NDAORALTABLET
Approved
May 2009
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
ADCIRCA (tadalafil) by Eli Lilly and Company is phosphodiesterase 5 inhibitors [moa]. First approved in 2009.
Drug data last refreshed 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ADCIRCA (tadalafil) is an oral phosphodiesterase 5 (PDE5) inhibitor approved in 2009 for pulmonary arterial hypertension (PAH). It works by relaxing smooth muscle in blood vessels to improve blood flow and reduce workload on the heart. The drug is indicated for patients with PAH to delay disease progression and improve exercise capacity.
$0.029BPart D
LOE ApproachingProduct approaching loss of exclusivity with modest Part D spending (~$29M in 2023) suggests a smaller commercial footprint requiring focused market defense strategies.
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
2,250 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.