NDAORALSUSPENSION
Approved
Jun 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
TADLIQ (tadalafil) by Fosun Pharma is phosphodiesterase 5 inhibitors [moa]. First approved in 2022.
Drug data last refreshed 23m ago · AI intelligence enriched Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TADLIQ is an oral suspension formulation of tadalafil, a phosphodiesterase 5 inhibitor approved by the FDA in June 2022 under sponsor Fosun Pharma. This small-molecule therapeutic works by inhibiting PDE5 to improve blood flow and is indicated for erectile dysfunction and pulmonary arterial hypertension depending on dosing. The suspension formulation offers an alternative delivery mechanism to traditional tablets, potentially improving patient adherence and accessibility.
$0.146MPart D
Peak12.3 years to LOEEarly-stage commercialization with minimal Medicare Part D penetration suggests a young product still building market awareness; brand teams will focus on practice building and formulary access.
Mechanism of Action
Phosphodiesterase 5 Inhibitors
Pharmacologic Class:
Phosphodiesterase 5 Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Actual Use Trial of Tadalafil 5 mg
Started Jan 2025
2,212 enrolled
Erectile Dysfunction
Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH
Started Apr 2024
126 enrolled
Chronic Obstructive Pulmonary DiseasePulmonary HypertensionDyspnea
Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction
Started Sep 2021
116 enrolled
Erectile Dysfunction
A Study of Macitentan/Tadalafil Combination Administered a Fixed-dose Combination Formulation Compared to the Reference Free Combination of Macitentan and Tadalafil
Started Apr 2021
18 enrolled
Healthy
A Study of Macitentan and Tadalafil as a Fixed Dose Combination and the Free Combination in Healthy Adult Participants
Started Jan 2020
62 enrolled
Healthy
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.