NDAORALTABLET1 Generic Approved
Approved
Nov 2003
Lifecycle
LOE Approaching
Competitive Pressure
45/100
Clinical Trials
20
Data completeness
6/8 — Strong
CIALIS (tadalafil) by Eli Lilly and Company is phosphodiesterase 5 inhibitors [moa]. Approved for phosphodiesterase 5 inhibitor [epc]. First approved in 2003.
Drug data last refreshed 3h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CIALIS (tadalafil) is an oral phosphodiesterase 5 (PDE5) inhibitor approved in 2003 for erectile dysfunction and benign prostatic hyperplasia. It works by relaxing smooth muscle and increasing blood flow to affected tissues. The drug is available in tablet form and represents a mature, well-established therapeutic option in the PDE5 inhibitor class.
$0.006BPart D
LOE ApproachingAs LOE approaches, the brand team is transitioning from growth-focused activities to life-cycle extension and cost-management strategies, likely with reduced headcount and budget reallocation.
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)
Master Study Protocol for the Cohort of the Specialist Network Stroke (SN Stroke)(Stroke-CORE)
Started Jul 2026
12,750 enrolled
Intracerebral HaemorrhagePaediatric StrokeStroke Acute+2 more
Boosting Referrals to Asthma Specialists for Patients Seen at the Emergency Room for an Asthma Exacerbation
Started Jul 2026
40 enrolled
Asthma AttackAsthma ControlAsthma Exacerbations+1 more
Assess Accuracy of Primary Care Asthma and COPD Diagnosis Using Oscillometry and FeNO vs Specialist Diagnosis
Started Dec 2025
600 enrolled
AsthmaCOPD
Actual Use Trial of Tadalafil 5 mg
Started Jan 2025
2,212 enrolled
Erectile Dysfunction
Impact of Dental Desensitization Facilitated by a Child Life Specialist Distress and Cooperation
Started Aug 2024
60 enrolled
DesensitizationDental AnxietyDental Care+2 more
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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.