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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)

Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction

Phase 3
Completed
Conditions
Erectile Dysfunction
Interventions
Device: MED3000 (Male)
Device: MED3000 (Female)
First Posted Date
2021-08-02
Last Posted Date
2023-09-21
Lead Sponsor
Futura Medical Developments Ltd.
Target Recruit Count
116
Registration Number
NCT04984993
Locations
🇵🇱

Provita Sp. z o.o., Katowice, Poland

🇺🇸

Johns Hopkins University, Baltimore, Maryland, United States

🇧🇬

Medical Center "Asklepii"OOD, Dupnitsa, Bulgaria

and more 15 locations

Efficacy and Safety of DKF-313 in Patients With Benign Prostatic Hyperplasia

Phase 3
Completed
Conditions
Benign Prostatic Hyperplasia
Interventions
First Posted Date
2021-07-01
Last Posted Date
2023-09-21
Lead Sponsor
Dongkook Pharmaceutical Co., Ltd.
Target Recruit Count
667
Registration Number
NCT04947631
Locations
🇰🇷

Ewha Womans University mokdong Hospital, Seoul, Korea, Republic of

The Use of Tadalafil in Confirmed COVID-19 Pneumonia.

Phase 4
Withdrawn
Conditions
Sars-CoV2
COVID
ARDS, Human
Interventions
First Posted Date
2021-06-30
Last Posted Date
2021-07-02
Lead Sponsor
Santa Barbara Cottage Hospital
Registration Number
NCT04946162

A Single Dose Randomized Five-Way Crossover Pharmacokinetics (PK) Study of Tadalafil Semi-Chewable (Gummy) Formulations in Healthy Volunteers

Phase 1
Not yet recruiting
Conditions
Erectile Dysfunction
Interventions
First Posted Date
2021-02-21
Last Posted Date
2024-06-13
Lead Sponsor
Seattle Gummy Company
Target Recruit Count
30
Registration Number
NCT04762082

Tadalafil to Overcome Immunosuppression During Chemoradiotherapy for IDH-wildtype Grade III-IV Astrocytoma

Phase 1
Completed
Conditions
Astrocytoma, Grade III
Grade IV Astrocytoma
Grade III Astrocytoma
Astrocytoma, Grade IV
Interventions
First Posted Date
2021-02-17
Last Posted Date
2023-06-13
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
18
Registration Number
NCT04757662
Locations
🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

Effectiveness and Tolerability of the On-demand Use of Combined Dapoxetine With Tadalafil and Combined Dapoxetine With Lidocaine 5% Spray in Treatment of Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Alone.

Phase 3
Conditions
Premature Ejaculation
Interventions
Drug: Dapoxietine and Combined Lidocaine 5% Spray
First Posted Date
2021-01-11
Last Posted Date
2021-01-11
Lead Sponsor
Sohag University
Target Recruit Count
60
Registration Number
NCT04703127
Locations
🇪🇬

Mohammed Abu El-Hamd, Sohag, Egypt

Effect of PDE5 Inhibition on Adipose Metabolism in Humans

Phase 2
Recruiting
Conditions
Obesity
Interventions
First Posted Date
2020-12-24
Last Posted Date
2024-12-12
Lead Sponsor
Vanderbilt University Medical Center
Target Recruit Count
100
Registration Number
NCT04684589
Locations
🇺🇸

Vanderbilt University Medical Center, Nashville, Tennessee, United States

Comparative Study Between Tadalafil Versus Tamsulosin as a Medical Expulsive Therapy for Lower Ureteric Stones

Phase 4
Conditions
Lower Ureteric Stones
Interventions
First Posted Date
2020-11-23
Last Posted Date
2022-03-04
Lead Sponsor
Beni-Suef University
Target Recruit Count
166
Registration Number
NCT04641507
Locations
🇪🇬

Ahmed Saleh, Giza, Egypt

Combined Effect of Continuous and Interval in Addition to Tadalafil Drug on Erectile Dysfunction

Not Applicable
Conditions
Erectile Dysfunction
Interventions
Other: Tadalafil 5Mg Tab + continuous and interval exercise
First Posted Date
2020-11-10
Last Posted Date
2020-11-10
Lead Sponsor
Cairo University
Target Recruit Count
60
Registration Number
NCT04623840
Locations
🇪🇬

Cairo Unoversity, Giza, Egypt

Safety and Efficacy of Tadalafil vs. Tadalafil With Sildosin in the Management of Moderately and Severely Symptomatic Patients of Prostatic Hyperplasia

Conditions
Safety and Efficacy of Tadalafil vs. Tadalafil With Sildosin in the Management of Moderately and Severely Symptomatic Patients of Prostatic Hyperplasia
Interventions
First Posted Date
2020-10-06
Last Posted Date
2020-10-06
Lead Sponsor
Menoufia University
Target Recruit Count
400
Registration Number
NCT04577040
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