Tadalafil 5mg
Drug: Placebo

First Posted Date: 2025-01-23

Last Posted Date: 2025-01-28

Lead Sponsor: Kafrelsheikh University

Target Recruit Count: 270

Registration Number: NCT06788704

Locations: 🇪🇬
Elsayed Abdelhalim Elsayed, Zagazig, Egypt

Evaluation of Efficacy of Botulinum Toxin A Plus Oral Tadalafil 5 mg in Diabetic Men With Erectile Dysfunction

Phase 2

Recruiting

Conditions: Erectile Dysfunction With Diabetes Mellitus

Interventions: Drug: Botulinum toxin A
Drug: Tadalafil 5mg

First Posted Date: 2024-09-04

Last Posted Date: 2024-12-03

Lead Sponsor: Aswan University Hospital

Target Recruit Count: 32

Registration Number: NCT06583590

Locations: 🇪🇬
Aswan University-Faculty of Medicine, Aswan, Aswan Governorate, Egypt

Evaluation of Tadalafil Combined with LIPUS for Treating Erectile Dysfunction

Not Applicable

Completed

Conditions: Erectile Dysfunction

Interventions: Drug: Tadalafil 5mg
Device: LIPUS (Low Intensity Pulsed Ultrasound)

First Posted Date: 2024-08-09

Last Posted Date: 2025-03-10

Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Target Recruit Count: 114

Registration Number: NCT06543628

Locations: 🇨🇳
The 2nd Affiliated Hospital, School of Medicine, Zhejiang University, HangZhou, Zhejiang, China

Genetic Factors of Erectile Dysfunction Degree and Response to Tadalafil Treatment in Patients With Diabetes

Phase 3

Recruiting

Conditions: Erectile Dysfunction With Diabetes Mellitus

Interventions: Drug: Tadalafil 5mg

First Posted Date: 2024-07-25

Last Posted Date: 2024-07-25

Lead Sponsor: University Medical Centre Ljubljana

Target Recruit Count: 90

Registration Number: NCT06520839

Locations: 🇸🇮
University Medical Centre Ljubljana, Ljubljana, Slovenia

Administration of Tadalafil in Patients With Benign Prostatic Hyperplasia

Phase 3

Completed

Conditions: BPH With Other Lower Urinary Tract Symptoms

Interventions: Drug: Tadalafil

First Posted Date: 2024-06-20

Last Posted Date: 2024-08-23

Lead Sponsor: Al-Azhar University

Target Recruit Count: 306

Registration Number: NCT06466369

Locations: 🇪🇬
outpatient clinic of the urology department at AlZahraa University Hospital, Al-Azhar University, Faculty of Medicine for Girls., Cairo, Egypt