MedPath

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 Trials
Related News

Aspire Biopharma Goes Public on Nasdaq Through SPAC Merger to Advance Fast-Absorbing Aspirin Development

• Aspire Biopharma Holdings successfully completed its business combination with PowerUp Acquisition Corp., securing Nasdaq listing under ticker symbol "ASBP" effective February 20, 2025. • The merger provides Aspire Biopharma critical capital access to accelerate development of its novel fast-absorbing aspirin technology for cardiac emergencies, which is positioned for fast-track FDA approval. • Stockholders approved the SPAC merger on January 31, 2025, marking a strategic milestone in Aspire's mission to advance its disruptive drug delivery mechanism technology.

United Therapeutics Completes Enrollment in Phase 3 TETON 1 IPF Trial of Inhaled Treprostinil

• United Therapeutics has fully enrolled its Phase 3 TETON 1 study, evaluating nebulized Tyvaso (treprostinil) for idiopathic pulmonary fibrosis (IPF). • The TETON 1 trial, with 598 patients across the U.S. and Canada, is part of a larger program assessing inhaled treprostinil in IPF and progressive pulmonary fibrosis (PPF). • Top-line data from the TETON 1 study is anticipated in the first half of 2026, potentially leading to a new treatment option for IPF patients. • If successful, United Therapeutics plans to seek FDA approval to expand Tyvaso's label to include IPF, and pursue European marketing authorization.

FDA Lifts Clinical Hold on Opella's Cialis OTC Switch Trial

• The FDA has lifted the clinical hold on Opella's actual use trial (AUT) for Cialis, supporting its potential switch to an over-the-counter (OTC) medication. • This decision marks Cialis as the first PDE-5 inhibitor to reach this milestone, paving the way for a new self-care solution for erectile dysfunction. • The AUT will evaluate Cialis's use under real-world conditions, ensuring consumers can self-diagnose and treat appropriately without medical supervision. • Opella is completing clinical and regulatory activities to initiate the pivotal AUT, with study information available on clinicaltrials.gov.

European Commission Approves Yuvanci, the First Single-Tablet Combination Therapy for Pulmonary Arterial Hypertension

• The European Commission has approved Yuvanci (macitentan and tadalafil) as a single-tablet combination therapy for pulmonary arterial hypertension (PAH). • Yuvanci is indicated for adult patients with WHO Functional Class II to III PAH already treated with macitentan and tadalafil as separate tablets. • The approval was based on the Phase 3 A DUE study, which demonstrated a significant reduction in pulmonary vascular resistance compared to monotherapies. • This single-tablet therapy addresses a significant unmet need by simplifying treatment regimens and potentially improving patient adherence.
© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy